EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. (1)
DOSAGE AND ADMINISTRATION

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With lenalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity. (2.1)

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Premediate with dexamethasone, diphenhydramine, ranitidine and acetaminophen. (2.2)

For Injection: 300 mg or 400 mg lyophilized powder in a single-dose vial for reconstitution. (3)
CONTRAINDICATIONS

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None. (4)
WARNINGS AND PRECAUTIONS

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Infusion reactions: Premedication is required. Interrupt EMPLICITI for Grade 2 or higher and permanently discontinue for severe infusion reaction. (2.2, 2.3, 5.1)

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Infections: Monitor for fever and other signs of infection and treat promptly. (5.2)

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Second Primary Malignancies (SPM): Higher incidences of SPM were observed in a controlled clinical trial of patients with multiple myeloma receiving EMPLICITI. (5.3)

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Hepatotoxicity: Monitor liver function and stop EMPLICITI if hepatotoxicity is suspected. (5.4)

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Interference with determination of complete response: EMPLICITI can interfere with assays used to monitor M-protein. This interference can impact the determination of complete response. (5.5)

Most common adverse reactions (20% or higher) are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, pneumonia. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Pregnancy: Embryo-fetal toxicity with combination three drug dosage regimen. (8.1)