Names and pronunciation
(El-oh-tooz′ue-mab) Empliciti
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Drug reference
(El-oh-tooz′ue-mab) Empliciti
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Func. class.: Antineoplastic
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Chem. class.: Monoclonal antibody
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ACTION: A humanized IgG1 mono- clonal antibody that binds to the sig- naling lymphocytic activation molecule family member 7 (SLAMF7), a cell surface glycoprotein receptor, and activates natural killer (NK) cell– mediated antibody-dependent cellular cytotoxicity of SLAMF7-expressing myeloma cells
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USES: Multiple myeloma in patients who have received 1 to 3 prior therapies, in combination with lenalidomide and dexamethasone
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CONTRAINDICATIONS Hypersensitivity, breastfeeding, hepatotox- icity, infection, infusion-related reactions, new primary malignancy, pregnancy Precautions: Hepatic disease
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INTERACTIONS Palifermin: should not be administered within 24 hr prior to, during infusion of, or within 24 hr after administration of antineoplastic agents Increased risk of developing severe hematologic and renal toxicity: Penicil- lamine: Do not use together Decrease immunologic response to tuber- culin purified protein derivative (PPD): Tuberculin Purified Protein Derivative, PPD NURSING CONSIDERATIONS
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DOSAGE AND ROUTES Multiple myeloma in patients who have received 1 to 3 prior therapies, in combination with lenalidomide and dexamethasone • Adults: IV 10 mg/kg weekly on cy- cles 1 and 2 (on days 1, 8, 15, and 22), then q2wk (on days 1 and 15), give in combination with lenalidomide 25 mg daily on days 1 through 21 and dexamethasone 28 mg PO (taken 3 to 24 hr prior to elotuzumab) on days 1, 8, 15, and 22 on cycles 1 and 2 and on days 1 and 15 of subsequent cycles; give dexamethasone 40 mg PO on days 8 and 22 of cycles 3 and beyond. Re- peat treatment cycles q28 days until disease progression Multiple myeloma in patients who have received at least 2 prior ther- apies including lenalidomide and a proteasome inhibitor, in combina- tion with pomalidomide and dexamethasone • Adults: IV 10 mg/kg weekly on cycles 1 and 2 (on days 1, 8, 15, and 22), then 20 mg/kg IV q4wk (on day 1) starting on cycle 3, give in combination with pomalidomide 4 mg PO daily on days 1 through 21 and PO dexamethasone (age 75 yr or less, 28 mg; age over 75 yr, 8 mg) at 3 to 24 hr prior to elotuzumab on days 1, 8, 15, and 22 on cycles 1 and 2 and on day 1 of subsequent cycles, give PO dexamethasone (age 75 yr or less, 40 mg; age over 75 yr, 20 mg) at 3 to 24 hr prior to elotuzumab on days 8, 15, and 22 of cycles 3 and beyond. Repeat treatment cycles q28days until disease pro- gression
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Available forms: Injection 300, 400 mg in single-dose vials
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Administer: IV route • Visually inspect parenteral products for particulate matter and discoloration prior to use • Premedication with acetaminophen PO, an IV/PO H1-blocker (diphenhydra mine), an IV/PO H2-blocker, and IV dexamethasone is required prior to each infusion; hold therapy for grade 2 or higher infusion-related reactions • Do not mix with other drugs or infuse with other drugs through the same IV line • Calculate the appropriate dose and reconstitute (using an 18-gauge or smaller needle) the 300-mg vial with 13 mL of sterile water for injection and the 400-mg vial with 17 mL of sterile water for injection • Following reconstitution, each vial contains overfill to allow for a maximum withdrawal of 12 mL for the 300-mg vial and 16 mL for the 400-mg vial; the final vial concentration is 25 mg/mL • Swirl the solution by rotating the vial; invert the vial a few times to dissolve the powder • The lyophilized powder should dis- solve within 10 min; allow the reconsti- tuted solution to stand for 5 to 10 min after all powder is dissolved • Withdraw the needed amount (mL) from the elotuzumab 25-mg/mL vials; do not exceed a maximum withdrawal of 12 mL for the 300-mg vial and of 16 mL for the 400-mg vial; discard any unused portion • Add the calculated amount of elotu- zumab to