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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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Preparation for EMPLICITI infusion

Preparation: Step 1

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

image shows examples of vial quantities needed for weight-based dosing for EMPLICITI image shows examples of vial quantities needed for weight-based dosing for EMPLICITI

Select patient weight below to calculate
recommended EMPLICITI dose.


If the adult patient
weighs:
41-60 kg
Multiply by
EMPLICITI dose:
10 mg/kg
For a total dose of: 410-600 mg
If the adult patient
weighs:
61-70 kg
Multiply by
EMPLICITI dose:
10 mg/kg
For a total dose of: 610-700 mg
If the adult patient
weighs:
71-80 kg
Multiply by
EMPLICITI dose:
10 mg/kg
For a total dose of: 710-800 mg
If the adult patient
weighs:
81-90 kg
Multiply by
EMPLICITI dose:
10 mg/kg
For a total dose of: 810-900 mg
If the adult patient
weighs:
91-100 kg
Multiply by
EMPLICITI dose:
10 mg/kg
For a total dose of: 91​0-1​000 mg
If the adult patient
weighs:
101-110 kg
Multiply by
EMPLICITI dose:
10 mg/kg
For a total dose of: 1010-1100 mg
If the adult patient
weighs:
111-120 kg
Multiply by
EMPLICITI dose:
10 mg/kg
For a total dose of: 1110-1200 mg
If the adult patient
weighs:
121-130 kg
Multiply by
EMPLICITI dose:
10 mg/kg
For a total dose of: 1210-1300 mg
If the adult patient
weighs:
131-140 kg
Multiply by
EMPLICITI dose:
10 mg/kg
For a total dose of: 1310-1400 mg

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

Preparation: Step 2

Determine the volume of SWFI needed for reconstitution1

image shows volumes needed for reconstitution for vial sizes of 300-mg and 400-mg vials
Strength
300-mg vial 400-mg vial
Amount of SWFI, USP required
for reconstruction
13 mL 17 mL
Deliverable volume of reconstituted
EMPLICITI in the vial
12 mL* 16 mL*
Post-reconstitution
concentration
25 mg/mL 25 mg/mL

*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.

Preparation: Step 3

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

Reconstitute1

shows image of how to reconstitute the EMPLICITI. It says to aseptically reconstitute each EMPLICITI vial with a syringe of adequate size and an 18 or smaller-gauge needle. A slight back pressure may be experienced during administration of the SWFI which is considered normal.
  • Aseptically reconstitute each EMPLICITI vial with a syringe of adequate size and a less than or equal to 18-gauge needle (e.g., 17-gauge)
  • A slight back pressure may be experienced during administration of the SWFI, which is considered normal

Mix1

Mix
  • 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 Stand1

LetStand
  • 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.

Preparation: Step 4

Dilute for infusion1


Dilution
  • 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
    230 mL of either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection (D5W), USP, into an infusion bag made of polyvinyl chloride or polyolefin
  • The volume of 0.9% Sodium Chloride Injection, USP or D5W can 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. 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 room light).

IMPORTANT SAFETY INFORMATION ABOUT 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.

Please see additional Important Safety Information below.

Previous: Dosing and administration

Next: Infusion rate and dose modifications

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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