Yinuoqing Efsubaglutide Alfa Injection

1. Indications and Usage
Type 2 Diabetes Mellitus: Used as an adjunct to diet and exercise for improving glycemic control in adult patients with type 2 diabetes.
Monotherapy: For patients who have not achieved adequate glycemic control with diet and exercise alone.
Combination Therapy: For patients who have not achieved adequate glycemic control on metformin alone, used in combination with metformin.
2. Dosage and Administration
Route of Administration: For Subcutaneous (SC) Injection ONLY.
Recommended Dosage:
Monotherapy: The recommended starting dose is 1 mg administered once weekly. To further improve glycemic control, the dose may be increased to 3 mg once weekly.
Combination Therapy: When added to metformin, the recommended dose is 3 mg administered once weekly.
Critical Administration Instructions:
Administration Site: Administer in the abdomen, thigh, or upper arm. Rotate injection sites within the same area.
Timing: Administer once weekly on the same day, with or without meals.
Missed Dose: If a dose is missed, administer it as soon as possible within 5 days. If more than 5 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day.
3. Mechanism of Action
GLP-1 Receptor Agonism: Efsubaglutide alfa is a long-acting GLP-1 receptor agonist.
Glucose-Dependent Insulin Secretion: It activates GLP-1 receptors on pancreatic beta cells, increasing glucose-dependent insulin secretion and suppressing glucagon release.
Gastric Emptying: It delays gastric emptying, which helps reduce postprandial glucose excursions and promotes satiety.
4. Safety and Warnings
Thyroid C-Cell Tumors: GLP-1 receptor agonists cause thyroid C-cell tumors in rodents. It is unknown whether efsubaglutide alfa causes such tumors in humans. It is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Pancreatitis: Acute pancreatitis has been reported with GLP-1 receptor agonists. Patients should be monitored for signs and symptoms of pancreatitis.
Hypersensitivity: Serious hypersensitivity reactions have been reported. Discontinue the drug if a hypersensitivity reaction is suspected.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: The most common adverse reactions are gastrointestinal disorders, including diarrhea, nausea, and vomiting. These typically occur during the early stages of treatment and are usually mild to moderate.
Low Blood Sugar: Hypoglycemia occurs at a low frequency when used as monotherapy but increases when combined with sulfonylureas or insulin.
Clinical Research Highlights: Phase 3 clinical trials demonstrated that efsubaglutide alfa significantly reduced hemoglobin A1c (HbA1c) and body weight compared to placebo in patients with type 2 diabetes.
6. Drug Interactions
Oral Medications: Due to the delayed gastric emptying effect, concomitant use with oral medications may decrease their absorption. This is particularly relevant for drugs with a narrow therapeutic index.
Hypoglycemic Agents: Concomitant use with insulin or sulfonylureas increases the risk of hypoglycemia; a reduction in the dose of the concomitant hypoglycemic agent may be necessary.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Efsubaglutide alfa. Excipients: Sodium phosphate dibasic (dodecahydrate), sodium phosphate dihydrogen monohydrate, mannitol, polysorbate 80, water for injection.
Appearance: Clear, colorless solution.
Packaging: Available as 1 mg/0.5 mL or 3 mg/0.5 mL single-use pre-filled pens.
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze. Protect from light.