TRELSTAR- triptorelin pamoate kit

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

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Active ingredient:
TRIPTORELIN PAMOATE (UNII: 08AN7WA2G0) (TRIPTORELIN - UNII:9081Y98W2V)
Available from:
Allergan, Inc.
INN (International Name):
TRIPTORELIN PAMOATE
Composition:
TRIPTORELIN 3.75 mg in 2 mL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
TRELSTAR is indicated for the palliative treatment of advanced prostate cancer [see  Clinical Studies (14) ]. TRELSTAR is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH [see Warnings and Precautions (5.1) ]. Risk Summary Based on findings in animal studies and mechanism of action, TRELSTAR can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . Expected hormonal changes that occur with TRELSTAR treatment increase the risk for pregnancy loss. In animal developmental and reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus. Dat
Product summary:
TRELSTAR is supplied in the TRELSTAR MIXJECT single-dose delivery system consisting of a vial with a Flip-Off seal containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids, a MIXJECT vial adapter, and a pre-filled syringe containing sterile water for injection, USP, 2 mL, pH 6 to 8.5. TRELSTAR 3.75 mg –NDC 0023-5902-04 (TRELSTAR 3.75 mg with MIXJECT single-dose delivery system) TRELSTAR 11.25 mg –NDC 0023-5904-12 (TRELSTAR 11.25 mg with MIXJECT single-dose delivery system) TRELSTAR 22.5 mg –NDC 0023-5906-23 (TRELSTAR 22.5 mg with MIXJECT single-dose delivery system) Storage Store at 20-25°C (68-77°F).  [See USP Controlled Room Temperature.]  Do not freeze TRELSTAR with MIXJECT.
Authorization status:
New Drug Application
Authorization number:
0023-5902-04, 0023-5904-12, 0023-5906-23

TRELSTAR- triptorelin pamoate

Allergan, Inc.

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

prescribing information for TRELSTAR.

TRELSTAR (triptorelin pamoate for injectable suspension), for intramuscular use

Initial U.S. Approval: 2000

RECENT MAJOR CHANGES

Warnings and Precautions, Embryo-Fetal Toxicity (5.9) 12/2018

INDICATIONS AND USAGE

TRELSTAR is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced

prostate cancer. (1)

DOSAGE AND ADMINISTRATION

TRELSTAR is administered as a single intramuscular injection in either buttock. Due to different release characteristics,

the dosage strengths are not additive and must be selected based upon the desired dosing schedule. (2.1)

3.75 mg every 4 weeks. (2.1)

11.25 mg every 12 weeks. (2.1)

22.5 mg every 24 weeks. (2.1)

DOSAGE FORMS AND STRENGTHS

Injectable suspension: 3.75 mg, 11.25 mg, 22.5 mg. (3)

CONTRAINDICATIONS

Known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH. (4)

WARNINGS AND PRECAUTIONS

Hypersensitivity: Anaphylactic shock, hypersensitivity, and angioedema have been reported. In the event of a reaction,

discontinue TRELSTAR and initiate appropriate medical management. (5.1)

Tumor Flare: Transient increase in serum testosterone levels can occur within the first few weeks of treatment. This

may worsen prostate cancer and result in spinal cord compression and urinary tract obstruction. Monitor patients at risk

and manage as appropriate. (5.2 and 5.3)

Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. Consider risks and

benefits. (5.4)

Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men

receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. (5.5)

Cardiovascular Diseases: Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in

men. Monitor for cardiovascular disease and manage according to current clinical practice. (5.6)

ADVERSE REACTIONS

3.75 mg: The most common adverse reactions (≥ 5%) during TRELSTAR 3.75 mg therapy included hot flushes,

skeletal pain, impotence, and headache. (6.1)

11.25 mg: The most common adverse reactions (≥ 5%) during TRELSTAR 11.25 mg therapy included hot flushes,

skeletal pain, headache, edema in legs, and leg pain. (6.1)

22.5 mg: The most common adverse reactions (≥ 5%) during TRELSTAR 22.5 mg therapy included hot flushes,

erectile dysfunction, and testicular atrophy. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088

or www.fda.gov/medwatch.

DRUG INTERACTIONS

None. (7)

USE IN SPECIFIC POPULATIONS

Pregnancy: TRELSTAR can cause fetal harm. (5.9, 8.1)

Females and males of reproductive potential: TRELSTAR may impair fertility. (8.3)

See 17 for PATIENT COUNSELING INFORMATION.

®

Revised: 12/2018

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

2.2 Reconstitution Instructions for TRELSTAR with MIXJECT SYSTEM

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 Hypersensitivity

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

5.2 Transient Increase in Serum Testosterone

5.3 Metastatic Vertebral Lesions and Urinary Tract Obstruction

5.4 Effect on QT/QTc Interval

5.5 Hyperglycemia and Diabetes

5.6 Cardiovascular Diseases

5.7 Laboratory Tests

5.8 Laboratory Test Interactions

5.9 Embryo-Fetal Toxicity

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

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, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

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

1 INDICATIONS AND USAGE

TRELSTAR is indicated for the palliative treatment of advanced prostate cancer [see Clinical

Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

TRELSTAR must be administered under the supervision of a physician.

TRELSTAR is administered by a single intramuscular injection in either buttock. Dosing schedule

depends on the product strength selected (Table 1). The lyophilized microgranules are to be

reconstituted in sterile water. No other diluent should be used.

