Generic name: ivacaftor
Dosage form: tablet, film coated
This dosage information does not include all the information needed to use Kalydeco safely and effectively. See full prescribing information for Kalydeco.
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Dosing Information in Adults and Children Ages 6 Years and Older
The recommended dose of KALYDECO for both adults and pediatric patients age 6 years and older is one 150 mg tablet taken orally every 12 hours (300 mg total daily dose) with fat-containing food. Examples of appropriate fat-containing food include eggs, butter, peanut butter, cheese pizza, etc. [see Clinical Pharmacology (12.3) and Patient Counseling Information (17.4)].
Dosage Adjustment for Patients with Hepatic Impairment
The dose of KALYDECO should be reduced to 150 mg once daily for patients with moderate hepatic impairment (Child-Pugh Class B). KALYDECO should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) at a dose of 150 mg once daily or less frequently [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3), and Patient Counseling Information (17.3)].
Dosage Adjustment for Patients Taking Drugs that are CYP3A Inhibitors
When KALYDECO is being co-administered with strong CYP3A inhibitors (e.g., ketoconazole) the dose should be reduced to 150 mg twice-a-week. The dose of KALYDECO should be reduced to 150 mg once daily when co-administered with moderate CYP3A inhibitors (e.g., fluconazole). Food containing grapefruit or Seville oranges should be avoided [see Drug Interactions (7.1), Clinical Pharmacology (12.3), and Patient Counseling Information (17.2)].