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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
Who might be right for Oxbryta® (voxelotor)? Find appropriate sickle cell disease (SCD) patients based on your practice

Please select the most common characteristics of the patients with SCD you treat to learn more

Currently taking hydroxyurea (HU) therapy

Yes

No

Age group

12-18 years

>18 years

Jamie is a potential patient because she has been treated with the max dose of HU and Oxbryta is indicated for patients as young as 4.1,2

Not an actual patient.

Jamie


  • 12-year-old African American female with SCD genotype HbSS
  • She likes to play soccer

Relevant past medical history:

  • Presented with 1 vaso-occlusive crisis (VOC) in the past year

Current treatment of SCD:

  • Treated with HU, on maximum tolerated dose
  • Taking folic acid

Baseline lab workup:

  • Hb = 7.5 g/dL
  • HbF = 20%
  • MCV = 115 fL
  • WBC = 5,500/µL
  • ANC = 2,000/µL
  • Reticulocytes = 9%
  • Absolute reticulocyte count = 250,000/µL
  • Platelet count = 240,000/µL
  • Total bilirubin = 4.5 mg/dL
  • Indirect bilirubin = 4 mg/dL
Maria is a patient who has similar characteristics to the HOPE trial population.1,2

Not an actual patient.

Maria


  • 30-year-old Hispanic female with SCD genotype HbSS
  • She works at a bank and is a busy mother of 2 children
Relevant medical history:
  • Pulmonary hypertension
  • Received 2 blood transfusions in the past year
  • History of 3 vaso-occlusive crises (VOCs) in the past year
Current treatment of SCD:
  • Treated with HU, on maximum tolerated dose
  • Taking folic acid and hydrocodone PRN (as needed)
Baseline lab workup:
  • Hb = 6.5 g/dL
  • HbF = 15%
  • MCV = 110 fL
  • WBC = 6,000/µL
  • ANC = 2,500/µL
  • Reticulocytes = 12%
  • Absolute reticulocyte count = 371,000/μL
  • Platelet count = 550,000/μL
  • Total bilirubin = 8 mg/dL
  • Indirect bilirubin = 7.5 mg/dL
Age group

12-18 years

>18 years

The safety profile observed in pediatric patients 12 to <17 years of age treated with Oxbryta was similar to that seen in adult patients.1

Not an actual patient.

Gabriel


  • Gabriel is a 14-year-old Hispanic male with SCD genotype HbSS
  • Both of Gabriel’s parents have busy work schedules
  • He often spends his free time playing video games and watching TV
Relevant medical history:
  • History of 3 vaso-occlusive crises (VOCs) in the past year
  • Established microalbuminuria and complains of yellowing in his eyes
  • Undergoes annual transcranial Doppler (TCD) screenings since diagnosis per guideline recommendations
Current treatment of SCD:
  • Family refuses HU
  • Taking oxycodone PRN (as needed)
Baseline lab workup:
  • Hb = 6.0 g/dL
  • HbF = 4%
  • MCV = 86 fL
  • WBC = 14,000/µL
  • ANC = 9,000/µL
  • Reticulocytes = 14%
  • Absolute reticulocyte count = 325,000/µL
  • Platelet count = 550,000/µL
  • Total bilirubin = 6 mg/dL
  • Indirect bilirubin = 5.5 mg/dL
  • Serum creatinine = 0.5 mg/dL
  • eGFR = 145 mL/min/1.73 m2
  • Urine albumin to creatinine ratio = 95 mg/g
Henry has had >2 vaso-occlusive crises (VOCs) in the past year, like 58% of patients in the HOPE trial.1

Not an actual patient.

Henry


  • 50-year-old African American male with SCD genotype HbSβ0 thalassemia
  • He is a consultant, traveling each week
Relevant medical history:
  • Cannot receive blood transfusions due to alloantibodies
  • History of 3 VOCs and 2 episodes of acute chest syndrome in the past year
  • Recently started an ACE inhibitor for diagnosis of proteinuria
Current treatment of SCD:
  • Discontinued HU therapy 5 years ago
  • Taking hydrocodone bitartrate PRN (as needed)
Baseline lab workup:
  • Hb = 7.0 g/dL
  • HbF = 12%
  • MCV = 65 fL
  • WBC = 13,200/µL
  • Reticulocytes = 10%
  • Absolute reticulocyte count = 480,000/µL
  • Platelet count = 450,000/µL
  • Total bilirubin = 7 mg/dL
  • Indirect bilirubin = 6.5 mg/dL
  • Serum creatinine = 1.2 mg/dL
  • eGFR = 60 mL/min/1.73 m2
  • Urine albumin to creatinine ratio = 500 mg/g
 Next: Oxbryta Safety Oxbryta safety LoadingEfficacy Efficacy Results

Examine data from the HOPE and HOPE-KIDS 1 trials

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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