Fitaro 0.25 mg/0.5 ml is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise for improving 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 who have established cardiovascular disease.

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

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

• BMI ≥ 27 kg/m² (overweight) with at least one weight-related comorbid condition such as hypertension, type 2 diabetes mellitus, or dyslipidemia.

  রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Therapeutic Class

GLP-1 receptor agonists

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

Fitaro contains semaglutide, 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. This dual action helps lower both fasting and postprandial blood glucose levels.

Semaglutide also delays gastric emptying during the early postprandial phase, contributing to appetite suppression and weight reduction. Its prolonged half-life is achieved through strong albumin binding, which decreases renal clearance and protects the molecule from enzymatic degradation. The drug is also stabilized against breakdown by the DPP-4 enzyme.

Dosage & Administration

Subcutaneous Injection:

• Initial dose: 0.25 mg once weekly for 4 weeks

• Dose escalation every 4 weeks as follows:

  • 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 a dose is not tolerated during escalation, the increase may be delayed for 4 weeks. If the maintenance dose is not tolerated, the dose may be temporarily reduced to 1.7 mg once weekly for up to 4 weeks before attempting escalation again.

Fitaro is administered once weekly at any time of the day, with or without meals, by 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 dosing schedule.

রেজিস্টার্ড চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন

Drug Interactions

When used with insulin or insulin secretagogues such as sulfonylureas, dose reduction of the concomitant agent may be required to reduce the risk of hypoglycemia. Fitaro does not significantly affect the absorption of most oral medications, though caution is advised.

Contraindications

Fitaro 0.25 mg/0.5 ml is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC), Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or known hypersensitivity to semaglutide.

Side Effects

Potential adverse effects include gastrointestinal symptoms, hypoglycemia when combined with insulin or secretagogues, and injection-site reactions. Patients should promptly report symptoms such as neck swelling, hoarseness, difficulty swallowing, or shortness of breath.

Precautions & Warnings

Warnings include risk of thyroid C-cell tumors, pancreatitis, diabetic retinopathy complications, acute kidney injury, and serious hypersensitivity reactions. Fitaro pens must never be shared between patients.

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 out of the reach of children.