VYVANSE- lisdexamfetamine dimesylate capsule VYVANSE- lisdexamfetamine dimesylate tablet, chewable

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LISDEXAMFETAMINE DIMESYLATE (UNII: SJT761GEGS) (LISDEXAMFETAMINE - UNII:H645GUL8KJ)
Available from:
Shire LLC
INN (International Name):
LISDEXAMFETAMINE DIMESYLATE
Composition:
LISDEXAMFETAMINE DIMESYLATE 10 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
VYVANSE® is indicated for the treatment of: - Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14.1)] - Moderate to Severe Binge Eating Disorder (BED) in adults [see Clinical Studies (14.2)] . Limitation of Use: VYVANSE is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of VYVANSE for the treatment of obesity have not been established [see Warnings and Precautions (5.2)] . VYVANSE is contraindicated in patients with: - Known hypersensitivity to amphetamine products or other ingredients of VYVANSE. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports [see Adverse Reactions (6.2)] . - Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensiv
Product summary:
Information for VYVANSE capsules: Information for VYVANSE chewable tablets: Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature, 20ºC to 25º C (68ºF to 77º F). Excursions permitted between 15ºC and 30º C (59 to 86º F) [see USP Controlled Room Temperature] . Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired VYVANSE by a medicine take-back program.
Authorization status:
New Drug Application
Authorization number:
59417-101-10, 59417-102-10, 59417-103-10, 59417-104-10, 59417-105-10, 59417-106-10, 59417-107-10, 59417-115-01, 59417-116-01, 59417-117-01, 59417-118-01, 59417-119-01, 59417-120-01

VYVANSE- lisdexamfetamine dimesylate tablet, chewable

Shire LLC

----------

MEDICATION GUIDE

VYVANSE® [Vi' - vans]

(lisdexamfetamine dimesylate) CII

Capsules and Chewable Tablets

What is the most important information I should know about VYVANSE?

VYVANSE is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep

VYVANSE in a safe place to prevent misuse and abuse. Selling or giving away VYVANSE may harm

others, and is against the law.

Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street

drugs.

VYVANSE is a stimulant medicine. Some people have had the following problems when taking stimulant

medicines such as VYVANSE:

Heart-related problems including:

sudden death in people who have heart problems or heart defects

sudden death, stroke and heart attack in adults

increased blood pressure and heart rate

Tell your doctor if you have any heart problems, heart defects, high blood pressure, or a family history of

these problems.

Your doctor should check you carefully for heart problems before starting VYVANSE.

Your doctor should check your blood pressure and heart rate regularly during treatment with VYVANSE.

Call your doctor right away if you have any signs of heart problems such as chest pain, shortness of breath,

or fainting while taking VYVANSE.

Mental (psychiatric) problems including:

In Children, Teenagers, and Adults:

new or worse behavior and thought problems

new or worse bipolar illness

In Children and Teenagers

new psychotic symptoms such as:

hearing voices

believing things that are not true

being suspicious

new manic symptoms

Tell your doctor about any mental problems you have or if you have a family history of suicide, bipolar

illness, or depression.

Call your doctor right away if you have any new or worsening mental symptoms or problems while taking

VYVANSE, especially:

seeing or hearing things that are not real

believing things that are not real

being suspicious

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]:

Fingers or toes may feel numb, cool, painful

Fingers or toes may change color from pale, to blue, to red

Tell your doctor if you have numbness, pain, skin color change, or sensitivity to temperature in your fingers

or toes.

Call your doctor right away if you have any signs of unexplained wounds appearing on fingers or toes while

taking VYVANSE.

What is VYVANSE?

VYVANSE is a central nervous system stimulant prescription medicine used to treat:

Attention-Deficit/Hyperactivity Disorder (ADHD). VYVANSE may help increase attention and

decrease impulsiveness and hyperactivity in patients with ADHD.

Binge Eating Disorder (BED). VYVANSE may help reduce the number of binge eating days in

patients with BED.

VYVANSE is not for weight loss. It is not known if VYVANSE is safe and effective for the treatment of

obesity.

It is not known if VYVANSE is safe and effective in children with ADHD under 6 years of age or in

patients with BED under 18 years of age.

Do not take VYVANSE if you:

are taking or have taken within the past 14 days an anti-depression medicine called a monoamine

oxidase inhibitor or MAOI.

are sensitive to, allergic to, or had a reaction to other stimulant medicines.

Before you take VYVANSE, tell your doctor if you have or if there is a family history of:

heart problems, heart defects, high blood pressure

mental problems including psychosis, mania, bipolar illness, or depression

circulation problems in fingers and toes

Tell your doctor if:

you have any kidney problems. Your doctor may lower your dose.

you are pregnant or plan to become pregnant. It is not known if VYVANSE may harm your unborn

baby.

you are breastfeeding or plan to breastfeed. VYVANSE can pass into your milk. Do not breastfeed

while taking VYVANSE. Talk to your doctor about the best way to feed your baby if you take

VYVANSE.

Tell your doctor about all of the medicines that you take, including prescription and over-the-counter

medicines, vitamins, and herbal supplements.

VYVANSE can affect the way other medicines work, and other medicines may affect how VYVANSE

works. Using VYVANSE with other medicines can cause serious side effects.

Especially tell your doctor if you take anti-depression medicines including MAOIs.

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a

new medicine.

Do not start any new medicine while taking VYVANSE without talking to your doctor first.

How should I take VYVANSE?

Take VYVANSE exactly as your doctor tells you to take it.

Your doctor may change your dose until it is right for you.

Take VYVANSE 1 time each day in the morning.

VYVANSE can be taken with or without food.

VYVANSE comes in capsules or chewable tablets.

Capsules:

VYVANSE capsules may be swallowed whole.

If you have trouble swallowing capsules, open your VYVANSE capsule and pour all the

powder into yogurt, water, or orange juice.

Use all of the VYVANSE powder from the capsule so you get all of the medicine.

Using a spoon, break apart any powder that is stuck together. Stir the VYVANSE

powder and yogurt, water or orange juice until they are completely mixed together.

Eat all the yogurt or drink all the water or orange juice right away after it has been

mixed with VYVANSE. Do not store the yogurt, water, or orange juice after it has

been mixed with VYVANSE. It is normal to see a filmy coating on the inside of

your glass or container after you eat or drink all the VYVANSE.

Chewable Tablets:

VYVANSE chewable tablets must be completely chewed before swallowing.

Your doctor may sometimes stop VYVANSE treatment for a while to check your ADHD or your

BED symptoms.

Your doctor may do regular checks of your heart, and blood pressure while taking VYVANSE.

Children should have their height and weight checked often while taking VYVANSE. VYVANSE

treatment may be stopped if a problem is found during these check-ups.

If you take too much VYVANSE, call your doctor or poison control center (1-800-222-1222) right away, or

get to the nearest hospital emergency room.

What should I avoid while taking VYVANSE?

Do not drive, operate machinery, or do other dangerous activities until you know how VYVANSE affects

you.

What are the possible side effects of VYVANSE?

VYVANSE may cause serious side effects, including:

See "What is the most important information I should know about VYVANSE?"

slowing of growth (height and weight) in children

The most common side effects of VYVANSE in ADHD include:

anxiety

dry mouth

trouble sleeping

decreased

appetite

irritability

upper stomach

pain

diarrhea

loss of appetite

vomiting

dizziness

nausea

weight loss

The most common side effects of VYVANSE in BED include:

dry mouth

constipation

trouble sleeping

feeling jittery

decreased

appetite

anxiety

increased heart

rate

Talk to your doctor if you have any side effects that bother you or do not go away.

These are not all the possible side effects of VYVANSE. For more information ask your doctor or

pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-

1088.

How should I store VYVANSE?

Store VYVANSE at room temperature, 68°F to 77°F (20°C to 25°C).

Protect VYVANSE from light.

Store VYVANSE in a safe place, like a locked cabinet.

Do not throw away unused VYVANSE in your household trash as it may harm other people or

animals. Ask your doctor or pharmacist about a medicine take-back program in your community.

Keep VYVANSE and all medicines out of the reach of children.

General information about the safe and effective use of VYVANSE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use

VYVANSE for a condition for which it was not prescribed. Do not give VYVANSE to other people, even if

they have the same symptoms that you have. It may harm them and it is against the law. If you would like

more information, talk with your doctor. You can ask your pharmacist or healthcare provider for information

about VYVANSE that is written for health professionals.

What are the ingredients in VYVANSE?

Active ingredient: lisdexamfetamine dimesylate

Capsule Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.

The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of the

following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide.

Chewable Tablet Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, guar gum,

magnesium stearate, mannitol, microcrystalline cellulose, sucralose, artificial strawberry flavor.

Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421. VYVANSE® is a registered

trademark of Shire LLC. © 2017 Shire US Inc.

For more information, go to www.vyvanse.com or call 1-800-828-2088.

This Medication Guide has been approved by the U.S. Food and Drug

Administration

Revised: JAN 2017

Revised: 10/2019

Document Id: d2aa8390-b739-4621-abff-bd18bf342f65

34391-3

Set id: 704e4378-ca83-445c-8b45-3cfa51c1ecad

Version: 65

Effective Time: 20191030

Shire LLC

VYVANSE- lisdexamfetamine dimesylate capsule

VYVANSE- lisdexamfetamine dimesylate tablet, chewable

Shire LLC

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use VYVANSE safely and effectively. See full

prescribing information for VYVANSE.

VYVANSE

(lisdexamfetamine dimesylate) capsules, for oral use, CII

VYVANSE

(lisdexamfetamine dimesylate) chewable tablets, for oral use, CII

Initial U.S. Approval: 2007

WARNING: ABUSE AND DEPENDENCE

See full prescribing information for complete boxed warning.

CNS stimulants (amphetamines and methylphenidate-containing products), including VYVANSE, have

a high potential for abuse and dependence (5.1, 9.2, 9.3)

Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on

therapy (5.1, 9.2)

RECENT MAJOR CHANGES

Dosage and Administration (2.2)

01/2017

Contraindications (4)

01/2017

Warnings and Precautions (5.7)

01/2017

INDICATIONS AND USAGE

VYVANSE is a central nervous system (CNS) stimulant indicated for the treatment of (1):

Attention Deficit Hyperactivity Disorder (ADHD)

Moderate to Severe Binge Eating Disorder (BED) in adults

Limitation of Use: VYVANSE is not indicated for weight loss. Use of other sympathomimetic drugs for weight loss has

been associated with serious cardiovascular adverse events. The safety and effectiveness of VYVANSE for the treatment

of obesity have not been established.

DOSAGE AND ADMINISTRATION

Indic atio n

Initial Dose

T itratio n

Sc he dule

Recommended Dose

Maximum Dose

ADHD (Adult and Pediatric

patients) (2.2)

30 mg every morning

10 mg or 20 mg

we e kly

30 mg to 70 mg per day

70 mg per day

BED (Adult patients) (2.3)

30 mg every morning

20 mg weekly

50 mg to 70 mg per day

70 mg per day

Prior to treatment, assess for presence of cardiac disease (2.4)

Severe renal impairment: Maximum dose is 50 mg/day (2.5)

End stage renal disease (ESRD): Maximum dose is 30 mg/day (2.5)

DOSAGE FORMS AND STRENGTHS

Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg (3)

Chewable tablets: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg (3)

CONTRAINDICATIONS

Known hypersensitivity to amphetamine products or other ingredients in VYVANSE (4)

Use with monoamine oxidase (MAO) inhibitor, or within 14 days of the last MAO inhibitor dose (4, 7.2)

WARNINGS AND PRECAUTIONS

Serious Cardiovascular Reactions: Sudden death has been reported in association with CNS stimulant treatment at

recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In

®

®

adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural

cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, or coronary artery disease (5.2)

Blood Pressure and Heart Rate Increases: Monitor blood pressure and pulse. Consider benefits and risks before use in

patients for whom blood pressure increases may be problematic (5.3)

Psychiatric Adverse Reactions: May cause psychotic or manic symptoms in patients with no prior history, or

exacerbation of symptoms in patients with pre-existing psychosis. Evaluate for bipolar disorder prior to stimulant use

(5.4)

Suppression of Growth: Monitor height and weight in pediatric patients during treatment (5.5)

Peripheral Vasculopathy, including Raynaud's phenomenon: Stimulants are associated with peripheral vasculopathy,

including Raynaud's phenomenon. Careful observation for digital changes is necessary during treatment with stimulants

(5.6)

Serotonin Syndrome: Increased risk when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but

also during overdosage situations. If it occurs, discontinue VYVANSE and initiate supportive treatment (4, 5.7, 10).

