Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Global Blood Therapeutics Netherlands B.V., Strawinskylaan 3051, 1077ZX Amsterdam, Netherlands
Oxbryta is indicated for the treatment of haemolytic anaemia due to sickle cell disease (SCD) in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.
Treatment should be initiated by physicians experienced in the management of SCD.
The recommended dose of Oxbryta is 1,500 mg (three 500 mg film-coated tablets) taken orally once daily.
If a dose is missed, treatment should be continued on the day following the missed dose.
The recommended dose of Oxbryta in patients 12 to <18 years of age is the same as for adults. The safety and efficacy of Oxbryta in paediatric patients below the age of 12 years have not been established yet. No data are available.
No dose adjustment is recommended in patients with mild to severe renal impairment. Oxbryta has not been evaluated in patients with end stage renal disease (ESRD) requiring dialysis (see section 4.4).
No dose adjustment of Oxbryta is recommended for patients with mild or moderate hepatic impairment. The recommended dose of voxelotor in patients with severe hepatic impairment (Child-Pugh C) is 1,000 mg (two 500 mg film-coated tablets) taken once daily (see section 4.4).
Oxbryta film-coated tablets should be swallowed whole with water. Oxbryta can be taken with or without food (see section 5.2). Tablets should not be cut, crushed, or chewed because of the unpleasant taste.
There was one report of overdose in the pivotal Phase 3 study where a patient took a total of 3,000 mg of voxelotor at one time. There were no adverse reactions associated with this event.
In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
3 years.
This medicinal product does not require any special storage conditions.
High-density polyethylene (HDPE) bottle with a polypropylene child-resistant cap and an aluminium induction seal. The bottle also contains a silica gel desiccant canister and polyester coil.
Pack-size of 90 film-coated tablets.
This medicinal product may persist in the environment (see section 5.3).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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