OZEMPIC 0.5/MG 1/PENFILL @

Indications

Approved Uses

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

Off-Label Uses

Chronic weight management/obesity (off-label for Ozempic; semaglutide 2.4 mg is approved as Wegovy). Other investigational/off-label uses include NAFLD/NASH and PCOS-related weight/metabolic management (evidence evolving).

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus: 0.25 mg subcutaneously once weekly for 4 weeks, then 0.5 mg once weekly; if additional glycemic control is needed after at least 4 weeks on 0.5 mg, increase to 1 mg once weekly. Maximum recommended dose is 1 mg once weekly

Initial Dose

0.25 mg subcutaneously once weekly for 4 weeks (initiation dose, not therapeutically effective for glycemic control)

Maintenance Dose

After 4 weeks on the initiation dose, the maintenance dose is 0.5 mg subcutaneously once weekly. If additional glycemic control is needed after at least 4 weeks on 0.5 mg, increase to 1 mg once weekly (maximum recommended dose).

Maximum Dose

1 mg subcutaneously once weekly

How to Take

For subcutaneous use only: inject semaglutide once weekly under the skin of the abdomen, thigh, or upper arm; rotate injection sites. Administer on the same day each week at any time of day, with or without meals. Do not administer intravenously or intramuscularly. Use a new needle for each injection, remove and safely dispose of the needle after use, and do not share the pen.

How to Prepare

Ready-to-use solution in a pre-filled pen (no reconstitution); inspect that the solution is clear and colorless to slightly yellow, attach a new needle for each injection, and do not use if discolored or contains particles.

Side Effects

Common Side Effects

Nausea, vomiting, diarrhea, constipation, abdominal pain, decreased appetite, and dyspepsia (including belching/flatulence) are common; injection-site reactions can occur.

Safety & Warnings

Contraindications

Personal or family history of medullary thyroid carcinoma (MTC); Multiple Endocrine Neoplasia syndrome type 2 (MEN 2); known serious hypersensitivity to semaglutide or any excipients.

Drug Interactions

Drug Interactions

Insulin and insulin secretagogues (e.g., sulfonylureas): increased hypoglycemia risk-consider dose reduction and monitor; delayed gastric emptying may affect absorption of concomitant oral medications-monitor drugs with narrow therapeutic index (e.g., warfarin) and adjust based on clinical response/INR.

Interaction Severity

MAJOR/clinically significant: insulin and sulfonylureas (increased hypoglycemia risk-consider dose reduction and monitor). MODERATE: concomitant oral drugs where delayed gastric emptying could affect absorption (monitor if narrow therapeutic index). Warfarin is not a consistent direct interaction but INR monitoring is prudent when glycemic control or weight changes occur.

Food Interaction

No food restrictions; administer subcutaneously with or without meals.

Special Populations

Elderly

Standard adult dosing - no dose adjustment required based on age alone; greater sensitivity in some elderly patients cannot be ruled out, monitor for GI tolerability

Kidney Impairment

No dose adjustment required in renal impairment (including severe); however, monitor renal function in patients with severe GI reactions/dehydration due to risk of acute kidney injury.

Liver Impairment

No dose adjustment required in hepatic impairment.

Storage & Patient Advice

Preparation Instructions

Ready-to-use solution in a pre-filled pen (no reconstitution); inspect that the solution is clear and colorless to slightly yellow, attach a new needle for each injection, and do not use if discolored or contains particles.

Missed Dose

If a dose is missed, administer it as soon as possible within 5 days; if more than 5 days have passed, skip the missed dose and resume the next dose on the regularly scheduled day.

Patient Counseling

Counsel to inject SC once weekly on the same day each week (abdomen/thigh/upper arm) and rotate sites; with or without meals. Explain titration (0.25 mg weekly for 4 weeks is for initiation and not maintenance). Discuss common GI effects and mitigation (smaller, lower-fat meals; hydration) and when to seek care (severe persistent abdominal pain-pancreatitis). Review hypoglycemia risk when combined with insulin/sulfonylureas and how to treat it. Warn about thyroid C-cell tumor risk/contraindication in patients with personal/family history of MTC or MEN2 and symptoms (neck mass, hoarseness, dysphagia). Storage: keep unopened pens refrigerated (2-8°C per SFDA); follow local label for in-use storage limits; do not share pens; use a new needle each time; missed dose within 5 days otherwise skip.

Monitoring Requirements

Monitor glycemic control (SMBG as appropriate and HbA1c about every 3 months until stable, then at least every 6 months). Monitor for GI intolerance and dehydration; check renal function if severe vomiting/diarrhea occurs or in those with renal impairment. Monitor for pancreatitis symptoms. In patients with diabetic retinopathy, monitor for progression. Monitor for hypoglycemia when used with insulin or sulfonylureas.

Pharmacology

Mechanism of Action

GLP-1 receptor agonist that increases glucose-dependent insulin secretion, decreases inappropriate glucagon secretion, slows gastric emptying, and reduces appetite/energy intake (contributing to weight loss).

Duration of Effect

Approximately 1 week per dose (supports once-weekly subcutaneous dosing); steady-state clinical effect is typically achieved after ~4-5 weeks.

Half-Life

Approximately 1 week (about 7 days; ~165-184 hours).

Bioavailability

Approximately 89% absolute bioavailability after subcutaneous administration.

Metabolism

Metabolized by proteolytic cleavage of the peptide backbone and sequential beta-oxidation of the fatty-acid side chain; not significantly metabolized by CYP450 enzymes.

Excretion

Eliminated as metabolites via urine and feces (no single organ as the major route; intact semaglutide is not excreted to a clinically relevant extent).

Product Information

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

Legal Disclaimer - Al Mujtama Pharmacy The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment. Al Mujtama Pharmacy assumes no legal or medical liability for: Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist Any discrepancy between the information provided and the product's package insert or SFDA guidelines Any misuse of medication resulting from personal interpretation of the content displayed Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication. By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation. Your health is a trust - always consult your doctor first.