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About Oxbryta®Reimbursement Information Clinical Trial DataSafety ProfileDosing Experience with Oxbryta Supporting ResourcesSupporting ResourcesContact UsVideosDownloadable resourcesFormulary Pack

Click here for Oxbryta®▼ (voxelotor) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

Product safety information

This section provides important information about Oxbryta®, including information from the Summary of Product Characteristics1

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Summary of the safety profile1

The most common adverse reactions with Oxbryta® include:

In the event of hypersensitivity, discontinue Oxbryta® permanently and initiate medical therapy1

Tabulated list of adverse reactions1
  • Adverse reactions were Grade 1 or 2 apart from the following Grade 3 events: Grade 3 diarrhoea (n=1), nausea (n=1), rash (n=1), rash generalised (n=3) and hypersensitivity (n=1)1
  • Abdominal pain includes abdominal pain, abdominal pain upper, and abdominal pain lower1
  • Rash includes rash, urticaria, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash papular1
Contraindications1

Contraindication: hypersensitivity to the active substance or to any of the excipients1

Special warnings and precautions for use1 Interaction with other medicinal products and other forms of interaction1Fertility, pregnancy and lactation1Information on the safety of Oxbryta® that is yet to be collected2

CYP, cytochrome P450; ESRD, end-stage renal disease; Hb, haemoglobin; HbA, adult haemoglobin; HbF, foetal haemoglobin; HbS, haemoglobin S; HbSS, sickle cell anaemia; HIV, human immunodeficiency virus; HPLC, high-performance liquid chromatography; MATE, multidrug and toxin extrusion protein; OAT, organic anion transporter; OATP, organic anion transporting polypeptide; PI, Prescribing Information; PK, pharmacokinetics; SCD, sickle cell disease.

References:

  1. Oxbryta® (voxelotor) Summary of Product Characteristics.
  2. Part VI: Summary of the European Union Risk Management Plan. Available at https://www.ema.europa.eu/en/documents/rmp-summary/oxbryta-epar-risk-management-plan-summary_en.pdf. Accessed July 2023.
Dosing & administration

What you need to know about Oxbryta® in clinical practice

Dosing & administration
Contact us

The Oxbryta® team are here to support you with any queries 

Contact us
PP-LTV-GBR-0103. Aug 2023

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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