Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Elexacaftor (UNII: RRN67GMB0V) (Elexacaftor - UNII:RRN67GMB0V), Tezacaftor (UNII: 8RW88Y506K) (Tezacaftor - UNII:8RW88Y506K), Ivacaftor (UNII: 1Y740ILL1Z) (Ivacaftor - UNII:1Y740ILL1Z)
Vertex Pharmaceuticals Incorporated
PRESCRIPTION DRUG
TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro data [see Clinical Pharmacology (12.1)] . If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation or a mutation that is responsive based on in vitro data. None. Risk Summary There are limited and incomplete human data from clinical trials on the use of TRIKAFTA or its individual components, elexacaftor, tezacaftor and ivacaftor, in pregnant women to inform a drug-associated risk. Although there are no animal reproduction studies with the concomitant administration of elexacaftor, tezacaftor and ivacaftor, separate reproductive and developmental studies were conducted with each active component of TRIKAFTA in pregnant rats and rabbits. In animal em
TRIKAFTA tablets are supplied in a co-packaged blister pack sealed into a printed wallet, containing elexacaftor, tezacaftor and ivacaftor fixed-dose combination tablets and ivacaftor tablets. Four such wallets are placed in a printed outer carton. TRIKAFTA oral granules are supplied in morning and evening unit-dose packets. The morning dose packets contain a fixed-dose combination of elexacaftor, tezacaftor, and ivacaftor oral granules. The evening dose packets contain ivacaftor oral granules. The packets are placed into a printed wallet. Four such wallets are placed in a printed outer carton. 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
TRIKAFTA- ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR VERTEX PHARMACEUTICALS INCORPORATED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TRIKAFTA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRIKAFTA. TRIKAFTA (ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR TABLETS; IVACAFTOR TABLETS), CO-PACKAGED FOR ORAL USE TRIKAFTA (ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR ORAL GRANULES; IVACAFTOR ORAL GRANULES), CO-PACKAGED INITIAL U.S. APPROVAL: 2019 RECENT MAJOR CHANGES Indications and Usage (1) 04/2023 Dosage and Administration (2) 04/2023 Warnings and Precautions, Hypersensitivity Reactions, Including Anaphylaxis (5.2) 08/2023 INDICATIONS AND USAGE TRIKAFTA is a combination of ivacaftor, a CFTR potentiator, tezacaftor, and elexacaftor indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one _F508del_ mutation in the _CFTR_ gene or a mutation in the _CFTR_ gene that is responsive based on _in vitro_ data. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one _F508del_ mutation or a mutation that is responsive based on _in vitro_ data. (1) DOSAGE AND ADMINISTRATION RECOMMENDED DOSAGE FOR ADULT AND PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER AGE WEIGHT MORNING DOSE EVENING DOSE 2 to less than 6 years Less than 14 kg One packet containing elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg oral granules One packet containing ivacaftor 59.5 mg oral granules 14 kg or more One packet containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg oral granules One packet containing ivacaftor 75 mg oral granules 6 to less than 12 years Less than 30 kg Two tablets, each containing elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg One tablet of ivacaftor 75 mg 30 kg or more Two tablets, each containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg One tablet of ivacaftor 150 mg 12 years and older - Two tablets, each containing elexacafto Přečtěte si celý dokument