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

ariad pharmaceuticals, inc. - ponatinib hydrochloride (unii: 96r6pu3d8j) (ponatinib - unii:4340891kfs) - ponatinib 15 mg - iclusig (ponatinib) is a kinase inhibitor indicated for the: - treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (cml) or ph+ all for whom no other tyrosine kinase inhibitor (tki) therapy is indicated. - treatment of adult patients with t315i-positive cml (chronic phase, accelerated phase, or blast phase) or t315i-positive philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all). limitations of use: iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed chronic phase cml [see warnings and precautions (5.7)]. none. risk summary based on its mechanism of action and findings in animals, iclusig can cause fetal harm when administered to a pregnant woman [see data] . there are no available data on iclusig use in pregnant women. in animal reproduction studies, oral administration of ponatinib to pregnant rats during organogenesis caused adverse developmental effects at doses lower than human exposur

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

takeda pharmaceuticals america, inc. - ponatinib hydrochloride (unii: 96r6pu3d8j) (ponatinib - unii:4340891kfs) - ponatinib 15 mg - iclusig is indicated for the treatment of adult patients with: - chronic phase (cp) chronic myeloid leukemia (cml) with resistance or intolerance to at least two prior kinase inhibitors. - accelerated phase (ap) or blast phase (bp) cml or philadelphia chromosome positive acute lymphoblastic leukemia (ph+ all) for whom no other kinase inhibitors are indicated. - t315i-positive cml (chronic phase, accelerated phase, or blast phase) or t315i-positive ph+ all. limitations of use : iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed cp-cml [see warnings and precautions (5.7)] . none. risk summary based on findings in animals and its mechanism of action [see clinical pharmacology (12.1)] , iclusig can cause fetal harm when administered to a pregnant woman. there are no available data on iclusig use in pregnant women. in animal reproduction studies, oral administration of ponatinib to pregnant rats during organogenesis caused adverse developmental effects at doses lower

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

takeda pharmaceuticals australia pty ltd - ponatinib hydrochloride, quantity: 48.1 mg (equivalent: ponatinib, qty 45 mg) - tablet, film coated - excipient ingredients: magnesium stearate; sodium starch glycollate; lactose monohydrate; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - iclusig is indicated for the treatment of adult patients with:,chronic phase (cp), accelerated phase (ap), or blast phase (bp) chronic myeloid ieukaemia (cml) whose disease is resistant to, or who are intolerant of at least two prior tyrosine kinase inhibitors; or where there is a t315i mutation.,philadelphia chromosome positive acute lymphoblastic ieukaemia (ph+ all) whose disease is resistant to, or who are intolerant of dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or where there is a t315i mutation.,therapy with iclusig should be initiated and monitored by a haematologist with expertise in managing adult ieukaemias.

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

takeda pharmaceuticals australia pty ltd - ponatinib hydrochloride, quantity: 16 mg (equivalent: ponatinib, qty 15 mg) - tablet, film coated - excipient ingredients: sodium starch glycollate; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - iclusig is indicated for the treatment of adult patients with:,chronic phase (cp), accelerated phase (ap), or blast phase (bp) chronic myeloid ieukaemia (cml) whose disease is resistant to, or who are intolerant of at least two prior tyrosine kinase inhibitors; or where there is a t315i mutation.,philadelphia chromosome positive acute lymphoblastic ieukaemia (ph+ all) whose disease is resistant to, or who are intolerant of dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or where there is a t315i mutation.,therapy with iclusig should be initiated and monitored by a haematologist with expertise in managing adult ieukaemias.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

incyte biosciences uk ltd - ponatinib hydrochloride - tablet - 15mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

incyte biosciences uk ltd - ponatinib hydrochloride - tablet - 45mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

incyte biosciences uk ltd - ponatinib hydrochloride - tablet - 30mg

Canada - English - Health Canada

takeda pharmaceuticals u.s.a., inc. - ponatinib (ponatinib hydrochloride) - tablet - 15mg - ponatinib (ponatinib hydrochloride) 15mg - antineoplastic agents

Canada - English - Health Canada

takeda pharmaceuticals u.s.a., inc. - ponatinib (ponatinib hydrochloride) - tablet - 45mg - ponatinib (ponatinib hydrochloride) 45mg - antineoplastic agents

European Union - English - EMA (European Medicines Agency)

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation.see sections 4.2 assessment of cardiovascular status prior to start of therapy and 4.4 situations where an alternative treatment may be considered.