Semaglutide: Clinical Drug Information
Complete clinical monograph for semaglutide — pharmacokinetics, dosing schedules, contraindications, drug interactions, and adverse reactions. For healthcare professionals and informed patients.
Drug Overview
- Generic Name: Semaglutide
- Drug Class: GLP-1 Receptor Agonist (Incretin Mimetic)
- Routes: Subcutaneous injection (once weekly), Oral tablet (once daily)
- Approved Indications: Type 2 diabetes mellitus, Chronic weight management
- Brand Names in India: Ozempic, Wegovy, Rybelsus, Semanat, Sundae, Noveltreat, GLIPIQ, Obeda, Semaglyn, Semasize
Pharmacokinetics
- Bioavailability: ~89% (subcutaneous), ~1% (oral)
- Time to peak: 1-3 days (SC), 1 hour (oral)
- Half-life: ~1 week (~165 hours)
- Steady state: 4-5 weeks
- Protein binding: >99% (albumin)
Dosing Schedule — Weight Management
0.25mg weeks 1-4 (initiation) → 0.5mg weeks 5-8 → 1.0mg weeks 9-12 → 1.7mg weeks 13-16 → 2.4mg week 17+ (maintenance).
Dosing Schedule — Type 2 Diabetes
0.25mg weeks 1-4 → 0.5mg weeks 5-8 → 1.0mg week 9+ (maintenance) → 2.0mg optional week 13+.
Dosing — Oral (Rybelsus)
3mg daily days 1-30 → 7mg day 31+ → 14mg optional day 61+. Take on empty stomach with 120ml plain water, 30 minutes before food.
Contraindications
Absolute: MTC/MEN2 history, hypersensitivity, pregnancy. Relative: pancreatitis history, severe gastroparesis, severe renal impairment (eGFR below 15).
Drug Interactions
- Sulfonylureas/Insulin: Increased hypoglycemia risk — dose reduction needed
- Oral contraceptives: Delayed absorption — use backup method initially
- Warfarin: May affect INR — monitor closely
- Levothyroxine: Delayed absorption — monitor TSH
Adverse Reactions (STEP 1 Trial)
Nausea 44%, Diarrhea 30%, Vomiting 24%, Constipation 24%, Abdominal pain 20%, Headache 14%, Fatigue 11%, Dyspepsia 9%, Dizziness 8%, Injection site reactions 3.2%, Gallstones 2.6%, Acute pancreatitis less than 1%.
Black Box Warning
Thyroid C-cell tumors observed in rodent studies. Not proven in humans after 49 million+ patient-years. Contraindicated if personal/family history of medullary thyroid carcinoma or MEN2 syndrome.
Storage
Before first use: 2-8°C (refrigerator). In use: up to 30°C for 56 days. Do not freeze. Protect from direct sunlight.
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