ADLYXIN- lixisenatide kit ADLYXIN- lixisenatide injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIXISENATIDE (UNII: 74O62BB01U) (LIXISENATIDE - UNII:74O62BB01U)

Available from:

sanofi-aventis U.S. LLC

INN (International Name):

Lixisenatide

Composition:

Lixisenatide 50 ug in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ADLYXIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use : - ADLYXIN has not been studied in patients with chronic pancreatitis or a history of unexplained pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis [see Warnings and Precautions (5.2)] . - ADLYXIN should not be used in patients with type 1 diabetes mellitus. - ADLYXIN has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis. ADLYXIN is contraindicated in patients with known severe hypersensitivity to lixisenatide or to any component of ADLYXIN. Hypersensitivity reactions including anaphylaxis have occurred with ADLYXIN [see Warnings and Precautions (5.1)and Adverse Reactions (6.1)] . Risk Summary The limited available data with lixisenatide in pregnant women are not sufficient to inform a drug-associated risk of major birth defects a

Product summary:

ADLYXIN (lixisenatide) injection is a clear and colorless solution supplied in a 3 mL single-patient-use pen. The green starter pen is 50 mcg/mL and delivers 14 doses of 10 mcg. The burgundy maintenance pen is 100 mcg/mL and delivers 14 doses of 20 mcg. The following packages are available: Prior to first use, ADLYXIN should be stored in a refrigerator, 36°F to 46°F (2°C to 8°C). Do not freeze. Keep the prefilled pen in the original package to protect it from light. After first use, store up to 86°F (30°C). Replace the pen cap after each use to protect from light. Discard pen 14 days after first use.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

ADLYXIN- LIXISENATIDE INJECTION, SOLUTION
sanofi-aventis U.S. LLC
----------
MEDICATION GUIDE
ADLYXIN ®(ad-LIX-in)
(lixisenatide)
injection, for subcutaneous use
What is the most important information I should know about ADLYXIN?
Do not share your ADLYXIN pen with other people, even if the needle
has been changed. You may give
other people a serious infection or get a serious infection from them.
ADLYXIN may cause serious side effects including inflammation of the
pancreas (pancreatitis), which
may be severe and lead to death.
Before using ADLYXIN, tell your healthcare provider if you have had:
•
pancreatitis
•
stones in your gallbladder (cholelithiasis)
•
a history of alcoholism
These medical problems may make you more likely to get pancreatitis.
Stop taking ADLYXIN and call your healthcare provider right away if
you have pain in your stomach
area (abdomen) that is severe and will not go away. The pain may be
felt going from your abdomen
through to your back. The pain may happen with or without vomiting.
These may be symptoms of
pancreatitis.
What is ADLYXIN?
ADLYXIN is an injectable prescription medicine that may improve blood
sugar (glucose) control in
adults with type 2 diabetes, when used with diet and exercise.
•
ADLYXIN is not for use in people with type 1 diabetes.
•
ADLYXIN has not been studied in people with a history of pancreatitis.
•
ADLYXIN has not been studied in people who have a stomach problem that
causes slow
emptying of the stomach (gastroparesis). ADLYXIN is not for people
with slow emptying of the
stomach.
•
It is not known if ADLYXIN is safe and effective in children.
Who should not use ADLYXIN?
Do not use ADLYXIN if you:
•
are allergic to lixisenatide or any of the ingredients in ADLYXIN. See
the end of this Medication
Guide for a complete list of ingredients in ADLYXIN.
Symptoms of a severe allergic reaction with ADLYXIN may include:
•
swelling of your face, lips, tongue, or
throat
•
problems breathing or swallowing
•
severe rash or itching
•
fainting or feeling d

Summary of Product characteristics

ADLYXIN- LIXISENATIDE
ADLYXIN- LIXISENATIDE INJECTION, SOLUTION
SANOFI-AVENTIS U.S. LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADLYXIN
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADLYXIN.
ADLYXIN (LIXISENATIDE) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
ADLYXIN is a glucagon-like peptide-1 (GLP-1) receptor agonist
indicated as an adjunct to diet and exercise
to improve glycemic control in adults with type 2 diabetes mellitus. (
1)
Limitations of Use: ( 1)
Has not been studied in patients with chronic pancreatitis or a
history of unexplained pancreatitis.
Consider other antidiabetic therapies in patients with a history of
pancreatitis.
Not for treatment of type 1 diabetes.
Has not been studied in patients with gastroparesis and is not
recommended in patients with
gastroparesis.
DOSAGE AND ADMINISTRATION
Initiate at 10 mcg once daily for 14 days. On Day 15, increase dosage
to 20 mcg once daily. ( 2.1)
Administer once daily within one hour before the first meal of the
day. ( 2.2)
Inject subcutaneously in the abdomen, thigh or upper arm. ( 2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 50 mcg/mL in a 3 mL single-patient-use prefilled pen (for
14 doses of 10 mcg per dose). ( 3)
Injection: 100 mcg/mL in a 3 mL single-patient-use prefilled pen (for
14 doses of 20 mcg per dose). ( 3)
CONTRAINDICATIONS
Severe hypersensitivity to lixisenatide or any component of ADLYXIN. (
4)
WARNINGS AND PRECAUTIONS
Anaphylaxis and Serious Hypersensitivity Reactions: Discontinue
ADLYXIN and promptly seek medical
advice. ( 5.1)
Pancreatitis: Discontinue promptly if pancreatitis is suspected. Do
not restart if pancreatitis is
confirmed. Consider other antidiabetic therapies in patients with a
history of pancreatitis. ( 5.2)
Never share ADLYXIN pen between patients, even if the needle is
changed. ( 5.3)
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin:
Patients taking an insulin
secretagogue or