EMPLICITI®(elotuzumab) for injection

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®

EMPLICITI™(elotuzumab) for injection

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®

EMPLICITI™(elotuzumab) for injection

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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Preparation for
EMPLICITI Infusion

PREPARATION:

Determine vial quantity based on patient weight

Because dosing for EMPLICITI is weight-based, the dose of EMPLICITI will vary by patient and may be provided through a combination of vial sizes1

EXAMPLES OF VIAL QUANTITIES NEEDED FOR WEIGHT-BASED DOSING OF EMPLICITI

*

Depending on the weight-based dose, the full amount in the vials may not be used.

How EMPLICITI is supplied and stored

SUPPLY

EMPLICITI is supplied in 300 and 400 mg single-dose vials. EMPLICITI is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake that is provided in 2 strengths.

300mg

Carton contents

300 mg single-dose vial for IV infusion

10-digit-NDC

0003-2291-11

11-digit-NDC

00003-2291-11

400mg

Carton contents

400 mg single-dose vial for IV infusion

10-digit-NDC

0003-4522-11

11-digit-NDC

00003-4522-11

Storage of reconstituted solution

If not used immediately, the infusion solution may be stored under refrigeration conditions: 2°C to 8°C (36°F–46°F) and protected from light for up to 24 hours.

  • A maximum of 8 hours of the total 24 hours can be at room temperature, 20°C to 25°C (68°F–77°F), and in room light

Storage of non-reconstituted vials

Store EMPLICITI under refrigeration at 2 degrees celsius to 8 degrees celsius

Refrigerate at 2°C to 8°C (36°F–46°F)

Protect EMPLICITI from light by storing in the original package until time of use

Protect EMPLICITI from light by storing in the original package until time of use

Do not freeze EMPLICITI

Do not freeze

Do not shake EMPLICITI

Do not shake

EPd Dosing

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ERd Dosing

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Dosing Modifications

Determine the volume of SWFI needed for reconstitution

Preparation Step 2 chart

*After reconstitution, each vial contains overfill to allow for withdrawal of 12 mL (300-mg) and 16 mL (400-mg), respectively.

SWFI, sterile water for injection; USP, United States Pharmacopeia.

How EMPLICITI is supplied and stored

SUPPLY

EMPLICITI is supplied in 300 and 400 mg single-dose vials. EMPLICITI is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake that is provided in 2 strengths.

300mg

Carton contents

300 mg single-dose vial for IV infusion

10-digit-NDC

0003-2291-11

11-digit-NDC

00003-2291-11

400mg

Carton contents

400 mg single-dose vial for IV infusion

10-digit-NDC

0003-4522-11

11-digit-NDC

00003-4522-11

Storage of reconstituted solution

If not used immediately, the infusion solution may be stored under refrigeration conditions: 2°C to 8°C (36°F–46°F) and protected from light for up to 24 hours.

  • A maximum of 8 hours of the total 24 hours can be at room temperature, 20°C to 25°C (68°F–77°F), and in room light

Storage of non-reconstituted vials

Store EMPLICITI under refrigeration at 2 degrees celsius to 8 degrees celsius

Refrigerate at 2°C to 8°C (36°F–46°F)

Protect EMPLICITI from light by storing in the original package until time of use

Protect EMPLICITI from light by storing in the original package until time of use

Do not freeze EMPLICITI

Do not freeze

Do not shake EMPLICITI

Do not shake

EPd Dosing

NEED RESOURCES FOR YOUR PATIENTS?

START HEREEPd Dosing

Previous Page Arrow
Next Page Arrow

Previous:
ERd Dosing

Next:
Dosing Modifications

Reconstitute lyophilized powder cake with appropriate volume of SWFI: reconstitute, mix, and let stand

RECONSTITUTE

Preparation Step 3 Chart

  • Aseptically reconstitute each EMPLICITI vial with a syringe of adequate size and a less than or equal to 18-gauge needle (eg, 17-gauge)
  • A slight back pressure may be experienced during administration of the SWFI, which is considered normal

MIX

Preparation Step 3 Chart

  • Hold the vial upright and swirl the solution by rotating the vial to dissolve the lyophilized cake
  • Invert the vial a few times in order to dissolve any powder that may be present on top of the vial or the stopper. Avoid vigorous agitation. DO NOT SHAKE
  • The lyophilized powder should dissolve in less than 10 minutes

LET STAND

Preparation Step 3 Chart

  • After the remaining solids are completely dissolved, allow the reconstituted solution to stand for 5 to 10 minutes
  • The reconstituted preparation results in a colorless to slightly yellow, clear to slightly opalescent solution
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
  • Discard the solution if any particulate matter or discoloration is observed

SWFI, sterile water for injection.

