OZEMPIC 0.25/MG 1/PENFILL @

Indications

Approved Uses

Adults with type 2 diabetes mellitus: (1) adjunct to diet and exercise to improve glycemic control; (2) to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

Dosage & Administration

Initial Dose

0.25 mg subcutaneously once weekly for 4 weeks (initiation dose only, not therapeutic)

Maintenance Dose

0.5 mg subcutaneously once weekly; may increase to 1 mg once weekly if additional glycemic control needed

How to Take

Administer as a subcutaneous injection once weekly on the same day each week into the abdomen, thigh, or upper arm; rotate injection sites. Do not administer intravenously or intramuscularly. Use a new needle for each injection and dispose of it after use; follow the pen instructions for use.

How to Prepare

Ready-to-use solution in a pre-filled pen for subcutaneous injection; inspect that the solution is clear and colorless before use and do not use if discolored/contains particles; attach a new needle and perform the pen flow check as per IFU; allow to reach room temperature for comfort if refrigerated.

Safety & Warnings

Contraindications

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

Drug Interactions

Drug Interactions

May delay gastric emptying and affect absorption of oral drugs; increased hypoglycemia risk with insulin or insulin secretagogues (e.g., sulfonylureas) so dose reduction/monitoring may be needed.

Food Interaction

No food restrictions; administer with or without meals.

Special Populations

Elderly

Standard adult dosing; no dose adjustment required based on age alone. Greater caution warranted in elderly due to increased risk of dehydration from GI side effects

Kidney Impairment

No dose adjustment required for renal impairment (including severe); use caution and monitor renal function if severe GI reactions occur due to dehydration/AKI risk.

Liver Impairment

No dose adjustment required in hepatic impairment.

Storage & Patient Advice

Preparation Instructions

Ready-to-use solution in a pre-filled pen for subcutaneous injection; inspect that the solution is clear and colorless before use and do not use if discolored/contains particles; attach a new needle and perform the pen flow check as per IFU; allow to reach room temperature for comfort if refrigerated.

Missed Dose

Administer as soon as possible within 5 days of the missed dose. If more than 5 days have passed, skip the missed dose and resume on the next regularly scheduled day. Do not administer two doses within 2 days

Monitoring Requirements

Monitor glycemic control (HbA1c about every 3 months until stable, then periodically) and self-monitored glucose as appropriate; monitor for worsening diabetic retinopathy in patients with pre-existing retinopathy; monitor renal function if severe GI reactions/dehydration occur; counsel/monitor for symptoms of pancreatitis and gallbladder disease; monitor for hypoglycemia when used with insulin/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.

Onset of Action

Glucose-lowering may begin within the first week; maximal effect typically after 4-5 weeks (steady state reached after ~4-5 weeks of once-weekly dosing).

Half-Life

Approximately 1 week (about 168 hours).

Bioavailability

Subcutaneous absolute bioavailability is approximately 89%.

Metabolism

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

Excretion

Eliminated as metabolites via urine and feces (approximately two‑thirds in urine and one‑third in feces); unchanged semaglutide is not expected to be excreted to a clinically relevant extent.

Product Information

Diabetes Type

Type 2

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