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Mounjaro™ (tirzepatide) injection
2.5 mg/5 mg/7.5 mg/10 mg/12.5 mg/15 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Can tirzepatide be used in patients with hepatitis?
No dosage adjustment is recommended for patients with mild, moderate, or severe hepatic impairment.
See important safety information, including boxed warning, in the attached prescribing information.
Use in Patients With Hepatitis
Clinical Pharmacology Study
No dosage adjustment of tirzepatide is recommended for patients with hepatic impairment.
In a clinical pharmacology study no change in tirzepatide pharmacokinectics was observed in subjects with varying degrees (mild, moderate, severe) of hepatic impairment compared with subjects with normal hepatic function after a single 5 mg dose.
SURPASS Phase 3 Studies
There is no information on the safety and efficacy of tirzepatide in patients with hepatitis because patients were excluded from SURPASS phase 3 studies if they had acute or chronic hepatitis, signs and symptoms of any liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) ≤3.0 times the ULN. Patients with NAFLD were eligible to participate in this trial if their ALT was ≥3.0 times the upper limit of normal (ULN).
Enclosed Prescribing Information
Date of Last Review: June 07, 2022