EMPLICITI

Elotuzumab exhibits nonlinear pharmacokinetics (PK) resulting in greater than proportional increases in area under the concentration-time curve (AUC) indicative of target-mediated clearance. The administration of the recommended 10 mg/kg EMPLICITI regimen with lenalidomide and dexamethasone is predicted to result in geometric mean (CV%) steady-state trough concentrations of 194 μg/mL (52%). The administration of the recommended EMPLICITI regimen with pomalidomide and dexamethasone is predicted t...

ELOQUENT-2 (NCT01239797) The efficacy and safety of EMPLICITI in combination with lenalidomide and dexamethasone were evaluated in ELOQUENT-2, a randomized, open-label trial in patients with multiple myeloma who had received one to three prior therapies and had documented progression following their most recent therapy. Eligible patients were randomized in a 1:1 ratio to receive either EMPLICITI in combination with lenalidomide and low-dose dexamethasone or lenalidomide and low-dose dexamethasone. Treatment was administered in 4-week cycles until disease progression or unacceptable toxicity. E...

The following clinically significant adverse reactions are described in detail in other sections of the label:

• Infusion reaction [see Warnings and Precautions (5.1) ] .
• Infections [see Warnings and Precautions (5.2) ] .
• Second Primary Malignancies [see Warnings and Precautions (5.3) ] .
• Hepatotoxicity [see Warnings and Precautions (5.4) ] .
• Interference with determination of complete response [see Warnings and Precautions (5.5) ] . Most common adverse reactions (20% or higher)
• with ...

None. None (4)

• 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)
• Infections: Monitor for fever and other signs of infection and treat promptly. (5.2)
• Second Primary Malignancies (SPM): Higher incidences of SPM were observed in a controlled clinical trial of patients with multiple myeloma receiving EMPLICITI. (5.3)
• Hepatotoxicity: Monitor liver function and stop EMPLICITI if hepatotoxicity...

7 DRUG INTERACTIONS 7.1 Drug Interactions For important drug interactions involving lenalidomide, pomalidomide and dexamethasone, refer to their respective prescribing information. 7.2 Laboratory Test Interference EMPLICITI may be detected in the SPEP and serum immunofixation assays of myeloma patients and could interfere with correct response classification. A small peak in the early gamma region...