Orsema 0.25mg Subcutaneous Injection

Uses of

Side Effects of

It is not known if Orsema 0.25 mg will cause thyroid tumors or medullary thyroid carcinoma (MTC) in people. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.

Pediatric Uses:

Safety and efficacy not established in pediatric patients.

Geriatric Use:

No overall differences in safety or efficacy were detected between geriatric patients and younger patients.

Renal Impairment:

No dose adjustment is recommended.

Hepatic Impairment:

No dose adjustment is recommended.

Pharmacology

Orsema 0.25 mg is a GLP-1 analogue with 94% sequence homology to human GLP-1. It acts as a GLP-1 receptor agonist, stimulating insulin secretion, lowering glucagon secretion, and delaying gastric emptying in a glucose-dependent manner.

Dosage & Administration

Subcutaneous injection:

• The starting dose: 0.25 mg Orsema 0.25 mg once weekly for 4 weeks subcutaneously.
• Dose Escalation:
  • Week 1 through 4: 0.25 mg
  • Week 5 through 8: 0.5 mg
  • Week 9 through 12: 1 mg
  • Week 13 through 16: 1.7 mg
• Maintenance dose: Week 17 and onwards: 2.4 mg

In the event of an overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.

Interaction

Initiating Orsema 0.25 mg concomitant with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia. Caution should be exercised when oral medications are concomitantly administered with Orsema 0.25 mg.

Contraindications

Orsema 0.25 mg is contraindicated in patients with personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) and hypersensitivity to Orsema 0.25 mg.

Pregnancy & Lactation

Limited data are available. Use during pregnancy or breastfeeding only if the potential benefit justifies the potential risk.

Precautions & Warnings

• Risk of Thyroid C-Cell Tumors.
• Pancreatitis.
• Diabetic Retinopathy Complications.
• Never Share Orsema 0.25 mg Pen Between Patients.
• Hypoglycemia with Concomitant Use of Insulin.
• Acute Kidney Injury.
• Hypersensitivity.

Storage Conditions

Store your Fitaro Injection in the refrigerator at 2°C to 8°C (36°F to 46°F).