Empliciti(elotuzumab 中文药名：埃罗妥珠单抗)

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Empliciti(elotuzumab 中文药名：埃罗妥珠单抗)为一种新免疫刺激治疗新药，获美国FDA批准治疗多发性骨髓瘤
批准日期：2015年11月30日  公司：Bristol-Myers Squibb
Empliciti（埃罗妥珠单抗 elotuzumab）注射，供静脉使用
【适应症和用法】
Empliciti（elotuzumab）联合Revlimid（lenalidomide，来那度胺）和地塞米松（dexamethasone）用于既往已接受一至三种治疗方案的复发性或难治性多发性骨髓瘤（MM）患者的治疗。
【剂型和规格】
注射：300毫克或400毫克的单一剂量小瓶用于重构冻干粉末。
【用法用量】
来那度胺和地塞米松10毫克/千克每周静脉给药前两个周期，每2周一次，直到疾病进展或不可接受的毒性。
Premediate地塞米松，苯海拉明，雷尼替丁和对乙酰氨基酚。
EMPLICITI Rx
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EMPLICITI
Leukemias, lymphomas, and other hematologic cancers  Only 4 drugs may be compared at once

Generic Name and Formulations:
Elotuzumab 300mg, 400mg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Company:
Bristol-Myers Squibb
 
Select therapeutic use: Leukemias, lymphomas, and other hematologic cancers
Indications for EMPLICITI:
In combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received 1–3 prior therapies.

Adult:
Give by IV infusion at initial rate of 0.5mL/min; may increase stepwise if no reactions develop; max rate 2mL/min. After 4 cycles, infusion rate may be increased up to max 5mL/min. Administer with lenalidomide and dexamethasone (see full labeling for dosing schedule). 10mg/kg every week for the first 2 cycles then every 2 weeks thereafter; continue until disease progression or unacceptable toxicity. Premedicate with dexamethasone, H1 blocker, H2 blocker, and acetaminophen before each infusion. Dose modifications: see full labeling.

Children:
Not established.

Contraindications:
Consult lenalidomide and dexamethasone prescribing information for contraindications before starting therapy.

Warnings/Precautions:
Interrupt infusion if Grade ≥2 infusion reactions occur and manage appropriately. Monitor for development of infections and treat promptly. Monitor for second primary malignancies. Monitor liver function periodically; discontinue if Grade ≥3 elevation of liver enzymes occur; consider resuming after return to baseline values. Pregnancy: not studied. Nursing mothers: not recommended.

Interactions:
May interfere with correct response classification in SPEP and serum immunofixation assays.

Pharmacological Class:
SLAMF7-directed immunostimulatory antibody.

Adverse Reactions:
Fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, pneumonia.

Note:
For lenalidomide and dexamethasone specific dosing and safety information, refer to the respective full prescribing labels.

Generic Availability:
NO

How Supplied:
Single-dose vial—1