Maximum Dose of Mounjaro (Tirzepatide)
The maximum approved dose of Mounjaro (tirzepatide) is 15 mg administered once weekly via subcutaneous injection. 1
Dosing Information
Tirzepatide (Mounjaro) is available in the following doses:
- 5 mg once weekly
- 10 mg once weekly
- 15 mg once weekly
The medication is typically initiated at a lower dose and then titrated up to minimize gastrointestinal side effects:
- Start at a lower dose (usually 2.5 mg weekly)
- Gradually increase by 2.5 mg increments every 4 weeks
- Continue titration until the target or maximum dose of 15 mg is reached
Clinical Evidence Supporting Maximum Dose
The 15 mg dose has demonstrated the greatest efficacy in clinical trials:
- In the SURMOUNT-1 trial, tirzepatide 15 mg produced the greatest weight loss (20.9%) compared to 10 mg (19.5%) and 5 mg (15.0%) at 72 weeks 1
- A meta-analysis showed that tirzepatide 15 mg weekly was associated with greater weight loss compared to semaglutide 2.4 mg weekly (mean difference 5.1%) 1
- In diabetes trials, tirzepatide 15 mg achieved the greatest HbA1c reductions (up to 2.37%) 2
Considerations When Prescribing Maximum Dose
Side Effect Profile
The incidence of adverse events increases with higher doses of tirzepatide:
- Gastrointestinal side effects are dose-dependent: 39% at 5 mg, 46% at 10 mg, and 49% at 15 mg 3
- Most common side effects include nausea, vomiting, diarrhea, and esophageal reflux 1
- Drug discontinuation due to adverse events is highest with the 15 mg dose (approximately 10%) 3
Special Populations
- Perioperative considerations: Due to effects on gastric emptying, tirzepatide may need to be temporarily discontinued before procedures requiring anesthesia to reduce aspiration risk 1
- Renal impairment: Use caution when initiating or increasing dose in people with kidney disease due to potential risk of acute kidney injury 1
Monitoring Requirements
When prescribing the maximum 15 mg dose:
- Monitor for gastrointestinal side effects, particularly during dose escalation
- Be aware of potential drug interactions with oral medications that have narrow therapeutic indices
- For patients using oral contraceptives, advise switching to non-oral methods or adding a non-oral method for 4 weeks after initiation and dose escalations 1
Important Safety Considerations
- Black box warning: Risk of thyroid C-cell tumors in rodents (human relevance not determined) 1
- Do not use in individuals with personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 1
- May cause gallbladder-related complications and gastrointestinal disorders including severe constipation and small bowel obstruction/ileus 1
The maximum 15 mg weekly dose provides the greatest efficacy for both weight loss and glycemic control, but must be balanced against the increased risk of adverse events, particularly gastrointestinal symptoms.