Table 1. TRELSTAR Recommended Dosing

Dosage

3.75 mg

11.25 mg

22.5 mg

Recommended dose

1 injection every

4 weeks

1 injection every

12 weeks

1 injection every

24 weeks

Due to different release characteristics, the dosage strengths are not additive and must be selected

based upon the desired dosing schedule.

The suspension should be administered immediately after reconstitution.

As with other drugs administered by intramuscular injection, the injection site should be alternated

periodically.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permit.

2.2 Reconstitution Instructions for TRELSTAR with MIXJECT SYSTEM

Please read the instructions completely before you begin.

MIXJECT Preparation

Wash your hands with soap and hot water and put on gloves immediately prior to preparing the

injection. Place the sealed tray on a clean, flat surface that is covered with a sterile pad or cloth. Peel

the cover away from the tray and remove the MIXJECT components and the TRELSTAR vial. Remove

the Flip-Off button from the top of the vial, revealing the rubber stopper. Place the vial in a standing

upright position on the prepared surface. Disinfect the rubber stopper with the alcohol wipe. Discard

the alcohol wipe and allow the stopper to dry. Proceed to MIXJECT Activation.

MIXJECT Activation

Peel the cover away from the blister pack

containing the vial adapter. Do not remove the vial

adapter from the blister pack. Place the blister pack

containing the vial adapter firmly on the vial top,

piercing the vial. Push down gently until you feel it

snap in place. Remove the blister pack from the vial

adapter.

(a) Screw the plunger rod into the barrel end of the

syringe. Remove the cap from the syringe barrel.

(b) Connect the syringe to the vial adapter by

screwing it clockwise into the opening on the side

of the vial adapter. Be sure to gently twist the

syringe until it stops turning to ensure a tight

connection.

While holding the vial, place your thumb on the

plunger rod and push the plunger rod in all the way

to transfer the diluent from the pre-filled syringe

into the vial. Do not release the plunger rod.

Keeping the plunger rod depressed, gently swirl the

vial so that the diluent rinses the sides of the vial.

This will ensure complete mixing of TRELSTAR

and the sterile water diluent. The suspension will

now have a milky appearance. In order to avoid

separation of the suspension, proceed to the next

steps without delay.

(a) Invert the MIXJECT system so that the vial is at

the top.

Grasp the MIXJECT system firmly by the syringe

and pull back the plunger rod slowly to draw the

reconstituted TRELSTAR into the syringe.

(b) Return the vial to its upright position, and

disconnect the vial adapter and vial from the

MIXJECT syringe assembly by turning the plastic

cap of the vial adapter clockwise.

Grasp only the plastic cap when removing.

Lift up the safety cover and remove the clear plastic

needle shield by pulling it from the assembly. The

safety cover should be perpendicular to the needle,

with the needle facing away from you. The syringe

containing the TRELSTAR suspension is now

ready for administration. The suspension should be

administered immediately after reconstitution.

After administering the injection, immediately

activate the safety mechanism by centering your

thumb or forefinger on the textured finger pad area

of the safety cover and pushing it forward over the

needle until you hear or feel it lock. Use

the one-handed technique and activate the

mechanism away from yourself and others.

Activation of the safety cover causes

virtually no splatter. Immediately discard the

syringe assembly after a single use into a suitable

sharps container.

3 DOSAGE FORMS AND STRENGTHS

Injectable suspension: 3.75 mg, 11.25 mg, 22.5 mg.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

TRELSTAR is contraindicated in individuals with a known hypersensitivity to triptorelin or any other

component of the product, or other GnRH agonists or GnRH [see Warnings and Precautions (5.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Anaphylactic shock, hypersensitivity, and angioedema related to triptorelin administration have been

reported. In the event of a hypersensitivity reaction, therapy with TRELSTAR should be discontinued

immediately and the appropriate supportive and symptomatic care should be administered.

5.2 Transient Increase in Serum Testosterone

Initially, triptorelin, like other GnRH agonists, causes a transient increase in serum testosterone levels.

As a result, isolated cases of worsening of signs and symptoms of prostate cancer during the first

weeks of treatment have been reported with GnRH agonists. Patients may experience worsening of

symptoms or onset of new symptoms, including bone pain, neuropathy, hematuria, or urethral or bladder

outlet obstruction [see Clinical Pharmacology (12.2)].

5.3 Metastatic Vertebral Lesions and Urinary Tract Obstruction

Cases of spinal cord compression, which may contribute to weakness or paralysis with or without fatal

complications, have been reported with GnRH agonists. If spinal cord compression or renal impairment

develops, standard treatment of these complications should be instituted, and in extreme cases an

immediate orchiectomy considered.

Patients with metastatic vertebral lesions and/or with upper or lower urinary tract obstruction should be

closely observed during the first few weeks of therapy.

5.4 Effect on QT/QTc Interval

Androgen deprivation therapy may prolong the QT/QTc interval. Providers should consider whether

the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long

QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs

known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic

monitoring of electrocardiograms and electrolytes.

5.5 Hyperglycemia and Diabetes

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving

GnRH agonists. Hyperglycemia may represent development of diabetes mellitus or worsening of

glycemic control in patients with diabetes. Monitor blood glucose and/or glycosylated hemoglobin

(HbA1c) periodically in patients receiving a GnRH agonist and manage with current practice for

treatment of hyperglycemia or diabetes.

