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Drug overview for EMPLICITI (elotuzumab):
Generic name: ELOTUZUMAB (EL-oh-TOOZ-ue-mab)
Drug class: Antineoplastic-Anti-SLAMF7 Monoclonal Antibody Agents
Therapeutic class: Antineoplastics
Elotuzumab, a recombinant humanized monoclonal antibody that is an antagonist of signaling lymphocytic activation molecule (SLAM) family member 7 (SLAMF7), is an antineoplastic agent; the drug also is referred to as an anti-CS1 (anti-CD2 subset 1) monoclonal antibody.
No enhanced Uses information available for this drug.
Generic name: ELOTUZUMAB (EL-oh-TOOZ-ue-mab)
Drug class: Antineoplastic-Anti-SLAMF7 Monoclonal Antibody Agents
Therapeutic class: Antineoplastics
Elotuzumab, a recombinant humanized monoclonal antibody that is an antagonist of signaling lymphocytic activation molecule (SLAM) family member 7 (SLAMF7), is an antineoplastic agent; the drug also is referred to as an anti-CS1 (anti-CD2 subset 1) monoclonal antibody.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for EMPLICITI (elotuzumab) have been approved by the FDA:
Indications:
Multiple myeloma
Professional Synonyms:
Plasma cell myeloma
Indications:
Multiple myeloma
Professional Synonyms:
Plasma cell myeloma
The following dosing information is available for EMPLICITI (elotuzumab):
If administration of one drug in the combination regimen is delayed, interrupted, or discontinued, therapy with the other drugs may be continued; however, since dexamethasone also is used to reduce the risk of infusion-related events associated with elotuzumab, clinical judgment should be used in deciding whether elotuzumab should be continued without dexamethasone. Clinicians should consult the respective manufacturers' labelings for information on recommended dosage modifications for lenalidomide and dexamethasone.
Elotuzumab is administered by IV infusion using a sterile, nonpyrogenic, low-protein-binding, 0.2- to 1.2-mcm inline filter.
Solutions of the drug should be administered via an infusion pump. Other drugs should not be administered simultaneously through the same IV line with elotuzumab infusion. Prior to administration, commercially available elotuzumab lyophilized powder for injection must be reconstituted and diluted using proper aseptic technique.
Unreconstituted elotuzumab lyophilized powder for injection should be stored in unopened vials at 2-8degreesC, and should not be frozen or shaken. Unopened vials should be retained in the original package for protection from light.
Solutions of the drug should be administered via an infusion pump. Other drugs should not be administered simultaneously through the same IV line with elotuzumab infusion. Prior to administration, commercially available elotuzumab lyophilized powder for injection must be reconstituted and diluted using proper aseptic technique.
Unreconstituted elotuzumab lyophilized powder for injection should be stored in unopened vials at 2-8degreesC, and should not be frozen or shaken. Unopened vials should be retained in the original package for protection from light.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| EMPLICITI 300 MG VIAL | Maintenance | Adults infuse 10 mg/kg at a rate not to exceed 5 mL/min by intravenous route every 2 weeks |
| EMPLICITI 400 MG VIAL | Maintenance | Adults infuse 10 mg/kg at a rate not to exceed 5 mL/min by intravenous route every 2 weeks |
No generic dosing information available.
The following drug interaction information is available for EMPLICITI (elotuzumab):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Sodium Iodide I 131/Myelosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1) DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1) |
HICON, SODIUM IODIDE I-131 |
There are 0 moderate interactions.
The following contraindication information is available for EMPLICITI (elotuzumab):
Drug contraindication overview.
The manufacturer states there are no known contraindications to the use of elotuzumab.
The manufacturer states there are no known contraindications to the use of elotuzumab.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Pregnancy |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Herpes zoster |
| Severe infection |
The following adverse reaction information is available for EMPLICITI (elotuzumab):
Adverse reaction overview.
Adverse effects reported in 10% or more of patients receiving elotuzumab in combination with lenalidomide and dexamethasone for the treatment of previously treated multiple myeloma and at an incidence that is at least 5% higher than that reported with lenalidomide and dexamethasone alone include fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, loss of appetite, pneumonia, extremity pain, headache, vomiting, weight loss, lymphopenia, cataracts, and oropharyngeal pain. Laboratory abnormalities reported in 10% or more of patients receiving elotuzumab in combination with lenalidomide and dexamethasone and at an incidence that is at least 5% higher than that reported with lenalidomide and dexamethasone alone include lymphopenia, leukopenia, thrombocytopenia, hypoalbuminemia, elevated concentrations of alkaline phosphatase, hyperglycemia, hypocalcemia, decreased serum bicarbonate concentrations, and hyperkalemia.
Adverse effects reported in 10% or more of patients receiving elotuzumab in combination with lenalidomide and dexamethasone for the treatment of previously treated multiple myeloma and at an incidence that is at least 5% higher than that reported with lenalidomide and dexamethasone alone include fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, loss of appetite, pneumonia, extremity pain, headache, vomiting, weight loss, lymphopenia, cataracts, and oropharyngeal pain. Laboratory abnormalities reported in 10% or more of patients receiving elotuzumab in combination with lenalidomide and dexamethasone and at an incidence that is at least 5% higher than that reported with lenalidomide and dexamethasone alone include lymphopenia, leukopenia, thrombocytopenia, hypoalbuminemia, elevated concentrations of alkaline phosphatase, hyperglycemia, hypocalcemia, decreased serum bicarbonate concentrations, and hyperkalemia.
There are 21 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bradycardia Hyperkalemia Hypocalcemia Infection Leukopenia Opportunistic fungal infection Peripheral motor neuropathy Pneumonia Thrombocytopenic disorder |
Abnormal hepatic function tests Acute renal failure Anemia Cataracts Hypertension Hypokalemia Hyponatremia Hypotension Lymphopenia Pulmonary thromboembolism |
| Rare/Very Rare |
|---|
|
Hypersensitivity drug reaction Hypoesthesia |
There are 23 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Anorexia Constipation Cough Diarrhea Fatigue Fever Hyperglycemia Peripheral sensory neuropathy Pharyngitis Upper respiratory infection |
Bone pain Chills Dyspnea Headache disorder Mouth irritation Muscle spasm Pain in extremities Peripheral edema Vomiting Weight loss |
| Rare/Very Rare |
|---|
|
Chest pain Mood changes Night sweats |
The following precautions are available for EMPLICITI (elotuzumab):
Safety and efficacy of elotuzumab have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate and well-controlled studies of elotuzumab in pregnant women. Animal reproduction studies have not been performed to date with the drug. Because elotuzumab is administered in combination with lenalidomide and dexamethasone, clinicians must consider that lenalidomide is contraindicated in pregnant women. (See Combination Therapy under Cautions: Warnings/Precautions.)
It is not known whether elotuzumab is distributed into milk. Because of the potential for serious adverse reactions in nursing infants, women should be advised to discontinue nursing during combination therapy with elotuzumab, lenalidomide, and dexamethasone. The effects of elotuzumab on nursing infants or on milk production are unknown.
In the phase 3 clinical trial evaluating elotuzumab in combination with lenalidomide and dexamethasone for the treatment of relapsed or refractory multiple myeloma, 57% of patients were 65 years of age or older. No overall differences in safety or efficacy were observed between geriatric patients and younger adults.
The following prioritized warning is available for EMPLICITI (elotuzumab):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for EMPLICITI (elotuzumab)'s list of indications:
| Multiple myeloma | |
| C90.0 | Multiple myeloma |
| C90.00 | Multiple myeloma not having achieved remission |
| C90.02 | Multiple myeloma in relapse |
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