elotuzumab

el-oh-TOOZ-ue-mab

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

REMS

Multiple myeloma in patients who have received 1–3 prior therapies (in combination with lenalidomide and dexamethasone).
Multiple myeloma in patients who have received ≥2 prior therapies including lenalidomide and a proteasome inhibitor (in combination with pomalidomide and dexamethasone).

Targets the SLAMF7 protein on tumor cells and Natural Killer cells to facilitate killing of myeloma cells.

Therapeutic effects:

Improved survival and decreased progression of multiple myeloma.

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

(blood levels)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	end of infusion	unknown

Contraindicated in:

OB: Pregnancy (may cause fetal harm) (since must be used with lenalidomide);
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children.

CV: bradycardia, hypertension, tachycardia

EENT: cataracts

F and E: hyperkalemia

GI: ↓appetite, ↓weight, ↑alkaline phosphatase, constipation, diarrhea, hypoalbuminemia, vomiting, HEPATOTOXICITY

Hemat: leukopenia, lymphopenia, thrombocytopenia

MS: pain

Neuro: headache, peripheral neuropathy

Resp: cough

Misc: fatigue, fever, infection, infusion reactions, MALIGNANCY, night sweats

Drug-drug:

None known.

In Combination with Lenalidomide and Dexamethasone

IV (Adults ): 10 mg/kg once weekly (on Days 1, 8, 15, and 22) of Cycles 1 and 2 (each cycle = 28 days; total of 8 doses), then every 2 wk (on Days 1 and 15) of each 28-day cycle; continue until disease progression or unacceptable toxicity.

In Combination with Pomalidomide and Dexamethasone

IV (Adults ): 10 mg/kg once weekly (on Days 1, 8, 15, and 22) of Cycles 1 and 2 (each cycle = 28 days; total of 8 doses), then 20 mg/kg every 4 wk (on Day 1 of each 28-day cycle); continue until disease progression or unacceptable toxicity.

Lyophilized powder for injection (requires reconstitution and dilution): 300 mg/vial; 400 mg/vial

Monitor for signs and symptoms of infusion reactions (fever, chills, hypertension, bradycardia, hypotension, rash, dyspnea, dizziness, light-headedness) frequently during and after infusion. If ≥Grade 2 infusion reaction occurs, interrupt infusion and institute supportive measures. With resolution to ≤Grade 1, restart elotuzumab at 0.5 mL/min and gradually ↑ at 0.5 mL/min every 30 min as tolerated to rate at which reaction occurred. Resume dose escalation if no recurrence of reaction. If reaction occurs, monitor vital signs every 30 min for 2 hr at end of infusion. If infusion reaction recurs, discontinue elotuzumab and do not restart on that day. Severe infusion reactions may require emergency treatment and permanent discontinuation. Follow delays and dose modifications for dexamethasone and lenalidomide as recommended.
Monitor for signs and symptoms of infection (fever, flu-like symptoms, cough, dyspnea, burning with urination, painful skin rash) during and after therapy.
Monitor for development of secondary primary malignancies during and after therapy.

Lab Test Considerations:

Obtain a negative pregnancy test before starting therapy.Monitor liver enzymes periodically during therapy. May cause hypoalbuminemia and ↑ alkaline phosphatase. If elevations ≥Grade 3 liver enzymes occur, discontinue elotuzumab. Consider continuing therapy when liver enzymes return to baseline values.
- May cause lymphopenia, leukopenia, and thrombocytopenia.
- May cause hyperglycemia, hypocalcemia, ↓ bicarbonate, and hyperkalemia.

