For Diabetes: Semaglutide is indicated as

• an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• It is also indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

For Obesity: Semaglutide is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with:

• BMI ≥30 kg/m² (obesity), or
• BMI ≥27 kg/m² (overweight) with at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Semaglutide is a glucagon-like peptide-1 (GLP-1) analogue with approximately 94% sequence homology to human GLP-1. It acts as a GLP-1 receptor agonist by selectively binding to and activating GLP-1 receptors. It lowers blood glucose in a glucose-dependent manner by stimulating insulin secretion and reducing glucagon secretion when blood glucose levels are elevated. Its glucose-lowering effect is also partly due to delayed gastric emptying. During hypoglycemia, it reduces insulin secretion without impairing glucagon response. Semaglutide also promotes weight loss and reduction in body fat mass primarily by decreasing appetite.

For Diabetes:

Semaglutide Tablet: Take Semaglutide at least 30 minutes before the first food, beverage, or other oral medications of the day with no more than 4 ounces (118 ml) of plain water only.

• Starter Dose: Start Semaglutide with 3 mg once daily for 30 days.
• Maintenance Dose: After 30 days on the 3 mg dose, increase the dose to 7 mg once daily.
• For Additional Glycemic Control: If additional glycemic control is needed after at least 30 days on the 7 mg dose, the dose can be increased to 14 mg once daily.

Semaglutide injection: The starting dose is 0.25 mg Semaglutide once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly to further improve glycemic control. Weekly doses higher than 1 mg are not recommended. Semaglutide is to be administered once weekly at any time of the day with or without meals. Semaglutide is to be injected subcutaneously in the abdomen, thigh or in upper arm. The injection site can be changed without dose adjustment. Semaglutide should not be administered intravenously or intramuscularly. The day of weekly administration can be changed if necessary as long as the time between two doses is at least 3 days (>72 hours). After selecting a new dosing day, once weekly dosing should be continued.

Switching patients between Semaglutide injection and Semaglutide tablet:

• Patients treated with once weekly Semaglutide injection 0.5 mg subcutaneous injection can be transitioned to Semaglutide 7 mg or 14 mg tablet. Patients can start Semaglutide tablet up to 7 days after their last injection of Semaglutide injection. There is no equivalent dose of Semaglutide tablet for Semaglutide injection 1 mg.
• Patients treated with Semaglutide 14 mg tablet daily can be transitioned to Semaglutide subcutaneous injection 0.5 mg once weekly. Patients can start Semaglutide injection the day after their last dose of Semaglutide tablet.

For Obesity: The starting dose is 0.25 mg Semaglutide once weekly for 4 weeks subcutaneously. If patients do not tolerate a dose during dose escalation, consider delaying dose escalation for 4 weeks. If patients do not tolerate the maintenance dose 2.4 mg, the dose can be temporarily decreased to 1.7 mg once weekly for maximum 4 weeks. After 4 weeks increase the dose to 2.4 mg. Weekly doses higher than 2.4 mg is not recommended. Semaglutide is to be administered once weekly at any time of the day with or without meals. Semaglutide is to be injected subcutaneously in the abdomen, thigh or in upper arm. The injection site can be changed without dose adjustment. Semaglutide should not be administered intravenously or intramuscularly. The day of weekly administration can be changed if necessary as long as the time between two doses is at least 2 days (>48 hours). After selecting a new dosing day, once weekly dosing should be continued.

With medicines: Semaglutide delays gastric emptying, which may affect the absorption of other orally administered drugs. Studies have been conducted to evaluate its effect on the absorption of concomitant oral medications at steady-state exposure.

With food & others: Concomitant intake of food may reduce the exposure of semaglutide.

• Semaxen is contraindicated in patients with hypersensitivity to semaglutide or any of the formulation ingredients, including excipients or container components.
• It is also contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
• Semaxen should not be used during pregnancy or breastfeeding.

Common: Vomiting, dyspepsia, gastritis, reflux/heartburn (GERD), abdominal pain, bloating, constipation, altered taste, fatigue, decreased appetite, flatulence, and increased pancreatic enzymes (lipase, amylase).

Rare: Severe allergic reactions (anaphylaxis) including breathing difficulty, facial/throat swelling, wheezing, tachycardia, pallor, dizziness, or weakness. Immediate medical attention is required.

Pregnancy: Very limited data exist in pregnant women. Semaxen should not be used during pregnancy. If pregnancy is planned or occurs, treatment should be stopped. It should be discontinued at least 2 months before planned pregnancy due to long half-life.

Lactation: It is unknown whether semaglutide passes into breast milk. Due to potential risks and lack of safety data, breastfeeding is not recommended during treatment. Semaxen should be discontinued at least 2 months before planned pregnancy.

Not indicated for type 1 diabetes or diabetic ketoacidosis. Patients should take precautions to avoid hypoglycemia while driving or operating machinery. It may increase heart rate; caution is required in patients with tachyarrhythmias. Risk of hypoglycemia increases when used with insulin or sulfonylureas; dose reduction of these agents may be required.

Pediatric: Safety and efficacy in patients under 18 years not established.
Elderly: No dose adjustment required.
Renal impairment: No adjustment needed in mild to severe impairment; not recommended in end-stage renal disease.
Hepatic impairment: No dose adjustment required, but caution is advised.

Overdose up to 4 mg single dose and 4 mg weekly has been reported, mainly causing nausea. No specific antidote exists. Treatment should be supportive based on symptoms.

Dose adjustment: When combined with metformin or TZDs, no adjustment needed. When used with insulin or sulfonylureas, dose reduction may be required.

Missed dose: Take as soon as possible within 5 days. If more than 5 days pass, skip and continue next scheduled dose.

GLP-1 receptor agonists

Injection: Store at 2°C–8°C in refrigerator. Do not freeze. Protect from light.
Tablet: Store below 30°C in a cool, dry place. Keep away from light. Keep out of reach of children.