an infusion bag made of polyvi- nyl chloride or polyolefin and then add enough 0.9% NaCl for injection or 5% dextrose injection so that the final diluted admixture concentration is between 1 and 6 mg/mL • Do NOT exceed 5 mL/kg of patient weight at any given dose • Storage following dilution: The di- luted admixture may be stored for up to 24 hr when refrigerated 36°F to 46°F (2°C to 8°C) and protected from light; a maximum of 8 hr (of the total 24 hr) may be at room temperature 68°F to 77°F (20°C to 25°C) • Administer the diluted admixture us- ing an infusion set and a sterile, nonpyro- genic, low-protein-binding filter (pore size of 0.2 to 1.2 micrometer); use an automated infusion pump • For the 10-mg/kg dose, give the diluted infusion IV at the appropriate in- fusion rate as follows: Cycle 1, dose 1: start at 0.5 mL/min for 30 min, increase to 1 mL/min for 30 min, then increase to a maximum rate of 2 mL/min Cycle 1, dose 2: start at 3 mL/min for 30 min, then increase to a maximum rate of 4 mL/min Cycle 1, doses 3 and 4, and all subsequent cycles: 5 mL/min; do not exceed this rate • For the 20 mg/kg dose, administer the diluted infusion intravenously at the appropriate infusion rate as follows: Dose 1: Start at 3 mL/min for 30 min, then increase to a maximum rate of 4 mL/min Dose 2 and all subsequent doses: 5 mL/ min; do not exceed this rate • Up titration of the infusion rate may be considered only in the absence of infu- sion reactions • Complete the infusion within 24 hr from reconstitution
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Assess: • Hypersensitivity: Assess for rash, throat tightness, dyspnea, stop infusion immediately • Infections: Assess for fever, flulike symptoms, may be fatal, treat as needed • New primary malignancy: Monitor for new malignancies • Infusion reactions: Assess for infusion reactions: redness, inflammation, burning at site within 24 hr of infusion, chills, fe- ver; stop infusion treat as needed, moni- tor VS • Pregnancy/breastfeeding: Do not use in pregnancy or breastfeeding. Males and females should use contraception if of reproductive potential E
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Evaluate: • Therapeutic response: decreasing symptoms and spread of multiple myeloma
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Patient and caregiver information: • Hypersensitivity: teach patient to report immediately rash, throat tightness, dyspnea • Infections: teach patient to report fe- ver, flulike symptoms, may be fatal • New primary malignancy: teach patient to report any new malignancies • Infusion reactions: teach patient to re- port infusion reactions: redness, inflam- mation, burning at site within 24 hr of in- fusion • Pregnancy/breastfeeding: identify if pregnancy is planned or suspected. Do not use in pregnancy or breastfeeding. Males and females should use contracep- tion if of reproductive potential
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PHARMACOKINETICS Onset, peak, duration unknown; half-life unknown
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• Adults: IV 10 mg/kg weekly on cy- cles 1 and 2 (on days 1, 8, 15, and 22), then q2wk (on days 1 and 15), give in combination with lenalidomide 25 mg daily on days 1 through 21 and dexamethasone 28 mg PO (taken 3 to 24 hr prior to elotuzumab) on days 1, 8, 15, and 22 on cycles 1 and 2 and on days 1 and 15 of subsequent cycles; give dexamethasone 40 mg PO on days 8 and 22 of cycles 3 and beyond. Re- peat treatment cycles q28 days until disease progression Multiple myeloma in patients who have received at least 2 prior ther- apies including lenalidomide and a proteasome inhibitor, in combina- tion with pomalidomide and dexamethasone
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• Adults: IV 10 mg/kg weekly on cycles 1 and 2 (on days 1, 8, 15, and 22), then 20 mg/kg IV q4wk (on day 1) starting on cycle 3, give in combination with pomalidomide 4 mg PO daily on days 1 through 21 and PO dexamethasone (age 75 yr or less, 28 mg; age over 75 yr, 8 mg) at 3 to 24 hr prior to elotuzumab on days 1, 8, 15, and 22 on cycles 1 and 2 and on day 1 of subsequent cycles, give PO dexamethasone (age 75 yr or less, 40 mg; age over 75 yr, 20 mg) at 3 to 24 hr prior to elotuzumab on days 8, 15, and 22 of cycles 3 and beyond. Repeat treatment cycles q28days until disease pro- gression
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