Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
ivacaftor
Vertex Pharmaceuticals (Ireland) Limited
R07AX02
ivacaftor
Other respiratory system products
Cystic Fibrosis
Kalydeco tablets are indicated:As monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1).In a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, and 3849+10kbC→T.In a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (CF) who have at least one F508del mutation in the CFTR gene (see section 5.1).Kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (CF) who have an R117H CFTR mutation or one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see sections 4.4 and 5.1).In a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one F508del mutation in the CFTR gene.
Revision: 38
Authorised
2012-07-23
103 B. PACKAGE LEAFLET 104 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT KALYDECO 75 MG FILM-COATED TABLETS KALYDECO 150 MG FILM-COATED TABLETS ivacaftor 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 or pharmacist. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Kalydeco is and what it is used for 2. What you need to know before you take Kalydeco 3. How to take Kalydeco 4. Possible side effects 5. How to store Kalydeco 6. Contents of the pack and other information 1. WHAT KALYDECO IS AND WHAT IT IS USED FOR Kalydeco contains the active substance ivacaftor. Ivacaftor acts at the level of the cystic fibrosis transmembrane conductance regulator (CFTR), a protein that forms a channel at the cell surface that allows the movement of particles such as chloride in and out of the cell. Due to mutations in the _CFTR_ gene (see below), chloride movement is reduced in those with cystic fibrosis (CF). Ivacaftor helps certain abnormal CFTR proteins open more often to improve chloride movement in and out of the cell. Kalydeco tablets are indicated: • As monotherapy for patients aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have an _R117H CFTR_ mutation or one of the following gating mutations in the _CFTR_ gene: _G551D_ , _G1244E_ , _G1349D_ , _G178R_ , _G551S_ , _S1251N_ , _S1255P_ , _S549N_ or _S549R_ . • In combination with tezacaftor/ivacaftor tablets for patients aged 6 years and older with CF who have two _F508del _ mutations in the _CFTR _ gene (homozygous for the _F508del _ mutation) or who have an _F508del _ mutation Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Kalydeco 75 mg film-coated tablets Kalydeco 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Kalydeco 75 mg film-coated tablets Each film-coated tablet contains 75 mg of ivacaftor. _Excipient with known effect _ _ _ Each film-coated tablet contains 83.6 mg of lactose monohydrate. Kalydeco 150 mg film-coated tablets Each film-coated tablet contains 150 mg of ivacaftor. _Excipient with known effect _ Each film-coated tablet contains 167.2 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Kalydeco 75 mg film-coated tablets Light blue, capsule-shaped film-coated tablets, printed with “V 75” in black ink on one side and plain on the other (12.7 mm × 6.8 mm in modified tablet shape). Kalydeco 150 mg film-coated tablets Light blue, capsule-shaped film-coated tablets, printed with “V 150” in black ink on one side and plain on the other (16.5 mm × 8.4 mm in modified tablet shape). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kalydeco tablets are indicated: • As monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have an _R117H CFTR_ mutation or one of the following gating (class III) mutations in the cystic fibrosis transmembrane conductance regulator ( _CFTR_ ) gene: _G551D_ , _G1244E_ , _G1349D_ , _G178R_ , _G551S_ , _S1251N_ , _S1255P_ , _S549N_ or _S549R_ (see sections 4.4 and 5.1). • In a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (CF) who are homozygous for the _F508del _ mutation or who are heterozygous for the _F508del_ mutation and have one of the following mutations in the _CFTR_ gene: _P67L, R117C, L206W, R352Q, A455E, D579G, _ 3 _711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, _ and _ _ _384 Les hele dokumentet