(voxelotor)

Prescribing Information
Download Prescribing Information

Health Professional Information

Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use OXBRYTA safely and effectively. See full prescribing information for OXBRYTA.

OXBRYTA® (voxelotor) tablets, for oral use
OXBRYTA® (voxelotor) tablets for oral suspension
Initial U.S. Approval: 2019

RECENT MAJOR CHANGES

Dosage and Administration (2)

10/2022

Warnings and Precautions, Hypersensitivity Reactions (5.1)

08/2023

INDICATIONS AND USAGE

OXBRYTA is a hemoglobin S polymerization inhibitor indicated for the treatment of sickle cell disease in adults and pediatric patients 4 years of age and older.

This indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1)

DOSAGE AND ADMINISTRATION

OXBRYTA can be taken with or without food. (2.7)

Recommended dosage:

•
Adults and pediatric patients 12 years and older: 1,500 mg orally once daily. (2.1)
•
Pediatric patients 4 to less than 12 years: Dosing with OXBRYTA is based on body weight. See Table 1 for complete dosing recommendations. (2.2)

Recommended dosage for severe hepatic impairment (Child Pugh C):

•
Adults and pediatric patients 12 years and older: 1,000 mg orally once daily. (2.3)
•
Pediatric patients 4 to less than 12 years: Reduce the dose of OXBRYTA based on body weight. See Table 2 for complete dosing recommendations. (2.4)

DOSAGE FORMS AND STRENGTHS

•
Tablets: 300 mg and 500 mg (3)
•
Tablets for oral suspension: 300 mg (3)

CONTRAINDICATIONS

Prior drug hypersensitivity to voxelotor or excipients. (4)

WARNINGS AND PRECAUTIONS

•
Hypersensitivity Reactions: Observe for signs and symptoms and manage promptly. (5.1)
•
Laboratory Test Interference: Perform quantification of hemoglobin species when patient is not receiving OXBRYTA. (5.2)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥10% with a difference of >3% compared to placebo) are headache, diarrhea, abdominal pain, nausea, rash, and pyrexia. (6.1)

Most common adverse reactions (incidence >10%) reported in pediatric patients 4 to <12 years are pyrexia, vomiting, rash, abdominal pain, diarrhea, and headache. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Sensitive CYP3A4 Substrates: Avoid coadministration of sensitive CYP3A4 substrates with a narrow therapeutic index. (7.2)
•
Strong or moderate CYP3A4 Inducers: Avoid coadministration with strong or moderate CYP3A4 inducers. If unavoidable, increase the dose of OXBRYTA. (2.5, 2.6, 7.1)

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 8/2023

Medication Guide
Download Consumer Medicine Information

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Additional Resources

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.

Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.

Available 9AM-5PM ET Monday to Friday; excluding holidays.

 

Submit a medical question for a Pfizer medicine or a vaccine. 

The submission will be reviewed during our standard business hours.

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, 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 medication, please call (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/medwatch or by calling (800) 332-1088.