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

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Visit the EMPLICITI Patient Site

Bristol-Myers Squibb Resources | BMS Access Support®

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

Visit the EMPLICITI Patient Site

This site is intended for
U.S. Healthcare Professionals only.

BMS Access Support®

Bristol-Myers Squibb Resources

U.S. Full Prescribing
Information

Patient Information

 

 

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

Visit the EMPLICITI Patient Site

This site is intended for
U.S. Healthcare Professionals only.

BMS Access Support®

Bristol-Myers Squibb Resources

U.S. Full Prescribing
Information

Patient Information

INDICATIONS

EMPLICITI® (elotuzumab) is indicated for the treatment of adult patients with multiple myeloma in combination with:

  • lenalidomide and dexamethasone after one to three prior therapies
  • pomalidomide and dexamethasone after at least two prior therapies including lenalidomide and a proteasome inhibitor
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EMPLICITI + Pd Dosing

EMPLICITI is administered as a component of the EPd regimen1

EMPLICITI® (elotuzumab) 10 or 20 mg/kg, pomalidomide 4 mg, and dexamethasone 8, 20, 28, or 40 mg

Treatment should continue until disease progression or unacceptable toxicity

EPd DOSING SCHEDULE

EMPLICITI® (elotuzumab) in combination with pomalidomide and dexamethasone (EPd) dosing schedule for Cycles 1 and 2

EPd, EMPLICITI + pomalidomide + dexamethasone; Pd, pomalidomide + dexamethasone.

*

In a 28-day cycle, days 23 through 28 are rest periods, during which no active therapy is given.

†

Oral dexamethasone (28 mg or 8 mg) should be taken between 3 and 24 hours before EMPLICITI infusion.

EMPLICITI® (elotuzumab) in combination with pomalidomide and dexamethasone (EPd) dosing schedule for Cycle 3+

*

In a 28-day cycle, days 23 through 28 are rest periods, during which no active therapy is given.

†

Oral dexamethasone (8 mg, 20 mg, 28 mg, or 40 mg) should be taken between 3 and 24 hours before EMPLICITI infusion.

†

On days that EMPLICITI is not administered, but a dose of dexamethasone is scheduled, dexamethasone 20 mg (patients ≤75 years old) or 40 mg (patients >75 years old) should be given orally.

Patients must be premedicated before each dose of EMPLICITI

PRETREATMENT ON DAYS THAT EMPLICITI IS ADMINISTERED

Adult patients must be premedicated before each dose of EMPLICITI® (elotuzumab) is administered as a component of the EPd regimen

If no infusion reactions develop, the infusion rate may be increased in a stepwise fashion as shown below:

INFUSION RATE FOR EMPLICITI†

EMPLICITI® (elotuzumab) in combination with pomalidomide and dexamethasone (EPd) dosing schedule

†

The maximum infusion rate should not exceed 5 mL/min.

The presence and severity of infusion reaction may lengthen the infusion time for EMPLICITI.

EPd Dosing

Dosing and Ordering Guide

A reference guide for dosing, ordering, and product returns, plus support services for you and your patients.

SELECTED IMPORTANT SAFETY INFORMATION

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.

Please see additional Important Safety Information below.

EPd Dosing

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Important Safety Information

Infusion Reactions

  • Infusion reactions were reported in 10% of patients treated with EMPLICITI in the ELOQUENT-2 trial [EMPLICITI + lenalidomide + dexamethasone (ERd) vs lenalidomide + dexamethasone (Rd)] and 3.3% in the ELOQUENT-3 trial [EMPLICITI + pomalidomide + dexamethasone (EPd) vs pomalidomide + dexamethasone (Pd)].
  • In the ELOQUENT-2 trial, all infusion reactions were Grade 3 or lower, with Grade 3 infusion reactions occurring in 1% of patients. The most common symptoms 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.
  • In the ELOQUENT-3 trial, 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-2 trial (N=635), infections were reported in 81% of patients in the ERd arm and 74% in the Rd arm. Grade 3-4 infections were 28% (ERd) and 24% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5% (ERd) and 2.2% (Rd). Opportunistic infections were reported in 22% (ERd) and 13% (Rd). Fungal infections were 10% (ERd) and 5% (Rd). Herpes zoster was 14% (ERd) and 7% (Rd).
  • In the ELOQUENT-3 trial (N=115), infections were reported in 65% of patients in both the EPd arm and the Pd arm. Grade 3-4 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-2 trial (N=635), invasive second primary malignancies (SPM) were 9% (ERd) and 6% (Rd). The rate of hematologic malignancies was 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).
  • In the ELOQUENT-3 trial (N=115), invasive SPMs 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% (ERd) vs 0.6% (Rd). 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 birth defects and miscarriage.
  • There is a risk of fetal harm, including severe life-threatening human birth defects, associated with lenalidomide and pomalidomide, and they are contraindicated for use in pregnancy. Refer to the respective product 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

  • ELOQUENT-2 trial:
    • Serious adverse reactions were 65% (ERd) and 57% (Rd). The most frequent serious adverse reactions in the ERd arm compared to the Rd arm were: pneumonia (15%, 11%), pyrexia (7%, 5%), 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 (62%, 52%), diarrhea (47%, 36%), pyrexia (37%, 25%), constipation (36%, 27%), cough (34%, 19%), peripheral neuropathy (27%, 21%), nasopharyngitis (25%, 19%), upper respiratory tract infection (23%, 17%), decreased appetite (21%, 13%), and pneumonia (20%, 14%).
  • ELOQUENT-3 trial:
    • 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 the Full Prescribing Information.

References

  1. EMPLICITI [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  2. Dimopoulos MA, Dytfeld D, Grosicki S, et al. Elotuzumab plus pomalidomide and dexamethasone for multiple myeloma. N Engl J Med. 2018;379(19):1811-1822.
  3. Lonial S, Dimopoulos M, Weisel K, et al. Extended 5-y follow-up (FU) of phase 3 ELOQUENT-2 study of elotuzumab + lenalidomide/dexamethasone (ELd) vs Ld in relapsed/refractory multiple myeloma (RRMM). Poster presentation at: 2018 American Society of Clinical Oncology (ASCO) Annual Meeting; June 1-5, 2018; Chicago, IL. Poster #8040.
  4. 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.
  5. BMS-REF-ELOT 039 [Data on file]. Bristol-Myers Squibb. 2016.
  6. Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab therapy for relapsed or refractory multiple myeloma. N Engl J Med. 2015;373(protocol):1-175.
  7. 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.
  8. BMS-REF-ELOT 047 [Data on file]. Bristol-Myers Squibb. 2016.
  9. Kurdi AT, Glavey SV, Bezman NA, et al. Antibody-dependent cellular phagocytosis by macrophages is a novel mechanism of action of elotuzumab. Mol Cancer Ther. 2018;17(7):1454-1463.
  10. Dimopoulos MA, Weisel K, Lonial S, et al. Elotuzumab plus lenalidomide/dexamethasone for relapsed/refractory multiple myeloma: Final overall survival results from the phase 3 ELOQUENT-2 trial. Presented at: 17th International Myeloma Workshop; September 12-15, 2019; Boston, MA. Oral presentation OAB-021.
689US1803827-02-01 01/20

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