Here is a downloadable resource that you might find
helpful when treating patients with KALYDECO.
A guide that covers dosage and administration, clinical
trials, clinical pharmacology, safety profile, and much more.
Indications and Usage
KALYDECO 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
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.
Important Safety Information
Transaminase (ALT or AST) Elevations
- Elevated transaminases have been reported in patients with CF receiving KALYDECO. It is recommended that ALT and AST be assessed prior to initiating KALYDECO, every 3 months during the first year of treatment, and annually thereafter. Patients who develop increased transaminase levels should be closely monitored until the abnormalities resolve. Dosing should be interrupted in patients with ALT or AST of greater than 5 times the upper limit of normal (ULN). Following resolution of transaminase elevations, consider the benefits and risks of resuming KALYDECO dosing
Concomitant Use with CYP3A Inducers
- Use of KALYDECO with strong CYP3A inducers, such as rifampin, substantially decreases the exposure of ivacaftor, which may reduce the therapeutic effectiveness of KALYDECO. Co-administration of KALYDECO with strong CYP3A inducers, such as rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. John's Wort is not recommended
Serious Adverse Reactions
- Serious adverse reactions, whether considered drug-related or not by the investigators, which occurred more frequently in patients treated with KALYDECO included abdominal pain, increased hepatic enzymes, and hypoglycemia
- The most common adverse reactions in Phase 3 trials with an incidence of ≥8% and at a higher incidence for patients treated with KALYDECO (N=109) than for placebo (N=104) were headache (24% vs 16%), oropharyngeal pain (22% vs 18%), upper respiratory tract infection (22% vs 14%), nasal congestion (20% vs 15%), abdominal pain (16% vs 13%), nasopharyngitis (15% vs 12%), diarrhea (13% vs 10%), rash (13% vs 7%), nausea (12% vs 11%), and dizziness (9% vs 1%)
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 is pronounced kuh-LYE-deh-koh
Please see the Full U.S. Prescribing Information
on this website.