5.6 Cardiovascular Diseases

Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported

in association with use of GnRH agonists in men. The risk appears low based on the reported odds

ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a

treatment for patients with prostate cancer. Patients receiving a GnRH agonist should be monitored for

symptoms and signs suggestive of development of cardiovascular disease and be managed according to

current clinical practice.

5.7 Laboratory Tests

Response to TRELSTAR should be monitored by measuring serum levels of testosterone periodically

or as indicated.

5.8 Laboratory Test Interactions

Chronic or continuous administration of triptorelin in therapeutic doses results in suppression of

pituitary-gonadal axis. Diagnostic tests of the pituitary-gonadal function conducted during treatment and

after cessation of therapy may therefore be misleading.

5.9 Embryo-Fetal Toxicity

Based on findings from animal studies and mechanism of action, TRELSTAR can cause fetal harm when

administered to a pregnant woman [Clinical Pharmacology (12.1)]. In animal developmental and

reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of

organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at

doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. Advise

pregnant patients and females of reproductive potential of the potential risk to the fetus [see Use in

Specific Populations (8.1)].

6 ADVERSE REACTIONS

6.1 Clinical Trials 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 with rates in the clinical trials of another

drug and may not reflect the rates observed in practice.

The safety of the three TRELSTAR formulations was evaluated in clinical trials involving patients with

advanced prostate cancer. Mean testosterone levels increased above baseline during the first week

following the initial injection, declining thereafter to baseline levels or below by the end of the second

week of treatment. The transient increase in testosterone levels may be associated with temporary

worsening of disease signs and symptoms, including bone pain, neuropathy, hematuria, and urethral or

bladder outlet obstruction. Isolated cases of spinal cord compression with weakness or paralysis of the

lower extremities have occurred [see Warnings and Precautions (5.3)].

Adverse reactions reported for each of the three TRELSTAR formulations in the clinical trials, are

presented in Table 2, Table 3, and Table 4. Often, causality is difficult to assess in patients with

metastatic prostate cancer. The majority of adverse reactions related to triptorelin are a result of its

pharmacological action, i.e., the induced variation in serum testosterone levels, either an increase in

testosterone at the initiation of treatment, or a decrease in testosterone once castration is achieved.

Local reactions at the injection site or allergic reactions may occur.

The following adverse reactions were reported to have a possible or probable relationship to therapy

as ascribed by the treating physician in at least 1% of patients receiving TRELSTAR 3.75 mg.

Table 2. TRELSTAR 3.75 mg: Treatment-Related Adverse

Reactions Reported by 1% or More of Patients During Treatment

Adverse Reactions

TRELSTAR 3.75

mg

N = 140

N

%

Application Site Disorders

Injection site pain

Body as a Whole

Hot flush

58.6

Pain

Leg pain

Fatigue

Cardiovascular Disorders

Hypertension

Central and Peripheral Nervous System

Dis orders

Headache

Dizziness

Gastrointestinal Disorders

Diarrhea

Vomiting

Musculoskeletal System Disorders

Skeletal pain

12.1

Psychiatric Disorders

Insomnia

Impotence

Emotional lability

Red Blood Cell Disorders

Anemia

Skin and Appendages Disorders

Pruritus

Urinary System Disorders

Urinary tract infection

Urinary retention

Adverse reactions for TRELSTAR 3.75 mg are coded using the WHO Adverse Reactions

Terminology (WHOART)

The following adverse reactions were reported to have a possible or probable relationship to therapy

as ascribed by the treating physician in at least 1% of patients receiving TRELSTAR 11.25 mg.

Table 3. TRELSTAR 11.25 mg: Treatment-Related Adverse

Reactions Reported by 1% or More of Patients During Treatment

Adverse Reactions

TRELSTAR 11.25 mg

N = 174

N

%

Application Site

Injection site pain

Body as a Whole

Hot flush

73.0

Leg pain

Pain

Back pain

Fatigue

Chest pain

Asthenia

Peripheral edema

Cardiovascular Disorders

Hypertension

Dependent edema

Central and Peripheral Nervous System

Dis orders

Headache

Dizziness

Leg cramps

*

Endocrine

Breast pain

Gynecomastia

Gastrointestinal Disorders

Nausea

Constipation

Dyspepsia

Diarrhea

Abdominal pain

Liver and Biliary System

Abnormal hepatic function

Metabolic and Nutritional Disorders

Edema in legs

Increased alkaline phosphatase

Musculoskeletal System Disorders

Skeletal pain

13.2

Arthralgia

Myalgia

Psychiatric Disorders

Decreased libido

Impotence

Insomnia

Anorexia

Respiratory System Disorders

Coughing

Dyspnea

Pharyngitis

Skin and Appendages

Rash

Urinary System Disorders

Dysuria

Urinary retention

Vision Disorders

Eye pain

Conjunctivitis

Adverse reactions for TRELSTAR 11.25 mg are coded using the WHO Adverse Reactions

Terminology (WHOART)

The following adverse reactions occurred in at least 5% of patients receiving TRELSTAR 22.5 mg.

The table includes all reactions whether or not they were ascribed to TRELSTAR by the treating

physician. The table also includes the incidence of these adverse reactions that were considered by the

treating physician to have a reasonable causal relationship or for which the relationship could not be

assessed.

