| Status: Welsh Government agreement | |
As monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more (tablets); infants aged at least 1 month and children weighing 3 kg to 25 kg (granules) 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. An agreement to enable patients in Wales to access this medicine has been confirmed by Welsh Government. Please refer to the Welsh Government written statements below. |
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Medicine details |
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| Medicine name | ivacaftor (Kalydeco®) |
| Formulation | film-coated tablets and granules |
| Reference number | 6040 |
| Indication | 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. Kalydeco granules are indicated as monotherapy for the treatment of infants aged at least 1 month, toddlers and children weighing 3 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 |
| Company | Vertex Pharmaceuticals UK Ltd |
| BNF chapter | Respiratory system |
| Submission type | N/A |
| Status | Welsh Government agreement |
| Date of issue | 08/05/2013 |
| Further information See also: |
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