Belzutifan
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Tejasvi Aryaputra
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Black Box Warning
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See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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Overview
Belzutifan is a hypoxia-inducible factor inhibitor that is FDA approved for the treatment of von Hippel-Lindau disease under certain conditions. There is a Black Box Warning for this drug as shown here. Common adverse reactions include headache, increased creatinine, nausea, anemia, decreased hemoglobin, dizziness, fatigue, and increased glucose.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Belzutifan FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Belzutifan in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Belzutifan in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Belzutifan FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Belzutifan in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Belzutifan in pediatric patients.
Contraindications
There is limited information regarding Belzutifan Contraindications in the drug label.
Warnings
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TITLE
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
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There is limited information regarding Belzutifan Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Belzutifan Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Belzutifan Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Belzutifan Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Belzutifan in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Belzutifan in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Belzutifan during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Belzutifan in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Belzutifan in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Belzutifan in geriatric settings.
Gender
There is no FDA guidance on the use of Belzutifan with respect to specific gender populations.
Race
There is no FDA guidance on the use of Belzutifan with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Belzutifan in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Belzutifan in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Belzutifan in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Belzutifan in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Belzutifan Administration in the drug label.
Monitoring
There is limited information regarding Belzutifan Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Belzutifan and IV administrations.
Overdosage
There is limited information regarding Belzutifan overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Belzutifan Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Belzutifan Mechanism of Action in the drug label.
Structure
There is limited information regarding Belzutifan Structure in the drug label.
Pharmacodynamics
There is limited information regarding Belzutifan Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Belzutifan Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Belzutifan Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Belzutifan Clinical Studies in the drug label.
How Supplied
There is limited information regarding Belzutifan How Supplied in the drug label.
Storage
There is limited information regarding Belzutifan Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Belzutifan Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Belzutifan interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Belzutifan Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Belzutifan Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.