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

takeda pharmaceuticals america, inc. - ixazomib citrate (unii: 46cwk97z3k) (ixazomib - unii:71050168a2) - ixazomib 4 mg - ninlaro is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. none. women should avoid becoming pregnant while being treated with ninlaro. risk summary ninlaro can cause fetal harm when administered to a pregnant woman. there are no human data available regarding the potential effect of ninlaro on pregnancy or development of the embryo or fetus. ixazomib caused embryo-fetal toxicity in pregnant rats and rabbits at doses resulting in exposures that were slightly higher then those observed in patients receiving the recommended dose [see data]. advise women of the potential risk to a fetus and to avoid becoming pregnant while being treated with ninlaro. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data in an embryo-fetal development study in pregnant rabbits there were

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

takeda pharmaceuticals australia pty ltd - ixazomib citrate, quantity: 3.29 mg (equivalent: ixazomib, qty 2.3 mg) - capsule - excipient ingredients: microcrystalline cellulose; purified talc; magnesium stearate; gelatin; titanium dioxide; iron oxide red; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - ninlaro is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

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

takeda pharmaceuticals australia pty ltd - ixazomib citrate, quantity: 4.3 mg (equivalent: ixazomib, qty 3 mg) - capsule - excipient ingredients: microcrystalline cellulose; purified talc; magnesium stearate; gelatin; titanium dioxide; iron oxide black; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; potassium hydroxide - ninlaro is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

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

takeda pharmaceuticals australia pty ltd - ixazomib citrate, quantity: 5.7 mg (equivalent: ixazomib, qty 4 mg) - capsule - excipient ingredients: microcrystalline cellulose; purified talc; magnesium stearate; gelatin; titanium dioxide; iron oxide yellow; iron oxide red; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - ninlaro is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Israel - English - Ministry of Health

takeda israel ltd - ixazomib as citrate - capsules - ixazomib as citrate 2.3 mg - ixazomib - ninlaro is indicated, in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Israel - English - Ministry of Health

takeda israel ltd - ixazomib as citrate - capsules - ixazomib as citrate 2.3 mg - ixazomib - ninlaro is indicated, in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Israel - English - Ministry of Health

takeda israel ltd - ixazomib as citrate - capsules - ixazomib as citrate 3 mg - ixazomib - ninlaro is indicated, in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Israel - English - Ministry of Health

takeda israel ltd - ixazomib as citrate - capsules - ixazomib as citrate 3 mg - ixazomib - ninlaro is indicated, in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Israel - English - Ministry of Health

takeda israel ltd - ixazomib as citrate - capsules - ixazomib as citrate 4 mg - ixazomib - ninlaro is indicated, in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Israel - English - Ministry of Health

takeda israel ltd - ixazomib as citrate - capsules - ixazomib as citrate 4 mg - ixazomib - ninlaro is indicated, in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.