Belzutifan can cause severe anemia that can require blood transfusion.
Belzutifan can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization.
- TRADE NAME: Welireg (Merck Sharpe & Dohme)
- INDICATIONS: Treatment of adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.
- CLASS: Hypoxia-inducible factor inhibitor
- HALF-LIFE: 14 hours
- FDA APPROVAL DATE: 08/13/2021
- CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
CYP3A4 substrates, hormonal contraceptives, UGT2B17 or CYP2C19 inhibitors - PREGNANCY: Can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective non-hormonal contraception during treatment. Advise males with female partners of reproductive potential to use effective contraception during treatment with belzutifan.
WARNING: EMBRYO-FETAL TOXICITY
EXPOSURE TO BELZUTIFAN DURING PREGNANCY CAN CAUSE EMBRYO-FETAL HARM.
VERIFY PREGNANCY STATUS PRIOR TO THE INITIATION OF BELZUTIFAN.
ADVISE PATIENTS OF THESE RISKS AND THE NEED FOR EFFECTIVE NON-HORMONAL CONTRACEPTION.
BELZUTIFAN CAN RENDER SOME HORMONAL CONTRACEPTIVES INEFFECTIVE.
See full prescribing information for complete boxed warning
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Page last updated 08/21/2024
