KALYDECO is indicated for the treatment of CF in patients age 6 years and older who have a G551D mutation in the CFTRa gene.
Click here for full Indication, including Limitations of Use.
aCFTR, cystic fibrosis transmembrane conductance regulator.
KALYDECO is a prescription medication used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a certain mutation in their CF gene called the G551D mutation.
KALYDECO is not for use in people with CF due to other mutations in the CF gene. It is not effective in patients with CF with 2 copies of the F508del mutation (F508del/F508del) in the CF gene.
It is not known if KALYDECO is safe and effective in children under 6 years of age.
KALYDECO should not be used with certain medications or herbal supplements.
Talk to your doctor before taking KALYDECO if you are taking:
Before you take KALYDECO, tell your doctor if you:
KALYDECO may affect the way other medications work, and other medications may affect how KALYDECO works.
Tell your doctor about all the medications you take, including:
The dose of KALYDECO may need to be adjusted when taken with certain medications.
Especially tell your doctor if you take:
KALYDECO can cause dizziness in some people who take it. Do not drive a car, use machinery, or do anything that needs you to be alert until you know how KALYDECO affects you.
You should avoid food containing grapefruit or Seville oranges while you are taking KALYDECO.
KALYDECO can cause serious side effects
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of KALYDECO. For more information, ask your doctor or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch, or call 1-800-FDA-1088.
KALYDECO™ (ivacaftor) is classified as a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator. KALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the G551D mutation.
Limitations of Use
KALYDECO is not effective in patients with CF who are homozygous for the F508del mutation in the CFTR gene and has not been studied in other populations of patients with CF.
Click here to access full Prescribing Information.
References: 1. KALYDECO [prescribing information]. Cambridge, MA: Vertex Pharmaceuticals Incorporated; August 2012. 2. Ramsey BW, Davies J, McElvaney NG, et al; for VX08-770-102 Study Group. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl J Med. 2011;365(18):1663-1672. 3. Davies JC, Wainwright CE, Canny GJ, et al; VX08-770-103 (ENVISION) Study Group. Efficacy and safety of ivacaftor in patients aged 6 to 11 years with cystic fibrosis with a G551D mutation. Am J Respir Crit Care Med. 2013;187(11):1219-1225. 4. Welsh MJ, Ramsey BW, Accurso F, Cutting GR. Membrane transport disorders: cystic fibrosis. In: Valle D, Beaudet AL, Vogelstein B, et al, eds. The Online Metabolic & Molecular Bases of Inherited Disease. The McGraw-Hill Companies, Inc; 2004:part 21, chap 201. http://dx.doi.org/10.1036/ommbid.236. Accessed August 5, 2013. 5. Rowe SM, Miller S, Sorscher EJ. Cystic fibrosis. N Engl J Med. 2005;352(19):1992-2001. 6. Zielenski J. Genotype and phenotype in cystic fibrosis. Respiration. 2000;67(2):117-133. 7. Welsh MJ, Smith AE. Molecular mechanisms of CFTR chloride channel dysfunction in cystic fibrosis. Cell. 1993;73(7):1251-1254. 8. Data on file. Cambridge, MA: Vertex Pharmaceuticals Incorporated; 2011. 9. Ramsey BW, Davies J, McElvaney NG, et al; for VX08-770-102 Study Group. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl J Med. 2011;365(18)(suppl):1-18. 10. Flume PA, Liou TG, Borowitz DS, et al; for VX08-770-104 Study Group. Ivacaftor in subjects with cystic fibrosis who are homozygous for the F508del-CFTR mutation. Chest. 2012;142(3):718-724. 11. US Department of Agriculture, Agricultural Research Service. Nutrient Data Laboratory Web site. http://www.ars.usda.gov/ba/bhnrc/ndl. Updated March 5, 2013. Accessed August 5, 2013.
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