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) in children, adolescents, and/or adults

with ADHD were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability,

insomnia, nausea, upper abdominal pain, and vomiting (6.1)

Most common adverse reactions (incidence ≥ 5% and at a rate at least twice placebo) in adults with BED were dry mouth,

insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Shire US Inc. at 1-800-828-2088 or FDA at 1-800-FDA-

1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Acidifying and Alkalinizing Agents: Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents

decrease amphetamine blood levels, while alkalinizing agents increase amphetamine blood levels. Adjust VYVANSE

dosage accordingly (2.6, 7.1)

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm (8.1)

Lactation: Breastfeeding not recommended (8.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 1/2018

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: ABUSE AND DEPENDENCE

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Pre-treatment Screening

2.2 General Instructions for Use

2.3 Dosage for Treatment of ADHD

2.4 Dosage for Treatment of Moderate to Severe BED in Adults

2.5 Dosage in Patients with Renal Impairment

2.6 Dosage Modifications due to Drug Interactions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Potential for Abuse and Dependence

5.2 Serious Cardiovascular Reactions

5.3 Blood Pressure and Heart Rate Increases

5.4 Psychiatric Adverse Reactions

5.5 Suppression of Growth

5.6 Peripheral Vasculopathy, including Raynaud's Phenomenon

5.7 Serotonin Syndrome

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Drugs Having Clinically Important Interactions with Amphetamines

7.2 Drugs Having No Clinically Important Interactions with VYVANSE

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Gender

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

9.3 Dependence

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Attention Deficit Hyperactivity Disorder (ADHD)

14.2 Binge Eating Disorder (BED)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage and Handling

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants (amphetamines and methylphenidate-containing products), including

VYVANSE, have a high potential for abuse and dependence. Assess the risk of abuse prior

to prescribing and monitor for signs of abuse and dependence while on therapy [see

Warnings and Precautions (5.1, 5.2), and Drug Abuse and Dependence (9.2, 9.3)].

1 INDICATIONS AND USAGE

VYVANSE is indicated for the treatment of:

Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14.1)]

Moderate to Severe Binge Eating Disorder (BED) in adults [see Clinical Studies (14.2)].

Sections or subsections omitted from the full prescribing information are not listed.

Limitation of Use:

VYVANSE is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for

weight loss has been associated with serious cardiovascular adverse events. The safety and

effectiveness of VYVANSE for the treatment of obesity have not been established [see Warnings and

Precautions (5.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Pre-treatment Screening

Prior to treating children, adolescents, and adults with CNS stimulants, including VYVANSE, assess for

the presence of cardiac disease (e.g., a careful history, family history of sudden death or ventricular

arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].

To reduce the abuse of CNS stimulants including VYVANSE, assess the risk of abuse, prior to

prescribing. After prescribing, keep careful prescription records, educate patients about abuse, monitor

for signs of abuse and overdose, and re-evaluate the need for VYVANSE use [see Warnings and

Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)].

2.2 General Instructions for Use

Take VYVANSE by mouth in the morning with or without food; avoid afternoon doses because of the

potential for insomnia. VYVANSE may be administered in one of the following ways:

Information for VYVANSE capsules:

Swallow VYVANSE capsules whole, or

Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. If the contents

of the capsule include any compacted powder, a spoon may be used to break apart the powder. The

contents should be mixed until completely dispersed. Consume the entire mixture immediately. It

should not be stored. The active ingredient dissolves completely once dispersed; however, a film

containing the inactive ingredients may remain in the glass or container once the mixture is

consumed.

Information for VYVANSE chewable tablets:

VYVANSE chewable tablets must be chewed thoroughly before swallowing.

VYVANSE capsules can be substituted with VYVANSE chewable tablets on a unit per unit/ mg per mg

basis (for example, 30 mg capsules for 30 mg chewable tablet) [see Clinical Pharmacology (12.3)].

Do not take anything less than one capsule or chewable tablet per day. A single dose should not be

divided.

2.3 Dosage for Treatment of ADHD

The recommended starting dose is 30 mg once daily in the morning in patients ages 6 and above.

Dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals up to

maximum dose of 70 mg/day [see Clinical Studies (14.1)].

2.4 Dosage for Treatment of Moderate to Severe BED in Adults

The recommended starting dose is 30 mg/day to be titrated in increments of 20 mg at approximately

weekly intervals to achieve the recommended target dose of 50 to 70 mg/day. The maximum dose is 70

mg/day [see Clinical Studies (14.2)]. Discontinue VYVANSE if binge eating does not improve.

2.5 Dosage in Patients with Renal Impairment

In patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m ), the maximum dose should not

exceed 50 mg/day. In patients with end stage renal disease (ESRD, GFR < 15 mL/min/1.73 m ), the

maximum recommended dose is 30 mg/day [see Use in Specific Populations (8.6)].

2.6 Dosage Modifications due to Drug Interactions

Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine.

Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium

bicarbonate) increase blood levels. Adjust VYVANSE dosage accordingly [see Drug Interactions (7.1)].

3 DOSAGE FORMS AND STRENGTHS

Information for VYVANSE capsules:

Capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg)

Capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg)

Capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg)

Capsules 40 mg: white body/blue green cap (imprinted with S489 and 40 mg)

Capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg)

Capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg)

Capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg)

Information for VYVANSE chewable tablets:

Chewable tablets 10 mg: White to off-white round shaped tablet debossed with '10' on one side and

'S489' on the other

Chewable tablets 20 mg: White to off-white hexagonal shaped tablet debossed with '20' on one side

and 'S489' on the other

Chewable tablets 30 mg: White to off-white arc triangular shaped tablet debossed with '30' on one

side and 'S489' on the other

Chewable tablets 40 mg: White to off-white capsule shaped tablet debossed with '40' on one side

and 'S489' on the other

Chewable tablets 50 mg: White to off-white arc square shaped tablet debossed with '50' on one side

and 'S489' on the other

Chewable tablets 60 mg: White to off-white arc diamond shaped tablet debossed with '60' on one

side and 'S489' on the other

4 CONTRAINDICATIONS

VYVANSE is contraindicated in patients with:

Known hypersensitivity to amphetamine products or other ingredients of VYVANSE. Anaphylactic

reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in

postmarketing reports [see Adverse Reactions (6.2)].

Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs

(including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of

hypertensive crisis [see Warnings and Precautions (5.7) and Drug Interactions (7.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Potential for Abuse and Dependence

CNS stimulants (amphetamines and methylphenidate-containing products), including VYVANSE, have a

high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for

signs of abuse and dependence while on therapy [see Drug Abuse and Dependence (9.2, 9.3)].

5.2 Serious Cardiovascular Reactions

Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant

treatment at recommended doses. Sudden death has been reported in children and adolescents with

structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended

doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy,

serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate

patients who develop exertional chest pain, unexplained syncope, or arrhythmias during VYVANSE

treatment.

5.3 Blood Pressure and Heart Rate Increases

CNS stimulants cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate

(mean increase about 3-6 bpm). Monitor all patients for potential tachycardia and hypertension.

5.4 Psychiatric Adverse Reactions

Exacerbation of Pre-existing Psychosis

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with

a pre-existing psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disorder

CNS stimulants may induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating

treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of

depressive symptoms or a family history of suicide, bipolar disorder, and depression).

New Psychotic or Manic Symptoms

CNS stimulants, at recommended doses, may cause psychotic or manic symptoms, e.g. hallucinations,

delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or

mania. If such symptoms occur, consider discontinuing VYVANSE. In a pooled analysis of multiple

short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in

0.1% of CNS stimulant-treated patients compared to 0% in placebo-treated patients.

5.5 Suppression of Growth

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.

Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including

VYVANSE. In a 4-week, placebo-controlled trial of VYVANSE in patients ages 6 to 12 years old with

ADHD, there was a dose-related decrease in weight in the VYVANSE groups compared to weight gain

in the placebo group. Additionally, in studies of another stimulant, there was slowing of the increase in

height [see Adverse Reactions (6.1)].

5.6 Peripheral Vasculopathy, including Raynaud's Phenomenon

Stimulants, including VYVANSE, are associated with peripheral vasculopathy, including Raynaud's

phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include

digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's

phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all

age groups throughout the course of treatment. Signs and symptoms generally improve after reduction

in dose or discontinuation of drug. Careful observation for digital changes is necessary during

treatment with stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate

for certain patients.

5.7 Serotonin Syndrome

Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in

combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine

oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine

reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan,

buspirone, and St. John's Wort [see Drug Interactions (7.1)]. Amphetamines and amphetamine derivatives

are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor

inhibition of CYP2D6 metabolism [see Clinical Pharmacology 12.3]. The potential for a pharmacokinetic

interaction exists with the co-administration of CYP2D6 inhibitors which may increase the risk with

increased exposure to the active metabolite of VYVANSE (dextroamphetamine). In these situations,

consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see

Drug Interactions (7.1)]. Serotonin syndrome symptoms may include mental status changes (e.g.,

agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood

pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor,

rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g.,

nausea, vomiting, diarrhea).

Concomitant use of VYVANSE with MAOI drugs is contraindicated [see Contraindications (4)].

Discontinue treatment with VYVANSE and any concomitant serotonergic agents immediately if

symptoms of serotonin syndrome occur, and initiate supportive symptomatic treatment. Concomitant use

of VYVANSE with other serotonergic drugs or CYP2D6 inhibitors should be used only if the potential

benefit justifies the potential risk. If clinically warranted, consider initiating VYVANSE with lower

doses, monitoring patients for the emergence of serotonin syndrome during drug initiation or titration,

and informing patients of the increased risk for serotonin syndrome.

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

Known hypersensitivity to amphetamine products or other ingredients of VYVANSE [see

Contraindications (4)]

Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see

Contraindications (4) and Drug Interactions (7.1)]

Drug Dependence [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and

Dependence (9.2, 9.3)]

Serious Cardiovascular Reactions [see Warnings and Precautions (5.2)]

Blood Pressure and Heart Rate Increases [see Warnings and Precautions (5.3)]

Psychiatric Adverse Reactions [see Warnings and Precautions (5.4)]

Suppression of Growth [see Warnings and Precautions (5.5)]

Peripheral Vasculopathy, including Raynaud's phenomenon [see Warnings and Precautions (5.6)]

Serotonin Syndrome [see Warnings and Precautions (5.7)]

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed

in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug

and may not reflect the rates observed in practice.

Attention Deficit Hyperactivity Disorder

The safety data in this section is based on data from the 4-week parallel-group controlled clinical

studies of VYVANSE in pediatric and adult patients with ADHD [see Clinical Studies (14.1)].

Adverse Reactions Associated with Discontinuation of Treatment in ADHD Clinical Trials

In the controlled trial in patients ages 6 to 12 years (Study 1), 8% (18/218) of VYVANSE-treated

patients discontinued due to adverse reactions compared to 0% (0/72) of placebo-treated patients. The

most frequently reported adverse reactions (1% or more and twice rate of placebo) were ECG voltage

criteria for ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, decreased

appetite and rash [2 instances for each adverse reaction, i.e., 2/218 (1%)]. Less frequently reported

adverse reactions (less than 1% or less than twice rate of placebo) included abdominal pain upper, dry

mouth, weight decreased, dizziness, somnolence, logorrhea, chest pain, anger and hypertension.

In the controlled trial in patients ages 13 to 17 years (Study 4), 3% (7/233) of VYVANSE-treated

patients discontinued due to adverse reactions compared to 1% (1/77) of placebo-treated patients. The

most frequently reported adverse reactions (1% or more and twice rate of placebo) were decreased

appetite (2/233; 1%) and insomnia (2/233; 1%). Less frequently reported adverse reactions (less than 1%

or less than twice rate of placebo) included irritability, dermatillomania, mood swings, and dyspnea.

In the controlled adult trial (Study 7), 6% (21/358) of VYVANSE-treated patients discontinued due to

adverse reactions compared to 2% (1/62) of placebo-treated patients. The most frequently reported

adverse reactions (1% or more and twice rate of placebo) were insomnia (8/358; 2%), tachycardia

(3/358; 1%), irritability (2/358; 1%), hypertension (4/358; 1%), headache (2/358; 1%), anxiety (2/358;

1%), and dyspnea (3/358; 1%). Less frequently reported adverse reactions (less than 1% or less than

twice rate of placebo) included palpitations, diarrhea, nausea, decreased appetite, dizziness, agitation,

depression, paranoia and restlessness.

