Kalydeco
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
KALYDECO is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have one of the following mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R.
KALYDECO is indicated for the treatment of CF in patients age 2 years and older who have an R117H mutation in the CFTR gene.
If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.
Limitations of Use
KALYDECO is not effective in patients with CF who are homozygous for the F508del mutation in the CFTR gene.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in KALYDECO tablets and oral granules is ivacaftor, a cystic fibrosis transmembrane conductance regulator potentiator, which has the following chemical name: N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide. Its molecular formula is C24H28N2O3 and its molecular weight is 392.49. Ivacaftor has the following structural formula:
Ivacaftor is a white to off-white powder that is practically insoluble in water (<0.05 microgram/mL).
KALYDECO is available as a light blue, capsule-shaped, film-coated tablet for oral administration containing 150 mg of ivacaftor. Each KALYDECO tablet contains 150 mg of ivacaftor and the following inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablet film coat contains carnauba wax, FD&C Blue #2, PEG 3350, polyvinyl alcohol, talc, and titanium dioxide. The printing ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac.
KALYDECO is also available as white to off-white granules for oral administration (sweetened but unflavored) and enclosed in a unit-dose packet containing 50 mg of ivacaftor or 75 mg of ivacaftor. Each unit-dose packet of KALYDECO oral granules contains 50 mg of ivacaftor or 75 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sucralose, and sodium lauryl sulfate.
Sources
Kalydeco Manufacturers
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Vertex Pharmaceuticals Incorporated
![Kalydeco (Ivacaftor) Tablet, Film Coated [Vertex Pharmaceuticals Incorporated]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Kalydeco | Vertex Pharmaceuticals Incorporated
2.1 General Dosing InformationKALYDECO 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)].
2.2 Dosing Information in Adults and Children Ages 6 Years and OlderThe 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)].
2.3 Dosing Information in Pediatric Patients Ages 2 to less than 6 YearsThe recommended dose of KALYDECO (oral granules) for patients ages 2 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 2 to less than 6 Years 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/dayThe 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)].
2.4 Dosing Information in Pediatric Patients less than 2 YearsA 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.
2.5 Dosage Adjustment for Patients with Hepatic ImpairmentThe 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)].
2.6 Dosage Adjustment for Patients Taking Drugs that are CYP3A InhibitorsWhen 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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