Product Description

Indications: Fitaro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in patients with type 2 diabetes and established cardiovascular disease. It is also indicated for chronic weight management in adults as an adjunct to a reduced-calorie diet and increased physical activity, in patients with a BMI ≥30 kg/m² (obesity) or ≥27 kg/m² (overweight) with at least one weight-related comorbidity such as hypertension, type 2 diabetes, or dyslipidemia.

Pharmacology: Semaglutide is a GLP-1 receptor agonist structurally similar to human GLP-1. It lowers blood glucose in a glucose-dependent manner by stimulating insulin secretion and reducing glucagon release when glucose levels are elevated. It also delays gastric emptying and reduces appetite, leading to decreased food intake and weight loss. During hypoglycemia, it reduces insulin secretion without impairing glucagon response.

Dosage & Administration: For diabetes, oral Semaglutide should be taken once daily at least 30 minutes before food, beverages, or other medications with a small amount of water. The initial dose is 3 mg daily for 30 days, increased to 7 mg daily, and may be further increased to 14 mg if needed. Injectable Semaglutide starts at 0.25 mg once weekly, increased to 0.5 mg after 4 weeks, and may be increased to 1 mg weekly if required. For obesity, treatment starts with 0.25 mg weekly for 4 weeks and is gradually increased up to a maintenance dose of 2.4 mg weekly. The injection is administered subcutaneously in the abdomen, thigh, or upper arm and should not be given intravenously or intramuscularly. Dose adjustments or switching between oral and injectable forms should follow clinical guidance.

Interaction: Fitaro delays gastric emptying and may affect the absorption of orally administered drugs. Food intake may reduce its absorption. Careful monitoring is recommended when co-administered with other medications.

Contraindications: Contraindicated in patients with hypersensitivity to Semaglutide or any component of the formulation, those with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, and in pregnancy or breastfeeding.

Side Effects: Common side effects include nausea, vomiting, abdominal discomfort, reflux, constipation, bloating, decreased appetite, fatigue, and altered taste. Rare but serious reactions include severe hypersensitivity reactions such as anaphylaxis, which require immediate medical attention.

Pregnancy & Lactation: Use during pregnancy is not recommended due to insufficient safety data. The drug should be discontinued at least 2 months before a planned pregnancy. Breastfeeding is not recommended due to potential risks to the infant.

Precautions & Warnings: Not indicated for type 1 diabetes or diabetic ketoacidosis. It may increase heart rate, so caution is required in patients with cardiac conditions. There is an increased risk of hypoglycemia when used with insulin or sulfonylureas; dose adjustments may be necessary. Patients should be cautious while driving due to possible hypoglycemia.

Use in Special Populations: Safety and efficacy in patients under 18 years have not been established. No dose adjustment is required in elderly patients. No dose adjustment is needed in mild to severe renal or hepatic impairment, but use is not recommended in end-stage renal disease.

Overdose Effects: Overdose may lead to gastrointestinal symptoms, especially nausea. There is no specific antidote, and treatment is supportive based on clinical symptoms. Missed doses should be taken within 5 days; otherwise, skip and continue the regular schedule.

Therapeutic Class: GLP-1 receptor agonists

Storage Conditions: Injection should be stored at 2°C–8°C in a refrigerator and should not be frozen. Tablets should be stored below 30°C in a cool, dry place away from light. Keep all medicines out of reach of children.