Generic name: ivacaftor 150mg
Dosage form: tablet, film coated
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General Dosing Information
KALYDECO should be taken with fat-containing food. Examples include eggs, butter, peanut butter, cheese pizza, whole-milk dairy products (such as whole milk, cheese, and yogurt), etc. [see Clinical Pharmacology (12.3) and Patient Counseling Information (17)].
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 [see Dosage and Administration (2.1)].
Dosing Information in Pediatric Patients Ages 2 to less than 6 Years
The recommended dose of KALYDECO (oral granules) for patients ages 2 to less than 6 years is weight-based according to Table 1.
|Body Weight (kg)||KALYDECO Dose||Total Daily Dose|
|Less than 14 kg||One 50 mg packet every 12 hours||100 mg/day|
|14 kg or greater||One 75 mg packet every 12 hours||150 mg/day|
The entire contents of each packet of oral granules should be mixed with one teaspoon (5 mL) of age-appropriate soft food or liquid and completely consumed. Food or liquid should be at or below room temperature. Once mixed, the product has been shown to be stable for one hour, and therefore should be consumed during this period. Some examples of soft foods or liquids may include puréed fruits or vegetables, yogurt, applesauce, water, milk, or juice. Each dose should be administered just before or just after fat-containing food [see Dosage and Administration (2.1)].
Dosing Information in Pediatric Patients less than 2 Years
A safe and efficacious dose of KALYDECO for pediatric patients less than 2 years of age has not been established. The use of KALYDECO (oral granules) in children under the age of 2 years is not recommended.
Dosage Adjustment for Patients with Hepatic Impairment
The dose of KALYDECO should be reduced to one tablet or one packet of oral granules 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 one tablet or one packet of oral granules once daily or less frequently [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3), and Patient Counseling Information (17)].
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 one tablet or one packet of oral granules twice a week. The dose of KALYDECO should be reduced to one tablet or one packet of granules 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)].
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