Adverse Reactions Occurring at an Incidence of ≥5% or More Among VYVANSE Treated Patients with

ADHD in Clinical Trials

The most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) reported in

children, adolescents, and/or adults were anorexia, anxiety, decreased appetite, decreased weight,

diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting.

Adverse Reactions Occurring at an Incidence of 2% or More Among VYVANSE Treated Patients with

ADHD in Clinical Trials

Adverse reactions reported in the controlled trials in pediatric patients ages 6 to 12 years (Study 1),

adolescent patients ages 13 to 17 years (Study 4), and adult patients (Study 7) treated with VYVANSE or

placebo are presented in Tables 1, 2, and 3 below.

Table 1 Adverse Reactions Reported by 2% or

More of Children (Ages 6 to 12 Years) with

ADHD Taking VYVANSE and at least Twice the

Incidence in Patients Taking Placebo in a 4-

Week Clinical Trial (Study 1)

VYVANSE

(n=218)

Placebo

(n=72)

Decreased Appetite

Insomnia

Abdominal Pain Upper

Irritability

Vomiting

Weight Decreased

Nausea

Dry Mouth

Dizziness

Affect lability

Rash

Pyrexia

Somnolence

Anorexia

Table 2 Adverse Reactions Reported by 2% or

More of Adolescent (Ages 13 to 17 Years)

Patients with ADHD Taking VYVANSE and at

least Twice the Incidence in Patients Taking

Placebo in a 4-Week Clinical Trial (Study 4)

VYVANSE

(n=233)

Placebo

(n=77)

Decreased Appetite

Insomnia

Weight Decreased

Dry Mouth

Palpitations

Anorexia

Tremor

Table 3 Adverse Reactions Reported by 2% or

More of Adult Patients with ADHD Taking

VYVANSE and at least Twice the Incidence in

Patients Taking Placebo in a 4-Week Clinical

Trial (Study 7)

VYVANSE

(n=358)

Placebo

(n=62)

Decreased Appetite

Insomnia

Dry Mouth

Diarrhea

Nausea

Anxiety

Anorexia

Feeling Jittery

Agitation

Increased Blood

Pressure

Hyperhidrosis

Restlessness

Decreased Weight

Dyspnea

Increased Heart Rate

Tremor

Palpitations

In addition, in the adult population erectile dysfunction was observed in 2.6% of males on VYVANSE

and 0% on placebo; decreased libido was observed in 1.4% of subjects on VYVANSE and 0% on

placebo.

Weight Loss and Slowing Growth Rate in Pediatric Patients with ADHD

In a controlled trial of VYVANSE in children ages 6 to 12 years (Study 1), mean weight loss from

baseline after 4 weeks of therapy was -0.9, -1.9, and -2.5 pounds, respectively, for patients receiving

30 mg, 50 mg, and 70 mg of VYVANSE, compared to a 1 pound weight gain for patients receiving

placebo. Higher doses were associated with greater weight loss with 4 weeks of treatment. Careful

follow-up for weight in children ages 6 to 12 years who received VYVANSE over 12 months suggests

that consistently medicated children (i.e. treatment for 7 days per week throughout the year) have a

slowing in growth rate, measured by body weight as demonstrated by an age- and sex-normalized mean

change from baseline in percentile, of -13.4 over 1 year (average percentiles at baseline and 12 months

were 60.9 and 47.2, respectively). In a 4-week controlled trial of VYVANSE in adolescents ages 13 to

17 years, mean weight loss from baseline to endpoint was -2.7, -4.3, and -4.8 lbs., respectively, for

patients receiving 30 mg, 50 mg, and 70 mg of VYVANSE, compared to a 2.0 pound weight gain for

patients receiving placebo.

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either

methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic

subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the

ages of 10 to 13 years), suggests that consistently medicated children (i.e. treatment for 7 days per week

throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less

growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound

during this period of development. In a controlled trial of amphetamine (d- to l-enantiomer ratio of 3:1)

in adolescents, mean weight change from baseline within the initial 4 weeks of therapy was -1.1 pounds

and -2.8 pounds, respectively, for patients receiving 10 mg and 20 mg of amphetamine. Higher doses

were associated with greater weight loss within the initial 4 weeks of treatment [see Warnings and

Precautions (5.5)].

Weight Loss in Adults with ADHD

In the controlled adult trial (Study 7), mean weight loss after 4 weeks of therapy was 2.8 pounds, 3.1

pounds, and 4.3 pounds, for patients receiving final doses of 30 mg, 50 mg, and 70 mg of VYVANSE,

respectively, compared to a mean weight gain of 0.5 pounds for patients receiving placebo.

Binge Eating Disorder

The safety data in this section is based on data from two 12 week parallel group, flexible-dose,

placebo-controlled studies in adults with BED [see Clinical Studies 14.2]. Patients with cardiovascular

risk factors other than obesity and smoking were excluded.

Adverse Reactions Associated with Discontinuation of Treatment in BED Clinical Trials

In controlled trials of patients ages 18 to 55 years, 5.1% (19/373) of VYVANSE-treated patients

discontinued due to adverse reactions compared to 2.4% (9/372) of placebo-treated patients. No single

adverse reaction led to discontinuation in 1% or more of VYVANSE-treated patients. Less commonly

reported adverse reactions (less than 1% or less than twice rate of placebo) included increased heart

rate, headache, abdominal pain upper, dyspnea, rash, insomnia, irritability, feeling jittery and anxiety.

Adverse Reactions Occurring at an Incidence of ≥5% or More Among VYVANSE Treated Patients with BED

in Clinical Trials

The most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) reported in

adults were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery,

and anxiety.

Adverse Reactions Occurring at an Incidence of 2% or More Among VYVANSE Treated Patients with BED

in Clinical Trials

Adverse reactions reported in the pooled controlled trials in adult patients (Study 11 and 12) treated with

VYVANSE or placebo are presented in Table 4 below.

Table 4 Adverse Reactions Reported by 2% or More

of Adult Patients with BED Taking VYVANSE and at

least Twice the Incidence in Patients Taking Placebo

in 12-Week Clinical Trials (Study 11 and 12)

VYVANSE

(N=373)

Placebo

(N=372)

Dry Mouth

Insomnia

Decreased Appetite

Increased Heart Rate

Feeling Jittery

Constipation

Anxiety

Diarrhea

Decreased Weight

Hyperhidrosis

Vomiting

Gastroenteritis

Paresthesia

Pruritus

Upper Abdominal Pain

Energy Increased

Urinary Tract Infection

Nightmare

Restlessness

Oropharyngeal Pain

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of VYVANSE. Because

these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably

estimate their frequency or establish a causal relationship to drug exposure. These events are as

follows: cardiomyopathy, mydriasis, diplopia, difficulties with visual accommodation, blurred vision,

eosinophilic hepatitis, anaphylactic reaction, hypersensitivity, dyskinesia, dysgeusia, tics, bruxism,

depression, dermatillomania, alopecia, aggression, Stevens-Johnson Syndrome, chest pain, angioedema,

urticaria, seizures, libido changes, frequent or prolonged erections, constipation, and rhabdomyolysis.

7 DRUG INTERACTIONS

7.1 Drugs Having Clinically Important Interactions with Amphetamines

Table 5 Drugs having clinically important interactions with amphetamines.

MAO Inhibitors (MAOI)

Clinical Impact

MAOI antidepressants slow amphetamine metabolism, increasing

amphetamines effect on the release of norepinephrine and other

monoamines from adrenergic nerve endings causing headaches and

other signs of hypertensive crisis. Toxic neurological effects and

malignant hyperpyrexia can occur, sometimes with fatal results.

Intervention

Do not administer VYVANSE during or within 14 days following the

Includes all preferred terms containing the word "insomnia."

Includes the preferred terms "heart rate increased" and

"tachycardia."

Intervention

administration of MAOI [see Contraindications (4)].

Examples

selegiline, isocarboxazid, phenelzine, tranylcypromine

Serotonergic Drugs

Clinical Impact

The concomitant use of VYVANSE and serotonergic drugs increases

the risk of serotonin syndrome.

Intervention

Initiate with lower doses and monitor patients for signs and symptoms of

serotonin syndrome, particularly during VYVANSE initiation or dosage

increase. If serotonin syndrome occurs, discontinue VYVANSE and the

concomitant serotonergic drug(s) [see Warnings and Precautions (5.7)].

Examples

selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine

reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl,

lithium, tramadol, tryptophan, buspirone, St. John's Wort

CYP2D6 Inhibitors

Clinical Impact

The concomitant use of VYVANSE and CYP2D6 inhibitors may

increase the exposure of dextroamphetamine, the active metabolite of

VYVANSE compared to the use of the drug alone and increase the risk

of serotonin syndrome.

Intervention

Initiate with lower doses and monitor patients for signs and symptoms of

serotonin syndrome particularly during VYVANSE initiation and after a

dosage increase. If serotonin syndrome occurs, discontinue VYVANSE

and the CYP2D6 inhibitor [see Warnings and Precautions (5.7) and

Overdosage (10)].

Examples

paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir

Alkalinizing Agents

Clinical Impact

Urinary alkalinizing agents can increase blood levels and potentiate the

action of amphetamine.

Intervention

Co-administration of VYVANSE and urinary alkalinizing agents should

be avoided.

Examples

Urinary alkalinizing agents (e.g. acetazolamide, some thiazides).

Acidifying Agents

Clinical Impact

Urinary acidifying agents can lower blood levels and efficacy of

amphetamines.

Intervention

Increase dose based on clinical response.

Examples

Urinary acidifying agents (e.g., ammonium chloride, sodium acid

phosphate, methenamine salts).

Tricyclic Antidepressants

Clinical Impact

May enhance the activity of tricyclic or sympathomimetic agents causing

striking and sustained increases in the concentration of d-amphetamine in

the brain; cardiovascular effects can be potentiated.

Intervention

Monitor frequently and adjust or use alternative therapy based on

clinical response.

Examples

desipramine, protriptyline

7.2 Drugs Having No Clinically Important Interactions with VYVANSE

From a pharmacokinetic perspective, no dose adjustment of VYVANSE is necessary when VYVANSE

is co-administered with guanfacine, venlafaxine, or omeprazole. In addition, no dose adjustment of

guanfacine or venlafaxine is needed when VYVANSE is co-administered [see Clinical Pharmacology

(12.3)].

From a pharmacokinetic perspective, no dose adjustment for drugs that are substrates of CYP1A2 (e.g.

theophylline, duloxetine, melatonin), CYP2D6 (e.g. atomoxetine, desipramine, venlafaxine), CYP2C19

(e.g. omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g. midazolam, pimozide, simvastatin) is

necessary when VYVANSE is co-administered [see Clinical Pharmacology (12.3)].

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

The limited available data from published literature and postmarketing reports on use of VYVANSE in

pregnant women are not sufficient to inform a drug-associated risk for major birth defects and

miscarriage. Adverse pregnancy outcomes, including premature delivery and low birth weight, have

been seen in infants born to mothers dependent on amphetamines [see Clinical Considerations]. In animal

reproduction studies, lisdexamfetamine dimesylate (a prodrug of d-amphetamine) had no effects on

embryo-fetal morphological development or survival when administered orally to pregnant rats and

rabbits throughout the period of organogenesis. Pre- and postnatal studies were not conducted with

lisdexamfetamine dimesylate. However, amphetamine (d- to l- ratio of 3:1) administration to pregnant

rats during gestation and lactation caused a decrease in pup survival and a decrease in pup body weight

that correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine. In

addition, adverse effects on reproductive performance were observed in pups whose mothers were

treated with amphetamine. Long-term neurochemical and behavioral effects have also been reported in

animal developmental studies using clinically relevant doses of amphetamine [see Data].

The estimated background risk of major birth defects and miscarriage for the indicated population is

unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the

U.S. general population, the estimated background risk of major birth defects and miscarriage in

clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

Amphetamines, such as VYVANSE, cause vasoconstriction and thereby may decrease placental

perfusion. In addition, amphetamines can stimulate uterine contractions increasing the risk of premature

delivery. Infants born to amphetamine-dependent mothers have an increased risk of premature delivery

and low birth weight.

Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding

difficulties, irritability, agitation, and excessive drowsiness.

Data

Animal Data

Lisdexamfetamine dimesylate had no apparent effects on embryo-fetal morphological development or

survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis at

doses of up to 40 and 120 mg/kg/day, respectively. These doses are approximately 4 and 27 times,

respectively, the maximum recommended human dose (MRHD) of 70 mg/day given to adolescents, on a

mg/m body surface area basis.

