SEMAGLUT

Glycemic Control & Weight Management

SEMAGLUT is a recombinant DNA–engineered analog of human glucagon-like peptide-1 (GLP-1). It is used in medical practice for the treatment of type 2 diabetes mellitus and is recognized for its effects on blood glucose regulation, appetite control, and body weight management.

When SEMAGLUT is used:

• In type 2 diabetes mellitus as an adjunct to diet and exercise

• To improve glycemic control

• Within treatment protocols aimed at reducing body weight and adipose tissue

• In patients with elevated cardiovascular risk (within approved indications)

Pharmacological properties:

Semaglutide is a GLP-1 receptor agonist with high homology to the endogenous human hormone. Its action includes:

• Glucose-dependent stimulation of insulin secretion

• Suppression of glucagon secretion in the presence of elevated glucose levels

• Delayed gastric emptying

• Reduction in appetite and caloric intake

The use of semaglutide is associated with weight reduction and improvements in lipid profile parameters.

Clinical effects:

• Reduction of fasting and postprandial glucose levels

• Improved glycemic control (HbA1c)

• Decrease in body weight and fat mass

• Reduced appetite and cravings for high-calorie foods

• Positive cardiovascular outcomes in patients with type 2 diabetes

Clinical studies have demonstrated significant body weight reduction (on average 10–15% of baseline body weight) in individuals with obesity.

Pharmaceutical quality:

• Recombinant analog of human GLP-1

• High biological purity

• Stable pharmaceutical formulation

• Manufactured in compliance with GMP standards

Dosage form:

Lyophilized white or off-white powder for solution for injection.

After reconstitution, a clear, colorless solution free of visible particles is obtained.

Packaging:

• 1 vial × 5 mg

• 2 vials × 5 mg

Storage conditions:

After reconstitution, store refrigerated at 2–8°C (36–46°F) and use within 56 days.

Do not freeze.

Administration:

Reconstitution: Add 2.0 mL of bacteriostatic water → final concentration approximately 2.5 mg/mL.

Weekly dose range: 250–2400 mcg (0.25–2.4 mg) once weekly (dose-escalation protocol).

Measurement convenience: At a concentration of 2.5 mg/mL, 1 unit (0.01 mL) ≈ 25 mcg using a U-100 insulin syringe.

Dosing & Titration:

Recommended dosing approach based on clinical studies and approved clinical data:

Weeks 1–4: 250 mcg (0.25 mg) once weekly to establish baseline tolerance

Weeks 5–8: 500 mcg (0.5 mg) once weekly

Weeks 9–12: 1000 mcg (1.0 mg) once weekly

Weeks 13–16: 1700 mcg (1.7 mg) once weekly

Weeks 17+: 2400 mcg (2.4 mg) once weekly as the target maintenance dose

The 2.4 mg once-weekly maintenance dose is FDA-approved for chronic weight management and represents the standard clinical approach.

Frequency: Once weekly (subcutaneous injection).

Timing: Administer on the same day each week at any time of day; rotate injection sites to minimize local irritation.

Laboratory Verification:

Certificate of Analysis (CoA):

BioRegen:

Manufacturer:

American Pharmaceutical, Inc.

Ohio, USA