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SCD Root CauseAbout OxbrytaEfficacyEfficacyClinical Data | Ages ≥12 YearsClinical Data | Ages 4 to <12 YearsPatient ProfilesSafetyDosingAccess & SupportAccess & SupportAccess & SupportSign up
IndicationFull Prescribing InformationPatient Prescribing Information andInstructions for UsePatient Site
Convenient, once-daily oral dosing with Oxbryta® (voxelotor)1,*

Ages ≥12 Years

Ages 4 to <12 Years

The recommended dosage of Oxbryta for adults and pediatric patients 12 years and older is 1,500 mg orally once daily

Once daily

If a dose is missed or entire dose is not taken, resume dosing the following day

With or without food

Patients should swallow Oxbryta tablets whole. Do not cut, crush, or chew the tablets

With or without hydroxyurea

No laboratory monitoring of Oxbryta requiredPlease see Full Prescribing Information and Patient Prescribing Information for complete information on Dosage and Administration.

Recommended dosage for adults and pediatric patients 12 years and older with hepatic impairment

  • The recommended dosage of Oxbryta in adults and pediatric patients 12 years and older with severe hepatic impairment (Child-Pugh C) is 1,000 mg orally once daily
  • No dosage adjustment of Oxbryta is required for patients with mild or moderate hepatic impairment

Recommended dosage of Oxbryta for adults and pediatric patients 12 years and older when used with concomitant strong or moderate CYP3A4 inducers

  • Avoid concomitant use of strong or moderate CYP3A4 inducers with Oxbryta
  • If concomitant use of strong CYP3A4 inducers is unavoidable, the recommended dosage of Oxbryta is 2,500 mg orally once daily. If concomitant use of moderate CYP3A4 inducers is unavoidable, the recommended dosage of Oxbryta is 2,000 mg orally once daily
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Dosing recommendations for Oxbryta in pediatric patients ages 4 to <12 years are based on patient’s ability to swallow tablets and on the patient’s weight

Once daily

If a dose is missed or entire dose is not taken, resume dosing the following day

With or without food

Patients should swallow Oxbryta tablets whole. Do not cut, crush, or chew the tablets. Do not swallow whole, cut, crush, or chew the tablets for oral suspension

Please see administration instructions below

With or without hydroxyurea

No laboratory monitoring of Oxbryta required
Scroll left to view table
RECOMMENDED OXBRYTA DOSAGE IN PEDIATRIC PATIENTS 4 TO <12 YEARS
Body Weight Recommended Dose (once daily)
≥40 kg 1,500 mg
20 kg to <40 kg 900 mg
10 kg to <20 kg 600 mg
For pediatric patients 4 years to <12 years, select the appropriate product (Oxbryta tablets 300 mg, Oxbryta tablets 500 mg, or Oxbryta tablets for oral suspension) based on the patient's ability to swallow tablets and on the patient's weight.Please see Full Prescribing Information and Instructions for Use for complete information on Dosage and Administration.Dose adjustments in pediatric patients 4 to <12 years

Recommended dosage for patients with hepatic impairment*

  • No dosage adjustment of Oxbryta is required for patients with mild or moderate hepatic impairment
  • For severe hepatic impairment, adjust Oxbryta dosage as recommended below
Scroll left to view table
SEVERE HEPATIC IMPAIRMENT (CHILD-PUGH C)
Body Weight Recommended Dose (once daily)
≥40 kg 1,000 mg (two 500 mg tablets)
or
900 mg (three 300 mg tablets for oral suspension or three 300 mg tablets)
20 kg to <40 kg 600 mg
10 kg to <20 kg 300 mg

Concomitant use with strong or moderate CYP3A4 inducers*

  • Avoid concomitant use of strong or moderate CYP3A4 inducers with Oxbryta
  • If concomitant use of strong or moderate CYP3A4 inducers is unavoidable, adjust the Oxbryta dosage as recommended in the table below
Scroll left to view table

Example

STRONG OR MODERATE CYP3A4 INDUCERS IN PEDIATRIC PATIENTS 4 TO <12 YEARS
Body Weight Recommended Dose
(once daily)
  Concomitant Use of Strong
CYP3A4 Inducers		 Concomitant Use of
Moderate CYP3A4 Inducers
≥40 kg 2,500 mg (five 500 mg tablets)
or
2,400 mg (eight 300 mg
tablets for oral suspension or
eight 300 mg tablets)		 2,000 mg (four 500 mg tablets)
or
2,100 mg (seven 300 mg tablets
for oral suspension or seven 300 mg tablets)
20 kg to <40 kg 1,500 mg 1,200 mg
10 kg to <20 kg 900 mg 900 mg
Please see Full Prescribing Information and Instructions for Use for complete information on Dosage and Administration.Important administration instructions

Oxbryta 300 mg and 500 mg tablets

  • Patients should swallow Oxbryta tablets whole
  • Do not cut, crush, or chew the tablets

