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KALYDECO is a brand name for Ivacaftor, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: KALYDECO (ivacaftor) tablets (150 mg) are indicated for the treatment of patients with cystic fibrosis (CF) aged 6 years and older and weighing 25 kg or more who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N,…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations KALYDECO should only be administered to patients who have a mutation in the CFTR gene listed in INDICATIONS. KALYDECO should only be prescribed by physicians with experience in the treatment of cystic fibrosis.
If the patient's genotype is unknown, an accurate and validated genotyping method should be performed to confirm the presence of an indicated mutation in at least one allele of the CFTR gene [see 10 CLINICAL PHARMACOLOGY and 14 CLINICAL TRIALS].
2 Recommended Dose and Dosage Adjustment Adults, adolescents, and children aged 2 months and older Adults, adolescents, and children aged 2 months and older should be dosed according to Table 1. 4 mg) 4 months to less than 6 months‡ ≥5 kg 1 packet (25 mg) 1 packet (25 mg) 6 months and older ≥5 kg to <7 kg 1 packet (25 mg) 1 packet (25 mg) ≥7 kg to <14 kg 1 packet (50 mg) 1 packet (50 mg) ≥14 kg to <25 kg 1 packet (75 mg) 1 packet (75 mg) ≥25 kg 1 tablet (150 mg) 1 tablet (150 mg) * Dose should be taken orally approximately 12 hours apart with fat-containing food.
† KALYDECO is not authorized for use in patients less than 2 months of age. ‡ Use of ivacaftor in patients less than 6 months of age born at a gestational age <37 weeks has not been evaluated. Hepatic Impairment Patients aged 2 months to less than 6 months Due to variability in maturation of cytochrome (CYP) enzymes involved in ivacaftor metabolism, treatment with KALYDECO is not recommended in patients less than 6 months of age with any level of hepatic impairment.
Patients aged 6 months and older No dose adjustment is necessary for patients aged 6 months and older with mild hepatic impairment (Child-Pugh Class A). The dose of KALYDECO should be one tablet or one packet of granules once daily for patients aged 6 months and older with moderate hepatic impairment (Child-Pugh Class B) based on dosing recommended for the age and weight in Table 2.
There is no experience in the use of KALYDECO in patients aged 6 months and older with severe hepatic impairment (Child-Pugh Class C) and therefore its use is not recommended unless the benefits outweigh the risks. In such cases, KALYDECO should be administered at a starting dose of one tablet or one packet of granules every other day and modified according to KALYDECO (ivacaftor) Tablets and Granules Page 6 of 43 tolerability and clinical response.
4 Drug-Drug Interactions]. 4 Drug-Drug Interactions]. , ketoconazole).
Table 3:
Dosing Schedule for Concomitant Use of KALYDECO with Strong CYP3A Inhibitors by Body Weight in Patients Aged 6 Months and Older† Body Weight (kg) KALYDECO Dose* ≥5 kg to <7 kg 1 packet (25 mg) twice a week, approximately 3 to 4 days apart.
≥7 kg to <14 kg 1 packet (50 mg) twice a week, approximately 3 to 4 days apart. ≥14 kg to <25 kg 1 packet (75 mg) twice a week, approximately 3 to 4 days apart. >25 kg 1 tablet (150 mg) twice a week, approximately 3 to 4 days apart. * Dosing intervals should be modified according to clinical response and tolerability.
† Treatment with ivacaftor is not recommended in patients less than 6 months of age who are taking concomitant strong or moderate CYP3A inhibitors. , fluconazole).
Table 4:
Dosing Schedule for Concomitant Use of KALYDECO with Moderate CYP3A Inhibitors by Body Weight in Patients Aged 6 Months and Older† Body Weight (kg) KALYDECO Dose* ≥5 kg to <7 kg 1 packet (25 mg) once daily ≥7 kg to <14 kg 1 packet (50 mg) once daily ≥14 kg to <25 kg 1 packet (75 mg) once daily >25 kg 1 tablet (150 mg) once daily * Dosing intervals should be modified according to clinical response and tolerability.
† Treatment with ivacaftor is not recommended in patients less than 6 months of age who are taking concomitant strong or moderate CYP3A inhibitors. g. rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, and St. 4 Drug-Drug Interactions].
Elevated transaminase (AST/ALT) levels Elevated transaminases have been reported in patients with CF treated with KALYDECO. Dosing should be interrupted in patients with ALT or AST of > 5 x upper limit of normal (ULN). 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data].
KALYDECO is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
For dose adjustment for patients with hepatic impairment, refer to Table 2.