Table 4. TRELSTAR 22.5 mg: Adverse Reactions Reported by 5% or More of Patients

During Treatment

Adverse Reactions

TRELSTAR 22.5 mg

N = 120

Treatment-Emergent

Treatment-Related

N

%

N

%

General Disorders and Administration Site

Conditions

Edema peripheral

Infections and Infestations

Influenza

15.8

Bronchitis

Endocrine

Diabetes Mellitus/Hyperglycemia

Musculoskeletal and Connective Tissue

Dis orders

Back pain

10.8

Arthralgia

Pain in extremity

Nervous System Disorders

Headache

Psychiatric Disorders

Insomnia

Renal and Urinary Disorders

Urinary tract infection

11.6

Urinary retention

Reproductive System and Breast Disorders

Erectile dysfunction

10.0

10.0

Testicular atrophy

Vascular Disorders

Hot flush

72.5

71.7

Hypertension

14.2

*

Adverse reactions for TRELSTAR 22.5 mg are coded using the Medical Dictionary for Regulatory

Activities (MedDRA)

Changes in Laboratory Values During Treatment

The following abnormalities in laboratory values not present at baseline were observed in 10% or more

of patients:

TRELSTAR 3.75 mg: There were no clinically meaningful changes in laboratory values detected during

therapy.

TRELSTAR 11.25 mg: Decreased hemoglobin and RBC count and increased glucose, BUN, SGOT,

SGPT, and alkaline phosphatase at the Day 253 visit.

TRELSTAR 22.5 mg: Decreased hemoglobin and increased glucose and hepatic transaminases were

detected during the study. The majority of the changes were mild to moderate.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of gonadotropin

releasing hormone agonists. Because these reactions are reported voluntarily from a population of

uncertain size, it is not always possible to reliably estimate their frequency or establish a causal

relationship to drug exposure.

During postmarketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to

infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing

hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed with a majority of

pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In

these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes,

ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical

attention has been required.

During postmarketing experience, convulsions, interstitial lung disease, and thromboembolic events

including, but not limited to, pulmonary emboli, cerebrovascular accident, myocardial infarction, deep

venous thrombosis, transient ischemic attack, and thrombophlebitis have been reported.

7 DRUG INTERACTIONS

No drug-drug interaction studies involving triptorelin have been conducted.

Human pharmacokinetic data with triptorelin suggest that C-terminal fragments produced by tissue

degradation are either degraded completely within tissues or are rapidly degraded further in plasma, or

cleared by the kidneys. Therefore, hepatic microsomal enzymes are unlikely to be involved in

triptorelin metabolism. However, in the absence of relevant data and as a precaution, hyperprolactinemic

drugs should not be used concomitantly with triptorelin since hyperprolactinemia reduces the number of

pituitary GnRH receptors.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings in animal studies and mechanism of action, TRELSTAR can cause fetal harm when

administered to a pregnant woman [see Clinical Pharmacology (12.1)]. Expected hormonal changes that

occur with TRELSTAR treatment increase the risk for pregnancy loss. In animal developmental and

reproductive toxicology studies, daily administration of triptorelin to pregnant rats during the period of

organogenesis caused maternal toxicity and embryo-fetal toxicities, including loss of pregnancy, at

doses as low as 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area. Advise

pregnant patients and females of reproductive potential of the potential risk to the fetus.

Data

Animal Data

Studies in pregnant rats administered triptorelin at doses of 2, 10, and 100 mcg/kg/day (approximately

equivalent to 0.2, 0.8, and 8 times the estimated human daily dose based on body surface area) during the

period of organogenesis demonstrated maternal toxicity and embryo-fetal toxicities. Embryo-fetal

toxicities consisted of pre-implantation loss, increased resorption, and reduced mean number of viable

fetuses at the high dose. Teratogenic effects were not observed in viable fetuses in rats or mice.

Doses administered to mice were 2, 20, and 200 mcg/kg/day (approximately equivalent to 0.1, 0.7, and 7

times the estimated human daily dose based on body surface area).

8.2 Lactation

The safety and efficacy of TRELSTAR have not been established in females. There are no data on the

presence of triptorelin in human milk, the effects of the drug on milk production, or the effects of the

drug on the breastfed child. Because of the potential for serious adverse reactions in a breastfed child

from TRELSTAR, a decision should be made to either discontinue breastfeeding, or discontinue the

drug taking into account the importance of the drug to the mother.

8.3 Females and Males of Reproductive Potential

Infertility

Males

Based on mechanism of action, TRELSTAR may impair fertility in males of reproductive potential [see

Clinical Pharmacology (12.1)].

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

Prostate cancer occurs primarily in an older population. Clinical studies with TRELSTAR have been

conducted primarily in patients ≥ 65 years [see Clinical Pharmacology (12.3) and Clinical Studies (14)].

8.6 Renal Impairment

Subjects with renal impairment had higher exposure than young healthy males [see Clinical

Pharmacology (12.3)].

8.7 Hepatic Impairment

Subjects with hepatic impairment had higher exposure than young healthy males [see Clinical

Pharmacology (12.3)].