A study was conducted with amphetamine (d- to l- enantiomer ratio of 3:1) in which pregnant rats

received daily oral doses of 2, 6, and 10 mg/kg from gestation day 6 to lactation day 20. These doses

are approximately 0.8, 2, and 4 times the MRHD of amphetamine (d- to l- ratio of 3:1) for adolescents of

20 mg/day, on a mg/m basis. All doses caused hyperactivity and decreased weight gain in the dams. A

decrease in pup survival was seen at all doses. A decrease in pup body weight was seen at 6 and 10

mg/kg which correlated with delays in developmental landmarks, such as preputial separation and

vaginal opening. Increased pup locomotor activity was seen at 10 mg/kg on day 22 postpartum but not at

5 weeks postweaning. When pups were tested for reproductive performance at maturation, gestational

5 weeks postweaning. When pups were tested for reproductive performance at maturation, gestational

weight gain, number of implantations, and number of delivered pups were decreased in the group whose

mothers had been given 10 mg/kg.

A number of studies from the literature in rodents indicate that prenatal or early postnatal exposure to

amphetamine (d- or d,l-) at doses similar to those used clinically can result in long-term neurochemical

and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered

locomotor activity, and changes in sexual function.

8.2 Lactation

Risk Summary

Lisdexamfetamine is a pro-drug of dextroamphetamine. Based on limited case reports in published

literature, amphetamine (d-or d, l-) is present in human milk, at relative infant doses of 2% to 13.8% of

the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.9 and 7.5. There are no

reports of adverse effects on the breastfed infant. Long-term neurodevelopmental effects on infants

from amphetamine exposure are unknown. It is possible that large dosages of dextroamphetamine might

interfere with milk production, especially in women whose lactation is not well established. Because of

the potential for serious adverse reactions in nursing infants, including serious cardiovascular

reactions, blood pressure and heart rate increase, suppression of growth, and peripheral vasculopathy,

advise patients that breastfeeding is not recommended during treatment with VYVANSE.

8.4 Pediatric Use

ADHD

Safety and effectiveness have been established in pediatric patients with ADHD ages 6 to 17 years [see

Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1)]. Safety and efficacy in

pediatric patients below the age of 6 years have not been established.

Safety and effectiveness in patients less than 18 years of age have not been established.

Growth Suppression

Growth should be monitored during treatment with stimulants, including VYVANSE, and children who

are not growing or gaining weight as expected may need to have their treatment interrupted [see

Warnings and Precautions (5.5), Adverse Reactions (6.1)].

Juvenile Animal Data

Studies conducted in juvenile rats and dogs at clinically relevant doses showed growth suppression that

partially or fully reversed in dogs and female rats but not in male rats after a four-week drug-free

recovery period.

A study was conducted in which juvenile rats received oral doses of 4, 10, or 40 mg/kg/day of

lisdexamfetamine dimesylate from day 7 to day 63 of age. These doses are approximately 0.3, 0.7, and 3

times the maximum recommended human daily dose of 70 mg on a mg/m basis for a child. Dose-related

decreases in food consumption, bodyweight gain, and crown-rump length were seen; after a four-week

drug-free recovery period, bodyweights and crown-rump lengths had significantly recovered in

females but were still substantially reduced in males. Time to vaginal opening was delayed in females at

the highest dose, but there were no drug effects on fertility when the animals were mated beginning on

day 85 of age.

In a study in which juvenile dogs received lisdexamfetamine dimesylate for 6 months beginning at 10

weeks of age, decreased bodyweight gain was seen at all doses tested (2, 5, and 12 mg/kg/day, which

are approximately 0.5, 1, and 3 times the maximum recommended human daily dose on a mg/m basis for

a child). This effect partially or fully reversed during a four-week drug-free recovery period.

8.5 Geriatric Use

Clinical studies of VYVANSE did not include sufficient numbers of subjects aged 65 and over to

determine whether they respond differently from younger subjects. Other reported clinical experience

and pharmacokinetic data [see Clinical Pharmacology (12.3)] have not identified differences in responses

between the elderly and younger patients. In general, dose selection for an elderly patient should start at

the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac

function, and of concomitant disease or other drug therapy.

8.6 Renal Impairment

Due to reduced clearance in patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m ), the

maximum dose should not exceed 50 mg/day. The maximum recommended dose in ESRD (GFR < 15

mL/min/1.73 m ) patients is 30 mg/day [see Clinical Pharmacology (12.3)].

Lisdexamfetamine and d-amphetamine are not dialyzable.

8.7 Gender

No dosage adjustment of VYVANSE is necessary on the basis of gender [see Clinical Pharmacology

(12.3)].

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

VYVANSE contains lisdexamfetamine, a prodrug of amphetamine, a Schedule II controlled substance.

9.2 Abuse

CNS stimulants, including VYVANSE, other amphetamines, and methylphenidate-containing products

have a high potential for abuse. Abuse is characterized by impaired control over drug use, compulsive

use, continued use despite harm, and craving.

Signs and symptoms of CNS stimulant abuse may include increased heart rate, respiratory rate, blood

pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss

of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility,

aggression, suicidal or homicidal ideation have also been seen. Abusers of CNS stimulants may chew,

snort, inject, or use other unapproved routes of administration which can result in overdose and death

[see Overdosage (10)].

To reduce the abuse of CNS stimulants, including VYVANSE, assess the risk of abuse prior to

prescribing. After prescribing, keep careful prescription records, educate patients and their families

about abuse and on proper storage and disposal of CNS stimulants, monitor for signs of abuse while on

therapy, and re-evaluate the need for VYVANSE use.

Studies of VYVANSE in Drug Abusers

A randomized, double-blind, placebo-control, cross-over, abuse liability study in 38 patients with a

history of drug abuse was conducted with single-doses of 50, 100, or 150 mg of VYVANSE, 40 mg of

immediate-release d-amphetamine sulphate (a controlled II substance), and 200 mg of diethylpropion

hydrochloride (a controlled IV substance). VYVANSE 100 mg produced significantly less "Drug

Liking Effects" as measured by the Drug Rating Questionnaire-Subject score, compared to d-

amphetamine 40 mg; and 150 mg of VYVANSE demonstrated similar "Drug-Liking Effects" compared

to 40 mg of d-amphetamine and 200 mg of diethylpropion.

Intravenous administration of 50 mg lisdexamfetamine dimesylate to individuals with a history of drug

abuse produced positive subjective responses on scales measuring "Drug Liking", "Euphoria",

"Amphetamine Effects", and "Benzedrine Effects" that were greater than placebo but less than those

produced by an equivalent dose (20 mg) of intravenous d-amphetamine.

9.3 Dependence

Tolerance

Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug's desired

and/or undesired effects over time) may occur during the chronic therapy of CNS stimulants including

VYVANSE.

Dependence

Physical dependence (a state of adaptation manifested by a withdrawal syndrome produced by abrupt

cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with

CNS stimulants including VYVANSE. Withdrawal symptoms after abrupt cessation following

prolonged high-dosage administration of CNS stimulants include extreme fatigue and depression.

10 OVERDOSAGE

Consult with a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice

for treatment of overdosage. Individual patient response to amphetamines varies widely. Toxic

symptoms may occur idiosyncratically at low doses.

Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration,

confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and

depression usually follow the central nervous system stimulation. Serotonin syndrome has been

reported with amphetamine use, including VYVANSE. Cardiovascular effects include arrhythmias,

hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea,

vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

Lisdexamfetamine and d-amphetamine are not dialyzable.

11 DESCRIPTION

VYVANSE (lisdexamfetamine dimesylate), a CNS stimulant, is for once-a-day oral administration. The

chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-

phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C

H N O·(CH O S) , which

corresponds to a molecular weight of 455.60. The chemical structure is:

Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL).

Information for VYVANSE capsules:

VYVANSE capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of

lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and

40.5 mg of lisdexamfetamine).

Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The

capsule shells contain gelatin, titanium dioxide, and one or more of the following: FD&C Red #3,

FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron Oxide.

Information for VYVANSE chewable tablets:

VYVANSE chewable tablets contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg of

lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, and 34.7 mg of

lisdexamfetamine).

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, guar gum, magnesium stearate,

mannitol, microcrystalline cellulose, sucralose, artificial strawberry flavor.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Lisdexamfetamine is a prodrug of dextroamphetamine. Amphetamines are non-catecholamine

sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD

and BED is not known.

12.2 Pharmacodynamics

Amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron and

increase the release of these monoamines into the extraneuronal space. The parent drug,

lisdexamfetamine, does not bind to the sites responsible for the reuptake of norepinephrine and

dopamine in vitro.

12.3 Pharmacokinetics

Pharmacokinetic studies after oral administration of lisdexamfetamine dimesylate have been conducted

in healthy adult (capsule and chewable tablet formulations) and pediatric (6 to 12 years) patients with

ADHD (capsule formulation). After single dose administration of lisdexamfetamine dimesylate,

pharmacokinetics of dextroamphetamine was found to be linear between 30 mg and 70 mg in a pediatric

study, and between 50 mg and 250 mg in an adult study. Dextroamphetamine pharmacokinetic parameters

following administration of lisdexamfetamine dimesylate in adults exhibited low inter-subject (<25%)

and intra-subject (<8%) variability.

There is no accumulation of lisdexamfetamine and dextroamphetamine at steady state in healthy adults.

Safety and efficacy have not been studied above the maximum recommended dose of 70 mg.

Absorption

Capsule formulation

Following single-dose oral administration of VYVANSE capsule (30 mg, 50 mg, or 70 mg) in patients

ages 6 to 12 years with ADHD under fasted conditions, T

of lisdexamfetamine and

dextroamphetamine was reached at approximately 1 hour and 3.5 hour post dose, respectively.

Weight/Dose normalized AUC and C

values were the same in pediatric patients ages 6 to 12 years

as the adults following single doses of 30 mg to 70 mg VYVANSE capsule.

Food effect on capsule formulation

Neither food (a high fat meal or yogurt) nor orange juice affects the observed AUC and C

dextroamphetamine in healthy adults after single-dose oral administration of 70 mg of VYVANSE

capsules. Food prolongs T

by approximately 1 hour (from 3.8 hour at fasted state to 4.7 hour after a

high fat meal or to 4.2 hour with yogurt). After an 8-hour fast, the AUC for dextroamphetamine

following oral administration of lisdexamfetamine dimesylate in solution and as intact capsules were

equivalent.

Chewable Tablet formulation

After a single dose administration of 60 mg VYVANSE chewable tablet in healthy subjects under fasted

conditions, T

of lisdexamfetamine and dextroamphetamine was reached at approximately 1 hour and

4.4 hour post dose, respectively. Compared to 60 mg VYVANSE capsule, exposure (C

and AUC)

to lisdexamfetamine was about 15% lower. The exposure (C

and AUC

) of dextroamphetamine is

similar between VYVANSE chewable tablet and VYVANSE capsule.

Food effect on tablet formulation

Administration of 60 mg VYVANSE chewable tablet with food (a high-fat meal) decreases the

exposure (C

and AUC

) of dextroamphetamine by about 5% to 7%, and prolongs mean T

approximately 1 hour (from 3.9 hrs at fasted state to 4.9 hours).

Elimination

Plasma concentrations of unconverted lisdexamfetamine are low and transient, generally becoming non-

quantifiable by 8 hours after administration. The plasma elimination half-life of lisdexamfetamine

typically averaged less than one hour in studies of lisdexamfetamine dimesylate in volunteers. The mean

plasma elimination half- life of dextroamphetamine was about 12 hours after oral administration of

lisdexamfetamine dimesylate.

Metabolism

Lisdexamfetamine is converted to dextroamphetamine and l-lysine primarily in blood due to the

hydrolytic activity of red blood cells after oral administration of lisdexamfetamine dimesylate. In vitro

data demonstrated that red blood cells have a high capacity for metabolism of lisdexamfetamine;

substantial hydrolysis occurred even at low hematocrit levels (33% of normal). Lisdexamfetamine is not

metabolized by cytochrome P450 enzymes.

Excretion

Following oral administration of a 70 mg dose of radiolabeled lisdexamfetamine dimesylate to 6 healthy

subjects, approximately 96% of the oral dose radioactivity was recovered in the urine and only 0.3%

recovered in the feces over a period of 120 hours. Of the radioactivity recovered in the urine, 42% of

the dose was related to amphetamine, 25% to hippuric acid, and 2% to intact lisdexamfetamine.

