Kalydeco (IVACAFTOR)
Kalydeco (IVACAFTOR) is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: Kalydeco; Generic name: IVACAFTOR; Drug class: Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC].
| Brand name | Kalydeco |
|---|---|
| Generic name | IVACAFTOR |
| Drug class | Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC] |
| Manufacturer | Vertex Pharmaceuticals Incorporated |
| Used for | 1 INDICATIONS AND USAGE KALYDECO is indicated for the treatment of 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 based on clinical and/or in vitro assay data [see Clinical Pharmacology (12.1) and Clinical Studies (14) ] . 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. KALYDECO is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis |
| Dosage | 2 DOSAGE AND ADMINISTRATION Age Weight Dosage Administration 1 month to less than 2 months 3 kg or greater One 5.8 mg packet every 12 hours Mixed with one teaspoon (5 mL) of soft food or liquid and administered orally with fat-containing food 2 months to less than 4 months 3 kg or greater One 13.4 mg packet every 12 hours 4 months to less than 6 months 5 kg or greater One 25 mg packet every 12 hours 6 months to less than 6 years 5 kg to less than 7 kg One 25 mg packet every 12 hours 7 kg to less |
| Active ingredient(s) | IVACAFTOR |
| Route | ORAL |
| Official label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25 |