埃罗妥珠单抗Empliciti（elotuzumab）

Indications and Uses
Elotuzumab EMPLICITI is an immunotherapy directed against SLAMF7 indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received 1 to 3 prior therapies.

Dosage and Administration
⑴ Lenalidomide and dexamethasone: 10 mg/kg intravenously weekly for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity.
⑵ Pre-medication with dexamethasone, diphenhydramine, ranitidine, and acetaminophen.

Dosage Form and Strength
Injection: 300 mg or 400 mg lyophilized powder in a single-dose vial for reconstitution.

Contraindications
None.

Warnings and Precautions
⑴ Infusion Reactions: Pre-medication required. Interrupt EMPLICITI for Grade 2 or higher and permanently discontinue for severe infusion reactions.
⑵ Infections: Monitor for fever and other signs of infection and treat promptly.
⑶ Second primary malignancies (SPM): A higher incidence of SPM was observed in controlled clinical trials of patients with multiple myeloma receiving EMPLICITI.
⑷ Hepatotoxicity: Monitor liver function and discontinue EMPLICITI if hepatotoxicity is suspected.
⑸ Interference with determination of complete remission: EMPLICITI may interfere with the M-protein assay used to monitor. This interference may affect determination of complete remission.

Adverse Reactions
The most common adverse reactions (20% or higher) are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, anorexia, pneumonia.

Use in special populations
Pregnancy: Embryo-fetal toxicity with three-drug combination regimen