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Dear Customer,

Bristol-Myers Squibb would like to inform you of the U.S. Food and Drug (FDA) approval of EMPLICITI® (elotuzumab) for use in 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.

As this information has the potential to impact your practice, we want to keep you updated and informed about the latest events and data associated with EMPLICITI.

Selected Important Safety Information

EMPLICITI with pomalidomide and dexamethasone is associated with Warnings and Precautions related to: Infusion Reactions, Infections, Second Primary Malignancies, Hepatotoxicity, Interference with Determination of Complete Response, Pregnancy/Females and Males of Reproductive Potential, and Adverse Reactions.

Please see detailed Important Safety Information below.

For additional information, please feel free to click the links below to learn more about this new indication:
IMPORTANT SAFETY INFORMATION

Infusion Reactions
  • Infusion reactions were reported in 3.3% of patients treated with EMPLICITI in the ELOQUENT-3 trial [EMPLICITI + pomalidomide + dexamethasone (EPd) vs pomalidomide + dexamethasone (Pd)]. The only infusion reaction symptom was chest discomfort (2%), which was Grade 1. All the patients who experienced an infusion reaction had them during the first treatment cycle.
  • If a Grade 2 or higher infusion reaction occurs, interrupt the EMPLICITI infusion and institute appropriate medical and supportive measures. If the infusion reaction recurs, stop the EMPLICITI infusion and do not restart it on that day. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment.
  • Premedicate with dexamethasone, H1 blocker, H2 blocker, and acetaminophen prior to EMPLICITI infusion.
Infections
  • In the ELOQUENT-3 trial (N=115), infections were reported in 65% of patients in both the EPd arm and the Pd arm. Grade 3 to 4 infections were reported in 13% (EPd) and 22% (Pd). Discontinuations due to infections were 7% (EPd) and 5% (Pd). Fatal infections were 5% (EPd) and 3.6% (Pd). Opportunistic infections were reported in 10% (EPd) and 9% (Pd). Herpes zoster was reported in 5% (EPd) and 1.8% (Pd).
  • Monitor patients for development of infections and treat promptly.
Second Primary Malignancies
  • In the ELOQUENT-3 trial (N=115), invasive second primary malignancies (SPM) were 0% (EPd) and 1.8% (Pd). Monitor patients for the development of SPMs.
Hepatotoxicity
  • In the ELOQUENT-2 trial (N=635), AST/ALT >3X the upper limit, total bilirubin >2X the upper limit, and alkaline phosphatase <2X the upper limit were 2.5% (EMPLICITI arm) vs 0.6% (control arm). Of 8 patients experiencing hepatotoxicity, 2 patients discontinued treatment while 6 patients had resolution and continued. Monitor liver enzymes periodically. Stop EMPLICITI upon ≥Grade 3 elevation of liver enzymes. Continuation of treatment may be considered after return to baseline values.
Interference with Determination of Complete Response
  • EMPLICITI is a humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.
Pregnancy/Females and Males of Reproductive Potential
  • There are no available data on EMPLICITI use in pregnant women to inform a drug-associated risk of major defects and miscarriage.
  • There is a risk of fetal harm, including severe life-threatening human birth defects, associated with pomalidomide, and it is contraindicated for use in pregnancy. Refer to the pomalidomide full prescribing information for requirements regarding contraception and the prohibitions against blood and/or sperm donation due to presence and transmission in blood and/or semen and for additional information.
Adverse Reactions
  • Serious adverse reactions were 22% (EPd) and 15% (Pd). The most frequent serious adverse reactions in the EPd arm compared to the Pd arm were: pneumonia (13%, 11%) and respiratory tract infection (7%, 3.6%).
  • The most common adverse reactions in EPd arm (≥20% EPd) and Pd, respectively, were constipation (22%, 11%) and hyperglycemia (20%, 15%).
Please see full Prescribing Information here U.S. Full Prescribing Information.

For additional information about EMPLICITI, call (1-844-367-5424) or visit EmplicitiHCP.com.

References:
  1. EMPLICITI [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2018


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