Pregnancy Category B1
There are no adequate studies evaluating the use of KALYDECO (ivacaftor) in pregnant women. KALYDECO should be used in pregnant women only if clearly needed.
Excretion of ivacaftor into human milk is probable. Caution should be exercised when KALYDECO is administered to a nursing woman.
The safety and efficacy of KALYDECO in patients 6 to 17 years of age with CF who have a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation in the CFTR gene have been demonstrated.
The efficacy of KALYDECO in children 2 to less than 6 years of age is extrapolated from efficacy in patients 6 years of age and older with support from population pharmacokinetic analyses showing similar drug exposure levels in adults and children 2 to less than 6 years of age.
The safety of KALYDECO in children 2 to less than 6 years of age is derived from a 24-week, open label clinical trial (Trial 6). The type and frequency of adverse reactions were similar to those in patients 6 years and older. Transaminase elevations were more common in patients who had abnormal transaminases at baseline. For patients with a history of transaminase elevations, more frequent monitoring of liver function tests should be considered.
The safety and efficacy of KALYDECO in patients with CF younger than age 2 years have not been established. The use of KALYDECO in children under the age of 2 years is not recommended.
CF is largely a disease of children and young adults. Clinical trials of KALYDECO did not include sufficient numbers of patients 65 years of age and over to determine whether they respond differently from younger patients.
See table on Dose Adjustments page for recommended dosage adjustments.
KALYDECO has not been studied in patients with mild, moderate, or severe renal impairment or in patients with end‑stage renal disease. No dose adjustment is necessary for patients with mild to moderate renal impairment; however, caution is recommended while using KALYDECO in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end‑stage renal disease.
Patients with CF homozygous for the F508del mutation in the CFTR gene1
No clinical improvement was seen with KALYDECO in a Phase 2 trial of such patients.1
KALYDECO is not effective in patients with CF who are homozygous for the F508del mutation in the CFTR gene.