European Union - English - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor, tezacaftor, elexacaftor - cystic fibrosis - other respiratory system products - kaftrio is indicated in a combination regimen with ivacaftor for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Israel - English - Ministry of Health

vertex pharmaceuticals (u.k) limited, israel - elexacaftor; ivacaftor; ivacaftor; tezacaftor - film coated tablets - ivacaftor 75 mg; tezacaftor 50 mg; elexacaftor 100 mg; ivacaftor 150 mg - ivacaftor, tezacaftor and elexacaftor - trikafta is indicated for the treatment of cystic fibrosis (cf) in patients aged 12 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.

European Union - English - EMA (European Medicines Agency)

vertex pharmaceuticals (ireland) limited - ivacaftor - cystic fibrosis - other respiratory system products - kalydeco tablets are indicated:as monotherapy for the treatment of adults, adolescents, and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4.4 and 5.1).in a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who are homozygous for the f508del mutation or who are heterozygous for the f508del mutation and have one of the following mutations in the cftr gene: p67l, r117c, l206w, r352q, a455e, d579g, 711+3a→g, s945l, s977f, r1070w, d1152h, 2789+5g→a, 3272 26a→g, and 3849+10kbc→t.in a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents, and children aged 6 years and older with cystic fibrosis (cf) who have at least one f508del mutation in the cftr gene (see section 5.1).kalydeco granules are indicated for the treatment of infants aged at least 4 months, toddlers and children weighing 5 kg to less than 25 kg with cystic fibrosis (cf) who have an r117h cftr mutation or one of the following gating (class iii) mutations in the cftr gene: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n or s549r (see sections 4.4 and 5.1).in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (cf) in paediatric patients aged 2 to less than 6 years who have at least one f508del mutation in the cftr gene.

Australia - English - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 75 mg - tablet, film coated - excipient ingredients: hypromellose acetate succinate; sodium lauryl sulfate; microcrystalline cellulose; lactose monohydrate; silicon dioxide; magnesium stearate; carnauba wax; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - trikafta is indicated for the treatment of cystic fibrosis (cf) in patients aged 6 years and older who have at least one f508del mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene.

Canada - English - Health Canada

vertex pharmaceuticals (canada) incorporated - ivacaftor; ivacaftor; elexacaftor; tezacaftor - granules - 60mg; 59.5mg; 80mg; 40mg - ivacaftor 60mg; ivacaftor 59.5mg; elexacaftor 80mg; tezacaftor 40mg

Canada - English - Health Canada

vertex pharmaceuticals (canada) incorporated - ivacaftor; ivacaftor; elexacaftor; tezacaftor - granules - 75mg; 75mg; 100mg; 50mg - ivacaftor 75mg; ivacaftor 75mg; elexacaftor 100mg; tezacaftor 50mg

United States - English - NLM (National Library of Medicine)

vertex pharmaceuticals incorporated - elexacaftor (unii: rrn67gmb0v) (elexacaftor - unii:rrn67gmb0v), tezacaftor (unii: 8rw88y506k) (tezacaftor - unii:8rw88y506k), ivacaftor (unii: 1y740ill1z) (ivacaftor - unii:1y740ill1z) - 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

Australia - English - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 75 mg - granules - excipient ingredients: hypromellose acetate succinate; sodium lauryl sulfate; lactose monohydrate; mannitol; sucralose; croscarmellose sodium; silicon dioxide; magnesium stearate - kalydeco is indicated for the treatment of cystic fibrosis (cf) in patients aged 4 months 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 section 4.4 special warnings and precautions for use, and section 5.1 pharmacodynamic properties).

Australia - English - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 50 mg - granules - excipient ingredients: hypromellose acetate succinate; sodium lauryl sulfate; lactose monohydrate; mannitol; sucralose; croscarmellose sodium; silicon dioxide; magnesium stearate - kalydeco is indicated for the treatment of cystic fibrosis (cf) in patients aged 4 months 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 section 4.4 special warnings and precautions for use, and section 5.1 pharmacodynamic properties).

Australia - English - Department of Health (Therapeutic Goods Administration)

vertex pharmaceuticals australia pty ltd - ivacaftor, quantity: 150 mg - tablet, film coated - excipient ingredients: carnauba wax; croscarmellose sodium; silicon dioxide; magnesium stearate; microcrystalline cellulose; sodium lauryl sulfate; hypromellose acetate succinate; lactose monohydrate; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - kalydeco is indicated for the treatment of cystic fibrosis (cf) in patients aged 4 months 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 section 4.4 special warnings and precautions for use, and section 5.1 pharmacodynamic properties)