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Elotuzumab: Drug information

Elotuzumab: Drug information
(For additional information see "Elotuzumab: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Empliciti
Pharmacologic Category
  • Antineoplastic Agent, Anti-SLAMF7;
  • Antineoplastic Agent, Monoclonal Antibody
Dosing: Adult

Note: Premedicate with dexamethasone, an H1-antagonist (eg, diphenhydramine), an H2-antagonist, and acetaminophen ~45 to 90 minutes prior to infusion (see "Premedications" below). Refer to the lenalidomide, pomalidomide, and dexamethasone monographs for dosing information.

Multiple myeloma, relapsed/refractory

Multiple myeloma, relapsed/refractory:

In combination with lenalidomide and dexamethasone (Ref):

Cycles 1 and 2: IV: 10 mg/kg once weekly on days 1, 8, 15, and 22 of a 28-day treatment cycle (in combination with lenalidomide and dexamethasone).

Cycle 3 and beyond: IV: 10 mg/kg once every 2 weeks on days 1 and 15 of a 28-day treatment cycle (in combination with lenalidomide and dexamethasone); continue until disease progression or unacceptable toxicity.

In combination with pomalidomide and dexamethasone (Ref):

Cycles 1 and 2: IV: 10 mg/kg once weekly on days 1, 8, 15, and 22 of a 28-day treatment cycle (in combination with pomalidomide and dexamethasone).

Cycle 3 and beyond: IV: 20 mg/kg once every 4 weeks on day 1 of a 28-day treatment cycle (in combination with pomalidomide and dexamethasone); continue until disease progression or unacceptable toxicity.

Premedications:

Dexamethasone: Oral and IV: Note: Dexamethasone dosing differs depending on chemotherapy regimen.

Elotuzumab/lenalidomide/dexamethasone regimen:

On days that elotuzumab is administered, give dexamethasone 28 mg orally 3 to 24 hours before elotuzumab infusion plus dexamethasone 8 mg IV 45 to 90 minutes prior to infusion. On days that elotuzumab is not administered but dexamethasone is due (eg, days 8 and 22 of cycle 3 and beyond), administer the standard dexamethasone dose (40 mg orally).

Due to compliance concerns on days that elotuzumab is administered, a one-time dexamethasone dose of 20 to 40 mg IV has been reported (in lieu of administering both oral and IV dexamethasone) (Ref).

Elotuzumab/pomalidomide/dexamethasone regimen:

Patients ≤75 years: On days that elotuzumab is administered, give dexamethasone 28 mg orally 3 to 24 hours before elotuzumab infusion plus dexamethasone 8 mg IV 45 to 90 minutes prior to infusion. On days that elotuzumab is not administered but dexamethasone is due (eg, days 8, 15, and 22 of cycle 3 and beyond), administer dexamethasone 40 mg orally.

Patients >75 years: On days that elotuzumab is administered, give dexamethasone 8 mg orally 3 to 24 hours before elotuzumab infusion plus dexamethasone 8 mg IV 45 to 90 minutes prior to infusion. On days that elotuzumab is not administered but dexamethasone is due (eg, days 8, 15, and 22 of cycle 3 and beyond), administer dexamethasone 20 mg orally.

Antipyretic: Oral: Acetaminophen 650 to 1,000 mg.

H1-antagonist: IV or Oral: Diphenhydramine 25 to 50 mg or equivalent.

H2-antagonist: The use of famotidine 20 mg IV has been reported (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl ≤89 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, CrCl ≤89 mL/minute did not have a clinically significant effect on elotuzumab pharmacokinetics. Dosage adjustment is not necessary in patients with kidney impairment or in patients on hemodialysis (Ref).

Dosing: Hepatic Impairment: Adult

Hepatic impairment prior to treatment:

Mild (total bilirubin ≤ULN and AST >ULN or total bilirubin 1 to 1.5 times ULN and any AST) impairment: There are no dosage adjustments provided in the manufacturer's labeling; however, mild impairment did not have a clinically significant effect on elotuzumab pharmacokinetics. Dosage adjustment is not necessary (Ref).

Moderate (total bilirubin >1.5 to 3 times ULN and any AST) to severe (total bilirubin >3 times ULN and any AST) impairment: There are no dosage adjustments provided in the manufacturer's labeling (effect is unknown). However, no need for dosage adjustment is expected (Ref).

Hepatotoxicity during treatment: Grade 3 or higher transaminase elevations: Withhold treatment; may consider continuing treatment after liver enzymes return to baseline.

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2 : The dosing in the FDA-approved prescribing information should be followed in all patients, regardless of obesity status. If a patient with a BMI ≥30 kg/m2 experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status (Ref).

Dosing: Adjustment for Toxicity: Adult

Refer to lenalidomide and pomalidomide monographs for dosage modifications for toxicity. If dosing of one drug in the regimen is delayed, interrupted, or discontinued, treatment with the other medications may continue as scheduled. However, if dexamethasone is delayed or discontinued, administer elotuzumab based on clinical judgment (due to hypersensitivity risk).

Infection: Treat promptly if infections occur.

