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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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Dosing and Administration
EMPLICITI + Rd

Dosing and Administration
EMPLICITI + Rd

ERd Dosing and Administration

ERd Dosing and Administration

EMPLICITI + Rd treatment regimen1


EMPLICITI is administered as a component of the ERd regimen

Chart showing EMPLICITI + Rd treatment regimen

Patients must be premedicated before each dose of EMPLICITI

Chart showing EMPLICITI + Rd treatment regimen

Pretreatment on days that EMPLICITI
is administered


3–24 hours prior to infusion

Dexamethasone 28 mg orally


Completed 45–90 minutes
prior to infusion

Dexamethasone 8 mg intravenously

H1 blocker: Diphenhydramine (25–50 mg

orally or intravenously) or equivalent

H2 blocker: Ranitidine (50 mg intravenously

or 150 mg orally) or equivalent

Acetaminophen (65​0–10​00 mg orally)

EMPLICITI + Rd dosing schedule1


Treatment should continue until disease progression or unacceptable toxicity

Chart showing dosing schedule for EMPLICITI + REVLIMID + dexamethasone

Cycles 1 and 2 (28 days each*):
EMPLICITI dosed once a week

EMPLICITI

10 mg/kg intravenously


Every

7

Days

Starting on day 1

of each cycle

 

Lenalidomide

25 mg orally


Every

Day

for First 21 Days

Dexamethasone

28 mg orally†


Every

7

Days

Starting on day 1

of each cycle

Dexamethasone

8 mg intravenously


Every

7

Days

Starting on day 1

of each cycle

Cycle 3+ (28 days*):

EMPLICITI

10 mg/kg intravenously


Every

14

Days

Starting on day 1

of each cycle

 

Lenalidomide

25 mg orally


Every

Day

for First 21 Days

Dexamethasone

28 mg† or 40 mg‡ orally


Every

7

Days

Starting on day 1

of each cycle

Dexamethasone

8 mg intravenously


Every

14

Days

Starting on day 1

of each cycle

ERd=EMPLICITI + lenalidomide + dexamethasone;
Rd=lenalidomide + dexamethasone
*In a 28-day cycle, days 23 through 28 are rest
periods, during which no active therapy is given.
†Oral dexamethasone (28 mg) taken between 3 and
24 hours before EMPLICITI infusion.

ERd=EMPLICITI + lenalidomide + dexamethasone;
Rd=lenalidomide + dexamethasone
*In a 28-day cycle, days 23 through 28 are rest
periods, during which no active therapy is given.
†Oral dexamethasone (28 mg) taken between 3 and
24 hours before EMPLICITI infusion.
‡On days that EMPLICITI is not administered, but a
dose of dexamethasone is scheduled,
dexamethasone 40 mg should be given orally.

ERd=EMPLICITI + lenalidomide + dexamethasone; Rd=lenalidomide + dexamethasone
*Oral dexamethasone (28 mg) taken between 3 and 24 hours before EMPLICITI infusion.
On days that EMPLICITI is not administered, but a dose of dexamethasone is scheduled, dexamethasone 40 mg should be given orally.

Dosing and Ordering Guide

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

Read now

IMPORTANT SAFETY
INFORMATION ABOUT 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.

Please see additional Important Safety Information below.


How EMPLICITI is supplied


EMPLICITI is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake that is provided in 2 strengths1

image of EMPLICITITM (elotuzumab), sterile, single-dose vials

[Sterile, single-dose vials]

image of storage directions, store EMPLICITI under refrigeration at 2◦C – 8◦C (which is 36◦F – 46 ◦F). Protect EMPLICITI from light by storing in the original package until time of use. Do not freeze. Do not shake

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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. 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.
  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.
 

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EMPLICITI™ (elotuzumab) Dosing and Ordering Guide (PDF)

Full Prescribing Information (PDF)

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