Specific Populations

Exposures of dextroamphetamine in specific populations are summarized in Figure 1.

Figure 1: Specific Populations

:

Drug Interaction Studies

Effects of other drugs on the exposures of dextroamphetamine are summarized in Figure 2.

Figure 1 shows the geometric mean ratios and the 90% confidence limits for C

and AUC of d-amphetamine.

Comparison for gender uses males as the reference. Comparison for age uses 55-64 years as the reference.

Figure 2: Effect of Other Drugs on VYVANSE:

The effects of VYVANSE on the exposures of other drugs are summarized in Figure 3.

Figure 3: Effect of VYVANSE on Other Drugs:

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility

Carcinogenesis

Carcinogenicity studies of lisdexamfetamine dimesylate have not been performed. No evidence of

carcinogenicity was found in studies in which d-, l-amphetamine (enantiomer ratio of 1:1) was

administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19

mg/kg/day in female mice, and 5 mg/kg/day in male and female rats.

Mutagenesis

Lisdexamfetamine dimesylate was not clastogenic in the mouse bone marrow micronucleus test in vivo

and was negative when tested in the E. coli and S. typhimurium components of the Ames test and in the

L5178Y/TK mouse lymphoma assay in vitro.

Impairment of Fertility

Amphetamine (d- to l-enantiomer ratio of 3:1) did not adversely affect fertility or early embryonic

development in the rat at doses of up to 20 mg/kg/day.

13.2 Animal Toxicology and/or Pharmacology

Acute administration of high doses of amphetamine (d- or d,l-) has been shown to produce long-lasting

neurotoxic effects, including irreversible nerve fiber damage, in rodents. The significance of these

findings to humans is unknown.

14 CLINICAL STUDIES

Efficacy of VYVANSE in the treatment of ADHD has been established in the following trials:

Three short-term trials in children (6 to 12 years, Studies 1, 2, 3)

One short-term trial in adolescents (13 to 17 years, Study 4)

One short-term trial in children and adolescents (6 to 17 years, Study 5)

Two short-term trials in adults (18 to 55 years, Studies 7, 8)

Two randomized withdrawal trials in children and adolescents (6 to 17 years, Study 6), and adults

(18 to 55 years, Study 9)

Efficacy of VYVANSE in the treatment of moderate to severe BED in adults has been established in the

following trials:

One randomized trial in adults (18 to 55 years, Study 10)

Two short-term trials in adults (18 to 55 years, Studies 11 and 12)

One randomized withdrawal study in adults (18 to 55 years, Study 13)

14.1 Attention Deficit Hyperactivity Disorder (ADHD)

Patients Ages 6 to 12 Years Old with ADHD

A double-blind, randomized, placebo-controlled, parallel-group study (Study 1) was conducted in

children ages 6 to 12 years (N=290) who met DSM-IV criteria for ADHD (either the combined type or

the hyperactive-impulsive type). Patients were randomized to receive final doses of 30 mg, 50 mg, or

70 mg of VYVANSE or placebo once daily in the morning for a total of four weeks of treatment. All

patients receiving VYVANSE were initiated on 30 mg for the first week of treatment. Patients assigned

to the 50 mg and 70 mg dose groups were titrated by 20 mg per week until they achieved their assigned

dose. The primary efficacy outcome was change in Total Score from baseline to endpoint in

investigator ratings on the ADHD Rating Scale (ADHD-RS), an 18-item questionnaire with a score

range of 0-54 points that measures the core symptoms of ADHD which includes both

hyperactive/impulsive and inattentive subscales. Endpoint was defined as the last post-randomization

treatment week (i.e. Weeks 1 through 4) for which a valid score was obtained. All VYVANSE dose

groups were superior to placebo in the primary efficacy outcome. Mean effects at all doses were

similar; however, the highest dose (70 mg/day) was numerically superior to both lower doses (Study 1

in Table 7). The effects were maintained throughout the day based on parent ratings (Conners' Parent

Rating Scale) in the morning (approximately 10 am), afternoon (approximately 2 pm), and early evening

(approximately 6 pm).

A double-blind, placebo-controlled, randomized, crossover design, analog classroom study (Study 2)

was conducted in children ages 6 to 12 years (N=52) who met DSM-IV criteria for ADHD (either the

combined type or the hyperactive-impulsive type). Following a 3-week open-label dose optimization

with Adderall XR , patients were randomly assigned to continue their optimized dose of Adderall XR

(10 mg, 20 mg, or 30 mg), VYVANSE (30 mg, 50 mg, or 70 mg), or placebo once daily in the morning

for 1 week each treatment. Efficacy assessments were conducted at 1, 2, 3, 4.5, 6, 8, 10, and 12 hours

post-dose using the Swanson, Kotkin, Agler, M.Flynn, and Pelham Deportment scores (SKAMP-DS), a

4-item subscale of the SKAMP with scores ranging from 0 to 24 points that measures deportment

problems leading to classroom disruptions. A significant difference in patient behavior, based upon the

average of investigator ratings on the SKAMP-DS across the 8 assessments were observed between

patients when they received VYVANSE compared to patients when they received placebo (Study 2 in

Table 7). The drug effect reached statistical significance from hours 2 to 12 post-dose, but was not

significant at 1 hour.

A second double-blind, placebo-controlled, randomized, crossover design, analog classroom study

(Study 3) was conducted in children ages 6 to 12 years (N=129) who met DSM-IV criteria for ADHD

(either the combined type or the hyperactive-impulsive type). Following a 4-week open-label dose

optimization with VYVANSE (30 mg, 50 mg, 70 mg), patients were randomly assigned to continue their

optimized dose of VYVANSE or placebo once daily in the morning for 1 week each treatment. A

significant difference in patient behavior, based upon the average of investigator ratings on the

SKAMP-Deportment scores across all 7 assessments conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0

hours post-dose, were observed between patients when they received VYVANSE compared to patients

when they received placebo (Study 3 in Table 7, Figure 4).

Patients Ages 13 to 17 Years Old with ADHD

A double-blind, randomized, placebo-controlled, parallel-group study (Study 4) was conducted in

adolescents ages 13 to 17 years (N=314) who met DSM-IV criteria for ADHD. In this study, patients

were randomized in a 1:1:1:1 ratio to a daily morning dose of VYVANSE (30 mg/day, 50 mg/day or 70

mg/day) or placebo for a total of four weeks of treatment. All patients receiving VYVANSE were

initiated on 30 mg for the first week of treatment. Patients assigned to the 50 mg and 70 mg dose groups

were titrated by 20 mg per week until they achieved their assigned dose. The primary efficacy outcome

was change in Total Score from baseline to endpoint in investigator ratings on the ADHD Rating Scale

(ADHD-RS). Endpoint was defined as the last post-randomization treatment week (i.e. Weeks 1 through

4) for which a valid score was obtained. All VYVANSE dose groups were superior to placebo in the

primary efficacy outcome (Study 4 in Table 7).

Patients Ages 6 to 17 Years Old: Short-Term Treatment in ADHD

A double-blind, randomized, placebo- and active-controlled parallel-group, dose-optimization study

(Study 5) was conducted in children and adolescents ages 6 to 17 years (n=336) who met DSM-IV

criteria for ADHD. In this eight-week study, patients were randomized to a daily morning dose of

VYVANSE (30, 50 or 70mg/day), an active control, or placebo (1:1:1). The study consisted of a

Screening and Washout Period (up to 42 days), a 7-week Double-blind Evaluation Period (consisting of

a 4-week Dose-Optimization Period followed by a 3-week Dose-Maintenance Period), and a 1-week

Washout and Follow-up Period. During the Dose Optimization Period, subjects were titrated until an

optimal dose, based on tolerability and investigator's judgment, was reached. VYVANSE showed

significantly greater efficacy than placebo. The placebo-adjusted mean reduction from baseline in the

ADHD-RS-IV total score was 18.6. Subjects on VYVANSE also showed greater improvement on the

Clinical Global Impression-Improvement (CGI-I) rating scale compared to subjects on placebo (Study 5

in Table 7).

Patients Ages 6 to 17 Years Old: Maintenance Treatment in ADHD

Maintenance of Efficacy Study (Study 6) - A double-blind, placebo-controlled, randomized withdrawal

study was conducted in children and adolescents ages 6 to 17 (N=276) who met the diagnosis of ADHD

(DSM-IV criteria). A total of 276 patients were enrolled into the study, 236 patients participated in

Study 5 and 40 subjects directly enrolled. Subjects were treated with open-label VYVANSE for at least

26 weeks prior to being assessed for entry into the randomized withdrawal period. Eligible patients had

to demonstrate treatment response as defined by CGI-S <3 and Total Score on the ADHD-RS ≤22.

Patients that maintained treatment response for 2 weeks at the end of the open label treatment period

were eligible to be randomized to ongoing treatment with the same dose of VYVANSE (N=78) or

switched to placebo (N=79) during the double-blind phase. Patients were observed for relapse

(treatment failure) during the 6 week double blind phase. A significantly lower proportion of treatment

failures occurred among VYVANSE subjects (15.8%) compared to placebo (67.5%) at endpoint of the

randomized withdrawal period. The endpoint measurement was defined as the last post-randomization

treatment week at which a valid ADHD-RS Total Score and CGI-S were observed. Treatment failure

was defined as a ≥50% increase (worsening) in the ADHD-RS Total Score and a ≥2-point increase in

the CGI-S score compared to scores at entry into the double-blind randomized withdrawal phase.

Subjects who withdrew from the randomized withdrawal period and who did not provide efficacy data at

their last on-treatment visit were classified as treatment failures (Study 6, Figure 5).

Adults: Short-Term Treatment in ADHD

A double-blind, randomized, placebo-controlled, parallel-group study (Study 7) was conducted in adults

ages 18 to 55 (N=420) who met DSM-IV criteria for ADHD. In this study, patients were randomized to

receive final doses of 30 mg, 50 mg, or 70 mg of VYVANSE or placebo for a total of four weeks of

treatment. All patients receiving VYVANSE were initiated on 30 mg for the first week of treatment.

Patients assigned to the 50 mg and 70 mg dose groups were titrated by 20 mg per week until they

achieved their assigned dose. The primary efficacy outcome was change in Total Score from baseline

to endpoint in investigator ratings on the ADHD Rating Scale (ADHD-RS). Endpoint was defined as the

last post-randomization treatment week (i.e. Weeks 1 through 4) for which a valid score was obtained.

All VYVANSE dose groups were superior to placebo in the primary efficacy outcome (Study 7 in

Table 7).

The second study was a multi-center, randomized, double-blind, placebo-controlled, cross-over,

modified analog classroom study (Study 8) of VYVANSE to simulate a workplace environment in 142

adults ages 18 to 55 who met DSM-IV-TR criteria for ADHD. There was a 4-week open-label, dose

optimization phase with VYVANSE (30 mg/day, 50 mg/day, or 70 mg/day in the morning). Patients were

then randomized to one of two treatment sequences: 1) VYVANSE (optimized dose) followed by

placebo, each for one week, or 2) placebo followed by VYVANSE, each for one week. Efficacy

assessments occurred at the end of each week, using the Permanent Product Measure of Performance

(PERMP), a skill-adjusted math test that measures attention in ADHD. PERMP total score results from

the sum of the number of math problems attempted plus the number of math problems answered

correctly. VYVANSE treatment, compared to placebo, resulted in a statistically significant improvement

in attention across all post-dose time points, as measured by average PERMP total scores over the

course of one assessment day, as well as at each time point measured. The PERMP assessments were

administered at pre-dose (-0.5 hours) and at 2, 4, 8, 10, 12, and 14 hours post-dose (Study 8 in Table 7,

Figure 6).

Adults: Maintenance Treatment in ADHD

A double-blind, placebo-controlled, randomized withdrawal design study (Study 9) was conducted in

adults ages 18 to 55 (N=123) who had a documented diagnosis of ADHD or met DSM-IV criteria for

ADHD. At study entry, patients must have had documentation of treatment with VYVANSE for a

minimum of 6 months and had to demonstrate treatment response as defined by Clinical Global

Impression Severity (CGI-S) ≤3 and Total Score on the ADHD-RS <22. ADHD-RS Total Score is a

measure of core symptoms of ADHD. The CGI-S score assesses the clinician's impression of the

patient's current illness state and ranges from 1 (not at all ill) to 7 (extremely ill). Patients that maintained

treatment response at week 3 of the open label treatment phase (N=116) were eligible to be randomized

to ongoing treatment with the same dose of VYVANSE (N=56) or switched to placebo (N=60) during

the double-blind phase. Patients were observed for relapse (treatment failure) during the 6-week

double-blind phase. The efficacy endpoint was the proportion of patients with treatment failure during

the double-blind phase. Treatment failure was defined as a ≥50% increase (worsening) in the ADHD-

RS Total Score and ≥2-point increase in the CGI-S score compared to scores at entry into the double-

blind phase. Maintenance of efficacy for patients treated with VYVANSE was demonstrated by the

significantly lower proportion of patients with treatment failure (9%) compared to patients receiving

placebo (75%) at endpoint during the double-blind phase (Study 9, Figure 7).