Infusion reactions: Grade 2 or greater: Interrupt infusion and manage symptoms as clinically appropriate. When symptoms improve to ≤ grade 1, restart elotuzumab infusion at a rate of 0.5 mL/minute and gradually increase the rate by 0.5 mL/minute every 30 minutes as tolerated to the rate at which the infusion reaction occurred. May continue to escalate the rate if there is no recurrence of the infusion reaction (see Administration). Monitor vital signs every 30 minutes during and for 2 hours after the end of the infusion in patients who experience an infusion reaction. If the reaction recurs, discontinue the elotuzumab infusion and do not restart on that day. Severe infusion reactions may require therapy discontinuation and emergency management.

Dosing: Older Adult

Refer to adult dosing. Concomitant therapy (eg, dexamethasone) dose may be lower in patients >75 years.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported with combination therapy in adults.

>10%:

Cardiovascular: Altered blood pressure (systolic ≥160 mmHg: 18% to 33%; systolic <90 mmHg: 7% to 29%; diastolic ≥100 mmHg: 8% to 17%), decreased heart rate (<60 bpm: 43% to 66%), increased heart rate (≥100 bpm: 23% to 48%), peripheral edema (13%)

Endocrine & metabolic: Decreased serum bicarbonate (63%), hyperglycemia (20% to 89%), hyperkalemia (32%), hypoalbuminemia (65% to 73%), hypocalcemia (58% to 78%), hypokalemia (23%), hyponatremia (40%), weight loss (14%)

Gastrointestinal: Constipation (22% to 36%), decreased appetite (21%), diarrhea (18% to 47%; grades 3/4: 5%), vomiting (14%; grades 3/4: <1%)

Hematologic & oncologic: Leukopenia (80% to 91%; grades 3/4: 32% to 52%), lymphocytopenia (10% to 99%; grades 3/4: 8% to 77%), thrombocytopenia (78% to 84%; grades 3/4: 17% to 19%)

Hepatic: Increased serum alkaline phosphatase (39%)

Immunologic: Antibody development (19% to 36%; neutralizing: 4% to 6%)

Infection: Herpes zoster infection (5% to 14%), infection (65% to 81%; fungal infection: 10%; opportunistic infection: 10% to 22%)

Nervous system: Fatigue (including asthenia: 62%), headache (15%), peripheral neuropathy (27%; grades 3/4: 4%)

Neuromuscular & skeletal: Limb pain (16%), muscle spasm (13%), ostealgia (15%)

Ophthalmic: Cataract (12%)

Respiratory: Cough (34%), dyspnea (15%), nasopharyngitis (25%), pneumonia (18% to 20%), respiratory tract infection (17%; serious: 3% to 7%), upper respiratory tract infection (23%)

Miscellaneous: Fever (37%; serious: 7%)

1% to 10%:

Cardiovascular: Chest pain (≥5%), pulmonary embolism (3%)

Dermatologic: Malignant neoplasm of skin (4%), night sweats (≥5%)

Hematologic & oncologic: Anemia (3%), malignant neoplasm (hematologic: 2%), malignant solid tumor (4%), second primary malignant neoplasm (9%)

Hepatic: Hepatotoxicity (3%)

Hypersensitivity: Hypersensitivity reaction (≥5%), infusion related reaction (3% to 10%)

Nervous system: Hypoesthesia (≥5%), mood changes (≥5%)

Renal: Acute kidney injury (3%)

Respiratory: Oropharyngeal pain (10%)

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to elotuzumab or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Hepatotoxicity: Liver enzyme elevations (AST/ALT more than 3 times ULN, total bilirubin more than 2 times ULN, and alkaline phosphatase less than 2 times ULN) have occurred.

• Infection: Infections (including grade 3 and 4 infections) were reported in the majority of multiple myeloma patients treated in the clinical trials, including fatal infections.

• Infusion reactions: Infusion reactions (eg, fever, chills, hypertension) have been reported; all reactions were grade 3 or lower. Bradycardia and hypotension have also occurred during infusion. The majority of infusion reactions occurred during the first dose.

• Secondary malignancy: Invasive second primary malignancies have been reported. In one clinical trial, the rate of hematologic malignancies was the same between the elotuzumab/lenalidomide/dexamethasone group versus the lenalidomide/dexamethasone group. Solid tumors and skin cancer were reported more frequently in the elotuzumab arm versus the control group.

Disease-related concerns:

• Interference with determination of myeloma response: Elotuzumab (a human IgG kappa monoclonal antibody) may be detected on serum protein electrophoresis and immunofixation assays which monitor for endogenous M-protein. Interference with these assays by elotuzumab may affect the determination of complete response and disease progression in some patients with IgG kappa myeloma protein.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Empliciti: 300 mg (1 ea) [contains polysorbate 80]

Solution Reconstituted, Intravenous [preservative free]:

Empliciti: 400 mg (1 ea) [contains polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Empliciti Intravenous)

300 mg (per each): $2,624.75

400 mg (per each): $3,499.63

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: For IV infusion only. Do not administer IV push or as a bolus. Premedicate with dexamethasone, acetaminophen, and an H1- and H2-antagonist (see Dosing) approximately 45 to 90 minutes prior to administration. Infuse in an environment equipped to monitor for and manage infusion reactions. Administer with an infusion set and a sterile, non-pyrogenic, low protein-binding filter (0.2 to 1.2 micrometer) using an automated infusion pump. Do not mix with or infuse with other medications. Infusion should be completed within 24 hours of reconstitution. Monitor for infusion reaction. Interrupt infusion for grade 2 or higher infusion reactions; if the reaction resolves or improves to ≤ grade 1, may resume infusion (see Dosage Adjustment for Toxicity). Monitor vital signs every 30 minutes during and for 2 hours after the end of the infusion in patients who experience an infusion reaction.