10 OVERDOSAGE

There is no experience of overdosage in clinical trials. In single dose toxicity studies in mice and rats,

the subcutaneous LD of triptorelin was 400 mg/kg in mice and 250 mg/kg in rats, approximately 500

and 600 times, respectively, the estimated monthly human dose based on body surface area. If

overdosage occurs, therapy should be discontinued immediately and the appropriate supportive and

symptomatic treatment administered.

11 DESCRIPTION

TRELSTAR is a white to slightly yellow lyophilized cake. When reconstituted, TRELSTAR has a

milky appearance. It contains a pamoate salt of triptorelin, a synthetic decapeptide agonist analog of

gonadotropin releasing hormone (GnRH). The chemical name of triptorelin pamoate is 5-oxo-L-prolyl-

L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide

(pamoate salt). The empirical formula is C

H N O · C

H O and the molecular weight is

1699.9. The structural formula is:

Structural formula for TRELSTAR (triptorelin pamoate).

The TRELSTAR products are sterile, lyophilized biodegradable microgranule formulations supplied

as single dose vials. Refer to Table 5 for the composition of each TRELSTAR product.

Table 5. TRELSTAR Composition

Ingredients

TRELSTAR

3.75 mg

TRELSTAR

11.25 mg

TRELSTAR

22.5 mg

triptorelin pamoate

(base units)

3.75 mg

11.25 mg

22.5 mg

poly-d,l-lactide-co-glycolide

138 mg

120 mg

183 mg

mannitol, USP

71 mg

74 mg

74 mg

carboxymethylcellulose sodium,

25 mg

26 mg

26 mg

polysorbate 80, NF

1.7 mg

1.7 mg

1.7 mg

When 2 mL sterile water is added to the vial containing TRELSTAR and mixed, a suspension is formed

which is intended as an intramuscular injection. TRELSTAR is available in a vial plus a MIXJECT vial

adapter, and a separate pre-filled syringe that contains sterile water for injection, USP, 2 mL, pH 6 to

8.5.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Triptorelin is a synthetic decapeptide agonist analog of gonadotropin releasing hormone (GnRH).

Comparative in vitro studies showed that triptorelin was 100-fold more active than native GnRH in

stimulating luteinizing hormone release from monolayers of dispersed rat pituitary cells in culture and

20-fold more active than native GnRH in displacing

I-GnRH from pituitary receptor sites. In animal

studies, triptorelin pamoate was found to have 13 fold higher luteinizing hormone-releasing activity and

21-fold higher follicle-stimulating hormone-releasing activity compared to the native GnRH.

12.2 Pharmacodynamics

Following the first administration, there is a transient surge in circulating levels of luteinizing hormone

(LH), follicle-stimulating hormone (FSH), testosterone, and estradiol [see Adverse Reactions (6)]. After

chronic and continuous administration, usually 2 to 4 weeks after initiation of therapy, a sustained

decrease in LH and FSH secretion and marked reduction of testicular steroidogenesis are observed. A

reduction of serum testosterone concentration to a level typically seen in surgically castrated men is

obtained. Consequently, the result is that tissues and functions that depend on these hormones for

maintenance become quiescent. These effects are usually reversible after cessation of therapy.

Following a single intramuscular injection of TRELSTAR:

TRELSTAR 3.75 mg: serum testosterone levels first increased, peaking on Day 4, and declined

thereafter to low levels by Week 4 in healthy male volunteers.

TRELSTAR 11.25 mg: serum testosterone levels first increased, peaking on Days 2 – 3, and declined

thereafter to low levels by Weeks 3 – 4 in men with advanced prostate cancer.

TRELSTAR 22.5 mg: serum testosterone levels first increased, peaking on Day 3, and declined thereafter

to low levels by Weeks 3 – 4 in men with advanced prostate cancer.

12.3 Pharmacokinetics

Results of pharmacokinetic investigations conducted in healthy men indicate that after intravenous bolus

administration, triptorelin is distributed and eliminated according to a 3-compartment model and

corresponding half-lives are approximately 6 minutes, 45 minutes, and 3 hours.

Abs orption

Following a single intramuscular injection of TRELSTAR to patients with prostate cancer, mean peak

serum concentrations of 28.4 ng/mL, 38.5 ng/mL, and 44.1 ng/mL occurred in 1 to 3 hours after the 3.75

mg, 11.25 mg, and 22.5 mg formulations, respectively.

Triptorelin did not accumulate over 9 months (3.75 mg and 11.25 mg) or 12 months (22.5 mg) of

treatment.

Dis tribution

The volume of distribution following a single intravenous bolus dose of 0.5 mg of triptorelin peptide

was 30 – 33 L in healthy male volunteers. There is no evidence that triptorelin, at clinically relevant

concentrations, binds to plasma proteins.

Elimination

Metabolism

The metabolism of triptorelin in humans is unknown, but is unlikely to involve hepatic microsomal

enzymes (cytochrome P-450). The effect of triptorelin on the activity of other drug metabolizing

enzymes is also unknown. Thus far, no metabolites of triptorelin have been identified. Pharmacokinetic

data suggest that C-terminal fragments produced by tissue degradation are either completely degraded

in the tissues, or rapidly degraded in plasma, or cleared by the kidneys.

