Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
tezacaftor, ivacaftor
Vertex Pharmaceuticals (Ireland) Limited
R07AX31
tezacaftor, ivacaftor
Other respiratory system products
Cystic Fibrosis
Symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (CF) aged 6 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (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.
Revision: 12
Authorised
2018-10-31
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SYMKEVI 50 MG/75 MG FILM-COATED TABLETS SYMKEVI 100 MG/150 MG FILM-COATED TABLETS tezacaftor/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 Symkevi is and what it is used for 2. What you need to know before you take Symkevi 3. How to take Symkevi 4. Possible side effects 5. How to store Symkevi 6. Contents of the pack and other information 1. WHAT SYMKEVI IS AND WHAT IT IS USED FOR SYMKEVI CONTAINS TWO ACTIVE SUBSTANCES, tezacaftor and ivacaftor. The medicine helps lung cells to work better in some patients with cystic fibrosis (CF). CF is an inherited condition in which the lungs and the digestive system can become clogged with thick, sticky mucus. Symkevi works on a protein called CFTR ( _cystic fibrosis transmembrane conductance regulator_ ), which is damaged in some people with CF (who have a mutation in the _CFTR_ gene). Ivacaftor causes the protein to work better while tezacaftor increases the amount of protein at the cell surface. Symkevi is normally taken with ivacaftor, another medicine. Symkevi taken with ivacaftor is for long-term treatment of patients aged 6 years and over who have CF with certain genetic mutations t hat result in reduced amount and/or function of the CFTR protein. Symkevi taken with ivacaftor helps your breathing by improving your lung function. You may also notice that you do not get ill as often and/or that it is easier to gain weight. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ _ _ 2 1. NAME OF THE MEDICINAL PRODUCT Symkevi 50 mg/75 mg film-coated tablets Symkevi 100 mg/150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Symkevi 50 mg/75 mg film-coated tablets Each tablet contains 50 mg of tezacaftor and 75 mg of ivacaftor. Symkevi 100 mg/150 mg film-coated tablets Each tablet contains 100 mg of tezacaftor and 150 mg of ivacaftor. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Symkevi 50 mg/75 mg film-coated tablets White, capsule-shaped tablet debossed with “V50” on one side and plain on the other (dimensions 12.70 mm x 6.78 mm). Symkevi 100 mg/150 mg film-coated tablets Yellow, capsule-shaped tablet debossed with “V100” on one side and plain on the other (dimensions 15.9 mm x 8.5 mm). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symkevi is indicated in a combination regimen with ivacaftor tablets for the treatment of patients with cystic fibrosis (CF) aged 6 years and older who are homozygous for the _F508del_ mutation or who are heterozygous for the _F508del_ mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator ( _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_ . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Symkevi should only be prescribed by physicians with experience in the treatment of CF. If the patient’s genotype is unknown, an accurate and validated genotyping method should be performed to confirm the presence of an indicated mutation using a genotyping assay. Posology _ _ Adults, adolescents and children aged 6 years and older should be dosed according to Table 1. _ _ 3 TABLE 1: DOSING RECOMMENDATIONS FOR PATIENTS AGED 6 YEARS AND OLDER AGE/WEIGHT MORNING (1 TABLET) EVENING (1 TABLET) 6 to < 12 years weighing < 30 kg tezacaftor 50 mg/ivacaftor 75 mg ivacaftor 75 mg 6 to < 12 years weigh Aqra d-dokument sħiħ