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U.S. Full Prescribing Information

EMPLICITI Patient Site

EMPLICITI™(elotuzumab) for injection

Call 1-844-EMPLICITI(1-844-367-5424)

Call 1-844-EMPLICITI(1-844-367-5424)

Visit the EMPLICITI Patient Site

Indication

EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

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Activate
the immune system

Based on preclinical studies, EMPLICITI directly activates Natural Killer Cells via SLAMF7 and tags myeloma cells for destruction through ADCC1

ADCC=antibody-dependent cellular cytotoxicity; SLAMF7=signaling lymphocytic activation molecule family member 7.

PFSHR 0.70 [95% CI, 0.57, 0.85]; P=0.0004 (co-primary endpoint)1
Median PFS 19.4 months with ERd [95% CI, 16.6, 22.2] vs
14.9 months with Rd [95% CI, 12.1, 17.2]1

ORR78.5% with ERd [95% CI, 73.6, 82.9] vs
65.5% with Rd [95% CI, 60.1, 70.7]; P=0.0002 (co-primary endpoint)1

*Interim analysis conducted with a minimum follow-up of 24 months1

IMPORTANT SAFETY INFORMATION
EMPLICITI with lenalidomide and dexamethasone is associated with the following Warnings and Precautions: 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.
The first and only immunostimulatory antibody
for the treatment of multiple myeloma
approved for use in combination with Rd in
patients who have received 1 to 3 prior therapies1
SOAR TO
LASTING PFS
1,2*
A Phase 3, randomized, open-label study conducted to evaluate the efficacy and safety of EMPLICITI in combination with Rd in 646 patients (EMPLICITI + Rd, n=321; Rd, n=325) with multiple myeloma who had received 1 to 3 prior therapies.1

ERd=EMPLICITI + lenalidomide + dexamethasone; Rd=lenalidomide + dexamethasone.
 
View Data
 
 
 
Activate
the immune system

Based on preclinical studies, EMPLICITI directly activates Natural Killer Cells via SLAMF7 and tags myeloma cells for destruction through ADCC1

ADCC=antibody-dependent cellular cytotoxicity; SLAMF7=signaling lymphocytic activation molecule family member 7.

PFSHR 0.70 [95% CI, 0.57, 0.85]; P=0.0004
(co-primary endpoint)1
Median PFS 19.4 months with ERd [95% CI, 16.6, 22.2] vs 14.9 months with Rd [95% CI, 12.1, 17.2]1

ORR78.5% with ERd [95% CI, 73.6, 82.9] vs
65.5% with Rd [95% CI, 60.1, 70.7]; P=0.0002
(co-primary endpoint)1

*Interim analysis conducted with a minimum follow-up of
24 months1

IMPORTANT SAFETY INFORMATION
EMPLICITI with lenalidomide and dexamethasone is
associated with the following Warnings and Precautions:
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.
The first and only immunostimulatory antibody
for the treatment of multiple myeloma
approved for use in combination with Rd in
patients who have received 1 to 3
prior therapies1
SOAR TO
LASTING PFS1,2*
A Phase 3, randomized, open-label study conducted to evaluate
the efficacy and safety of EMPLICITI in combination with Rd
in 646 patients (EMPLICITI + Rd, n=321; Rd, n=325) with multiple
myeloma who had received 1 to 3 prior therapies.1

ERd=EMPLICITI + lenalidomide + dexamethasone;
Rd=lenalidomide + dexamethasone.
 
View Data
 
 
More Important Safety Information

Important Safety
Information

Important Safety
Information

Infusion Reactions

  • EMPLICITI can cause infusion reactions. Common symptoms include 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. 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 infusing with EMPLICITI.

Infections

  • In a clinical trial of patients with multiple myeloma (N=635), infections were reported in 81.4% of patients in the EMPLICITI with lenalidomide/dexamethasone arm (ERd) and 74.4% in the lenalidomide/dexamethasone arm (Rd). Grade 3-4 infections were 28% (ERd) and 24.3% (Rd). Opportunistic infections were reported in 22% (ERd) and 12.9% (Rd). Fungal infections were 9.7% (ERd) and 5.4% (Rd). Herpes zoster was 13.5% (ERd) and 6.9% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5% (ERd) and 2.2% (Rd). Monitor patients for development of infections and treat promptly.

