Leukemias, lymphomas, and other hematologic cancers:

Indications for: EMPLICITI

Treatment of multiple myeloma: in combination with lenalidomide and dexamethasone in patients who have received 1–3 prior therapies; or in combination with pomalidomide and dexamethasone in patients who have received ≥2 prior therapies including lenalidomide and a proteasome inhibitor.

Adult Dosage:

Give by IV infusion at initial rate of 0.5mL/min (10mg/kg dose) or 3mL/min (20mg/kg dose); may increase stepwise if no reactions develop (see full labeling); max rate 5mL/min. In combination with lenalidomide and dexamethasone: 10mg/kg every week for the first 2 cycles then every 2 weeks thereafter. In combination with pomalidomide and dexamethasone: 10mg/kg every week for first 2 cycles; then starting at cycle 3, give 20mg/kg every 4 weeks. Both: continue until disease progression or unacceptable toxicity. For dosing schedule of lenalidomide, pomalidomide, and dexamethasone: see full labeling. Premedicate with dexamethasone, H1 blocker, H2 blocker, and acetaminophen before each infusion. Dose modifications: see full labeling.

Children Dosage:

Not established.

EMPLICITI Contraindications:

Consult lenalidomide, pomalidomide, and dexamethasone prescribing information for contraindications before starting therapy (eg, pregnancy).

EMPLICITI 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.

EMPLICITI Classification:

SLAMF7-directed immunostimulatory antibody.

EMPLICITI Interactions:

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

Adverse Reactions:

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

Note:

For lenalidomide, pomalidomide, and dexamethasone specific dosing and safety information, refer to their respective full labeling.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1