Drug Detail:Kalydeco (Ivacaftor [ eye-va-kaf-tor ])
Generic Name: ivacaftor 150mg
Drug Class: CFTR potentiators
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 [see Dosage and Administration (2.5)].
Recommended Dosage in Pediatric Patients Aged 1 Month to Less than 6 Years
The recommended dosage of KALYDECO (oral granules) for pediatric patients ages 1 month to less than 6 years is weight-based provided in Table 1. Take KALYDECO orally with fat-containing food [see Dosage and Administration (2.5)].
| Age | Body Weight (kg) | KALYDECO Dosage |
|---|---|---|
|
||
| 1 month to less than 2 months*† | 3 kg or greater | One packet (containing 5.8 mg ivacaftor) every 12 hours |
| 2 months to less than 4 months*† | 3 kg or greater | One packet (containing 13.4 mg ivacaftor) every 12 hours |
| 4 months to less than 6 months† | 5 kg or greater | One packet (containing 25 mg ivacaftor) every 12 hours |
| 6 months to less than 6 years of age | 5 kg to less than 7 kg | One packet (containing 25 mg ivacaftor) every 12 hours |
| 7 kg to less than 14 kg | One packet (containing 50 mg ivacaftor) every 12 hours | |
| 14 kg or greater | One packet (containing 75 mg ivacaftor) every 12 hours | |
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 [see Dosage and Administration (2.5)] 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 dose adjustment is necessary for patients aged 6 months or older [see Clinical Pharmacology (12.3)].
- 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 [see Dosage and Administration (2.2)].
- 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 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 dose, in patients aged 6 months or older with severe hepatic impairment after weighing the risks and benefits of treatment [see Dosage and Administration (2.1, 2.2) and Clinical Pharmacology (12.3)].
- 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 [see Dosage and Administration (2.2)].
- 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 [see Drug Interactions (7.1), Clinical Pharmacology (12.3)]. Take KALYDECO with fat-containing food [see Dosage and Administration (2.5)].
Dosage modification for patients 6 months of age and older taking CYP3A inhibitors:
- Moderate CYP3A inhibitors:
- 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 [see Dosage and Administration (2.2)].
- 6 years of age and older: 150 mg orally once daily.
- Strong CYP3A inhibitors:
- 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 twice a week based on dosing recommended for age and weight in Table 1 [see Dosage and Administration (2.2)].
- 6 years of age and older: 150 mg orally twice weekly.
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. [see Clinical Pharmacology (12.3)].
Instruction for Administration of Oral Granules
Administer each dose of KALYDECO oral granules immediately before or after ingestion of fat-containing food. Mix the entire contents of each packet of oral granules with one teaspoon (5 mL) of age-appropriate soft food or liquid that is at or below room temperature. Some examples of soft foods or liquids may include puréed fruits or vegetables, yogurt, applesauce, water, breast milk, infant formula, milk, or juice. Food or liquid should be at or below room temperature. Once mixed, the product should be completely consumed within one hour.
