HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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OXBRYTA (voxelotor)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
OXBRYTA Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older.
This indication is approved under accelerated approval based on...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage for Adults and Pediatric Patients 12 Years and Older
The recommended dosage of OXBRYTA is 1,500 mg orally once...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Tablets: 300 mg light purple to purple, oval shaped, biconvex, debossed with "G 300" on one side.
Tablets: 500 mg light yellow to yellow, oval shaped, biconvex, debossed with "GBT 500" on...
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Contraindications
4 CONTRAINDICATIONS
OXBRYTA is contraindicated in patients with a history of serious drug hypersensitivity reaction to voxelotor or excipients. Clinical manifestations may include generalized rash, urticaria, mild shortness...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
Serious hypersensitivity reactions after administration of OXBRYTA have occurred in <1% of patients...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on Voxelotor
Strong or Moderate CYP3A4...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no available...
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Description
11 DESCRIPTION
OXBRYTA contains voxelotor, a hemoglobin S polymerization inhibitor. The chemical name of voxelotor is 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Voxelotor is a hemoglobin S (HbS) polymerization inhibitor that binds to HbS with a 1:1 stoichiometry and exhibits...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Voxelotor was not carcinogenic in a 26-week study in RasH2 transgenic mice at oral...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Adults and Pediatric Patients 12 Years and Older
The efficacy and safety of OXBRYTA in SCD was evaluated in HOPE, a Phase 3 randomized,...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
The 300 mg tablet is film-coated, light purple to purple, oval shaped, biconvex, debossed with "G 300" on one side, available in:
- •
- Bottles of 60 tablets with one...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
...
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Instructions For Use
This Instructions for Use has been approved by the U.S. Food... |
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Other
This product's label may have been updated. For most recent prescribing information, please visit www.pfizer.com. For medical information...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.