País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
Voxelotor
Pfizer Europe MA EEIG
B06AX03
Voxelotor
Other hematological agents
Anemia; Anemia, Hemolytic; Anemia, Sickle Cell
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.
Revision: 4
Authorised
2022-02-14
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OXBRYTA 500 MG FILM-COATED TABLETS voxelotor This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Oxbryta is and what it is used for 2. What you need to know before you take Oxbryta 3. How to take Oxbryta 4. Possible side effects 5. How to store Oxbryta 6. Contents of the pack and other information 1. WHAT OXBRYTA IS AND WHAT IT IS USED FOR WHAT OXBRYTA IS AND HOW IT WORKS Oxbryta contains the active substance voxelotor. Voxelotor works on a protein in red blood cells called haemoglobin to help it take up oxygen that red blood cells can deliver throughout the body. Patients with the condition called sickle cell disease have an altered form of haemoglobin called sickle haemoglobin which is different from the normal haemoglobin. When the sickle haemoglobin gives up oxygen to the tissues, it sticks together to form long rods and causes red blood cells to alter their shape to that of a crescent moon making these cells rigid and sickled shape. Sickle red blood cells cannot deliver oxygen as well as healthy red blood cells and are also broken down more quickly, leading to lowered levels of red blood cells (haemolytic anaemia). By improving the way the altered haemoglobin holds onto oxygen, Oxbryta improves the function of red blood c Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Oxbryta 500 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg of voxelotor. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light yellow to yellow, oval shaped, biconvex, film-coated tablet of approximately 18 mm × 10 mm, debossed with “GBT 500” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated by physicians experienced in the management of SCD. Posology 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. _Paediatric population _ 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. Special populations _Renal impairment _ 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). 3 _Hepatic impairment _ 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) Llegiu el document complet