Excretion

Triptorelin is eliminated by both the liver and the kidneys. Following intravenous administration of 0.5

mg triptorelin peptide to six healthy male volunteers with a creatinine clearance of 149.9 mL/min,

41.7% of the dose was excreted in urine as intact peptide with a total triptorelin clearance of 211.9

mL/min. This percentage increased to 62.3% in patients with liver disease who have a lower creatinine

clearance (89.9 mL/min). It has also been observed that the nonrenal clearance of triptorelin (patient

anuric, CI

= 0) was 76.2 mL/min, thus indicating that the nonrenal elimination of triptorelin is mainly

dependent on the liver.

Special Populations

Age and Race

The effects of age and race on triptorelin pharmacokinetics have not been systematically studied.

However, pharmacokinetic data obtained in young healthy male volunteers aged 20 to 22 years with an

elevated creatinine clearance (approximately 150 mL/min) indicate that triptorelin was eliminated twice

as fast in this young population as compared with patients with moderate renal insufficiency. This is

related to the fact that triptorelin clearance is partly correlated to total creatinine clearance, which is

well known to decrease with age [see Use in Specific Populations (8.6) and (8.7)].

Pediatric

TRELSTAR has not been evaluated in patients less than 18 years of age [see Use in Specific

Populations (8.4)].

Hepatic and Renal Impairment

After an intravenous bolus injection of 0.5 mg triptorelin, the two distribution half-lives were

unaffected by renal and hepatic impairment. However, renal insufficiency led to a decrease in total

triptorelin clearance proportional to the decrease in creatinine clearance as well as increases in volume

of distribution and consequently, an increase in elimination half-life (see Table 6). In subjects with

hepatic insufficiency, a decrease in triptorelin clearance was more pronounced than that observed with

renal insufficiency. Due to minimal increases in the volume of distribution, the elimination half-life in

subjects with hepatic insufficiency was similar to subjects with renal insufficiency. Subjects with renal

or hepatic impairment had 2 to 4-fold higher exposure (AUC values) than young healthy males [see Use

in Specific Populations (8.6) and (8.7)].

Table 6. Pharmacokinetic Parameters (Mean ± SD) in Healthy Volunteers and

Special Populations Following an IV Bolus Injection of 0.5 mg Triptorelin

Group

C

(ng/mL)

AUC

(h·ng/mL)

Cl

(mL/min)

Cl

(mL/min)

t

(h)

Cl

(mL/min)

6 healthy

male

volunteers

48.2

±11.8

36.1

±5.8

211.9

±31.6

90.6

±35.3

2.81

±1.21

149.9

±7.3

6 males with

moderate

renal

impairment

45.6

±20.5

69.9

±24.6

120.0

±45.0

23.3

±17.6

6.56

±1.25

39.7

±22.5

6 males with

severe renal

impairment

46.5

±14.0

88.0

±18.4

88.6

±19.7

±2.9

7.65

±1.25

±6.0

6 males with

liver disease

54.1

±5.3

131.9

±18.1

57.8

±8.0

35.9

±5.0

7.58

±1.17

89.9

±15.1

creat

max

inf

p

re nal

1/2

c re at

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In rats, triptorelin doses of 120, 600, and 3000 mcg/kg given every 28 days (approximately 0.3, 2, and 8

times the human monthly dose based on body surface area) resulted in increased mortality with a drug

treatment period of 13 – 19 months. The incidences of benign and malignant pituitary tumors and

histiosarcomas were increased in a dose-related manner. No oncogenic effect was observed in mice

administered triptorelin for 18 months at doses up to 6000 mcg/kg every 28 days (approximately 8 times

the human monthly dose based on body surface area).

Mutagenicity studies performed with triptorelin using bacterial and mammalian systems (in vitro Ames

test and chromosomal aberration test in CHO cells and an in vivo mouse micronucleus test) provided no

evidence of mutagenic potential.

After 60 days of subcutaneous treatment followed by a minimum of four estrus cycles prior to mating,

triptorelin, at doses of 2, 20, and 200 mcg/kg/day in saline (approximately 0.2, 2, and 16 times the

estimated human daily dose based on body surface area) or 2 monthly injections as slow release

microspheres (~20 mcg/kg/day), had no effect on the fertility or general reproductive function of

female rats.

No studies were conducted to assess the effect of triptorelin on male fertility.

14 CLINICAL STUDIES

TRELSTAR 3.75 mg

TRELSTAR 3.75 mg was studied in a randomized, active control trial of 277 men with advanced

prostate cancer. The clinical trial population consisted of 59.9% Caucasian, 39.3% Black, and 0.8%

Other. There was no difference observed with triptorelin response between racial groups. Men were

between 47 and 89 years of age (mean = 71 years). Patients received either TRELSTAR 3.75 mg (N =

140) or an approved GnRH agonist monthly for 9 months. The primary efficacy endpoints were both

achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 253.

Castration levels of serum testosterone (≤ 1.735 nmol/L; equivalent to 50 ng/dL) in patients treated with

TRELSTAR 3.75 mg were achieved at Day 29 in 125 of 137 (91.2%) patients and at Day 57 in 97.7% of

patients. Maintenance of castration levels of serum testosterone from Day 57 through Day 253 was

found in 96.2% of patients treated with TRELSTAR 3.75 mg.

The presence of an acute-on-chronic flare phenomenon was also studied as a secondary efficacy

endpoint. Serum LH levels were measured at 2 hours after repeat TRELSTAR 3.75 mg administration

on Days 85 and 169. One hundred twenty-four of the 126 evaluable patients (98.4%) on Day 85 had a

serum LH level of ≤ 1.0 IU/L at 2 hours after dosing, indicating desensitization of the pituitary

gonadotroph receptors.

