KALYDECO® (ivacaftor) Study
for People With the R117H Mutation
Study 5 (R117H)
In Study 5
- KALYDECO was studied in 69 people age 6 years and older with an R117H mutation in the CF gene. These people took KALYDECO or placebo every 12 hours with fat-containing food for 24 weeks
Your healthcare provider can tell you more about KALYDECO and the R117H mutation. Talk to your doctor about whether KALYDECO is right for you.
- Change in lung function was the main endpoint, or measure, of this study
- Lung function was measured in a test called FEV1, or forced expiratory volume exhaled in 1 second
- Other endpoints included change in sweat chloride, change in CF respiratory symptoms (such as cough, mucus production, and trouble breathing), change in body mass index (BMI), time to first pulmonary exacerbation, and safety
- BMI is a measure of a person’s weight relative to height
- Pulmonary exacerbation is any new, or change in, antibiotics that people had to take because of 4 or more symptoms involving their sinuses or lungs
- People in this study kept taking their other CF therapies
Some people in this study showed improvement in these endpoints, but others did not
- Please talk to your healthcare provider to learn more about the results of this study
What is KALYDECO® (ivacaftor)?
KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have one of the following mutations in their CF gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R.
KALYDECO is used for the treatment of CF in patients age 2 years and older who have an R117H mutation in their CF gene.
KALYDECO is not for use in people with CF due to other mutations in the CF gene. KALYDECO is not effective in patients with CF with two copies of the F508del mutation (F508del/F508del) in the CF gene.
It is not known if KALYDECO is safe and effective in children under 2 years of age.
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 medications such as phenobarbital, carbamazepine (Tegretol®, Carbatrol®, Equetro®) or phenytoin (Dilantin®, Phenytek®); or St. John’s wort.
Talk to your doctor before taking KALYDECO if you take any of these medicines or supplements.