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

takeda pharmaceuticals america, inc. - brigatinib (unii: hyw8db273j) (brigatinib - unii:hyw8db273j) - brigatinib 30 mg - alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive metastatic non-small cell lung cancer (nsclc) as detected by an fda-approved test [see dosage and administration (2.1)] . none. risk summary based on its mechanism of action and findings in animals, alunbrig can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no clinical data on the use of alunbrig in pregnant women. administration of brigatinib to pregnant rats during the period of organogenesis resulted in dose-related skeletal anomalies at doses as low as 12.5 mg/kg/day (approximately 0.7 times the human exposure by auc at 180 mg once daily) as well as increased post-implantation loss, malformations, and decreased fetal body weight at doses of 25 mg/kg/day (approximately 1.26 times the human exposure at 180 mg once daily) or greater (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated back

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

ariad pharmaceuticals inc. - brigatinib (unii: hyw8db273j) (brigatinib - unii:hyw8db273j) - brigatinib 30 mg - alunbrig is indicated for the treatment of patients with anaplastic lymphoma kinase (alk)-positive metastatic non-small cell lung cancer (nsclc) who have progressed on or are intolerant to crizotinib. this indication is approved under accelerated approval based on tumor response rate and duration of response [see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. none. risk summary based on its mechanism of action and findings in animals, alunbrig can cause fetal harm when administered to a pregnant woman [see data and clinical pharmacology (12.1)] . there are no clinical data on the use of alunbrig in pregnant women. administration of brigatinib to pregnant rats during the period of organogenesis resulted in dose-related skeletal anomalies at doses as low as 12.5 mg/kg/day (approximately 0.7 times the human exposure by auc at 180 mg once daily) as well as increased post-implantation loss, malformatio

Israel - English - Ministry of Health

takeda israel ltd - brigatinib - film coated tablets - brigatinib 30 mg - brigatinib - alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive metastatic non-small cell lung cancer (nsclc)

Israel - English - Ministry of Health

takeda israel ltd - brigatinib - film coated tablets - brigatinib 30 mg - brigatinib - alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive metastatic non-small cell lung cancer (nsclc)

Israel - English - Ministry of Health

takeda israel ltd - brigatinib - film coated tablets - brigatinib 90 mg - brigatinib - alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive metastatic non-small cell lung cancer (nsclc)

Israel - English - Ministry of Health

takeda israel ltd - brigatinib - film coated tablets - brigatinib 90 mg - brigatinib - alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive metastatic non-small cell lung cancer (nsclc)

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

takeda malaysia sdn bhd - brigatinib -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

takeda malaysia sdn bhd - brigatinib -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

takeda malaysia sdn bhd - brigatinib -

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

takeda pharmaceuticals australia pty ltd - brigatinib, quantity: 90 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; magnesium stearate; hydrophobic colloidal silica anhydrous; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - alunbrig is indicated for the treatment of adult patients with anaplastic lymphoma kinase (alk)-positive locally advanced or metastatic non-small cell lung cancer (nsclc).