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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.
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.
Belzutifan can cause severe anemia that can require blood transfusion.
Belzutifan can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization.
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.
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