linvoseltamab

Contraindicated in:

OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

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

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema, hypertension

Derm: rash

EENT: nasal congestion

F and E: hypophosphatemia

GI: ↓appetite, ↑liver enzymes, constipation, diarrhea, nausea, vomiting, hyperbilirubinemia

GU: ↑serum creatinine

Hemat: anemia, leukopenia, lymphopenia, neutropenia, thrombocytopenia

MS: pain

Neuro: ↓consciousness, encephalopathy, fatigue, headache, IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME (ICANS), insomnia, peripheral neuropathy, confusion, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Resp: cough, dyspnea

Misc: cytokine release syndrome (CRS), fever, hypogammaglobulinemia, INFECTION, INFUSION-RELATED REACTIONS

Interactions ⬆ ⬇

Drug-drug:

May suppress activity of CYP450 drug-metabolizing enzymes (especially within 14 days after 1st dose and during/after onset of cytokine release syndrome); careful monitoring of CYP450 substrates is recommended.

Availability ⬆ ⬇

Solution for injection: 2 mg/mL; 20 mg/mL

Route/Dosage ⬆ ⬇

IV (Adults ): Day 1 (step-up dose 1): 5 mg as a single dose; Day 8 (step-up dose 2): 25 mg as a single dose; Day 15 (1st treatment dose): 200 mg as a single dose; Weekly dosing schedule: 200 mg administered 1 wk after 1st treatment dose and then once weekly from Wk 4 to Wk 13 (total of 10 treatment doses); Biweekly dosing schedule: 200 mg starting at Wk 14 and then every 2 wk. For patients who have achieved and maintained a very good partial response or better at Wk 24 AND have received ≥17 doses of 200 mg, administer 200 mg every 4 wk starting at Wk 24 or after. Continue until disease progression or unacceptable toxicity.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: T-cell engagers, monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

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

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Inform patient that they must be counseled about risk of CRS and neurologic toxicity, including ICANS, and provided with LYNOZYFIC Patient Wallet Card. Advise patient to immediate notify health care provider if signs/symptoms of CRS or neurologic toxicity occur.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Advise patient to refrain from driving or operating heavy or potentially dangerous machinery for 48 hr after each step-up dose and in the event of new onset of any neurological symptoms until resolved.
Advise patient of the risk for neutropenia and serious infections and to immediately notify health care provider if fever, chills, or other signs of infection occur.
Inform patient of risk for hepatotoxicity and to notify health care provider if fatigue, anorexia, right upper abdominal pain, dark urine, or jaundice occur.
Rep: May cause fetal harm. Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Advise women of reproductive potential to use effective contraception and not to breastfeed during therapy and for 3 mo after last dose.

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Indications ⬇

Contraind./Precautions ⬆ ⬇