eservative
Single Use Vial –
Discard unused portion.
Rx Only
Close
INGREDIENTS AND APPEARANCE
BLINCYTO
blinatumomab kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-160
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55513-160-01 1 in 1 PACKAGE; Type 0: Not a Combination Product
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL 3.088 mL
Part 2 1 VIAL 10.6 mL
Part 1 of 2
BLINCYTO
blinatumomab injection, powder, lyophilized, for solution
Product Information
Item Code (Source) NDC:55513-150
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BLINATUMOMAB (UNII: 4FR53SIF3A) (BLINATUMOMAB - UNII:4FR53SIF3A) BLINATUMOMAB 12.5 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 1.19 mg in 1 mL
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) 8.27 mg in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.23 mg in 1 mL
TREHALOSE DIHYDRATE (UNII: 7YIN7J07X4) 34 mg in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55513-150-01 3.088 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125557 12/18/2014
Part 2 of 2
IV STABILIZER
iv stabilizer solution
Product Information
Item Code (Source) NDC:55513-155
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 5.25 mg in 1 mL
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) 228.38 mg in 1 mL
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 10 mg in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55513-155-01 10.6 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125557 12/18/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125557 12/18/2014
FDA批准Blincyto治疗急性淋巴膜细胞白血病一种的罕见形式
接受监管局批准的第一个抗-CD19药物
2014年12月3日美国食品和药品监管局(FDA)批准Blincyto(blinatumomab)治疗有费城染色体费城前体B-细胞急性淋巴膜细胞白血病(B-细胞ALL)患者，一种非常见形式的ALL。
前体 B-细胞ALL是一种迅速升长类型癌症其中骨髓制造太多B-细胞原始淋巴细胞，一种不成熟的白细胞。白血病患者的骨髓细胞有时发生费城染色体[Philadelphia chromosome]是一种异常 。美国国家癌症研究所估计2014年6,020美国人将被诊断有ALL和1,440 将死于该病。
Blincyto是免疫治疗的实例，一种治疗用人免疫系统的某些部分与疾病斗争例如癌症。Blincyto是吸引机体T-细胞，白细胞或淋巴细胞的一种类型，破坏白血病细胞的第一个被批准药物。该药物作用如同一种蛋白被称为CD19，它在大多数B-细胞原始淋巴细胞表面发现，和CD3，在T-细胞淋巴细胞上一种蛋白间的一种连接剂[connector]。它意向治疗癌症治疗后返回(复发的)或对既往治疗 不反应(难治性)的患者。
FDA的药品评价和研究中心血液学和肿瘤学产品室主任Richard Pazdur，医学博士说：“免疫治疗，尤其是Blincyto有其独特的作用机制，对有白血病患者尤其鼓舞人有前途。“”“认识到这个新治疗的潜能，FDA与承 |
