Fitaro 0.5 mg/0.5 ml is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is also approved to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease.

In addition, Fitaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with:

• Body mass index (BMI) ≥ 30 kg/m² (obesity), or

• BMI ≥ 27 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia.

  রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Composition

Each pre-filled syringe contains Semaglutide INN in solution for injection:

• 0.25 mg in 0.5 ml

• 0.5 mg in 0.5 ml

• 1 mg in 0.5 ml

• 1.7 mg in 0.75 ml

• 2.4 mg in 0.75 ml

Pharmacology

Semaglutide is a long-acting GLP-1 analogue with approximately 94% sequence homology to native human GLP-1. It selectively binds to and activates the GLP-1 receptor, enhancing glucose-dependent insulin secretion while suppressing inappropriate glucagon release. Fitaro also slows gastric emptying during the early postprandial phase, contributing to reduced post-meal glucose excursions.
Its prolonged duration of action is achieved through strong albumin binding, which reduces renal clearance and protects the molecule from metabolic degradation. Additionally, semaglutide is resistant to degradation by the dipeptidyl peptidase-4 (DPP-4) enzyme.

Dosage & Administration

Subcutaneous Injection:

• Starting dose: 0.25 mg once weekly for 4 weeks

• Dose escalation every 4 weeks:

  • Weeks 1–4: 0.25 mg

  • Weeks 5–8: 0.5 mg

  • Weeks 9–12: 1 mg

  • Weeks 13–16: 1.7 mg

• Maintenance dose: 2.4 mg once weekly from Week 17 onward

If dose escalation is not tolerated, it may be delayed for 4 weeks. If the maintenance dose is not tolerated, temporarily reduce to 1.7 mg once weekly for up to 4 weeks, then increase back to 2.4 mg.
Fitaro is administered once weekly, with or without meals, via subcutaneous injection into the abdomen, thigh, or upper arm.

Missed Dose:
If the next scheduled dose is more than 48 hours away, administer as soon as possible. If less than 48 hours remain, skip the missed dose and resume the regular schedule.

Drug Interactions

When initiating Fitaro with insulin or insulin secretagogues (e.g., sulfonylureas), dose reduction of the concomitant agent may be required to minimize hypoglycemia risk. Although no clinically significant effects on oral drug absorption have been observed, caution is advised when co-administering oral medications.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Contraindications

Fitaro is contraindicated in patients with:

• Personal or family history of medullary thyroid carcinoma (MTC)

• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

• Known hypersensitivity to semaglutide

Side Effects

Potential adverse effects include gastrointestinal symptoms, hypoglycemia (when used with insulin or secretagogues), and injection-site reactions. Patients should report symptoms suggestive of thyroid tumors such as neck swelling, hoarseness, dysphagia, or dyspnea.

Precautions & Warnings

Warnings include risk of thyroid C-cell tumors, pancreatitis, diabetic retinopathy complications, acute kidney injury, hypoglycemia with concomitant insulin use, and serious hypersensitivity reactions. Pens must never be shared between patients.

Use in Special Populations

Safety and efficacy have not been established in pediatric patients. No dose adjustment is required in renal or hepatic impairment. Greater sensitivity in elderly patients cannot be excluded.

Storage Conditions

Store refrigerated at 2°C to 8°C. Do not freeze. After first use, the pen may be stored refrigerated for up to 56 days. Protect from heat and light and keep the pen cap on when not in use.