Description
Kalydeco® (ivacaftor) is an oral medication used to treat cystic fibrosis (CF) in patients aged 1 month and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation. Ivacaftor enhances the function of the CFTR protein, improving chloride transport across cell membranes, which helps alleviate the symptoms of CF.
| Fact Table |
| Formula | C24H28N2O3 |
| License | US FDA, EMA |
| Bioavailability | ~35% (increased with fat-containing meals) |
| Legal status | Rx-only |
| Chemical Name | Ivacaftor |
| Elimination half-life | ~12 hours |
| Dosage (Strength) | 150 mg tablets (taken every 12 hours with fat-containing food) |
| Pregnancy | Category B – Use if clearly needed |
| Brands | Kalydeco |
| Protein binding | ~99% |
| PubChem CID | 16220172 |
| MedlinePlus | a613032 |
| ChEBI | 68511 |
| ATC code | R07AX02 |
| DrugBank | DB08820 |
| KEGG | D09725 |
| Routes of administration | Oral |
Directions
Kalydeco is administered orally every 12 hours with fat-containing food. The dosage varies based on age and weight:
- Adults and children aged 6 years and older: One 150 mg tablet every 12 hours.
- Children aged 6 months to less than 6 years:
- Weight 7 kg to less than 14 kg: One 50 mg packet of oral granules every 12 hours.
- Weight 14 kg or more: One 75 mg packet of oral granules every 12 hours.
- Children aged 1 month to less than 6 months:
- Weight 3 kg to less than 4 kg: One 20 mg packet of oral granules every 12 hours.
- Weight 4 kg and above: One 25 mg packet of oral granules every 12 hours.
For oral granules, mix the contents of each packet with one teaspoon (5 mL) of soft food or liquid at or below room temperature and administer within one hour of preparation.
Ingredients
Active ingredient: ivacaftor. Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.
Contraindications
Kalydeco is contraindicated in patients with known hypersensitivity to ivacaftor or any of its components.
Cautions
- Elevated Transaminases: Monitor liver function tests (ALT and AST) before initiating treatment, every three months during the first year, and annually thereafter. Interrupt dosing if transaminase levels exceed five times the upper limit of normal.
- Cataracts: Cases of non-congenital lens opacities have been reported in pediatric patients. Baseline and follow-up ophthalmological examinations are recommended in pediatric patients initiating Kalydeco treatment.
- Drug Interactions: Avoid concomitant use with strong CYP3A inducers (e.g., rifampin, St. John's wort) as they may reduce ivacaftor exposure. Dose adjustments are necessary when co-administered with moderate or strong CYP3A inhibitors (e.g., fluconazole, ketoconazole).
Side Effects
Common adverse reactions include:
- Upper respiratory tract infection
If any severe or concerning side effects occur, contact your healthcare provider promptly.
IMPORTANT NOTE:
The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.
Product Code : 12936
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