TRELSTAR 11.25 mg

TRELSTAR 11.25 mg was studied in a randomized, active control trial of 346 men with advanced

prostate cancer. The clinical trial population consisted of 48% Caucasian, 38% Black, and 15% Other.

There was no difference observed with triptorelin response between racial groups. Men were between

45 and 96 years of age (mean = 71 years). Patients received either TRELSTAR 11.25 mg (N = 174)

every 12 weeks for a total of up to 3 doses (maximum treatment period of 253 days) or TRELSTAR 3.75

mg (N = 172) every 28 days for a total of up to 9 doses. The primary efficacy endpoints were both

achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 253.

Castration levels of serum testosterone (≤ 1.735 nmol/L; equivalent to 50 ng/dL) were achieved at Day

29 in 167 of 171 (97.7%) patients treated with TRELSTAR 11.25 mg, and maintenance of castration

levels of serum testosterone from Day 57 through Day 253 was found in 94.4% of patients treated with

TRELSTAR 11.25 mg.

TRELSTAR 11.25 mg.

TRELSTAR 22.5 mg

TRELSTAR 22.5 mg was studied in a non-comparative trial of 120 men with advanced prostate cancer.

The clinical trial population consisted of 64% Caucasian, 23% Black, and 13% Other, with a mean age

of 71.1 years (range 51-93). Patients received TRELSTAR 22.5 mg (N = 120) every 24 weeks for a

total of 2 doses (maximum treatment period of 337 days). The primary efficacy endpoints included

achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 337.

Castration levels of serum testosterone (≤ 1.735 nmol/L; equivalent to 50 ng/dL) were achieved at Day

29 in 97.5% (117 of 120) of patients treated with TRELSTAR 22.5 mg. Castration was maintained in

93.3% of patients in the period from Day 57 to Day 337.

A summary of the clinical studies for TRELSTAR is provided in Table 7.

Table 7. Summary of TRELSTAR Clinical Studies

Product

Strength

3.75 mg

11.25 mg

22.5 mg

Number of

Patients

Treatment

Schedule

every 4 weeks

every 12 weeks

every 24 weeks

Duration of

Study

253 days

253 days

337 days

Castration Rate

on Day 29, %

(n/N)

91.2%

(125/137)

97.7%

(167/171)

97.5% (117/120)

Rate of

Castration

Maintenance

from Days 57 –

253, %

96.2%

94.4%

not applicable

Rate of

Castration

Maintenance

from Days 57 –

337, % (n/N)

not applicable

not applicable

93.3%

(112/120)

Maintenance of castration was calculated using a frequency distribution.

Cumulative maintenance of castration was calculated using a survival analysis (Kaplan-Meier)

technique.

Calculation includes 5 patients who discontinued the study but who had castrate levels of testosterone

prior to discontinuation.

16 HOW SUPPLIED/STORAGE AND HANDLING

TRELSTAR is supplied in the TRELSTAR MIXJECT single-dose delivery system consisting of a vial

with a Flip-Off seal containing sterile lyophilized triptorelin pamoate microgranules incorporated in a

biodegradable copolymer of lactic and glycolic acids, a MIXJECT vial adapter, and a pre-filled

syringe containing sterile water for injection, USP, 2 mL, pH 6 to 8.5.

TRELSTAR 3.75 mg –NDC 0023-5902-04 (TRELSTAR 3.75 mg with MIXJECT single-dose delivery

system)

TRELSTAR 11.25 mg –NDC 0023-5904-12 (TRELSTAR 11.25 mg with MIXJECT single-dose

delivery system)

TRELSTAR 22.5 mg –NDC 0023-5906-23 (TRELSTAR 22.5 mg with MIXJECT single-dose delivery

system)

Storage

Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature.] Do not freeze TRELSTAR

with MIXJECT.

17 PATIENT COUNSELING INFORMATION

Hypersensitivity

Inform patients that if they have experienced hypersensitivity with other GnRH agonist drugs like

TRELSTAR, TRELSTAR is contraindicated [see Contraindications (4)].

Tumor Flare

Inform patients that TRELSTAR can cause tumor flare during the first weeks of treatment. Inform

patients that the increase in testosterone can cause an increase in urinary symptoms or pain. Advise

patients to contact their healthcare provider if uretral obstruction, spinal cord compression,

paralysis, or new or worsened symptoms occur after beginning TRELSTAR treatment [see Warnings

and Precautions (5.2)].

Hyperglycemia and Diabetes

Advise patients that there is an increased risk of hyperglycemia and diabetes with TRELSTAR

therapy. Inform patients that periodic monitoring for hyperglycemia and diabetes is required when

being treated with TRELSTAR [see Warnings and Precautions (5.5)].

Cardiovascular Disease

Inform patients that there is an increased risk of myocardial infarction, sudden cardiac death, and

stroke with TRELSTAR treatment. Advise patients to immediately report signs and symptoms

associated with these events to their healthcare provider for evaluation [see Warnings and

Precautions (5.6)].

Urogenital Disorders

Advise patients that TRELSTAR may cause impotence.

Infertility

Inform patients that TRELSTAR may cause infertility [(see Use In Specific Populations (8.3)].