Table 7: Summary of Primary Efficacy Results from Short-term Studies of VYVANSE in

Children, Adolescents, and Adults with ADHD

Study

Number

(Age

range)

Primary

Endpoint

Treatment Group

Mean

Bas eline

Score (SD)

LS Mean

Change from

Baseline (SE)

Placebo-s ubtracted

Difference (95% CI)

SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval.

Study 1

(6 - 12

years)

ADHD-RS-

VYVANSE (30

mg/day)

43.2 (6.7)

-21.8 (1.6)

-15.6 (-19.9, -11.2)

VYVANSE (50

mg/day)

43.3 (6.7)

-23.4 (1.6)

-17.2 (-21.5, -12.9)

VYVANSE (70

mg/day)

45.1(6.8)

-26.7 (1.5)

-20.5 (-24.8, -16.2)

Placebo

42.4 (7.1)

-6.2 (1.6)

Study 2

(6 - 12

years)

Average

SKAMP-DS

VYVANSE (30, 50 or

70 mg/day)

0.8 (0.1)

-0.9 (-1.1, -0.7)

Placebo

1.7 (0.1)

Study 3

(6 - 12

years)

Average

SKAMP-DS

VYVANSE (30, 50 or

70 mg/day)

0.9 (1.0)

0.7 (0.1)

-0.7 (-0.9, -0.6)

Placebo

0.7 (0.9)

1.4 (0.1)

Study 4

(13 - 17

years)

ADHD-RS-

VYVANSE (30

mg/day)

38.3 (6.7)

-18.3 (1.2)

-5.5 (-9.0, -2.0)

VYVANSE (50

mg/day)

37.3 (6.3)

-21.1 (1.3)

-8.3 (-11.8, -4.8)

VYVANSE (70

mg/day)

37.0 (7.3)

-20.7 (1.3)

-7.9 (-11.4, -4.5)

Placebo

38.5 (7.1)

-12.8 (1.2)

Study 5

(6 - 17

years)

ADHD-RS-

VYVANSE (30, 50 or

70 mg/day)

40.7 (7.3)

-24.3 (1.2)

-18.6 (-21.5, -15.7)

Placebo

41.0 (7.1)

-5.7 (1.1)

Study 7

(18 - 55

years)

ADHD-RS-

VYVANSE (30

mg/day)

40.5 (6.2)

-16.2 (1.1)

-8.0 (-11.5, -4.6)

VYVANSE (50

mg/day)

40.8 (7.3)

-17.4 (1.0)

-9.2 (-12.6, -5.7)

VYVANSE (70

mg/day)

41.0 (6.0)

-18.6 (1.0)

-10.4 (-13.9, -6.9)

Placebo

39.4 (6.4)

-8.2 (1.4)

Study 8

(18 - 55

years)

Average

PERMP

VYVANSE (30, 50 or

70 mg/day)

260.1 (86.2)

312.9 (8.6)

23.4 (15.6, 31.2)

Placebo

261.4 (75.0)

289.5 (8.6)

Figure 4 LS Mean SKAMP Deportment Subscale Score by Treatment and Time-point for

Children Ages 6 to 12 with ADHD after 1 Week of Double Blind Treatment (Study 3)

*

Difference (drug minus placebo) in least-squares mean change from baseline.

Doses statistically significantly superior to placebo.

Pre-dose SKAMP-DS was not collected.

LS Mean for SKAMP-DS (Study 2 and 3) or PERMP (Study 8) is post-dose average score over all sessions of

the treatment day, rather than change from baseline.

Pre-dose SKAMP-DS (Study 3) or PERMP (Study 8) total score, averaged over both periods.

Higher score on the SKAMP-Deportment scale indicates more severe symptoms

Figure 5 Kaplan-Meier Estimated Proportion of Patients with Treatment Failure for Children and

Adolescent Ages 6-17 (Study 6)

Figure 6 LS Mean (SE) PERMP Total Score by Treatment and Time-point for Adults Ages 18 to

55 with ADHD after 1 Week of Double Blind Treatment (Study 8)

Higher score on the PERMP scale indicates less severe symptoms.

Figure 7 Kaplan-Meier Estimated Proportion of Subjects with Relapse in Adults with ADHD

(Study 9)

14.2 Binge Eating Disorder (BED)

A phase 2 study evaluated the efficacy of VYVANSE 30, 50 and 70 mg/day compared to placebo in

reducing the number of binge days/week in adults with at least moderate to severe BED. This

randomized, double-blind, parallel-group, placebo-controlled, forced-dose titration study (Study 10)

consisted of an 11-week double-blind treatment period (3 weeks of forced-dose titration followed by 8

weeks of dose maintenance). VYVANSE 30 mg/day was not statistically different from placebo on the

primary endpoint. The 50 and 70 mg/day doses were statistically superior to placebo on the primary

endpoint.

The efficacy of VYVANSE in the treatment of BED was demonstrated in two 12-week randomized,

double-blind, multi-center, parallel-group, placebo-controlled, dose-optimization studies (Study 11 and

Study 12) in adults aged 18-55 years (Study 11: N=374, Study 12: N=350) with moderate to severe BED.

A diagnosis of BED was confirmed using DSM-IV criteria for BED. Severity of BED was determined

based on having at least 3 binge days per week for 2 weeks prior to the baseline visit and on having a

Clinical Global Impression Severity (CGI-S) score of ≥4 at the baseline visit. For both studies, a binge

day was defined as a day with at least 1 binge episode, as determined from the subject's daily binge

diary.

Both 12-week studies consisted of a 4-week dose-optimization period and an 8-week dose-maintenance

period. During dose-optimization, subjects assigned to VYVANSE began treatment at the titration dose

of 30 mg/day and, after 1 week of treatment, were subsequently titrated to 50mg/day. Additional

increases to 70 mg/day were made as tolerated and clinically indicated. Following the dose-optimization

period, subjects continued on their optimized dose for the duration of the dose-maintenance period.

The primary efficacy outcome for the two studies was defined as the change from baseline at Week 12

in the number of binge days per week. Baseline is defined as the weekly average of the number of binge

days per week for the 14 days prior to the baseline visit. Subjects from both studies on VYVANSE had

a statistically significantly greater reduction from baseline in mean number of binge days per week at

Week 12. In addition, subjects on VYVANSE showed greater improvement as compared to placebo

across key secondary outcomes with higher proportion of subjects rated improved on the CGI-I rating

scale, higher proportion of subjects with 4-week binge cessation, and greater reduction in the Yale-

Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) total score.

Table 8: Summary of Primary Efficacy Results in BED

Study

Number

Treatment Group

Primary Efficacy Measure: Binge Days per Week at

Week 12

Mean Baseline

Score (SD)

LS Mean Change

from Baseline

(SE)

Placebo-

s ubtracted

Difference (95%

CI)

SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence

interval.

Study 11

VYVANSE (50 or 70

mg/day)

4.79 (1.27)

-3.87 (0.12)

-1.35 (-1.70, -1.01)

Placebo

4.60 (1.21)

-2.51 (0.13)

Study 12

VYVANSE (50 or 70

mg/day)

4.66 (1.27)

-3.92 (0.14)

-1.66 (-2.04, -1.28)

Placebo

4.82 (1.42)

-2.26 (0.14)

A double-blind, placebo controlled, randomized withdrawal design study (Study 13) was conducted to

evaluate maintenance of efficacy based on time to relapse between VYVANSE and placebo in adults

aged 18 to 55 (N=267) with moderate to severe BED. In this longer-term study patients who had

responded to VYVANSE in the preceding 12-week open-label treatment phase were randomized to

continuation of VYVANSE or placebo for up to 26 weeks of observation for relapse. Response in the

open-label phase was defined as 1 or fewer binge days each week for four consecutive weeks prior to

*

Difference (drug minus placebo) in least-squares mean change from baseline.

Doses statistically significantly superior to placebo.

the last visit at the end of the 12-week open-label phase and a CGI-S score of 2 or less at the same visit.

Relapse during the double-blind phase was defined as having 2 or more binge days each week for two

consecutive weeks (14 days) prior to any visit and having an increase in CGI-S score of 2 or more

points compared to the randomized-withdrawal baseline. Maintenance of efficacy for patients who had

an initial response during the open-label period and then continued on VYVANSE during the 26-week

double-blind randomized-withdrawal phase was demonstrated with VYVANSE being superior over

placebo as measured by time to relapse.

Figure 8 Kaplan-Meier Estimated Proportion of Subjects with Relapse in Adults with BED (Study

13)

Examination of population subgroups based on age (there were no patients over 65), gender, and race

did not reveal any clear evidence of differential responsiveness in the treatment of BED.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Information for VYVANSE capsules:

VYVANSE capsules 10 mg: pink body/pink cap (imprinted with S489 and 10 mg), bottles of 100,

NDC 59417-101-10

VYVANSE capsules 20 mg: ivory body/ivory cap (imprinted with S489 and 20 mg), bottles of 100,

NDC 59417-102-10

VYVANSE capsules 30 mg: white body/orange cap (imprinted with S489 and 30 mg), bottles of

100, NDC 59417-103-10

VYVANSE capsules 40 mg: white body/blue green cap (imprinted with S489 and 40 mg), bottles of

100, NDC 59417-104-10

VYVANSE capsules 50 mg: white body/blue cap (imprinted with S489 and 50 mg), bottles of 100,

NDC 59417-105-10

VYVANSE capsules 60 mg: aqua blue body/aqua blue cap (imprinted with S489 and 60 mg), bottles

of 100, NDC 59417-106-10

VYVANSE capsules 70 mg: blue body/orange cap (imprinted with S489 and 70 mg), bottles of 100,

NDC 59417-107-10

Information for VYVANSE chewable tablets:

VYVANSE chewable tablets 10 mg: White to off-white round shaped tablet debossed with '10' on

one side and 'S489' on the other, bottles of 100, NDC 59417-115-01

VYVANSE chewable tablets 20 mg: White to off-white hexagonal shaped tablet debossed with '20'

on one side and 'S489' on the other, bottles of 100, NDC 59417-116-01

VYVANSE chewable tablets 30 mg: White to off-white arc triangular shaped tablet debossed with

'30' on one side and 'S489' on the other, bottles of 100, NDC 59417-117-01

VYVANSE chewable tablets 40 mg: White to off-white capsule shaped tablet debossed with '40' on

one side and 'S489' on the other, bottles of 100, NDC 59417-118-01

VYVANSE chewable tablets 50 mg: White to off-white arc square shaped tablet debossed with '50'

on one side and 'S489' on the other, bottles of 100, NDC 59417-119-01

VYVANSE chewable tablets 60 mg: White to off-white arc diamond shaped tablet debossed with

'60' on one side and 'S489' on the other, bottles of 100, NDC 59417-120-01

16.2 Storage and Handling

Dispense in a tight, light-resistant container as defined in the USP.

Store at room temperature, 20ºC to 25º C (68ºF to 77º F). Excursions permitted between 15ºC and 30º C

(59 to 86º F) [see USP Controlled Room Temperature].

Disposal

Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining,

unused, or expired VYVANSE by a medicine take-back program.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Controlled Substance Status/High Potential for Abuse and Dependence

Advise patients that VYVANSE is a controlled substance and it can be abused and lead to dependence

and not to give VYVANSE to anyone else [see Drug Abuse and Dependence (9.1, 9.2, and 9.3)]. Advise

patients to store VYVANSE in a safe place, preferably locked, to prevent abuse. Advise patients to

dispose of remaining, unused, or expired VYVANSE by a medicine take-back program.

Serious Cardiovascular Risks

Advise patients that there is a potential serious cardiovascular risk including sudden death, myocardial

infarction, stroke, and hypertension with VYVANSE use. Instruct patients to contact a healthcare

provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or

other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].

Hypertension and Tachycardia

Instruct patients that VYVANSE can cause elevations of their blood pressure and pulse rate and they

should be monitored for such effects.

Psychiatric Risks

Advise patients that VYVANSE at recommended doses may cause psychotic or manic symptoms even in

patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].

