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EMPLICITI™ (elotuzumab) for injection, for intravenous use
Brief Summary of Prescribing Information. For complete prescribing information
consult official package insert.
INDICATIONS AND USAGE
EMPLICITI (elotuzumab) is indicated in combination with lenalidomide and
dexamethasone for the treatment of patients with multiple myeloma who have
received one to three prior therapies.
CONTRAINDICATIONS
There are no contraindications to EMPLICITI. Because EMPLICITI is indicated for
use in combination with lenalidomide and dexamethasone, healthcare providers
should consult the prescribing information of these products for a complete
description of contraindications before starting therapy.
WARNINGS AND PRECAUTIONS
Infusion Reactions
EMPLICITI can cause infusion reactions. Infusion reactions were reported in
approximately 10% of patients treated with EMPLICITI with lenalidomide and
dexamethasone in the randomized trial in multiple myeloma. All reports of infusion
reaction were Grade 3 or lower. Grade 3 infusion reactions occurred in 1% of
patients. The most common symptoms of an infusion reaction included fever, chills,
and hypertension. Bradycardia and hypotension also developed during infusions.
In the trial, 5% of patients required interruption of the administration of EMPLICITI
for a median of 25 minutes due to infusion reactions, and 1% of patients
discontinued due to infusion reactions. Of the patients who experienced an
infusion reaction, 70% (23/33) had them during the first dose.
Administer premedication consisting of dexamethasone, antihistamines (H1 and
H2 blockers) and acetaminophen prior to EMPLICITI infusion [see Dosage and
Administration (2.2) in full Prescribing Information].
Interrupt EMPLICITI infusion for Grade 2 or higher infusion reactions and institute
appropriate medical management [see Dosage and Administration (2.3) in full
Prescribing Information].
Infections
In a clinical trial of patients with multiple myeloma (N=635), infections were
reporte [