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Kalydeco Dosage

Generic name: ivacaftor 150mg
Dosage form: tablet, film coated; oral granule

Medically reviewed by Drugs.com. Last updated on Sep 29, 2020.

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, yogurt, breast milk or infant formula), etc. [see Clinical Pharmacology (12.3) and Patient Counseling Information (17)].

Recommended Dosage in Adults and Pediatric Patients Aged 6 Years and Older

The recommended dosage of KALYDECO for adults and pediatric patients ages 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)].

Recommended Dosage in Pediatric Patients Aged 4 Months to Less than 6 Years

The recommended dosage of KALYDECO (oral granules) for patients ages 4 months to less than 6 years is weight-based according to Table 1.

Table 1: Dosage of KALYDECO Oral Granules by Body Weight in Pediatric Patients Ages 4 months to less than 6 Years
Age Body Weight (kg) KALYDECO Dosage Total Daily Dose
*
KALYDECO is not recommended for use in children under 4 months of age.
KALYDECO is not recommended for use in children aged 4 months to less than 6 months with hepatic impairment and/or taking concomitant moderate or strong CYP3A inhibitors
4 months* to less than 6 months 5 kg or greater One 25 mg packet every 12 hours 50 mg/day
6 months or older 5 kg to less than 7 kg One 25 mg packet every 12 hours 50 mg/day
7 kg to 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

Instructions for Administration of Oral Granules

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, breast milk, infant formula, milk, or juice. Each dose should be administered just before or just after fat-containing food [see Dosage and Administration (2.1)].

Dosage Adjustment for Patients with Hepatic Impairment Aged 6 Months and Older

The dosage of KALYDECO should be reduced to one tablet or one packet of oral granules once daily for patients aged 6 months and older with moderate hepatic impairment (Child-Pugh Class B). KALYDECO should be used with caution in patients aged 6 months and older with severe hepatic impairment (Child-Pugh Class C), at a dosage of one tablet or one packet of oral granules once daily or less frequently. Use is not recommended in patients with hepatic impairment below 6 months of age [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3), and Patient Counseling Information (17)].

Dosage Adjustment for Patients Aged 6 Months and Older Taking Drugs that are CYP3A Inhibitors

When KALYDECO is being co-administered with strong CYP3A inhibitors (e.g., ketoconazole) in patients aged 6 months or older, 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). Concomitant use of moderate or strong CYP3A inhibitors is not recommended in patients below 6 months of age. Food containing grapefruit should be avoided [see Drug Interactions (7.1), Clinical Pharmacology (12.3), and Patient Counseling Information (17)].

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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