OZEMPIC 1/MG 1/PENFILL @

Indications

Approved Uses

Adults with type 2 diabetes mellitus: (1) as an adjunct to diet and exercise to improve glycemic control; (2) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

Off-Label Uses

Weight management/obesity (off-label use of Ozempic; semaglutide has a separate product/indication for chronic weight management in many regions).

Dosage & Administration

Dosing by Condition

Type 2 diabetes (and for CV risk reduction in eligible T2DM patients): 0.25 mg SC once weekly for 4 weeks, then 0.5 mg once weekly; if additional control needed, increase to 1 mg once weekly after at least 4 weeks on 0.5 mg. (Some jurisdictions also allow escalation to 2 mg once weekly after at least 4 weeks on 1 mg, depending on locally approved strengths.)

Initial Dose

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

Maintenance Dose

0.5 mg subcutaneously once weekly; may increase to 1 mg once weekly after at least 4 weeks at 0.5 mg

Maximum Dose

2 mg subcutaneously once weekly.

Children's Dosage

Not approved for children under 18 years

Dose Adjustment Notes

No dose adjustment is generally required in renal or hepatic impairment, but monitor renal function if severe GI reactions/dehydration occur. Titrate to improve tolerability: 0.25 mg weekly for 4 weeks (initiation, not effective for glycemic control) → 0.5 mg weekly for at least 4 weeks → may increase to 1 mg weekly if needed; when used with insulin or a sulfonylurea, consider lowering the insulin/sulfonylurea dose to reduce hypoglycemia risk.

How to Take

Administer by subcutaneous injection once weekly on the same day each week into the abdomen, thigh, or upper arm; rotate injection sites. May be given at any time of day, with or without meals. Do not administer intravenously or intramuscularly. If changing the day of weekly administration, ensure at least 48 hours between doses.

Side Effects

Common Side Effects

Nausea, vomiting, diarrhea, constipation, abdominal pain; decreased appetite and dyspepsia are also common.

Side Effect Frequency

Very common (>10%): nausea, diarrhea. Common (1-10%): vomiting, constipation, abdominal pain, dyspepsia, decreased appetite; hypoglycemia when used with insulin/sulfonylurea; injection-site reactions; increased heart rate. Uncommon (0.1-1%): acute pancreatitis, cholelithiasis. Frequency not known/rare: anaphylaxis/serious hypersensitivity; diabetic retinopathy complications (reported in trials, particularly with rapid glycemic improvement).

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.

Warnings & Precautions

Risk of thyroid C-cell tumors (counsel on neck mass/hoarseness/dysphagia), pancreatitis (discontinue if suspected), diabetic retinopathy complications (especially with rapid A1c improvement), hypoglycemia with insulin/secretagogues, acute kidney injury from dehydration due to GI adverse effects (ensure hydration/monitor renal function), serious hypersensitivity reactions, and acute gallbladder disease; not recommended for type 1 diabetes or DKA.

Age Restriction

Not approved under 18 years.

Drug Interactions

Interaction Severity

MAJOR/clinically significant: concomitant insulin or sulfonylureas increase hypoglycemia risk-consider dose reduction and monitor glucose. MODERATE: delayed gastric emptying may affect absorption of some oral drugs; monitor drugs with a narrow therapeutic index (e.g., warfarin/INR, levothyroxine) as clinically indicated. Routine additional contraception is not generally required for semaglutide based on available evidence, but counsel if significant vomiting/diarrhea could impair oral contraceptive absorption.

Food Interaction

No clinically relevant food interaction for subcutaneous Ozempic; it can be administered with or without meals.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Not approved for children under 18 years

Storage & Patient Advice

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.

Stopping the Medicine

Can be stopped without tapering, but consult prescriber to plan alternative glycemic therapy because glucose may rise after discontinuation.

Overdose

Symptoms may include severe nausea, vomiting (± diarrhea) and hypoglycemia (especially with concomitant insulin/secretagogues); management is supportive/symptomatic with glucose monitoring, consider poison control, and effects may be prolonged due to long half-life (~1 week).

Patient Counseling

Inject SC once weekly on the same day each week (abdomen/thigh/upper arm) and rotate sites; can be taken any time of day with or without meals; do not share the pen. Explain titration and that early nausea is common and often improves; advise smaller/low-fat meals and hydration. Review missed-dose rule: if a dose is missed, take within 5 days; otherwise skip and take next scheduled dose (and ensure ≥48 hours between doses if changing day). Store unopened pens refrigerated (2-8°C per SFDA); do not freeze; after first use, follow local labeling for in-use storage/time limits. Seek care for severe persistent abdominal pain (pancreatitis), symptoms of hypoglycemia (especially with insulin/SU), vision changes (retinopathy), or neck mass/dysphagia (thyroid warning).

Pharmacology

Mechanism of Action

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

Duration of Effect

At least 1 week (supports once-weekly dosing); clinical effect persists through the weekly dosing interval at steady state.

Half-Life

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

Protein Binding

>99% (primarily albumin).

Product Information

Available Dosage Forms

Solution for injection in a pre-filled pen for subcutaneous use.

Composition per Dose

Each 3 mL pre-filled pen delivers 4 doses of 1 mg/0.75 mL (1.34 mg/mL): semaglutide 1 mg per 0.75 mL dose; excipients: disodium phosphate dihydrate, propylene glycol, phenol, water for injections, hydrochloric acid/sodium hydroxide for pH adjustment

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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