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  1. Medical Information Right
  2. Oncology Right
  3. Retevmo (selpercatinib) capsules Right
  4. Does hepatic impairment affect Retevmo® (selpercatinib pharmacokinetic properties?
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Retevmo ® (selpercatinib) capsules

40 mg, 80 mg

Full Prescribing Information

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.

Does hepatic impairment affect Retevmo® (selpercatinib pharmacokinetic properties?

Selpercatinib dosing modifications are recommended for patients with severe hepatic impairment.

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Effect of Hepatic Impairment on Selpercatinib Pharmacokinetic Properties

Close monitoring of patients with impaired hepatic function is important.1

Selpercatinib Dosing in Severe Hepatic Impairment

Patients with severe hepatic impairment should be dosed with 80 mg selpercatinib twice daily. In patients with severe hepatic impairment (Child-Pugh class C), the selpercatinib AUC0-INF increased by 77%.1

Selpercatinib Dosing in Mild and Moderate Hepatic Impairment

No dose adjustment is required for patients with mild or moderate hepatic impairment.1

After a dose of 160 mg, the selpercatinib exposure (AUC) in patients with mild and moderate hepatic impairment (Child-Pugh class A and B) is comparable to that of healthy subjects.1

Hepatic Impairment Classifications

Hepatic Impairment Classification by Total Bilirubin and Aspartate Aminotransferase Values summarizes total bilirubin and aspartate aminotransferase values associated with hepatic impairment classifications.1

Hepatic Impairment Classification by Total Bilirubin and Aspartate Aminotransferase Values1

Hepatic Impairment Classification

Associated Clinical Values

Mild 

Total bilirubin ≤ ULN and AST > ULN, OR

Total bilirubin > 1 to 1.5 times ULN and any AST

Moderate

Total bilirubin > 1.5 to 3 times ULN and any AST

Severe

Total bilirubin > 3 times ULN and any AST

Abbreviations: AST = aspartate aminotransferase; ULN = upper limit of normal

Enclosed Prescribing Information

RETEVMO® (selpercatinib) capsules, for oral use, Lilly

References

1Retevmo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2022.

Date of Last Review: January 04, 2023

Additional related information:

  • RETEVMO® (selpercatinib): Pharmacokinetic Properties
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