TRIKAFTA- elexacaftor, tezacaftor, and ivacaftor kit

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

Elexacaftor (UNII: RRN67GMB0V) (Elexacaftor - UNII:RRN67GMB0V), Tezacaftor (UNII: 8RW88Y506K) (Tezacaftor - UNII:8RW88Y506K), Ivacaftor (UNII: 1Y740ILL1Z) (Ivacaftor - UNII:1Y740ILL1Z)

Հասանելի է:

Vertex Pharmaceuticals Incorporated

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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

Ապրանքի ամփոփագիր:

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].

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

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