Adlyxin Lixisenatide Injection

1. Indications and Usage
Glycemic Control in Type 2 Diabetes:
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:
Not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
2. Dosage and Administration
Route of Administration:
For Subcutaneous Injection ONLY. Administer once daily, at any time within 1 hour before a meal.
Recommended Dosage:
Initial Dose: 10 mcg once daily for the first 14 days to minimize gastrointestinal side effects.
Maintenance Dose: After 14 days, increase the dose to 20 mcg once daily.
Administration Instructions:
If a dose is missed, it should be administered within 1 hour before the next meal. If the patient does not remember within 1 hour before the meal, the dose should be skipped, and the regular schedule resumed the next day.
3. Mechanism of Action
GLP-1 Receptor Agonist:
Lixisenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist that activates the GLP-1 receptor.
Glucose-Dependent Insulin Secretion:
It stimulates glucose-dependent insulin secretion and suppresses glucagon secretion.
Delayed Gastric Emptying:
It significantly delays gastric emptying, which is particularly effective in reducing postprandial (after-meal) glucose excursions.
4. Safety and Warnings
Acute Pancreatitis:
Monitor for signs and symptoms of pancreatitis (e.g., persistent severe abdominal pain). Discontinue promptly if suspected.
Hypoglycemia:
The risk of hypoglycemia is increased when lixisenatide is used concomitantly with a sulfonylurea or insulin. Consider reducing the dose of the sulfonylurea or insulin.
Renal Impairment:
Gastrointestinal adverse reactions (nausea, vomiting, diarrhea) may lead to dehydration and subsequent acute renal failure. Caution is advised in patients with renal impairment.
Immunogenicity:
Patients may develop anti-lixisenatide antibodies. The clinical significance is not fully established.
5. Adverse Reactions
Most Common:
Hypoglycemia (especially with sulfonylurea), nausea, vomiting, diarrhea, headache, dizziness, and fatigue.
Gastrointestinal Events:
Gastrointestinal adverse reactions are the most frequent side effects, occurring primarily during the dose-escalation phase (first 2-3 weeks) and generally decreasing over time.
6. Drug Interactions
Oral Medications:
Due to delayed gastric emptying, lixisenatide may impact the absorption of concomitantly administered oral medications.
Narrow Therapeutic Index Drugs: Caution is advised for drugs like warfarin or drugs requiring rapid absorption.
Oral Contraceptives: Administer oral contraceptives at least 1 hour before or 11 hours after lixisenatide injection to ensure adequate absorption.
Acetaminophen (Paracetamol): Used as a marker drug in studies; absorption is delayed, though total exposure (AUC) is generally unchanged.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Lixisenatide (recombinant human GLP-1 analog).
Available Strengths: Prefilled pens (e.g., 10 mcg/0.2 mL and 20 mcg/0.3 mL).
Storage:
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. In-use pens may be stored at room temperature (below 30°C/86°F) for up to 28 days.