Rx Item-EMPLICITI- elotuzumab injection, powder, lyophilized, for solution 400mg

For: Multiple Myeloma

Empliciti (elotuzumab) is a Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody indicated for the combination treatment of patients with multiple myeloma. EMPLICITI (elotuzumab) is white to off-white lyophilized powder available as follows:

Carton Content


NDC

One 300 mg single-dose vial


0003-2291-11

One 400 mg single-dose vial


0003-4522-11

Store EMPLICITI under refrigeration at 2�C to 8�C (36�F-46�F). Protect EMPLICITI from light by storing in the original package until time of use. Do not freeze or shake. These highlights do not include all the information needed to use EMPLICITI safely and effectively. See full prescribing information for EMPLICITI.

EMPLICITI� (elotuzumab) for injection, for intravenous use
Initial U.S. Approval: 2015
RECENT MAJOR CHANGES

Indications and Usage (1) 11/2018
Dosage and Administration (2.1, 2.2, 2.5) 11/2018
Warnings and Precautions (5.1, 5.2, 5.3, 5.4) 11/2018
INDICATIONS AND USAGE

EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in

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combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. (1)
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combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. (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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With pomalidomide and dexamethasone: 10 mg/kg administered intravenously every week for the first two cycles and 20 mg/kg every 4 weeks thereafter until disease progression or unacceptable toxicity. (2.2)
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Premedicate with dexamethasone, diphenhydramine, ranitidine and acetaminophen. (2.3)

DOSAGE FORMS AND STRENGTHS

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

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. (2.3, 2.4, 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)

ADVERSE REACTIONS

Most common adverse reactions (20% or higher)

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with lenalidomide and dexamethasone are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, pneumonia. (6.1)
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with pomalidomide and dexamethasone are constipation and hyperglycemia. (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.
USE IN SPECIFIC POPULATIONS

Pregnancy: Embryo-fetal toxicity in combination with lenalidomide and dexamethasone or pomalidomide and dexamethasone. (8.1)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2019

Rx Item-EMPLICITI- elotuzumab injection,
RX00003-4522-11

Rx Item-EMPLICITI- elotuzumab injection,
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