Suppression of Growth

Advise patients that VYVANSE may cause slowing of growth including weight loss [see Warnings and

Precautions (5.5)].

Impairment in Ability to Operate Machinery or Vehicles

Advise patients that VYVANSE may impair their ability to engage in potentially dangerous activities

such as operating machinery or vehicles. Instruct patients to find out how VYVANSE will affect them

before engaging in potentially dangerous activities [see Adverse Reactions (6.1, 6.2)].

before engaging in potentially dangerous activities [see Adverse Reactions (6.1, 6.2)].

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]

Instruct patients beginning treatment with VYVANSE about the risk of peripheral vasculopathy,

including Raynaud's phenomenon, and associated signs and symptoms: fingers or toes may feel numb,

cool, painful, and/or may change from pale, to blue, to red. Instruct patients to report to their physician

any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct

patients to call their physician immediately with any signs of unexplained wounds appearing on

fingers or toes while taking VYVANSE. Further clinical evaluation (e.g. rheumatology referral) may

be appropriate for certain patients [see Warnings and Precautions (5.6)].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome with concomitant use of VYVANSE and other

serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium,

tramadol, tryptophan, buspirone, St. John's Wort, and with drugs that impair metabolism of serotonin (in

particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid

[see Contraindications (4), Warnings and Precautions (5.7) and Drug Interactions (7.1)]. Advise patients to

contact their healthcare provider or report to the emergency room if they experience signs or symptoms

of serotonin syndrome.

Concomitant Medications

Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-

counter drugs because there is a potential for interactions [see Drug Interactions (7.1)].

Pregnancy

Advise patients of the potential fetal effects from the use of VYVANSE during pregnancy. Advise

patients to notify their healthcare provider if they become pregnant or intend to become pregnant during

treatment with VYVANSE [see Use in Specific Populations (8.1)].

Lactation

Advise women not to breastfeed if they are taking VYVANSE [see Use in Specific Populations (8.2)].

Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421

Made in USA

For more information call 1-800-828-2088

VYVANSE is a registered trademark of Shire LLC

©2018 Shire US Inc.

US Pat No. 7,105,486, 7,223,735, 7,655,630, 7,659,253, 7,659,254, 7,662,787, 7,662,788, 7,671,030,

7,671,031, 7,674,774, 7,678,770, 7,678,771, 7,687,466, 7,687,467, 7,713,936, 7,718,619, 7,723,305

MEDICATION GUIDE

VYVANSE [Vi' - vans]

(lisdexamfetamine dimesylate) CII

Capsules and Chewable Tablets

What is the most important information I should know about VYVANSE?

VYVANSE is a federally controlled substance (CII) because it can be abused or lead to

dependence. Keep VYVANSE in a safe place to prevent misuse and abuse. Selling or giving away

VYVANSE may harm others, and is against the law.

Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or

street drugs.

VYVANSE is a stimulant medicine. Some people have had the following problems when taking

stimulant medicines such as VYVANSE:

®

1.

Tell your doctor if you have any heart problems, heart defects, high blood pressure, or a family history

of these problems.

Your doctor should check you carefully for heart problems before starting VYVANSE.

Your doctor should check your blood pressure and heart rate regularly during treatment with

VYVANSE.

Call your doctor right away if you have any signs of heart problems such as chest pain,

shortness of breath, or fainting while taking VYVANSE.

2.

In Children, Teenagers, and Adults:

new or worse behavior and thought problems

new or worse bipolar illness

In Children and Teenagers

new psychotic symptoms such as:

hearing voices

believing things that are not true

being suspicious

new manic symptoms

Tell your doctor about any mental problems you have or if you have a family history of suicide, bipolar

illness, or depression.

Call your doctor right away if you have any new or worsening mental symptoms or problems

while taking VYVANSE, especially:

seeing or hearing things that are not real

believing things that are not real

being suspicious

3.

Tell your doctor if you have numbness, pain, skin color change, or sensitivity to temperature in your

fingers or toes.

Call your doctor right away if you have any signs of unexplained wounds appearing on fingers or

toes while taking VYVANSE.

What is VYVANSE?

VYVANSE is a central nervous system stimulant prescription medicine used to treat:

Attention-Deficit/Hyperactivity Disorder (ADHD). VYVANSE may help increase attention and

decrease impulsiveness and hyperactivity in patients with ADHD.

Binge Eating Disorder (BED). VYVANSE may help reduce the number of binge eating days in

patients with BED.

Heart-related problems including:

sudden death in people who have heart problems or heart defects

sudden death, stroke and heart attack in adults

increased blood pressure and heart rate

Mental (psychiatric) problems including:

Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's

phenomenon]:

Fingers or toes may feel numb, cool, painful

Fingers or toes may change color from pale, to blue, to red

VYVANSE is not for weight loss. It is not known if VYVANSE is safe and effective for the treatment

of obesity.

It is not known if VYVANSE is safe and effective in children with ADHD under 6 years of age or in

patients with BED under 18 years of age.

Do not take VYVANSE if you:

are taking or have taken within the past 14 days an anti-depression medicine called a monoamine

oxidase inhibitor or MAOI.

are sensitive to, allergic to, or had a reaction to other stimulant medicines.

Before you take VYVANSE, tell your doctor if you have or if there is a family history of:

heart problems, heart defects, high blood pressure

mental problems including psychosis, mania, bipolar illness, or depression

circulation problems in fingers and toes

Tell your doctor if:

you have any kidney problems. Your doctor may lower your dose.

you are pregnant or plan to become pregnant. It is not known if VYVANSE may harm your

unborn baby.

you are breastfeeding or plan to breastfeed. VYVANSE can pass into your milk. Do not

breastfeed while taking VYVANSE. Talk to your doctor about the best way to feed your baby if

you take VYVANSE.

Tell your doctor about all of the medicines that you take, including prescription and over-the-

counter medicines, vitamins, and herbal supplements.

VYVANSE can affect the way other medicines work, and other medicines may affect how VYVANSE

works. Using VYVANSE with other medicines can cause serious side effects.

Especially tell your doctor if you take anti-depression medicines including MAOIs.

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get

a new medicine.

Do not start any new medicine while taking VYVANSE without talking to your doctor first.

How should I take VYVANSE?

Take VYVANSE exactly as your doctor tells you to take it.

Your doctor may change your dose until it is right for you.

Take VYVANSE 1 time each day in the morning.

VYVANSE can be taken with or without food.

VYVANSE comes in capsules or chewable tablets.

Caps ules :

VYVANSE capsules may be swallowed whole.

If you have trouble swallowing capsules, open your VYVANSE capsule and pour all the

powder into yogurt, water, or orange juice.

Use all of the VYVANSE powder from the capsule so you get all of the medicine.

Using a spoon, break apart any powder that is stuck together. Stir the VYVANSE

powder and yogurt, water or orange juice until they are completely mixed together.

Eat all the yogurt or drink all the water or orange juice right away after it has been mixed

with VYVANSE. Do not store the yogurt, water, or orange juice after it has been mixed

with VYVANSE. It is normal to see a filmy coating on the inside of your glass or

container after you eat or drink all the VYVANSE.

Chewable Tablets:

VYVANSE chewable tablets must be completely chewed before swallowing.

Your doctor may sometimes stop VYVANSE treatment for a while to check your ADHD or

your BED symptoms.

Your doctor may do regular checks of your heart, and blood pressure while taking VYVANSE.

Children should have their height and weight checked often while taking VYVANSE.

VYVANSE treatment may be stopped if a problem is found during these check-ups.

If you take too much VYVANSE, call your doctor or poison control center (1-800-222-1222) right

away, or get to the nearest hospital emergency room.

What should I avoid while taking VYVANSE?

Do not drive, operate machinery, or do other dangerous activities until you know how VYVANSE

affects you.

What are the possible side effects of VYVANSE?

VYVANSE may cause serious side effects, including:

See "What is the most important information I should know about VYVANSE?"

slowing of growth (height and weight) in children

The most common side effects of VYVANSE in ADHD include:

anxiety

dry mouth

trouble sleeping

decreased appetite

irritability

upper stomach pain

diarrhea

loss of appetite

vomiting

dizziness

nausea

weight loss

The most common side effects of VYVANSE in BED include:

dry mouth

constipation

trouble sleeping

feeling jittery

decreased appetite

anxiety

increased heart rate

Talk to your doctor if you have any side effects that bother you or do not go away.

These are not all the possible side effects of VYVANSE. For more information ask your doctor or

pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-

FDA-1088.

How should I store VYVANSE?

Store VYVANSE at room temperature, 68°F to 77°F (20°C to 25°C).

Protect VYVANSE from light.

Store VYVANSE in a safe place, like a locked cabinet.

Do not throw away unused VYVANSE in your household trash as it may harm other people or

animals. Ask your doctor or pharmacist about a medicine take-back program in your community.

Keep VYVANSE and all medicines out of the reach of children.

General information about the safe and effective use of VYVANSE.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not

use VYVANSE for a condition for which it was not prescribed. Do not give VYVANSE to other

people, even if they have the same symptoms that you have. It may harm them and it is against the law. If

you would like more information, talk with your doctor. You can ask your pharmacist or healthcare

provider for information about VYVANSE that is written for health professionals.

What are the ingredients in VYVANSE?

Active ingredient: lisdexamfetamine dimesylate

Capsule Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium

stearate. The capsule shells (imprinted with S489) contain gelatin, titanium dioxide, and one or more of

the following: FD&C Red #3, FD&C Yellow #6, FD&C Blue #1, Black Iron Oxide, and Yellow Iron

Oxide.

Chewable Tablet Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, guar gum,

magnesium stearate, mannitol, microcrystalline cellulose, sucralose, artificial strawberry flavor.

Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421. VYVANSE is a registered

trademark of Shire LLC.

2017 Shire US Inc.

For more information, go to www.vyvanse.com or call 1-800-828-2088.

This Medication Guide has been approved by the U.S. Food and Drug

Administration

Revised: JAN 2017

PRINCIPAL DISPLAY PANEL - 10 mg Capsule Bottle Label

NDC 59417-101-10

Vyvans e

(lisdexamfetamine

dimesylate) capsules

10 mg

CII

Rx only

100 CAPSULES

Shire

PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Label

NDC 59417-102-10

Vyvans e

(lisdexamfetamine

dimesylate) capsules

20 mg

CII

Rx only

100 CAPSULES

Shire

®

®

PRINCIPAL DISPLAY PANEL - 30 mg Capsule Bottle Label

NDC 59417-103-10

Vyvans e

(lisdexamfetamine

dimesylate) capsules

30 mg

CII

Rx only

100 CAPSULES

Shire

PRINCIPAL DISPLAY PANEL - 40 mg Capsule Bottle Label

NDC 59417-104-10

Vyvans e

(lisdexamfetamine

dimesylate) capsules

40 mg

CII

Rx only

100 CAPSULES

Shire

PRINCIPAL DISPLAY PANEL - 50 mg Capsule Bottle Label

NDC 59417-105-10

Vyvans e

(lisdexamfetamine

dimesylate) capsules

®

®

®

50 mg

CII

Rx only

100 CAPSULES

Shire

PRINCIPAL DISPLAY PANEL - 60 mg Capsule Bottle Label

NDC 59417-106-10

Vyvans e

(lisdexamfetamine

dimesylate) capsules

60 mg

CII

Rx only

100 CAPSULES

Shire

PRINCIPAL DISPLAY PANEL - 70 mg Capsule Bottle Label

NDC 59417-107-10

Vyvans e

(lisdexamfetamine

dimesylate) capsules

70 mg

CII

Rx only

100 CAPSULES

Shire

®

®

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC 59417-115-01

Vyvans e

(lisdexamfetamine

dimesylate) chewable tablets

10 mg

100 CHEWABLE

TABLETS

Chew tablets completely

before swallowing. Do

not swallow tablets whole.

CII

Rx only

Shire

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label

NDC 59417-116-01

Vyvans e

(lisdexamfetamine

dimesylate) chewable tablets

20 mg

100 CHEWABLE

®

®

TABLETS

Chew tablets completely

before swallowing. Do

not swallow tablets whole.

CII

Rx only

Shire

PRINCIPAL DISPLAY PANEL - 30 mg Tablet Bottle Label

NDC 59417-117-01

Vyvans e

(lisdexamfetamine

dimesylate) chewable tablets

30 mg

100 CHEWABLE

TABLETS

Chew tablets completely

before swallowing. Do

not swallow tablets whole.

