for: Diabetes Type 2
Adlyxin (lixisenatide) is a once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus.
How Supplied
ADLYXIN injection is supplied in a disposable single-patient use pen containing a sterile, clear solution for subcutaneous administration. Each prefilled pen contains 3 mL solution. The green starter pen contains 50 mcg/mL of ADLYXIN and delivers 14 doses of 10 mcg, and the burgundy maintenance pen contains 100 mcg/mL of ADLYXIN and delivers 14 doses of 20 mcg.
The following packages are available:
Starter Pack, NDC 0024-5745-02: For treatment initiation, Starter Pack contains 1 prefilled green pen of ADLYXIN 10 mcg (NDC 0024-5741-01) and 1 prefilled burgundy pen of ADLYXIN 20 mcg (NDC 0024-5740-00).
Maintenance Pack, NDC 0024-5747-02: Contains 2 prefilled burgundy pens for ADLYXIN 20 mcg (NDC 0024-5740-00).
16.2 Storage and Handling
Prior to first use, ADLYXIN should be stored in a refrigerator, 36°F�"46°F (2°C�"8°C). Do not freeze. Keep the prefilled pen in the original package to protect it from light.
After first use, store below 86°F (30°C). Replace the pen cap after each use to protect from light. Discard pen 14 days after first use.
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 or diabetic ketoacidosis.
Has not been studied in combination with short acting insulin.
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 3 mL in green prefilled pen (for 14 pre-set doses; 10 mcg per dose) (3).
Injection: 100 mcg/mL in 3 mL in burgundy prefilled pen (for 14 pre-set doses; 20 mcg per dose) (3).
CONTRAINDICATIONS
Hypersensitivity to ADLYXIN or any product components. Hypersensitivity reactions including anaphylaxis have occurred with 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 Sulfonylurea or Basal Insulin: When ADLYXIN is used with a sulfonylurea or basal insulin, consider lowering the dose of the sulfonylurea or basal insulin to reduce the risk of hypoglycemia. (5.4).
Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. ADLYXIN is not recommended in patients with end stage renal disease (5.5).
Immunogenicity: Patients may develop antibodies to lixisenatide. If there is worsening glycemic control or failure to achieve targeted glycemic control, significant injection site reactions or allergic reactions, alternative antidiabetic therapy should be considered (5.6).
Macrovascular Outcomes: Clinical studies have not shown macrovascular risk reduction with ADLYXIN or any other antidiabetic drug (5.7).
ADVERSE REACTIONS
The most common adverse reactions (≥5%) of patients treated with ADLYXIN are nausea, vomiting, headache, diarrhea, dizziness, and hypoglycemia (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
ADLYXIN delays gastric emptying which may impact absorption of concomitantly administered oral medications. Oral medications that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, or medications for which a delay in effect is undesirable, such as acetaminophen, should be administered 1 hour before ADLYXIN (7.1, 12.3).
Oral contraceptives should be taken at least 1 hour before ADLYXIN administration or 11 hours after the dose of ADLYXIN (7.1, 12.3).
USE IN SPECIFIC POPULATIONS
Pregnancy: ADLYXIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (8.1).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 1/2019
Clinical Information
Gen. Code and Des.
71735 lixisenatide SUBCUT PEN INJCTR 10-20 (1)
Strength
10 mcg/0.2 mL per dose (1)-20 mcg/0.2 mL per dose (1)
Dose Form
PEN INJECTOR (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
68200600 INCRETIN MIMETICS
Active Ingredients
15267 lixisenatide 320367133
Inactive Ingredients
3199 phenol 108952
756 sodium acetate 127093
