Medically reviewed by Drugs.com. Last updated on Nov 16, 2021.
Applies to the following strengths: 40 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Von Hippel-Lindau Syndrome
120 mg orally once daily until disease progression or unacceptable toxicity
Use: For treatment of von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery
Renal Dose Adjustments
Mild (CrCl 60 to less than 90 mL/min) to moderate (CrCl 30 to less than 60 mL/min) renal dysfunction: No adjustment recommended.
Severe (CrCl 15 to 30 mL/min) to end-stage renal dysfunction: Data not available
Liver Dose Adjustments
Mild (total bilirubin upper limit of normal [ULN] or less and aspartate aminotransferase [AST] greater than ULN or total bilirubin greater than 1 to 1.5 x ULN and any AST) hepatic impairment: No adjustment recommended.
Moderate to severe (total bilirubin greater than 1.5 x ULN and any AST) hepatic impairment: Data not available
Recommended Dose Reductions:
- First dose reduction: 80 mg orally once daily
- Second dose reduction: 40 mg orally once daily
- Third dose reduction: Permanently discontinue therapy.
Dose Modifications for Adverse Reactions:
- Hemoglobin less than 9 g/dL or transfusion indicated: Withhold therapy until hemoglobin 9 g/dL or greater; resume at reduced dose or discontinue depending on the severity of anemia
- Life-threatening or urgent intervention indicated: Withhold therapy until hemoglobin 9 g/dL or greater; resume at reduced dose or permanently discontinue
- Decreased oxygen saturation with exercise (e.g., pulse oximeter less than 88%): Consider withholding therapy until resolved; resume at the same dose or at a reduced dose depending on the severity of hypoxia.
- Decreased oxygen saturation at rest (e.g., pulse oximeter less than 88% or partial pressure of oxygen (PaO2) 55 mm Hg or less) or urgent intervention indicated: Withhold therapy until resolved; resume at reduced dose or discontinue depending on the severity of hypoxia
US BOXED WARNINGS:
- This drug can cause fetal harm when administered during pregnancy.
- This drug can render some hormonal contraceptives ineffective.
- Verify pregnancy status prior to the initiation of therapy.
- Advise patients of these risks and the need for effective nonhormonal contraception.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
- This drug should be taken at the same time each day and may be taken with or without food.
- If a dose of this drug is missed, it can be taken as soon as possible on the same day. Resume the regular schedule the next day. Do not take extra tablets to make up for the missed dose.
- If vomiting occurs any time after taking this drug, do not retake the dose. Take the next dose the next day.
- Store this drug at 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F and 86F).
- Renal function
- Red blood cells
- Read the patient approved labeling each time you receive this medicine.
- Red blood cell levels will be monitored routinely by your healthcare provider because this drug can cause severe anemia that may require blood transfusions.
- Contact your healthcare provider if you experience any symptoms of anemia.
- This drug can cause severe hypoxia that may require discontinuation, supplemental oxygen, or hospitalization.
- Contact your healthcare provider if you experience symptoms of hypoxia.
- Pregnant women and females of reproductive potential should understand the risk to a fetus.
- Females of reproductive potential should use effective nonhormonal contraception while taking this drug and for 1 week after.
- Male patients with female partners of reproductive potential should use effective contraception during therapy and for 1 week after.
- Do not breastfeed during therapy with this drug and for 1 week after.
More about belzutifan
- Check interactions
- Side effects
- During pregnancy
- Drug class: miscellaneous antineoplastics
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