Table 2:
Dosing Recommendations by Body Weight in Patients Aged 6 Months and Older for Patients with Hepatic Impairment† Hepatic Impairment Weight Dosing Mild (Child-Pugh Class A) ≥5 kg to <7 kg No Dosage adjustment ≥7 kg to <14 kg ≥14 kg to <25 kg ≥25 kg Moderate (Child- Pugh Class B) ≥5 kg to <7 kg 1 packet (25 mg) once daily ≥7 kg to <14 kg 1 packet (50 mg) once daily ≥14 kg to <25 kg 1 packet (75 mg) once daily ≥25 kg 1 tablet (150 mg) once daily Severe (Child- Pugh Class C) ≥5 kg to <7 kg Not recommended unless the benefit outweighs the risk.
Dose as follows in such cases: 1 packet (25 mg) every other day* ≥7 kg to <14 kg Not recommended unless the benefit outweighs the risk. Dose as follows in such cases: 1 packet (50 mg) every other day* ≥14 kg to <25 kg Not recommended unless the benefit outweighs the risk.
Dose as follows in such cases: 1 packet (75 mg) every other day* ≥25 kg Not recommended unless the benefit outweighs the risk. Dose as follows in such cases: 1 tablet (150 mg) every other day* * Dosing intervals should be modified according to clinical response and tolerability.
† Treatment with ivacaftor is not recommended in patients less than 6 months of age with any level of hepatic impairment. Renal Impairment No dosage adjustment is necessary for mild to moderate renal impairment. 3 Pharmacokinetics]. 4 Drug-Drug Interactions].
4 Drug-Drug Interactions]. , ketoconazole).
Table 3:
Dosing Schedule for Concomitant Use of KALYDECO with Strong CYP3A Inhibitors by Body Weight in Patients Aged 6 Months and Older† Body Weight (kg) KALYDECO Dose* ≥5 kg to <7 kg 1 packet (25 mg) twice a week, approximately 3 to 4 days apart.
≥7 kg to <14 kg 1 packet (50 mg) twice a week, approximately 3 to 4 days apart. ≥14 kg to <25 kg 1 packet (75 mg) twice a week, approximately 3 to 4 days apart. >25 kg 1 tablet (150 mg) twice a week, approximately 3 to 4 days apart. * Dosing intervals should be modified according to clinical response and […]
4 Administration KALYDECO tablets and granules should be taken with fat-containing food. Meals and snacks recommended in CF guidelines or meals recommended in standard nutritional guidelines contain adequate amounts of fat. A serving size of foods appropriate for age from a typical CF diet should be given.
Examples of meals that contain fat are those prepared with butter or oils or those containing eggs, cheeses, nuts, whole milk, breast milk, infant formula, or meats. Food containing grapefruit should be avoided. 3 Pharmacokinetics]. Granules • For oral use.
• The entire contents of each packet of granules should be mixed with 1 teaspoon (5 mL) of age-appropriate soft food or liquid and completely consumed. • Food or liquid should be at or below room temperature. • Each packet is for single use only.
Once mixed, the product has been shown to be stable for 1 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 (except for grapefruit juice).
• Each dose should be administered just before or just after fat-containing food. If mixed with food, KALYDECO granules must not be stored for future use. Tablets For oral use. , patients should not chew, break, or dissolve the tablet).
5 Missed Dose If a dose is missed within 6 hours of the scheduled time, the missed dose should be taken as soon as possible with fat-containing food. If more than 6 hours have passed since the dose should have been taken, this dose should be skipped, and the usual dosing schedule resumed.
5 OVERDOSAGE There have been no reports of overdose with KALYDECO. Ivacaftor doses as high as 500 mg/kg in rats and 2000 mg/kg in mice were administered. These doses are 13- and 27-fold higher, respectively, than the intended daily therapeutic dose PrKALYDECO® (ivacaftor) Tablets and Granules Page 9 of 43 of 300 mg for ivacaftor for patients aged 6 years and older.
The highest single dose used in a clinical trial was 800 mg in a solution formulation without any treatment-related adverse events. 5 days (9 doses) in a trial evaluating the effect of KALYDECO on electrocardiograms (ECGs) in healthy adult patients.
Adverse events reported at a higher incidence compared to placebo included dizziness and diarrhea. No specific antidote is available for overdose with KALYDECO. Treatment of overdose with KALYDECO consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
For management of a suspected drug overdose, contact your regional poison control centre. KALYDECO (ivacaftor) Tablets and Granules Page 10 of 43 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 5 – Dosage Forms, Strengths, Composition and Packaging.
4 mg of ivacaftor, 25 mg of ivacaftor, 50 mg of ivacaftor or 75 mg of ivacaftor. KALYDECO 150 mg tablets Light blue, capsule-shaped film-coated tablets printed with “V 150” in black ink on one side and plain on the other. Each tablet […]