What is the maximum dose of Mounjaro (tirzepatide)?

Maximum Dose of Mounjaro (Tirzepatide)

The maximum approved dose of Mounjaro (tirzepatide) is 15 mg once weekly administered as a subcutaneous injection. 1, 2

Dosing Schedule and Titration

• Tirzepatide therapy should be initiated at 2.5 mg weekly for the first 4 weeks 2
• After 4 weeks at the initial dose, the dose can be increased to 5 mg once weekly 2
• Further dose escalations can occur based on clinical response and tolerability:
  • Increase to 10 mg once weekly after at least 4 weeks on the 5 mg dose 2
  • Increase to the maximum dose of 15 mg once weekly after at least 4 weeks on the 10 mg dose 2, 1

Administration Considerations

• Tirzepatide is administered as a subcutaneous injection once weekly 2
• The injection can be given at any time of day, regardless of meals 2
• No dose adjustments are required for patients with renal impairment 2

Clinical Efficacy at Maximum Dose

• At the maximum 15 mg dose, tirzepatide has demonstrated:
  • HbA1c reduction of up to 2.58% in type 2 diabetes 3
  • Weight reduction of up to 20.9% of body weight in patients with obesity 4
  • 91% of patients achieving ≥5% weight reduction and 57% achieving ≥20% weight reduction at the 15 mg dose 4

Side Effects and Monitoring

• Common side effects are dose-dependent and include:
  • Gastrointestinal effects: nausea (10-31%), diarrhea (7-23%), vomiting (2-12%), constipation (3-5%), and abdominal pain (3-5%) 2
  • Most gastrointestinal side effects are mild to moderate in severity and occur primarily during the dose escalation period 4, 5

Important Precautions

• Monitor for signs of pancreatitis and discontinue tirzepatide if suspected 2
• Use caution in patients with kidney disease when initiating or increasing the dose due to potential risk of acute kidney injury 2
• Tirzepatide carries a black box warning regarding the risk of thyroid C-cell tumors in rodents (human relevance not determined) 1, 2
• The medication is contraindicated in patients with personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2 2

Special Populations

• Tirzepatide has been studied in pediatric populations (10 to <18 years) with type 2 diabetes at doses up to 10 mg weekly 6
• The medication has shown efficacy in patients with metabolic dysfunction-associated steatohepatitis (MASH) at the maximum 15 mg dose 7
• For patients with prediabetes and obesity, the 15 mg dose has demonstrated significant weight reduction and prevention of progression to type 2 diabetes over a 3-year period 5