Kalydeco Dosage

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

The recommended dosage of KALYDECO for adults and pediatric patients aged 6 years and older is 150 mg orally every 12 hours (300 mg total daily dose) with fat-containing food.

Recommended Dosage in Pediatric Patients Aged 1 Month to Less than 6 Years

The recommended dosage of KALYDECO (oral granules) for pediatric patients aged 1 month to less than 6 years is weight-based provided in Table 1. Take KALYDECO orally with fat-containing food.

Recommended Dosage for Patients with Hepatic Impairment

KALYDECO is not recommended in patients less than 6 months of age with any level of hepatic impairment. The following is the recommended dosage of KALYDECO taken with fat-containing food for patients aged 6 months and older with hepatic impairment:

• Mild Hepatic Impairment (Child-Pugh Class A):
  • Less than 6 months of age: KALYDECO is not recommended.
  • No dosage adjustment is necessary for patients aged 6 months or older.
• Moderate Hepatic Impairment (Child-Pugh Class B):
  • Less than 6 months of age: KALYDECO is not recommended.
  • 6 months to less than 6 years of age: one packet (containing 25 mg, 50 mg, or 75 mg ivacaftor) of oral granules once daily based on dosing recommended for age and weight in Table 1.
  • 6 years of age and older: 150 mg orally once daily.
• Severe Hepatic Impairment (Child-Pugh Class C): Should not be used in patients less than 6 months of age. In patients aged 6 months and older should be used with caution. KALYDECO has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), but exposure is expected to be higher than in patients with moderate hepatic impairment. Therefore, use with caution at a reduced dosage, in patients aged 6 months or older with severe hepatic impairment after weighing the risks and benefits of treatment.
  • Less than 6 months of age: KALYDECO is not recommended.
  • 6 months to less than 6 years of age: one packet (containing 25 mg, 50 mg, or 75 mg ivacaftor) of oral granules once daily or less frequently based on dosing recommended for age and weight in Table 1.
  • 6 years of age and older: 150 mg orally once daily or less frequently.

Dosage Modification for Patients Taking Drugs that are CYP3A Inhibitors

Concomitant use of moderate or strong CYP3A inhibitors is not recommended in patients below 6 months of age. Food or drink containing grapefruit should be avoided. Take KALYDECO with fat-containing food.

Administration Information

Administer KALYDECO tablets or oral granules 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..