Empliciti

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/10/2021
Empliciti Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Empliciti?

Empliciti (elotuzumab) for injection is a SLAMF7-directed immunostimulatory antibody indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

What Are Side Effects for Empliciti?

Common side effects of Empliciti include:

Tell your doctor if you have serious side effects of Empliciti including:

Dosage for Empliciti

The dose of Empliciti given with lenalidomide and dexamethasone is 10 mg/kg administered intravenously every week for the first two cycles and every 2 weeks thereafter until disease progression or unacceptable toxicity. Premedicate with:

What Drugs, Substances, or Supplements Interact with Empliciti?

Empliciti may interact with other drugs.

Tell your doctor all medications and supplements you use.

Empliciti During Pregnancy and Breastfeeding

Empliciti is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Empliciti passes into breast milk. Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended.

Additional Information

Our Empliciti (elotuzumab) for injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Empliciti Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, itchy, chilled, feverish, light-headed, or short of breath.

Call your doctor at once if you have:

  • fever, cough, flu-like symptoms;
  • pain or burning when you urinate;
  • painful skin rash;
  • liver problems--loss of appetite, stomach pain or swelling, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • signs of pneumonia--fever, chills, cough with mucus, chest pain, feeling short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • fever, cough, tiredness;
  • numbness, weakness, tingling, or burning pain in your arms or legs;
  • loss of appetite;
  • cold symptoms such as runny nose or sore throat;
  • diarrhea, constipation; or
  • increased thirst, increased urination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Empliciti (Elotuzumab for Injection)

Empliciti Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described in detail in other sections of the label:

  • Infusion reaction [see WARNINGS AND PRECAUTIONS].
  • Infections [see WARNINGS AND PRECAUTIONS].
  • Second Primary Malignancies [see WARNINGS AND PRECAUTIONS].
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS].
  • Interference with determination of complete response [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

EMPLICITI In Combination With Lenalidomide And Dexamethasone [ELOQUENT-2]

The safety data described in this section are based on the ELOQUENT-2 study, a randomized, open-label clinical trial in patients with previously treated multiple myeloma. In ELOQUENT-2, EMPLICITI 10 mg/kg was administered with lenalidomide and dexamethasone [see Clinical Studies]. For adverse reaction evaluation, EMPLICITI combined with lenalidomide and dexamethasone was compared with lenalidomide and dexamethasone alone.

The mean age of the population was 66 years and 57% of patients were 65 years of age or older. Sixty percent (60%) of the population were male, 84% were white, 10% were Asian, and 4% were black. The Eastern Cooperative Oncology Group (ECOG) performance status was 0 in 47%, 1 in 44%, and 2 in 9% of patients.

These data reflect exposure of 318 patients to EMPLICITI and 317 to control with a median number of cycles of 19 for EMPLICITI and 14 for control.

Serious adverse reactions were reported in 65% of patients treated on the EMPLICITI arm and 57% for patients treated on the control arm. The most frequent serious adverse reactions in the EMPLICITI arm compared to the control arm were: pneumonia (15% vs. 11%), pyrexia (7% vs. 5%), respiratory tract infection (3.1% vs. 1.3%), anemia (2.8% vs. 1.9%), pulmonary embolism (3.1% vs. 2.5%), and acute renal failure (2.5% vs. 1.9%).

The proportion of patients who discontinued any component of the treatment regimen due to adverse reactions as listed below was similar for both treatment arms; 6.0% for patients treated on the EMPLICITI arm and 6.3% for patients treated on the control.

Adverse reactions occurring at a frequency of 10% or higher in the EMPLICITI arm and 5% or higher than the lenalidomide and dexamethasone arm for the randomized trial in multiple myeloma are presented in Table 6.

Table 6: ELOQUENT-2: Adverse Reactions with a 10% or Higher Incidence for EMPLICITI-Treated Patients and a 5% or Higher Incidence than Lenalidomide and Dexamethasone-Treated Patients [All Grades]

