elranatamab

High Alert

Relapsed or refractory multiple myeloma in patients who have previously received ≥4 lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Contraindicated in:

OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

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

CV: arrhythmia, edema, HF

Derm: dry skin, rash, skin exfoliation

F and E: hypokalemia

GI: ↑liver enzymes, constipation, diarrhea, hepatotoxicity, hypoalbuminemia, nausea, vomiting, abdominal pain

GU: ↑serum creatinine, acute kidney injury

Hemat: anemia, bleeding, leukopenia, lymphopenia, neutropenia, thrombocytopenia, thrombosis

Local: injection site reactions

Metab: ↓appetite

MS: pain

Neuro: encephalopathy, fatigue, headache, insomnia, motor dysfunction, neuropathy, Guillain-Barré syndrome, IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS)

Resp: cough, dyspnea

Misc: cytokine release syndrome (CRS), fever, hypogammaglobulinemia, infection

Drug-drug:

May suppress activity of CYP450 drug-metabolizing enzymes (especially after first dose on Day 1 and up to 14 days after the 32 mg dose on Day 4 and during/after onset of cytokine release syndrome); careful monitoring of CYP450 substrates is recommended.

Solution for SUBQ injection: 40 mg/mL

SC (Adults ): Day 1 (step-up dose 1): 12 mg as single dose; Day 4 (step-up dose 2): 32 mg as single dose; Day 8 (1st treatment dose): 76 mg as single dose; Weekly dosing schedule: 76 mg administered 1 wk after first treatment dose and then once weekly through Wk 24; Biweekly dosing schedule (for responders only): 76 mg on Wk 25; then every 2 wk thereafter.

Elrexfio

Acts as a T-cell engager, binding to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen expressed on the surface of multiple myeloma cells, resulting in facilitated lysis of malignant cells.

Therapeutic effects:

Slowed progression of multiple myeloma.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies, T-cell engagers

Absorption: 56% absorbed following SUBQ administration.

Distribution: Not widely distributed to tissues.

Metabolism/Excretion: Metabolized into small peptides by catabolic pathways. Excretion pathway unknown.

Half-Life: 22 days.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	7 days	unknown

Explain the purpose and side effects of elranatamab to patient. If an appointment is missed, contact health care professional as soon as possible to reschedule. Advise patient to read Medication Guide before starting and periodically during therapy in case of changes.
REMS: Explain need for continued medical follow-up to assess effectiveness and possible side effects of medication. Teach the patient how to recognize and respond to signs and symptoms of neurologic toxicities, including CRS and ICANS. Advise patient to wear medical ID describing disease process and medication regimen at all times in case of emergencies. Explain and assist completion of the patient wallet card, which should be carried by the patient at all times. More information be found at ELREXFIO REMS (https://www.elrexfiorems.com).
Instruct patient to notify health care professional or call 911 immediately to seek medical care if any signs of neurologic toxicity (headache, tremors and shaking, body weakness, seizures, confusion, delirium, difficulty with speech or writing) or CRS (fever; shaking chills; fast heartbeat; low blood pressure; confusion; muscle or joint pains; headache; dizziness; nausea; vomiting; trouble breathing; wheezing; swelling of face, eyes, lips, or tongue; difficulty swallowing/breathing) occur.
Advise patient to avoid driving or operating heavy or potentially dangerous machinery during and for 48 hr after step-up dosing and with new onset of any neurologic toxicity. Otherwise, caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Advise patient to notify health care professional if signs and symptoms of infusion reactions (fever, chills or shivering, muscle or joint pain, nausea, vomiting, diarrhea, tiredness, dizziness, sweating, hives, itching, shortness of breath, wheezing) occur.
Advise patient to report symptoms of infection and neutropenia (fever, chills, cough, headache, fatigue, weakness, flu-like symptoms, painful or bloody urination, rash, nonhealing wound).
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: May cause fetal harm. Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise patients who may become pregnant to use effective contraception during treatment and for ≥4 mo following the last dose. Elranatamab is associated with hypogammaglobulinemia; therefore, assessment of immunoglobulin levels in newborns of mothers treated with elranatamab should be considered. Advise women not to breastfeed during treatment with elranatamab and for 4 mo after the last dose.

EL-ra-NAT-a-mab

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Indications ⬇

Contraind./Precautions ⬆ ⬇

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Interactions ⬆ ⬇

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US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