Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ivacaftor (UNII: 1Y740ILL1Z) (ivacaftor - UNII:1Y740ILL1Z)
Vertex Pharmaceuticals Incorporated
ivacaftor
ivacaftor 150 mg
ORAL
PRESCRIPTION DRUG
KALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients age 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. None. Risk Summary There are limited and incomplete human data from clinical trials and postmarketing reports on use of KALYDECO in pregnant women. In animal reproduction studies, oral administration of ivacaftor to pregnant rats and rabbits during organogenesis demonstrated no teratogenicity or adverse effects on fetal development at doses that produced maternal exposures up to approximately 5 (rats) and 11 (rabbits) times the exposure at the maximum recommended human dose
KALYDECO (ivacaftor) tablets are supplied as light blue, film-coated, capsule-shaped tablets containing 150 mg of ivacaftor. Each tablet is printed with the characters "V 150" on one side and plain on the other, and is packaged as follows: KALYDECO (ivacaftor) oral granules are supplied as small, white to off-white granules and enclosed in unit-dose packets as follows: Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].
New Drug Application
KALYDECO- IVACAFTOR TABLET, FILM COATED KALYDECO- IVACAFTOR GRANULE VERTEX PHARMACEUTICALS INCORPORATED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE KALYDECO SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KALYDECO. KALYDECO (IVACAFTOR) TABLETS, FOR ORAL USE KALYDECO (IVACAFTOR) ORAL GRANULES INITIAL U.S. APPROVAL: 2012 RECENT MAJOR CHANGES Indications and Usage (1) 05/2023 Dosage and Administration (2) 05/2023 Warnings and Precautions, Hypersensitivity Reactions, Including Anaphylaxis (5.2) 08/2023 INDICATIONS AND USAGE KALYDECO is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 1 month and older who have at least one mutation in the _CFTR_ gene that is responsive to ivacaftor based on clinical and/or _in vitro_ assay data. (12.1, 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. (1) 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 than 14 kg One 50 mg packet every 12 hours 14 kg or greater One 75 mg packet every 12 hours 6 years and older - One 150 mg tablet every 12 hours Taken orally with fat-containing food See full prescribing information for the recommended dosage in patients 6 months and older with moderate or severe hepatic impairment. (2.3, 8.6) See full prescribing information for dosage modif Přečtěte si celý dokument