Second Primary Malignancies

  • In a clinical trial of patients with multiple myeloma (N=635), invasive second primary malignancies (SPM) were 9.1% (ERd) and
    5.7% (Rd). The rate of hematologic malignancies were the same between ERd and Rd treatment arms (1.6%). Solid tumors were reported in 3.5% (ERd) and 2.2% (Rd). Skin cancer was reported in 4.4% (ERd) and 2.8% (Rd). Monitor patients for the development of SPMs.

Hepatotoxicity

  • Elevations in liver enzymes (AST/ALT greater than 3 times the upper limit, total bilirubin greater than 2 times the upper limit, and alkaline phosphatase less than 2 times the upper limit) consistent with hepatotoxicity were 2.5% (ERd) and 0.6% (Rd). Two patients experiencing hepatotoxicity discontinued treatment; however, 6 out of 8 patients had resolution and continued treatment. Monitor liver enzymes periodically. Stop EMPLICITI upon Grade 3 or higher elevation of liver enzymes. After return to baseline values, continuation of treatment may be considered.

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 studies with EMPLICITI with pregnant women to inform any drug associated risks.
  • There is a risk of fetal harm, including severe life-threatening human birth defects associated with lenalidomide and it is contraindicated for use in pregnancy. Refer to the lenalidomide 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

  • Infusion reactions were reported in approximately 10% of patients treated with EMPLICITI with lenalidomide and dexamethasone. All reports of infusion reaction were Grade 3 or lower. Grade 3 infusion reactions occurred in 1% of patients.
  • Serious adverse reactions were 65.4% (ERd) and 56.5% (Rd). The most frequent serious adverse reactions in the ERd arm compared to the Rd arm were: pneumonia (15.4%, 11%), pyrexia (6.9%, 4.7%), respiratory tract infection (3.1%, 1.3%), anemia (2.8%, 1.9%), pulmonary embolism (3.1%, 2.5%), and acute renal failure (2.5%, 1.9%).
  • The most common adverse reactions in ERd and Rd, respectively (>20%) were fatigue (61.6%, 51.7%), diarrhea (46.9%, 36.0%), pyrexia (37.4%, 24.6%), constipation (35.5%, 27.1%), cough (34.3%, 18.9%), peripheral neuropathy (26.7%, 20.8%), nasopharyngitis (24.5%, 19.2%), upper respiratory tract infection (22.6%, 17.4%), decreased appetite (20.8%, 12.6%), and pneumonia (20.1%, 14.2%).

Please see the Full Prescribing Information.

References

  1. EMPLICITI [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  2. Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab therapy for relapsed or refractory multiple myeloma. N Engl J Med. 2015;373(7):621-631.
  3. Cheng M, Chen Y, Xiao W, Sun R, Tian Z. NK cell-based immunotherapy for malignant diseases. Cell Mol Immunol. 2013;10(3):230-252.
  4. Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab therapy for relapsed or refractory multiple myeloma. N Engl J Med. 2015;373(suppl):1-18.
  5. BMS-REF-ELOT 047 [Data on file]. Bristol-Myers Squibb. 2016.
  6. Lonial S, Dimopoulos M, Weisel K, et al. Phase 3 ELOQUENT-2 study: extended 4-y follow-up (FU) of elotuzumab plus lenalidomide/dexamethasone (ELd) vs Ld in relapsed/refractory multiple myeloma (RRMM). Poster presentation at: 2017 American Society of Clinical Oncology (ASCO) Annual Meeting; June 2–6, 2017; Chicago, IL. Poster #8028.
  7. BMS-REF-ELOT 039 [Data on file]. Bristol-Myers Squibb. 2016.
  8. BMS-REF-ELOT 048 [Data on file]. Bristol-Myers Squibb. 2016.
  9. BMS-REF-ELOT 008 [Data on file]. Bristol-Myers Squibb. 2015.
689US1600896-04-01 05/17

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© 2017 Bristol-Myers Squibb Company.
All rights reserved. 689US1600896-02-01 02/17

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