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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
YourSource™ is a support network 
to help patients start and continue treatment as prescribedEverything you need to enroll your patientsDownload, complete, and sign the Prescription/Enrollment Form to prescribe Oxbryta. Please discuss the enrollment process with your patients (or their Authorized Caregivers*) so they know which portions of the Form they are required to complete for enrollment.

Your patients (or their Authorized Caregivers) must complete and sign the Patient Authorization Form to begin receiving support from YourSource.
An Authorized Caregiver is someone who is legally authorized to make decisions on behalf of the patient.YourSource HCP PortalEnroll patients online at YourSourcePortal.com
YourSourcePortal.com
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Download/print/faxDownload the Prescription/Enrollment Form at EnrollOxbryta.com, then fax the completed Form to (888) 418-4178
EnrollOxbryta.com
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Helpful tips for enrollmentOnce you and your patients have discussed how YourSource can be there for them: Complete all sections of the Prescription/Enrollment Form and sign/enter the date in the appropriate boxes Verify that patient’s contact and insurance information is correct
(you may also include a copy of your patient’s insurance card with the Form)
Provide all requested contact information for quick and efficient communication Make sure your patient, or their Authorized Caregiver, reads, signs, and dates the Patient Authorization and Consent Form
Complete all sections of the Prescription/Enrollment Form and sign/enter the date in the appropriate boxes Verify that patient’s contact and insurance information is correct (you may also include a copy of your patient’s insurance card with the Form) Provide all requested contact information for quick and efficient communication Make sure your patient, or their Authorized Caregiver, reads, signs, and dates the Patient Authorization and Consent FormYourSource is a support network to help patients start and continue treatment as prescribedSupport for your eligible patients throughout the treatment processExplore the access and support available to your patients
Visit the YourSource website
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Subject to eligibility and certain terms and conditions.

Your patients’ way to financial assistancePatients with commercial health insuranceThe YourSource Commercial Copay Program provides financial assistance with out-of-pocket deductibles, copay, or coinsurance costs for eligible patients.‡,§Patients who are uninsuredIf your patient does not have health insurance, YourSource may be able to help them find programs that provide assistance.Patients with government-funded health insuranceIf your patient has Medicare/Medicare Part D, Medicaid, TRICARE, or another government insurance plan, YourSource may be able to help identify financial support resources.Subject to eligibility and certain limits, terms and conditions, and annual reenrollment requirements.Patients are not eligible for the YourSource Commercial Copay Program if they are enrolled in a state- or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs healthcare, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico.YourSource offers ongoing assistance for your patients prescribed Oxbryta YourSource Care Coordinators
 
  • Provide reimbursement support to eligible patients
     
  • Discuss and verify insurance benefits
     
  • Communicate if prior authorization is necessary
     
  • Inform you and your patients (or their Authorized Caregivers) about out-of-pocket costs
     
  • Provide information about appeals process if coverage is denied
YourSource Nurse Support Team||
 
  • Provides adherence education
     
  • Answers general questions about treatment with Oxbryta
The Nurse Support Team does not provide medical advice or case-management services. Patients should always talk with you, their healthcare provider, if they need guidance about their specific condition or overall health. YourSource Access Navigators
 
  • Your regionally aligned Access Navigator can answer general questions and provide information on access requirements related to Oxbryta, including YourSource resources, navigating the insurance process, and the Pfizer Patient Assistance Program
     
  • Access Navigators also contact patients who opted in during enrollment to schedule and provide an introductory session about the services provided by YourSource
The Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation. Free medications from Pfizer are provided through the Pfizer Patient Assistance Foundation. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc. with distinct legal restrictions. If patient has a Medicare Part D plan and is eligible for the Pfizer Patient Assistance Program, YourSource will notify patient’s Part D plan of their enrollment in the Pfizer Patient Assistance Program. Your patients’ Specialty Pharmacy#
 
  • Coordinates shipment of Oxbryta once prescribed
     
  • Follows up with patients (or their Authorized Caregivers) after shipments are delivered
     
  • Monitors prescription refills and requests refill authorization as needed
     
  • Notifies you and your patients of any treatment challenges or refill issues
     
  • Answers general questions your patients (or their Authorized Caregivers) may have (pharmacist available by phone 24/7)
The Specialty Pharmacy does not replace the role of a patient’s healthcare provider. Patients should talk with their doctor if they need guidance about their specific condition or overall health.YourSource™

To learn more, call (833) 428-4868, Option 1 M-F, 8am-8pm ET
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Access & SupportGet the latest information about Oxbryta delivered to your inboxSign upLoading

To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

© 2024 Pfizer Inc. All rights reserved.

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