Primary Term EMPLICITI + Lenalidomide and Dexamethasone
N=318
Lenalidomide and Dexamethasone
N=317
All Grades Grade 3/4 All Grades Grade 3/4
Fatigue* 62 13 52 12
Diarrhea 47 5.0 36 4.1
Pyrexia 37 2.5 25 2.8
Constipation 36 1.3 27 0.3
Cough† 34 0.3 19 0
Peripheral Neuropathy‡ 27 3.8 21 2.2
Nasopharyngitis 25 0 19 0
Upper Respiratory Tract Infection 23 0.6 17 1.3
Decreased Appetite 21 1.6 13 1.3
Pneumonia§ 20 14 14 9
Pain in Extremities 16 0.9 10 0.3
Headache 15 0.3 8 0.3
Vomiting 14 0.3 9 0.9
Weight Decreased 14 1.3 6 0
Lymphopenia 13 9 7 3.2
Cataracts 12 6 6 2.8
Oropharyngeal Pain 10 0 4 0
* The term fatigue is a grouping of the following terms: fatigue and asthenia.
† The term cough is a grouping of the following terms: cough, productive cough, and upper airway cough.
‡ The term peripheral neuropathy is a grouping of the following terms: peripheral neuropathy, axonal neuropathy, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
§The term pneumonia is a grouping of the following terms: pneumonia, atypical pneumonia, bronchopneumonia, lobar pneumonia, bacterial pneumonia, fungal pneumonia, pneumonia influenza, and pneumococcal pneumonia.

Laboratory abnormalities worsening from baseline and occurring at a frequency of 10% or higher in the EMPLICITI group and 5% or higher than the lenalidomide and dexamethasone group (criteria met for all Grades or Grade 3/4) for ELOQUENT-2 are presented in Table 7.

Table 7: ELOQUENT-2: Laboratory Abnormalities Worsening from Baseline and with a 10% or Higher Incidence for EMPLICITITreated Patients and a 5% Higher Incidence than Lenalidomide and Dexamethasone-Treated Patients [Criteria met for All Grades or Grade 3/4]

Laboratory Parameter EMPLICITI + Lenalidomide and Dexamethasone
N=318
Lenalidomide and Dexamethasone
N=317
All Grades Grade 3/4 All Grades Grade 3/4
Hematology
Lymphopenia 99 77 98 49
Leukopenia 91 32 88 26
Thrombocytopenia 84 19 78 20
Liver and Renal Function Tests
Hypoalbuminemia 73 3.9 66 2.3
Elevated Alkaline Phosphatase 39 1.3 30 0
Chemistry
Hyperglycemia 89 17 85 10
Hypocalcemia 78 11 77 4.7
Low Bicarbonate 63 0.4 45 0
Hyperkalemia 32 7 22 1.6

Vital sign abnormalities were assessed by treatment arm for the randomized trial in multiple myeloma and are presented in Table 8. Percentages are based on patients who had at least one vital sign abnormality any time during the course of study.

Table 8: ELOQUENT-2 Vital Sign Abnormalities

Vital Sign Parameter EMPLICITI + Lenalidomide and Dexamethasone
N=318 %
Lenalidomide and Dexamethasone
N=317 %
Systolic Blood Pressure ≥160 mmHg 33 21
Diastolic Blood Pressure ≥100 mmHg 17 12
Systolic Blood Pressure <90 mmHg 29 8
Heart Rate ≥100 bpm 48 30
Heart Rate <60 bpm 66 31

EMPLICITI In Combination With Pomalidomide And Dexamethasone [ELOQUENT-3]

The safety data described in this section are based on ELOQUENT-3, a randomized, open-label clinical trial in patients with previously treated multiple myeloma. In ELOQUENT-3, EMPLICITI 10 mg/kg and 20 mg/kg was administered with pomalidomide and dexamethasone [see Clinical Studies]. For adverse reaction evaluation, EMPLICITI combined with pomalidomide and dexamethasone was compared with pomalidomide and dexamethasone alone.

The mean age of the population was 66 years and 63% of patients were 65 years of age or older. Fifty-seven percent of the population were male, 78% were white, 20% were Asian, and none were black. The ECOG performance status was 0 in 43%, 1 in 46%, and 2 in 10% of patients. These data reflect exposure of 60 patients to EMPLICITI and 55 to control with a median number of cycles of 9 for EMPLICITI and 5 for control.

Serious adverse reactions were reported in 22% of patients treated on the EMPLICITI arm and 15% for patients treated on the control arm. The most frequent serious adverse reactions in the EMPLICITI arm compared to the control arm were: pneumonia (13% vs. 11%) and respiratory tract infection (7% vs. 3.6%). The proportion of patients who discontinued any component of the treatment regimen due to adverse reactions were 5.0% of the patients in the EMPLICITI arm and 1.8% of the patients in the control arm.

Adverse reactions occurring at a frequency of 10% or higher in the EMPLICITI arm and 5% or higher than the pomalidomide and dexamethasone arm for the randomized trial in multiple myeloma are presented in Table 9.

