KALYDECO- ivacaftor tablet, film coated KALYDECO- ivacaftor granule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

ivacaftor (UNII: 1Y740ILL1Z) (ivacaftor - UNII:1Y740ILL1Z)

Disponibil de la:

Vertex Pharmaceuticals Incorporated

INN (nume internaţional):

ivacaftor

Compoziție:

ivacaftor 150 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

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].

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

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