Infusion rate:

10 mg/kg dose:

First infusion (Cycle 1, Dose 1): Infuse at 0.5 mL/minute for the first 30 minutes. If no infusion reactions occur, may increase the rate to 1 mL/minute for the next 30 minutes. If tolerated, may then increase the rate to 2 mL/minute until infusion completion (maximum rate: 2 mL/minute).

Second infusion (Cycle 1, Dose 2): If no infusion reactions occurred during the prior infusion, initiate at 3 mL/minute for the first 30 minutes. If tolerated, may then increase the rate to 4 mL/minute until infusion completion (maximum rate: 4 mL/minute).

Subsequent infusions (Cycle 1, Doses 3 and 4 and all subsequent infusions): If no infusion reactions occurred during the prior infusion, initiate and infuse at 5 mL/minute until completion (maximum rate: 5 mL/minute).

20 mg/kg dose:

First infusion (Dose 1): Initiate infusion at 3 mL/minute for the first 30 minutes. Infusion rates which were escalated to 5 mL/minute at the 10 mg/kg dose must be decreased to 3 mL/minute at the first infusion at 20 mg/kg dose. If no infusion reactions occur at 3 mL/minute, may increase the rate to 4 mL/minute until infusion completion (maximum rate: 4 mL/minute).

Second and subsequent infusions (Dose 2 and all subsequent infusions): If no infusion reactions occurred during the prior infusion, initiate and infuse at 5 mL/minute until completion (maximum rate: 5 mL/minute).

Use: Labeled Indications

Multiple myeloma, relapsed/refractory:

Treatment of multiple myeloma (in combination with lenalidomide and dexamethasone) in adults who have received 1 to 3 prior therapies.

Treatment of multiple myeloma (in combination with pomalidomide and dexamethasone) in adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor.

Medication Safety Issues
Sound-alike/look-alike issues:

Elotuzumab may be confused with daratumumab, eculizumab, emapalumab, emicizumab, enfortumab vedotin, erenumab, evolocumab, isatuximab

Empliciti may be confused with Empaveli

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

Desmopressin: Hyponatremia-Associated Agents may enhance the hyponatremic effect of Desmopressin. Risk C: Monitor therapy

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification

Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Reproductive Considerations

Elotuzumab is indicated for use in combination with lenalidomide or pomalidomide. Due to its potential to cause fetal harm, lenalidomide and pomalidomide are only available through a REMS program. Patients who could become pregnant and patients with partners who could become pregnant using these combinations must be able to comply with pregnancy testing and contraception requirements for lenalidomide or pomalidomide. Refer to the lenalidomide or pomalidomide monograph for additional information.

Pregnancy Considerations

Animal reproduction studies have not been conducted. Elotuzumab is indicated for use in combination with lenalidomide or pomalidomide. Due to its potential to cause fetal harm, lenalidomide and pomalidomide are only available through a REMS program. Refer to the lenalidomide or pomalidomide monograph for additional information.

Breastfeeding Considerations

It is not known if elotuzumab is present in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer.

Monitoring Parameters

Liver function tests (periodically). Monitor for signs/symptoms of infusion reactions (monitor vital signs every 30 minutes during and for 2 hours after the end of the infusion in patients who experience an infusion reaction), infections (opportunistic, fungal, herpes zoster, and other infections), and second primary malignancies.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Elotuzumab is a humanized IgG1 immunostimulatory monoclonal antibody directed against the signaling lymphocytic activation molecule family member 7 (SLAMF7, also called CS1 [cell surface glycoprotein CD2 subset 1) protein. SLAMF7 is expressed on most myeloma and natural killer cells, but not on normal tissues; more than 95% of bone marrow myeloma cells express SLAMF7 (Lonial 2015). Elotuzumab directly activates natural killer cells (NK) through both the SLAMF7 pathway and Fc receptors. It also targets SLAMF7 on myeloma cells and mediates antibody-dependent cellular cytotoxicity (ADCC) of myeloma cells through the CD16 pathway (Lonial 2015). Elotuzumab with lenalidomide demonstrated increased NK cell activation and increased anti-tumor activity. Elotuzumab has also shown increased anti-tumor activity when used in combination with pomalidomide.

Pharmacokinetics (Adult Data Unless Noted)

Half-life elimination: ~97% of the maximum steady-state concentration is expected to be eliminated with a geometric mean (CV%) of 78 to 82.4 days.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Body weight: Clearance increases with increasing body weight.

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