Table 9: ELOQUENT-3: Adverse Reactions with a 10% or Higher Incidence for EMPLICITI-Treated Patients and a 5% or Higher Incidence than Pomalidomide and Dexamethasone-Treated Patients [All Grades]

Adverse Reaction EMPLICITI + Pomalidomide and Dexamethasone
N=60
Pomalidomide and Dexamethasone
N=55
All Grades Grade 3/4 All Grades Grade 3/4
Constipation 22 1.7 11 0
Hyperglycemia 20 8 15 7
Pneumonia* 18 10 13 11
Diarrhea 18 0 9 0
Respiratory Tract Infection 17 0 9 1.8
Bone Pain 15 3.3 9 0
Dyspnea 15 3.3 7 1.8
Muscle Spasms 13 0 5 0
Edema Peripheral 13 0 7 1
Lymphopenia 10 8 1.8 1.8
* The term pneumonia is grouping of the following terms: pneumonia, atypical pneumonia, lower respiratory tract infection, pneumoccocal sepsis, pneumonia bacterial, pneumonia influenza.

Other clinically important adverse reactions reported in patients treated with EMPLICITI that did not meet the criteria for inclusion in Table 6 and 9 but occurred at a frequency of 5% or greater in the EMPLICITI group and at a frequency at least twice the control rate for the randomized trial in multiple myeloma are listed below:

General disorders and administration site conditions: chest pain, night sweats

Immune system disorders: hypersensitivity

Nervous system disorders: hypoesthesia

Psychiatric disorders: mood altered

Laboratory abnormalities worsening from baseline and occurring at a frequency of 10% or higher in ELOQUENT-3 in the EMPLICITI group and 5% or higher than the pomalidomide and dexamethasone group (criteria met for all Grades or Grade 3/4) for the randomized trial in multiple myeloma are presented in Table 10.

Table 10: ELOQUENT-3: Laboratory Abnormalities Worsening from Baseline and with a 10% or Higher Incidence for EMPLICITITreated Patients and a 5% Higher Incidence than Pomalidomide and Dexamethasone-Treated Patients [Criteria met for All Grades or Grade 3/4]

Laboratory Parameter EMPLICITI + Pomalidomide and Dexamethasone
N=60
Pomalidomide and Dexamethasone
N=55
All Grades Grade 3/4 N= All Grades Grade 3/4
Hematology
Lymphopenia 98 70 91 35
Leukopenia 80 52 87 35
Thrombocytopenia 78 17 73 20
Liver and Renal Function Tests
Hypoalbuminemia 65 1.7 56 1.8
Chemistry
Hypocalcemia 58 3.3 40 1.8
Hyperglycemia 40 3.3 25 1.8
Hyponatremia 40 5 18 0
Hypokalemia 23 5 16 3.6

Vital sign abnormalities were assessed by treatment arm for the randomized trial in multiple myeloma and are presented in Table 11. Percentages are based on all treated patients

Table 11: ELOQUENT-3: Vital Sign Abnormalities

Vital Sign Parameter EMPLICITI + Pomalidomide and Dexamethasone
N=60 %
Pomalidomide and Dexamethasone
N=55 %
Systolic Blood Pressure ≥160 mmHg 18 13
Diastolic Blood Pressure ≥100 mmHg 8 4.0
Systolic Blood Pressure <90 mmHg 7 7
Heart Rate ≥100 bpm 23 24
Heart Rate <60 bpm 43 22

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity to EMPLICITI. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.

Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to EMPLICITI in the studies described below with the incidences of antibodies in other studies or to other products may be misleading.

Of 390 patients across four clinical studies including ELOQUENT-2 and in 53 patients in the ELOQUENT-3 trial, who were treated with EMPLICITI and evaluable for the presence of antiproduct antibodies, 72 patients (18.5%) in the four clinical trials and 19 patients (36%) in the ELOQUENT-3 trial tested positive for treatment-emergent anti-product antibodies by an electrochemiluminescent (ECL) assay. In 63 (88%) of the 72 patients in the four clinical trials, anti-product antibodies occurred within the first 2 months of the initiation of EMPLICITI treatment and resolved by 2 to 4 months in 49 (78%) patients. In the ELOQUENT-3 trial, in all 19 patients, anti-product antibodies occurred within the first 2 months of the initiation of EMPLICITI treatment and were resolved by 2 to 3 months in 18 (95%) patients.

Neutralizing antibodies post-treatment were detected in 19 of 299 patients in the four clinical trials and 2 of 53 patients in the ELOQUENT-3 trial who were evaluable for the presence of neutralizing antibodies.

Read the entire FDA prescribing information for Empliciti (Elotuzumab for Injection)

© Empliciti Patient Information is supplied by Cerner Multum, Inc. and Empliciti Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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