ORKAMBI- lumacaftor and ivacaftor tablet, film coated ORKAMBI- lumacaftor and ivacaftor granule

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

lumacaftor (UNII: EGP8L81APK) (lumacaftor - UNII:EGP8L81APK), ivacaftor (UNII: 1Y740ILL1Z) (ivacaftor - UNII:1Y740ILL1Z)

Dostupné s:

Vertex Pharmaceuticals Incorporated

INN (Mezinárodní Name):

lumacaftor

Složení:

lumacaftor 200 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene. Limitations of Use The efficacy and safety of ORKAMBI have not been established in patients with CF other than those homozygous for the F508del mutation. None. Risk Summary There are limited and incomplete human data from clinical trials and postmarketing reports on use of ORKAMBI or its individual components, lumacaftor or ivacaftor, in pregnant women to inform a drug-associated risk. In animal reproduction studies, oral administration of lumacaftor 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 8 (rats) and 5 (rabbits) times the exposure at the maxim

Přehled produktů:

ORKAMBI (lumacaftor 200 mg/ivacaftor 125 mg) is supplied as pink, oval-shaped tablets; each tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor, printed with "2V125" in black ink on one side and plain on the other, and is packaged as follows: ORKAMBI (lumacaftor 100 mg/ivacaftor 125 mg) is supplied as pink, oval-shaped tablets; each tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor, printed with "1V125" in black ink on one side and plain on the other, and is packaged as follows: ORKAMBI (lumacaftor/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].

Stav Autorizace:

New Drug Application

Charakteristika produktu

ORKAMBI- LUMACAFTOR AND IVACAFTOR TABLET, FILM COATED
ORKAMBI- LUMACAFTOR AND IVACAFTOR GRANULE
VERTEX PHARMACEUTICALS INCORPORATED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ORKAMBI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ORKAMBI.
ORKAMBI (LUMACAFTOR AND IVACAFTOR) TABLETS, FOR ORAL USE
ORKAMBI (LUMACAFTOR AND IVACAFTOR) ORAL GRANULES
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Indications and Usage (1)
09/2022
Dosage and Administration (2)
09/2022
Warnings and Precautions, Hypersensitivity Reactions,
Including Anaphylaxis (5.3)
08/2023
INDICATIONS AND USAGE
ORKAMBI is a combination of ivacaftor, a cystic fibrosis transmembrane
conductance regulator (CFTR)
potentiator, and lumacaftor, indicated for the treatment of cystic
fibrosis (CF) in patients aged 1 year and
older who are homozygous for the _F508del_ mutation in the _CFTR_
gene. If the patient's genotype is
unknown, an FDA-cleared CF mutation test should be used to detect the
presence of the _F508del _mutation
on both alleles of the_ CFTR_ gene. (1)
Limitations of Use:
The efficacy and safety of ORKAMBI have not been established in
patients with CF other than those
homozygous for the _F508del _mutation. (1)
DOSAGE AND ADMINISTRATION
AGE GROUP WEIGHT
DOSE
ADMINISTRATION
1 through 2
years
7 kg to < 9
kg
1 packet of lumacaftor 75 mg/ivacaftor 94
mg granules
Mixed with one
teaspoon (5 mL)
of soft food or
liquid and
administered
orally EVERY 12
HOURS with fat-
containing food
9 kg to < 14
kg
1 packet of lumacaftor 100 mg/ivacaftor 125
mg granules
≥14 kg
1 packet of lumacaftor 150 mg/ivacaftor 188
mg granules
2 through 5
years
<14 kg
1 packet of lumacaftor 100 mg/ivacaftor 125
mg granules
≥14 kg
1 packet of lumacaftor 150 mg/ivacaftor 188
mg granules
6 through 11
years
-
2 tablets of lumacaftor 100 mg/ivacaftor 125
mg
(lumacaftor 200 mg/ivacaftor 250 mg per
dose)
Taken orally
EVERY 12 HOURS
with fat-
containing food
12 years and
older
-
2 tablets of lumacaftor 20