Continuation of TRELSTAR Treatment

Inform patients that TRELSTAR is usually continued, often with additional medication, after the

development of metastatic castration-resistant prostate cancer [see Dosage and Administration (2.1)].

For all medical inquiries contact:

Allergan

Medical Communications

1-800-678-1605

Distributed By:

Allergan USA, Inc.

Madison, NJ 07940

Manufactured By:

Debiopharm Research & Manufacturing SA

CH-1920 Martigny, Switzerland

MIXJECT is manufactured by:

West Pharma. Services IL, Ltd.

Ra'anana, Israel

The pre-filled syringe containing sterile water for injection is manufactured by:

Baxter Pharmaceutical Solutions, LLC

927 South Curry Pike

Bloomington, Indiana 47403

TRELSTAR® and its design are registered trademarks of Allergan Sales, LLC

MIXJECT® is a registered trademark of West Pharma. Services IL, Ltd.

© 2018 Allergan. All rights reserved.

v2.0USPI5902

PRINCIPAL DISPLAY PANEL

NDC 0023-5902-04

Trelstar 3.75 mg

3.75 mg every 4 weeks

Allergan

PRINCIPAL DISPLAY PANEL

NDC 0023-5904-12

Trelstar 11.25 mg

11.25 mg every 12 weeks

Allergan

PRINCIPAL DISPLAY PANEL

NDC 0023-5906-23

Trelstar 22.5 mg

22.5 mg every 24 weeks

Allergan

TRELSTAR

triptorelin pamoate kit

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 0 23-59 0 2

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 0 23-59 0 2-0 4

1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

0 6 /15/20 0 0

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 VIAL, SINGLE-DOSE

2 mL

Pa rt 2

1 SYRINGE

2 mL

Part 1 of 2

TRELSTAR

triptorelin pamoate injection, powder, lyophilized, for suspension

Product Information

Route of Administration

INTRAMUSCULAR

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TRIPTO RELIN PAMO ATE (UNII: 0 8 AN7WA2G0 ) (TRIPTORELIN - UNII:9 0 8 1Y9 8 W2V)

TRIPTORELIN

3.75 mg in 2 mL

Inactive Ingredients

Ingredient Name

Stre ng th

MANNITO L (UNII: 3OWL53L36 A)

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

Packag ing

#

Item

Co de

Package Description

Marketing Start

Date

Marketing End

Date

1

2 mL in 1 VIAL, SINGLE-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 20 715

0 6 /15/20 0 0

Part 2 of 2

DILUENT

diluent liquid

Product Information

Route of Administration

INTRAMUSCULAR

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

2 mL in 1 SYRINGE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 20 715

0 6 /15/20 0 0

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 20 715

0 6 /15/20 0 0

TRELSTAR

triptorelin pamoate kit

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 0 23-59 0 4

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 0 23-59 0 4-12

1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

0 6 /29 /20 0 1

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 VIAL, SINGLE-DOSE

2 mL

Pa rt 2

1 SYRINGE

2 mL

Part 1 of 2

TRELSTAR

triptorelin pamoate injection, powder, lyophilized, for suspension

Product Information

Route of Administration

INTRAMUSCULAR

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TRIPTO RELIN PAMO ATE (UNII: 0 8 AN7WA2G0 ) (TRIPTORELIN - UNII:9 0 8 1Y9 8 W2V)

TRIPTORELIN

11.25 mg in 2 mL

Inactive Ingredients

Ingredient Name

Stre ng th

MANNITO L (UNII: 3OWL53L36 A)

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

Packag ing

#

Item

Co de

Package Description

Marketing Start

Date

Marketing End

Date

1

2 mL in 1 VIAL, SINGLE-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 2128 8

0 6 /29 /20 0 1

Part 2 of 2

DILUENT

diluent liquid

Product Information

Route of Administration

INTRAMUSCULAR

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

2 mL in 1 SYRINGE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 2128 8

0 6 /29 /20 0 1

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 2128 8

0 6 /29 /20 0 1

TRELSTAR

triptorelin pamoate kit

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 0 23-59 0 6

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 0 23-59 0 6 -23

1 in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct

0 3/11/20 10

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 VIAL, SINGLE-DOSE

2 mL

Pa rt 2

1 SYRINGE

2 mL

Part 1 of 2

TRELSTAR

triptorelin pamoate injection, powder, lyophilized, for suspension

Product Information

Route of Administration

INTRAMUSCULAR

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TRIPTO RELIN PAMO ATE (UNII: 0 8 AN7WA2G0 ) (TRIPTORELIN - UNII:9 0 8 1Y9 8 W2V)

TRIPTORELIN

22.5 mg in 2 mL

Inactive Ingredients

Ingredient Name

Stre ng th

MANNITO L (UNII: 3OWL53L36 A)

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

Packag ing

#

Item

Package Description

Marketing Start

Marketing End

Allergan, Inc.

#

Co de

Package Description

Date

Date

1

2 mL in 1 VIAL, SINGLE-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 22437

0 3/11/20 10

Part 2 of 2

DILUENT

diluent liquid

Product Information

Route of Administration

INTRAMUSCULAR

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

2 mL in 1 SYRINGE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 22437

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 22437

0 3/11/20 10

Labeler -

Allergan, Inc. (144796497)

Revised: 12/2018

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