What is the highest approved dose of Ozempic (semaglutide)?

Highest Approved Dose of Ozempic (Semaglutide)

The maximum FDA-approved dose of Ozempic (semaglutide) for subcutaneous injection is 2 mg once weekly. 1

Dosing Information and Titration Schedule

Ozempic is administered as a once-weekly subcutaneous injection with a structured titration schedule:

1. Initial dosing: 0.25 mg once weekly for 4 weeks

   • This starting dose is intended for treatment initiation and is not effective for glycemic control 2

2. First titration: Increase to 0.5 mg once weekly after 4 weeks

3. Second titration (if needed): After at least 4 weeks on 0.5 mg, may increase to 1 mg once weekly

   • The FDA label previously listed 1 mg as the maximum dose 2

4. Higher dosing: Based on more recent clinical evidence, 2 mg once weekly is now the highest approved dose for patients requiring additional glycemic control 1

Evidence Supporting Higher Dosing

The SUSTAIN FORTE trial demonstrated that:

• Semaglutide 2.0 mg was superior to 1.0 mg in reducing HbA1c (-2.2% vs -1.9%)
• Additional weight loss was achieved with the higher dose (-6.9 kg vs -6.0 kg)
• The safety profile was similar between the two doses 1

Clinical Considerations

• Patient selection: The 2 mg dose is particularly beneficial for patients who haven't reached glycemic targets on the 1 mg dose (approximately 20-30% of patients) 1

• Safety profile: Gastrointestinal disorders remain the most common adverse events (34% with 2 mg vs 31% with 1 mg) 1

• Dose escalation importance: Gradual dose escalation is critical to mitigate gastrointestinal side effects 3

• Administration timing: Ozempic can be administered on the same day each week, at any time of day, with or without meals 2

Common Pitfalls to Avoid

1. Inadequate titration period: Ensure at least 4 weeks between dose increases to improve tolerability 2

2. Missing the dose window: If a dose is missed, administer within 5 days of the scheduled dose; if more than 5 days have passed, skip and resume the regular schedule 2

3. Confusing with other formulations: Do not confuse Ozempic (subcutaneous semaglutide for diabetes) with Wegovy (higher-dose subcutaneous semaglutide for weight management) or Rybelsus (oral semaglutide) 4

4. Overlooking renal function: No dose adjustment is required for semaglutide in renal impairment, unlike some other antidiabetic medications 4

Semaglutide has demonstrated superior glycemic control and weight reduction compared to other GLP-1 receptor agonists, making the higher 2 mg dose an important option for treatment intensification in patients with inadequate response to lower doses.