See the mutations KALYDECO is indicated for

KALYDECO is for the treatment of cystic fibrosis (CF) in people age 6 months and older who have one of the following 38 CF gene mutations:

2789+5G→A D110H F1052V G551S R117H S549R
3272-26A→G D1152H F1074L K1060T R347H S945L
3849+10kbC→T D1270N G1069R L206W R352Q S977F
711+3A→G D579G G1244E P67L R74W  
A1067T E193K G1349D R1070Q S1251N  
A455E E56K G178R R1070W S1255P  
D110E E831X G551D R117C S549N  
2789+5G→A E831X R1070W
3272-26A→G F1052V R117C
3849+10kbC→T F1074L R117H
711+3A→G G1069R R347H
A1067T G1244E R352Q
A455E G1349D R74W
D110E G178R S1251N
D110H G551D S1255P
D1152H G551S S549N
D1270N K1060T S549R
D579G L206W S945L
E193K P67L S977F
E56K R1070Q  
  • The following mutations were not included in the clinical studies but are predicted to respond based on results from a laboratory setting: A1067T, D110E, D110H, D1270N, E56K, E193K, F1052V, F1074L, G1069R, K1060T, R74W, and R1070Q
  • F508del and 26 other mutations are not responsive to KALYDECO based on clinical and/or laboratory data

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What is KALYDECO® (ivacaftor)?

KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 months and older who have at least one mutation in their CF gene that is responsive to KALYDECO.

Talk to your doctor to learn if you have an indicated CF gene mutation.

It is not known if KALYDECO is safe and effective in children under 6 months of age.

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Important Safety Information

Who should not take KALYDECO?

Do not take KALYDECO if you take certain medicines or herbal supplements, such as:

  • the antibiotics rifampin (Rifamate®, Rifater®) or rifabutin (Mycobutin®)
  • seizure medicines such as phenobarbital, carbamazepine (Tegretol®, Carbatrol®, and Equetro®), or phenytoin (Dilantin®, Phenytek®)
  • St. John’s wort (Hypericum perforatum)

Talk to your doctor before taking KALYDECO if you take any of the medicines or supplements listed above.

EXPAND

What is KALYDECO® (ivacaftor)?

KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 months and older who have at least one mutation in their CF gene that is responsive to KALYDECO.

Talk to your doctor to learn if you have an indicated CF gene mutation.

It is not known if KALYDECO is safe and effective in children under 6 months of age.