Oxbryta 300 mg tablets for oral suspension

  • Patients should disperse tablets for oral suspension immediately before administration in a cup and in room temperature clear liquid (such as drinking water, clear soda, apple juice, clear electrolyte drinks, clear flavored drinks, or clear sports drinks) before swallowing
Scroll left to view table
OXBRYTA 300 MG TABLETS FOR ORAL SUSPENSION
Recommended Daily Dose Number of Tablets
for Oral Suspension		 Minimum Recommended
Volume of Clear Drink
300 mg 1 5 mL (1 teaspoon)
600 mg 2 10 mL (2 teaspoons)
900 mg 3 15 mL (3 teaspoons)
1,200 mg 4 20 mL (4 teaspoons)
1,500 mg 5 25 mL (5 teaspoons)
2,100 mg 7 35 mL (7 teaspoons)
2,400 mg 8 40 mL (8 teaspoons)
  • After the tablets start to disintegrate, swirl the contents of the cup until the tablets are dispersed, wait 1 to 5 minutes, swirl the contents of the cup again, and then orally administer the contents of the cup. The tablet(s) will not completely dissolve; there will still be small tablet clumps in the mixture
  • Resuspend any residue left in the cup in more clear drink and administer. Repeat until no tablet residue is left in the cup
  • Do not swallow whole, cut, crush, or chew the tablets for oral suspension
  • Please see Instructions for Use for detailed information

Tablets for oral suspension may be substituted for tablets in adults and pediatric patients 12 years and older with difficulty swallowing the tablets. Use the number of tablets for oral suspension needed to achieve the recommended dose.

Tablets for oral suspension may be substituted for tablets in adults and pediatric patients 12 years and older with difficulty swallowing the tablets. Use the number of tablets for oral suspension needed to achieve the recommended dose.

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Reference:Oxbryta Full Prescribing Information. South San Francisco, CA: Global Blood Therapeutics, Inc.; 08/2023.Get the latest information about Oxbryta delivered to your inboxSign upLoading

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PP-LTV-USA-2392
Indications and UsageOxbryta 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 increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Important Safety InformationCONTRAINDICATIONS
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 of breath, mild facial swelling, and eosinophilia.

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Serious hypersensitivity reactions after administration of Oxbryta have occurred in <1% of patients treated. Clinical manifestations may include generalized rash, urticaria, mild shortness of breath, mild facial swelling, and eosinophilia.

Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in postmarketing experience with Oxbryta. Patients who develop a combination of skin rash, fever, peripheral eosinophilia, and internal systemic organ involvement (e.g., hepatic, renal, pulmonary) while receiving Oxbryta should undergo medical evaluation.

Advise patients of the signs and symptoms of severe hypersensitivity reactions, including DRESS. If hypersensitivity reactions occur, discontinue Oxbryta and administer appropriate medical therapy. Do not reinitiate Oxbryta in patients who experience these symptoms with previous use.

Laboratory Test Interference
Oxbryta administration may interfere with measurement of Hb subtypes (HbA, HbS, and HbF) by high-performance liquid chromatography (HPLC). If precise quantitation of Hb species is required, chromatography should be performed when the patient has not received Oxbryta therapy in the immediately preceding 10 days.

ADVERSE REACTIONS
Clinical Trials Experience
Adults and Pediatric Patients 12 Years of Age and Older
Serious adverse reactions occurred in 3% (3/88) of patients receiving Oxbryta 1,500 mg, which included headache, drug hypersensitivity, and pulmonary embolism occurring in 1 patient each. Permanent discontinuation due to an adverse reaction (Grades 1-4) occurred in 5% (4/88) of patients who received Oxbryta 1,500 mg.

The most common adverse reactions occurring in ≥10% of patients treated with Oxbryta 1,500 mg with a difference of >3% compared to placebo: Headache (32% vs. 25%), Diarrhea (23% vs. 11%), Abdominal Pain (23% vs. 16%), Nausea (19% vs. 10%), Rash (15% vs. 11%), and Pyrexia (15% vs. 8%).

Pediatric Patients 4 to <12 Years
The safety of Oxbryta in pediatric patients 4 to <12 years with SCD was evaluated in an open-label, Phase 2 study. In this study, 45 patients 4 to <12 years of age received doses of Oxbryta tablets for oral suspension based on weight at baseline. Thirty-five patients received Oxbryta for 24 weeks and 26 patients for 48 weeks. The most common adverse reactions (>10%) reported in pediatric patients 4 to <12 years were pyrexia (36%), vomiting (33%), rash (20%), abdominal pain (18%), diarrhea (18%), and headache (18%).

The overall safety profile of Oxbryta in pediatric patients 4 to <12 years was similar to that seen in adults and pediatric patients 12 years and older.

DRUG INTERACTIONS
Strong or Moderate CYP3A4 Inducers
Coadministration of strong or moderate CYP3A4 inducers may decrease voxelotor plasma and whole blood concentrations and may lead to reduced efficacy. Avoid coadministration of Oxbryta with strong or moderate CYP3A4 inducers. Increase the Oxbryta dosage when coadministration with a strong or moderate CYP3A4 inducer is unavoidable.

Sensitive CYP3A4 Substrates
Voxelotor increased the systemic exposure of midazolam (a sensitive CYP3A4 substrate). Avoid coadministration of Oxbryta with sensitive CYP3A4 substrates with a narrow therapeutic index. If concomitant use is unavoidable, consider dose reduction of the sensitive CYP3A4 substrate(s).

USE IN SPECIFIC POPULATIONS
Lactation
Because of the potential for serious adverse reactions in the breastfed child, including changes in the hematopoietic system, advise patients that breastfeeding is not recommended during treatment with Oxbryta, and for at least 2 weeks after the last dose.

Recommended Dosage for Hepatic Impairment
Severe hepatic impairment increases voxelotor exposures. For severe hepatic impairment (Child Pugh C) reduce dose to 1,000 mg orally once daily for adults and pediatric patients ≥12 years. Dose reduction for pediatric patients 4 to <12 years is dependent on body weight (please refer to Table 2 in the Full Prescribing Information).

Please see Full Prescribing Information for more information about Oxbryta.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 increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

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PP-MCL-USA-0367