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

e.r. squibb & sons, l.l.c. - elotuzumab (unii: 1351pe5ugs) (elotuzumab - unii:1351pe5ugs) - elotuzumab 300 mg - none. there are no available data on empliciti use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. animal reproduction studies have not been conducted with elotuzumab. empliciti is administered in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone. lenalidomide and pomalidomide can cause embryo-fetal harm and are contraindicated for use in pregnancy. refer to the lenalidomide, pomalidomide and dexamethasone prescribing information for additional information. lenalidomide and pomalidomide are only available through a rems program. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. there are no data on the presence of empliciti in hum

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

bristol-myers squibb australia pty ltd - elotuzumab, quantity: 440 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; citric acid monohydrate; sucrose; polysorbate 80; water for injections - empliciti (elotuzumab) 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)

bristol-myers squibb australia pty ltd - elotuzumab, quantity: 340 mg - injection, powder for - excipient ingredients: sodium citrate dihydrate; citric acid monohydrate; sucrose; polysorbate 80; water for injections - empliciti (elotuzumab) 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

bristol, myers squibb (israel) limited, israel - elotuzumab - powder for concentrate for solution for infusion - elotuzumab 300 mg/vial - elotuzumab - empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment ofadult patients with relapsed and refractory multiple myeloma who have received at least two priortherapies, including lenalidomide and a proteasome inhibitor, and have demonstrated diseaseprogression on the last therapy.

Israel - English - Ministry of Health

bristol, myers squibb (israel) limited, israel - elotuzumab - powder for concentrate for solution for infusion - elotuzumab 400 mg/vial - elotuzumab - empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last therapy.

European Union - English - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - elotuzumab - multiple myeloma - antineoplastic agents - empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).

Canada - English - Health Canada

bristol-myers squibb canada - elotuzumab - powder for solution - 440mg - elotuzumab 440mg - antineoplastic agents

Canada - English - Health Canada

bristol-myers squibb canada - elotuzumab - powder for solution - 340mg - elotuzumab 340mg - antineoplastic agents

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

bristol-myers squibb pharmaceuticals ltd - elotuzumab - powder for solution for infusion - 400mg

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

bristol-myers squibb pharmaceuticals ltd - elotuzumab - powder for solution for infusion - 300mg