How EMPLICITI is supplied and stored

SUPPLY

EMPLICITI is supplied in 300 and 400 mg single-dose vials. EMPLICITI is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake that is provided in 2 strengths.

300mg

Carton contents

300 mg single-dose vial for IV infusion

10-digit-NDC

0003-2291-11

11-digit-NDC

00003-2291-11

400mg

Carton contents

400 mg single-dose vial for IV infusion

10-digit-NDC

0003-4522-11

11-digit-NDC

00003-4522-11

Storage of reconstituted solution

If not used immediately, the infusion solution may be stored under refrigeration conditions: 2°C to 8°C (36°F–46°F) and protected from light for up to 24 hours.

  • A maximum of 8 hours of the total 24 hours can be at room temperature, 20°C to 25°C (68°F–77°F), and in room light

Storage of non-reconstituted vials

Store EMPLICITI under refrigeration at 2 degrees celsius to 8 degrees celsius

Refrigerate at 2°C to 8°C (36°F–46°F)

Protect EMPLICITI from light by storing in the original package until time of use

Protect EMPLICITI from light by storing in the original package until time of use

Do not freeze EMPLICITI

Do not freeze

Do not shake EMPLICITI

Do not shake

EPd Dosing

NEED RESOURCES FOR YOUR PATIENTS?

START HEREEPd Dosing

Previous Page Arrow
Next Page Arrow

Previous:
ERd Dosing

Next:Dosing Modifications

Dilute for infusion

Preparation Step 4 Chart

  • Once the reconstitution is completed, withdraw the necessary volume for the calculated dose from each vial, up to a maximum of 16 mL from 400-mg vial and 12 mL from 300-mg vial
  • Further dilute with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection (D5W), USP, into an infusion bag made of polyvinyl chloride or polyolefin. The final infusion concentration should range between 1 mg/mL and 6 mg/mL
  • The volume of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP should be adjusted so as not to exceed 5 mL/kg of patient weight at any given dose of EMPLICITI

Complete the EMPLICITI infusion within 24 hours of reconstitution of the EMPLICITI lyophilized powder.

Administer the entire EMPLICITI infusion with an infusion set and a sterile, nonpyrogenic, low-protein-binding filter (with a pore size of 0.2 to 1.2 micrometer) using an automated infusion pump.

Do not mix EMPLICITI with, or administer as an infusion with, other medicinal products. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of EMPLICITI with other agents.

How EMPLICITI is supplied and stored

SUPPLY

EMPLICITI is supplied in 300 and 400 mg single-dose vials. EMPLICITI is a sterile, nonpyrogenic, preservative-free lyophilized powder that is white to off-white, whole or fragmented cake that is provided in 2 strengths.

300mg

Carton contents

300 mg single-dose vial for IV infusion

10-digit-NDC

0003-2291-11

11-digit-NDC

00003-2291-11

400mg

Carton contents

400 mg single-dose vial for IV infusion

10-digit-NDC

0003-4522-11

11-digit-NDC

00003-4522-11

Storage of reconstituted solution

If not used immediately, the infusion solution may be stored under refrigeration conditions: 2°C to 8°C (36°F–46°F) and protected from light for up to 24 hours.

  • A maximum of 8 hours of the total 24 hours can be at room temperature, 20°C to 25°C (68°F–77°F), and in room light

Storage of non-reconstituted vials

Store EMPLICITI under refrigeration at 2 degrees celsius to 8 degrees celsius

Refrigerate at 2°C to 8°C (36°F–46°F)

Protect EMPLICITI from light by storing in the original package until time of use

Protect EMPLICITI from light by storing in the original package until time of use

Do not freeze EMPLICITI

Do not freeze

Do not shake EMPLICITI

Do not shake

EPd Dosing

NEED RESOURCES FOR YOUR PATIENTS?

START HEREEPd Dosing

Previous Page Arrow
Next Page Arrow

Previous:
ERd Dosing

Next:Dosing Modifications

 
More Important Safety Information

Important Safety
Information More Important Safety InformationCollapse

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. BMS-REF-ELOT 048 [Data on file]. Bristol-Myers Squibb. 2016.
  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.
 

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