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Kalydeco


Kalydeco
is a medicine used to treat cystic fibrosis, an inherited disease that has severe effects on the lungs, the digestive system and other organs. Cystic fibrosis affects the cells that produce mucus and digestive juices. As a result, these secretions become thick and cause blockage. Build-up of thick and sticky secretions in the lungs causes inflammation and long-term infection. In the gut, blockage of the tubes from the pancreas slows down the digestion of food and causes poor growth.

Kalydeco is used on its own to treat cystic fibrosis in patients aged 1 year and above who have one of nine mutations (changes) in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator’ (CFTR). The mutations are: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N and S549R (also known as gating mutations).

Kalydeco is also used on its own to treat patients with cystic fibrosis aged 18 years and above who have the R117H mutation in the CFTR gene.

Kalydeco is also used together with another cystic fibrosis medicine containing the active substances tezacaftor and ivacaftor to treat patients with cystic fibrosis aged 12 years and above who have a mutation called F508del in the CFTR gene. The two medicines are used in patients who have inherited the F508del mutation from both parents and therefore have the mutation in both copies of the CFTR gene. They are also used in patients who have inherited the F508del mutation from one parent and also have one of the following mutations in CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, or 3849+10kbC→T.

Kalydeco contains the active substance ivacaftor.


How to use Kaledeco

Kalydeco can only be obtained with a prescription. It should only be prescribed by a doctor with experience in the treatment of cystic fibrosis, and only in patients confirmed to have the mutations mentioned above.

Kalydeco is available as tablets (150 mg) and as granules (50 mg and 75 mg) in a sachet. For children aged 1 year and above and weighing 7 to 25 kg, the granules should be used. They should be mixed with 5 ml of soft food or liquid to make a suspension to be taken by mouth.

The tablets are used in adults and children aged 6 years and above and weighing 25 kg or more.

The dose and frequency depends on whether Kalydeco is used alone or together with tezacaftor / ivacaftor.

The doses of Kalydeco may need to be adjusted if the patient is also taking a type of medicine called a ‘moderate or strong CYP3A inhibitor’, such as certain antibiotics or medicines for fungal infections. The doses may also need to be adjusted in patients with reduced liver function.

For more information about using Kalydeco, see the package leaflet or contact your doctor or pharmacist.


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