Linvoseltamab

LYNOZYFIC

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Pronunciation: lin-voe-SEL-ta-mab (lin-oe-ZI-fik)

Linvoseltamab ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Linvoseltamab ballicule

Linvoseltamab LYNOZYFIC mascot mnemonic cartoon — Visual mnemonic: Linvoseltamab mascot
**“Linn votes specifically”**

What it isBCMA×CD3 bispecific T-cell–engaging antibody; relapsed or refractory multiple myeloma.

Why this oneIts intravenous delivery distinguishes it from subcutaneous BCMA bispecifics while remaining off-the-shelf unlike CAR-T.

What limits itCytokine release syndrome and ICANS require step-up dosing and monitoring; hypogammaglobulinemia raises infection risk.

Linvoseltamab molecular structure (skeletal formula) — Molecular structure: Linvoseltamab

FDA-approved for

Relapsed or refractory multiple myeloma (2025)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), can be serious or life-threatening. Initiate with step-up dosing. Available only through the LYNOZYFIC REMS.

FDA dosing	Population	Start	Target	Max
Relapsed or refractory multiple myeloma after >=4 prior lines (incl. proteasome inhibitor, immunomodulatory agent, anti-CD38 mAb); accelerated approval	Adults	Step-up: 5 mg (Day 1), 25 mg (Day 8), then 200 mg (Day 15)	200 mg weekly for 10 doses, then 200 mg every 2 weeks	At/after Week 24, if VGPR or better and >=17 doses of 200 mg: 200 mg every 4 weeks

Renal No clinically significant differences in mild-moderate renal impairment (CrCl 30-89 mL/min); unknown in severe/ESRD

Hepatic No clinically significant differences in mild hepatic impairment; unknown in moderate-severe

See label tables for restarting after dose delays (dependent on last dose and elapsed time)

Instructions

Administer only as an intravenous infusion after dilution in 0.9% sodium chloride
Premedicate (acetaminophen, diphenhydramine, dexamethasone) to reduce CRS/IRR
Hospitalize for 24 hours after each of the two step-up doses
Provide anti-infective prophylaxis (incl. PJP and herpesvirus)

Available strengths

inj 5, 200 mg

Cautions

Cytokine release syndrome (CRS)
Neurologic toxicity, including ICANS
Infections (serious/fatal, including opportunistic; PML reported)
Neutropenia
Hepatotoxicity
Embryo-fetal toxicity

Adverse reactions

Musculoskeletal pain
Cytokine release syndrome
Cough
Upper respiratory tract infection
Diarrhea
Fatigue
Pneumonia
Nausea
Headache
Dyspnea

Pregnancy May cause fetal harm based on mechanism of action; no human data. Can cause B-cell lymphocytopenia in infants exposed in utero.

Lactation No data on presence in human milk; advise not to breastfeed during treatment and for 3 months after last dose.

Cost

Linvoseltamab (LYNOZYFIC)

Strength		#/mo	generic $/unit	CostPlus
5 mg	inj	per unit		not offered
200 mg	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Linvoseltamab is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

⚠ BOXED WARNINGS

Cytokine release syndrome
Neurologic toxicity including ICANS

Classes and tags

Immunomodulators

Clinical profile

Therapeutic safety burden4 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryN/A (post-2015 labeling)

Defining liabilityCytokine release, ICANS and severe infections

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