OXBRYTA Highlights

(voxelotor)

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

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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
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