Administered in combination with lenalidomide or pomalidomide.
Premedication:3–24 hr before elotuzumab infusion, administer 28 mg of dexamethasone PO. 45–90 min prior to elotuzumab administration, administer dexamethasone 8 mg IV, H₁ blocker (diphenhydramine 25–50 mg PO or IV or equivalent), H₂ blocker (famotidine 20 mg IV), and acetaminophen 650–1000 mg PO. If one dose or drug in regimen is delayed, interrupted, or discontinued, treatment with other drugs may continue. If dexamethasone is delayed or discontinued, use clinical judgement regarding risk of hypersensitivity to determine whether to continue.
Dexamethasone: On days elotuzumab is administered, give dexamethasone 28 mg PO 3–24 hr before elotuzumab plus 8 mg IV 45–90 min before elotuzumab. On days elotuzumab not administered but dexamethasone is scheduled (Days 8 and 22 of cycle 3 and all subsequent cycles), give 40 mg PO.
Intermittent Infusion: Reconstitute each 300 mg vial with 13 mL and each 400 mg vial with 17 mL Sterile Water for Injection for a reconstituted volume of 12 mL or 16 mL, respectively and a concentration of 25 mg/mL. Swirl and invert vial to dissolve powder. Should dissolve within 10 min. Do not shake. Once completely dissolved, allow solution to stand for 5–10 min. Solution is colorless to slightly yellow and clear to slightly opalescent. Do not use solutions that are discolored or contain particulate matter. Diluent: Withdraw required volume for dose, up to 16 mL from 400 mg vial and 12 mL from 300 mg vial. Dilute further with 230 mL of 0.9% NaCl or D5W in a polyvinyl chloride or polyolefin IV bag. May adjust volume so as not to exceed 5 mL/kg of patient weight. Solution is stable for 24 hr if refrigerated and protected from light with up to 8 hr at room temperature.
Rate: Infuse through a sterile, nonpyrogenic, low-protein-binding 0.2–1.2 micrometer filter using an automated infusion pump. 10 mg/kg dose: Start rate at 0.5 mL/min. Cycle 1, Dose 1,infuse at a rate of 0.5 mL/min. If no reactions develop, may ↑ rate after 30–60 min to 1 mL/min, and after 60 min to 2 mL/min. Cycle 1, Dose 2,infuse at a rate of 3 mL/min. If no reactions develop, may ↑ rate after 30 min to 4 mL/min. Cycle 1, Dose 3 and 4 and all subsequent cycles, infuse at a rate of 5 mL/min.
20 mg/kg dose
Starting with Cycle 3, infuse 20 mg/kg dose at 3 ml/min every 4 wk. In patients who have increased to 5 mL/min at 10 mg/kg dose, decrease dose to 3 ml/min at first dose of 20 mg/kg, may ↑ rate to 4 ml/min after ≥30 min without infusion reaction. If no reactions, infuse Dose 2 and all further doses at 5 ml/min. In patients who received 4 cycles of elotuzumab, infusion rate may be ↑ to a maximum of 5 mL/min. Complete infusion within 24 hr of reconstitution.
Y-Site Incompatibility: Do not mix with or infuse with other medications.

Inform patient of premedication regimen. Advise patient to read Patient Information prior to first infusion.
Instruct patient to notify health care professional if signs and symptoms of infusion reactions occur within 24 hr of infusion, and if signs and symptoms of infection or liver problems (tiredness, weakness, loss of appetite, yellowing of skin or eyes, color changes in stools, confusion, swelling of stomach area) occur.
Inform patient of risk of developing secondary infections.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Rep: Advise patient that lenalidomide and pomalidomide are teratogenic and have REMS programs for combination of lenolidomide or pomalidomide with elotuzumab (REVLIMID REMS® and POMALYST REMS). Requirements regarding contraception, pregnancy testing, sperm donation, and transmission of sperm must be followed. Advise patient to notify health care professional if pregnancy is planned or suspected and avoid breastfeeding.

Improved survival and decreased progression of multiple myeloma.

Empliciti

NDC Code

0003- E.R. Squibb and Sons, L.L.C.
- 0003-2291- EMPLICITI
  - 0003-2291-11- 1 VIAL, SINGLE-USE in 1 CARTON (0003-2291-11) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

0003- E.R. Squibb and Sons, L.L.C.
- 0003-4522- EMPLICITI
  - 0003-4522-11- 1 VIAL, SINGLE-USE in 1 CARTON (0003-4522-11) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

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