Maximum Single Dose of Ozempic (Semaglutide)
The maximum approved single subcutaneous dose of Ozempic for type 2 diabetes is 2.0 mg once weekly, administered after proper dose escalation. 1
FDA-Approved Dosing Protocol
The FDA label establishes a clear dose escalation schedule that must be followed 1:
- Start at 0.25 mg once weekly for 4 weeks (this is not a therapeutic dose but serves to minimize gastrointestinal side effects) 2, 3, 1
- Increase to 0.5 mg once weekly after the initial 4 weeks, maintaining this dose for at least 4 weeks 2, 3, 1
- If additional glycemic control is needed, escalate to 1.0 mg once weekly after at least 4 weeks on 0.5 mg 2, 3, 1
- The maximum approved dose is 2.0 mg once weekly for type 2 diabetes, which can be reached after at least 4 weeks on the 1.0 mg dose 4, 1, 5
Higher Doses in Clinical Context
While 2.0 mg is the maximum FDA-approved dose for type 2 diabetes, higher doses exist in specific contexts 4, 5:
- For chronic weight management (not type 2 diabetes treatment alone), semaglutide is approved at 2.4 mg once weekly 6, 4, 7
- Investigational doses up to 7.2 mg once weekly have been studied in clinical trials for obesity with type 2 diabetes, showing superior weight loss and glycemic control, though this dose is not yet FDA-approved 8
Critical Safety Considerations
Never skip the dose escalation protocol, as rapid titration is the leading cause of intolerable gastrointestinal side effects that result in treatment discontinuation in 8-10% of patients 2, 3:
- Nausea occurs in approximately 18-22% of patients on semaglutide versus 7% with placebo 6, 2
- Each dose level requires a minimum of 4 weeks before escalation 2, 3, 1
- Gastrointestinal adverse events are dose-dependent and typically transient 5, 7
Absolute Contraindications
Do not administer semaglutide at any dose to patients with 2, 3, 4:
- Personal or family history of medullary thyroid carcinoma
- Multiple endocrine neoplasia syndrome type 2 (MEN2)
- History of severe hypersensitivity reaction to semaglutide
- Pregnancy or lactation
Renal and Hepatic Dosing
No dose adjustment is required for any degree of renal or hepatic impairment, including end-stage renal disease or dialysis 6, 3, 1. This makes semaglutide particularly valuable in patients with diabetic kidney disease, though monitoring for dehydration-related acute kidney injury is essential if severe gastrointestinal symptoms occur 6, 2.
Concomitant Medication Adjustments
When initiating or escalating semaglutide doses 2:
- Reduce basal insulin by approximately 20% to minimize hypoglycemia risk
- Consider reducing sulfonylurea dose by 50% or discontinuing when starting semaglutide
Administration Details
Semaglutide should be injected subcutaneously in the abdomen, thigh, or upper arm at any time of day, with or without meals, on the same day each week 3, 1.