CII

Rx only

Shire

®

PRINCIPAL DISPLAY PANEL - 40 mg Tablet Bottle Label

NDC 59417-118-01

Vyvans e

(lisdexamfetamine

dimesylate) chewable tablets

40 mg

100 CHEWABLE

TABLETS

Chew tablets completely

before swallowing. Do

not swallow tablets whole.

CII

Rx only

Shire

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

NDC 59417-119-01

Vyvans e

(lisdexamfetamine

dimesylate) chewable tablets

®

®

50 mg

100 CHEWABLE

TABLETS

Chew tablets completely

before swallowing. Do

not swallow tablets whole.

CII

Rx only

Shire

PRINCIPAL DISPLAY PANEL - 60 mg Tablet Bottle Label

NDC 59417-120-01

Vyvans e

(lisdexamfetamine

dimesylate) chewable tablets

60 mg

100 CHEWABLE

TABLETS

Chew tablets completely

before swallowing. Do

not swallow tablets whole.

CII

Rx only

Shire

®

VYVANSE

lisdexamfetamine dimesylate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 417-10 1

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT76 1GEGS) (LISDEXAMFETAMINE -

UNII:H6 45GUL8 KJ)

LISDEXAMFETAMINE

DIMESYLATE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C RED NO . 3 (UNII: PN2ZH5LOQY)

Product Characteristics

Color

PINK

S core

no sco re

S hap e

CAPSULE (CAPSULE)

S iz e

16 mm

Flavor

Imprint Code

S48 9 ;10 mg

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 417-10 1-10

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /30 /20 14

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 219 77

0 8 /30 /20 14

VYVANSE

lisdexamfetamine dimesylate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 417-10 2

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT76 1GEGS) (LISDEXAMFETAMINE -

UNII:H6 45GUL8 KJ)

LISDEXAMFETAMINE

DIMESYLATE

20 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

Product Characteristics

Color

WHITE (ivo ry)

S core

no sco re

S hap e

CAPSULE (CAPSULE)

S iz e

16 mm

Flavor

Imprint Code

S48 9 ;20 mg

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 417-10 2-10

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/10 /20 0 7

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 219 77

12/10 /20 0 7

VYVANSE

lisdexamfetamine dimesylate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 417-10 3

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT76 1GEGS) (LISDEXAMFETAMINE -

UNII:H6 45GUL8 KJ)

LISDEXAMFETAMINE

DIMESYLATE

30 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C RED NO . 3 (UNII: PN2ZH5LOQY)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

Product Characteristics

Color

WHITE (white) , ORANGE (o range)

S core

no sco re

S hap e

CAPSULE (CAPSULE)

S iz e

16 mm

Flavor

Imprint Code

S48 9 ;30 mg

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 417-10 3-10

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/23/20 0 7

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 219 77

0 2/23/20 0 7

VYVANSE

lisdexamfetamine dimesylate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 417-10 4

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT76 1GEGS) (LISDEXAMFETAMINE -

UNII:H6 45GUL8 KJ)

LISDEXAMFETAMINE

DIMESYLATE

40 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

Product Characteristics

Color

WHITE (white) , TURQUOISE (blue-green)

S core

no sco re

S hap e

CAPSULE (CAPSULE)

S iz e

16 mm

Flavor

Imprint Code

S48 9 ;40 mg

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 417-10 4-10

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/10 /20 0 7

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 219 77

12/10 /20 0 7

VYVANSE

lisdexamfetamine dimesylate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 417-10 5

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT76 1GEGS) (LISDEXAMFETAMINE -

UNII:H6 45GUL8 KJ)

LISDEXAMFETAMINE

DIMESYLATE

50 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

Product Characteristics

Color

WHITE (white) , BLUE (blue)

S core

no sco re

S hap e

CAPSULE (CAPSULE)

S iz e

16 mm

Flavor

Imprint Code

S48 9 ;50 mg

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 417-10 5-10

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/23/20 0 7

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 219 77

0 2/23/20 0 7

VYVANSE

lisdexamfetamine dimesylate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 417-10 6

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT76 1GEGS) (LISDEXAMFETAMINE -

UNII:H6 45GUL8 KJ)

LISDEXAMFETAMINE

DIMESYLATE

6 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

Product Characteristics

Color

TURQUOISE (aqua)

S core

no sco re

S hap e

CAPSULE (CAPSULE)

S iz e

16 mm

Flavor

Imprint Code

S48 9 ;6 0 mg

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 417-10 6 -10

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/10 /20 0 7

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 219 77

12/10 /20 0 7

VYVANSE

lisdexamfetamine dimesylate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 417-10 7

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT76 1GEGS) (LISDEXAMFETAMINE -

UNII:H6 45GUL8 KJ)

LISDEXAMFETAMINE

DIMESYLATE

70 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

GELATIN, UNSPECIFIED (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C RED NO . 3 (UNII: PN2ZH5LOQY)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

Product Characteristics

Color

BLUE (blue) , ORANGE (o range)

S core

no sco re

S hap e

CAPSULE (CAPSULE)

S iz e

16 mm

Flavor

Imprint Code

S48 9 ;70 mg

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 417-10 7-10

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/23/20 0 7

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 219 77

0 2/23/20 0 7

VYVANSE

lisdexamfetamine dimesylate tablet, chewable

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 417-115

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT76 1GEGS) (LISDEXAMFETAMINE -

UNII:H6 45GUL8 KJ)

LISDEXAMFETAMINE

DIMESYLATE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MANNITO L (UNII: 3OWL53L36 A)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

GUAR GUM (UNII: E8 9 I16 37KE)

Product Characteristics

Color

WHITE (White to o ff-white)

S core

no sco re

S hap e

ROUND

S iz e

Flavor

STRAWBERRY

Imprint Code

10 ;S48 9

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 417-115-0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA20 8 510

0 1/28 /20 17

VYVANSE

lisdexamfetamine dimesylate tablet, chewable

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 417-116

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT76 1GEGS) (LISDEXAMFETAMINE -

UNII:H6 45GUL8 KJ)

LISDEXAMFETAMINE

DIMESYLATE

20 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MANNITO L (UNII: 3OWL53L36 A)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

GUAR GUM (UNII: E8 9 I16 37KE)

Product Characteristics

Color

WHITE (White to o ff-white)

S core

no sco re

S hap e

HEXAGON (6 SIDED)

S iz e

10 mm

Flavor

STRAWBERRY

Imprint Code

20 ;S48 9

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 417-116 -0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA20 8 510

0 1/28 /20 17

VYVANSE

lisdexamfetamine dimesylate tablet, chewable

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 417-117

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT76 1GEGS) (LISDEXAMFETAMINE -

UNII:H6 45GUL8 KJ)

LISDEXAMFETAMINE

DIMESYLATE

30 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MANNITO L (UNII: 3OWL53L36 A)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

GUAR GUM (UNII: E8 9 I16 37KE)

Product Characteristics

Color

WHITE (White to o ff-white)

S core

no sco re

S hap e

TRIANGLE

S iz e

11mm

Flavor

STRAWBERRY

Imprint Code

30 ;S48 9

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 417-117-0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA20 8 510

0 1/28 /20 17

VYVANSE

lisdexamfetamine dimesylate tablet, chewable

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 417-118

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT76 1GEGS) (LISDEXAMFETAMINE -

UNII:H6 45GUL8 KJ)

LISDEXAMFETAMINE

DIMESYLATE

40 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MANNITO L (UNII: 3OWL53L36 A)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

GUAR GUM (UNII: E8 9 I16 37KE)

Product Characteristics

Color

WHITE (White to o ff-white)

S core

no sco re

S hap e

OVAL (CAPSULE)

S iz e

14mm

Flavor

STRAWBERRY

Imprint Code

40 ;S48 9

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 417-118 -0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA20 8 510

0 1/28 /20 17

VYVANSE

lisdexamfetamine dimesylate tablet, chewable

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 417-119

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT76 1GEGS) (LISDEXAMFETAMINE -

UNII:H6 45GUL8 KJ)

LISDEXAMFETAMINE

DIMESYLATE

50 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MANNITO L (UNII: 3OWL53L36 A)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

GUAR GUM (UNII: E8 9 I16 37KE)

Product Characteristics

Color

WHITE (White to o ff-white)

S core

no sco re

S hap e

SQUARE

S iz e

10 mm

Flavor

STRAWBERRY

Imprint Code

50 ;S48 9

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 417-119 -0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA20 8 510

0 1/28 /20 17

VYVANSE

lisdexamfetamine dimesylate tablet, chewable

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 417-120

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LISDEXAMFETAMINE DIMESYLATE (UNII: SJT76 1GEGS) (LISDEXAMFETAMINE -

UNII:H6 45GUL8 KJ)

LISDEXAMFETAMINE

DIMESYLATE

6 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MANNITO L (UNII: 3OWL53L36 A)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

GUAR GUM (UNII: E8 9 I16 37KE)

Product Characteristics

Color

WHITE (White to o ff-white)

S core

no sco re

S hap e

DIAMOND

S iz e

14mm

Flavor

STRAWBERRY

Imprint Code

6 0 ;S48 9

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 417-120 -0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA20 8 510

0 1/28 /20 17

Labeler -

Shire LLC (626122043)

Establishment

Shire LLC

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

AMRI

Re nsse la e r,

Inc .

12419 379 3

ANALYSIS(59 417-10 1, 59 417-10 2, 59 417-10 3, 59 417-10 4, 59 417-10 5, 59 417-10 6 , 59 417-10 7, 59 417-

115, 59 417-116 , 59 417-117, 59 417-118 , 59 417-119 , 59 417-120 ) , API MANUFACTURE(59 417-10 1,

59 417-10 2, 59 417-10 3, 59 417-10 4, 59 417-10 5, 59 417-10 6 , 59 417-10 7, 59 417-115, 59 417-116 , 59 417-

117, 59 417-118 , 59 417-119 , 59 417-120 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ca mbre x

Cha rle s

City, Inc

78 29 74257

ANALYSIS(59 417-10 1, 59 417-10 2, 59 417-10 3, 59 417-10 4, 59 417-10 5, 59 417-10 6 , 59 417-10 7, 59 417-

115, 59 417-116 , 59 417-117, 59 417-118 , 59 417-119 , 59 417-120 ) , API MANUFACTURE(59 417-10 1, 59 417-

10 2, 59 417-10 3, 59 417-10 4, 59 417-10 5, 59 417-10 6 , 59 417-10 7, 59 417-115, 59 417-116 , 59 417-117,

59 417-118 , 59 417-119 , 59 417-120 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pa the o n

Ma nufa c turing

Services LLC

0 79 41556 0

ANALYSIS(59 417-10 1, 59 417-10 2, 59 417-10 3, 59 417-10 4, 59 417-10 5, 59 417-10 6 , 59 417-10 7) ,

MANUFACTURE(59 417-10 1, 59 417-10 2, 59 417-10 3, 59 417-10 4, 59 417-10 5, 59 417-10 6 , 59 417-

10 7) , PACK(59 417-10 1, 59 417-10 2, 59 417-10 3, 59 417-10 4, 59 417-10 5, 59 417-10 6 , 59 417-10 7)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Metrics, Inc.

8 6 7220 26 1

ANALYSIS(59 417-10 1, 59 417-10 2, 59 417-10 3, 59 417-10 4, 59 417-10 5, 59 417-10 6 , 59 417-10 7)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pa the o n

Pha rma c e utic a ls

Inc .

0 0 528 6 8 22

ANALYSIS(59 417-10 1, 59 417-10 2, 59 417-10 3, 59 417-10 4, 59 417-10 5, 59 417-10 6 , 59 417-10 7,

59 417-115, 59 417-116 , 59 417-117, 59 417-118 , 59 417-119 , 59 417-120 ) , MANUFACTURE(59 417-

10 1, 59 417-10 2, 59 417-10 3, 59 417-10 4, 59 417-10 5, 59 417-10 6 , 59 417-10 7, 59 417-115, 59 417-

116 , 59 417-117, 59 417-118 , 59 417-119 , 59 417-120 ) , PACK(59 417-10 1, 59 417-10 2, 59 417-10 3,

59 417-10 4, 59 417-10 5, 59 417-10 6 , 59 417-10 7, 59 417-115, 59 417-116 , 59 417-117, 59 417-118 ,

59 417-119 , 59 417-120 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Sharp Packaging Systems,

Inc .

1436 9 6 49 5

PACK(59 417-10 1, 59 417-10 2, 59 417-10 3, 59 417-10 4, 59 417-10 5, 59 417-10 6 ,

59 417-10 7)

Revised: 10/2019

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