Awiqli Icodec Insulin Injection

1. Indications and Usage
Type 2 Diabetes Mellitus: Used as basal insulin for the treatment of adult patients with type 2 diabetes mellitus to improve glycemic control.
2. Dosage and Administration
Route of Administration: For Subcutaneous (SC) Injection ONLY.
Recommended Dosage:
Initial Dosing: For patients naïve to insulin, the recommended starting dose is 70 units once weekly, or individualized based on patient status. Doses can be titrated in increments of 10 units.
Conversion: When switching from daily basal insulin, the weekly dose is generally calculated as the total daily basal dose multiplied by 7, rounded to the nearest 10 units.
Critical Administration Instructions:
Timing: Administer once weekly on the same day of the week, with or without meals.
Missed Dose: If a missed dose occurs within 3 days of the scheduled day, administer immediately and resume the original weekly schedule. If more than 3 days have passed, administer the missed dose and start a new weekly schedule on the day the dose was missed.
3. Mechanism of Action
Receptor Binding: Binds specifically to insulin receptors, producing pharmacological effects identical to endogenous human insulin, regulating glucose metabolism.
Albumin Binding: Reversibly binds to serum albumin, forming a reservoir in the circulation that allows for slow and continuous release.
Prolonged Duration: This mechanism provides a stable, long-acting basal profile with a duration of action exceeding one week.
4. Safety and Warnings
Hypoglycemia: The most common adverse reaction. Risk increases if meals are skipped, during unplanned vigorous exercise, or when combined with other glucose-lowering drugs.
Hypersensitivity: Contraindicated in patients with severe hypersensitivity to icodec insulin or any excipients.
Hypokalemia: Like all insulin therapies, may cause hypokalemia, which needs to be monitored in certain clinical contexts.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Hypoglycemia (including nocturnal hypoglycemia), injection site reactions, and hypersensitivity reactions.
Clinical Research Highlights: Phase 3 clinical trials (ONWARDS 1-6) demonstrated that once-weekly icodec insulin provided non-inferior glycemic control compared to daily basal insulin (e.g., insulin glargine or degludec), with a comparable safety profile regarding hypoglycemia.
6. Drug Interactions
Glucose-Lowering Agents: Concomitant use with oral antidiabetics (e.g., sulfonylureas, metformin) or GLP-1 receptor agonists increases the risk of hypoglycemia; dose reduction of the concomitant agent may be necessary.
Drugs Affecting Glucose Metabolism: Certain drugs may alter glucose-lowering activity. Beta-blockers, ACE inhibitors, and salicylates may increase the risk of hypoglycemia, while corticosteroids and thiazides may raise blood glucose levels.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Icodec insulin (recombinant DNA technology). Concentration: 700 units/mL.
Appearance: Clear, colorless solution.
Packaging: Available in single-use pre-filled pens (e.g., 1 mL, 1.5 mL, or 3 mL).
Storage: Store in a refrigerator at 2°C to 8°C; do not freeze. After first use, it may be kept at room temperature (below 30°C) or in the refrigerator for up to 12 weeks.