Linvoseltamab: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: July 22, 2025🚩 Report this page

Linvoseltamab

Other Monoclonal Antibodies and Antibody Drug Conjugates

Sold as Lynozyfic

EU EMA

Drug class: Other Monoclonal Antibodies and Antibody Drug Conjugates
Availability: See label
Markets covered: 1
Products on record: 1

L01FXOther Monoclonal Antibodies and Antibody Drug Conjugates

Overview

Linvoseltamab is an active pharmaceutical ingredient in the Other Monoclonal Antibodies and Antibody Drug Conjugates group (L01FX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	July 22, 2025

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised July 22, 2025[1]

LYNOZYFIC is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.

How to take

Sources & citations

[1]European Medicines Agency · EMEA/H/C/006370 · revised July 22, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Treatment should be initiated and supervised by physicians experienced in the treatment of multiple myeloma. 4). Prior to initiating treatment, complete blood count should be performed. 4). 6). 8). Pretreatment medicinal products should be administered until two full doses are tolerated without CRS and/or IRR.
, 500 to 1000 mg oral) 30 to 60 minutes prior to infusion Subsequent 200 mg doses • If the patient experienced CRS and/or IRR with the prior infusion, repeat pretreatment medicinal products as described above for the 2nd 200 mg dose.
• Once the 200 mg dose is tolerated without CRS and/or IRR: o If the patient received 40 mg dexamethasone IV with the prior infusion, step down to 10 mg dexamethasone IV and continue other pretreatment medicinal products as described above.
o If the patient received 10 mg dexamethasone IV with the prior infusion, discontinue all pretreatment medicinal products. Prophylactic therapy Prophylactic treatment per local institutional guidelines for Pneumocystis jirovecii pneumonia (PJP) and herpes simplex and zoster viruses is recommended for all patients.
4). 4 Recommended posology The recommended step-up treatment doses, full treatment dose, and treatment frequency are presented in Table 2. Each dose should only be administered if the previous dose is tolerated. For doses that are not tolerated, refer to Table 3, Table 4, and Table 5.
All patients should be monitored for signs and symptoms of potential CRS, IRR, and ICANS during administration and for 24 hours after the end of the infusion of the first step‑up treatment dose. 4). 4).
Table 2:
Recommended posology Dosing schedule Daya LYNOZYFIC dose Step-up dosing schedule Week 1 Day 1 Step-up treatment dose 1 5 mg Week 2 Day 1 Step-up treatment dose 2 25 mg Week 3 Day 1 First full treatment dose 200 mg Weekly dosing schedule Week 4 to Week 13 for 10 treatment doses Full treatment doses 200 mg Every 2 weeks dosing schedule Week 14 and every 2 weeks thereafter Full treatment doses 200 mg Patients who have received at least 17 doses of 200 mg and have confirmed response of very good partial response (VGPR) or better per international myeloma working group (IMWG) criteria at or after Week 24b Every 4 weeks dosing schedule At week 24 or after and every 4 weeks thereafter Treatment doses 200 mg a Weekly doses should be at least 5 days apart.
b Patients who have not achieved VGPR or better at Week 24 should continue receiving LYNOZYFIC every 2 weeks. Duration of treatment Treatment should be continued until disease progression or unacceptable toxicity. Management of adverse reactions Table 3 describes the management of CRS.
Table 4 describes the management of ICANS. Table 5 describes the management of other adverse events. 4). Evaluate and treat other causes of fever, hypoxia and hypotension. If CRS is suspected, withhold LYNOZYFIC until CRS resolves. CRS should be managed according to the recommendations in Table 3 and per current practice guidelines.
5 Supportive therapy for CRS should be administered, which may include intensive care for severe or life-threatening CRS.
Table 3:
Recommendations for management of cytokine release syndrome Gradea Presenting symptoms Recommendations Grade 1 Fever ≥ 38 ºCb • Withhold treatment until CRS resolves. • Provide supportive care, which may include intensive care. • Consider anticytokine therapyc and/or corticosteroidsd.
• When restarting treatment, refer to Table 6.
Grade 2 Fever ≥ 38 ºCb with:
Hypotension responsive to fluids and not requiring vasopressors and/or hypoxia requiring low-flow oxygene by nasal cannula or blow-by • Withhold treatment until CRS resolves. • Provide supportive care, which may include intensive care.
• If symptoms do not improve within 4 hours, […]

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised July 22, 2025[1]

Summary of safety profile The most frequent adverse reactions were musculoskeletal pain (52%), cytokine release syndrome (46%), neutropenia (43%), cough (42%), diarrhoea (39%), anaemia (38%), fatigue (36%), pneumonia (32%), and upper respiratory tract infection (30%).
Serious adverse reactions occurred in 75% of patients who received LYNOZYFIC. The most frequent serious adverse reactions were cytokine release syndrome (27%), pneumonia (13%), COVID-19 (7%), and acute kidney injury (5%). 16 Permanent discontinuation of LYNOZYFIC due to adverse reactions occurred in 19% of patients.
7%). 1). Unless otherwise stated, the frequencies of adverse reactions in Table 8 are based on all- cause adverse event frequencies identified in 117 patients exposed to linvoseltamab during a median duration of 53 weeks (range 1, 167) in the clinical study.
Adverse reactions observed during the clinical study are listed below by MedDRA system organ class classification and by frequency. Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000) and not known (frequency cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 9 Psychiatric disorders Insomnia Very common 13 0 Nervous system disorders Encephalopathy (excl. 7 a Pneumonia includes atypical pneumonia, COVID-19 pneumonia, haemophilus infection, influenza, metapneumovirus infection, PJP, pneumonia, pneumonia cytomegaloviral, pneumonia fungal, pneumonia influenzal, and pneumonia viral.
b Upper respiratory tract infection includes acute sinusitis, bronchitis, nasopharyngitis, pharyngitis, respiratory tract infection, rhinitis, rhinovirus infection, sinobronchitis, sinusitis, upper respiratory tract infection, and viral upper respiratory tract infection.
c Urinary tract infection includes cystitis, escherichia urinary tract infection, klebsiella urinary tract infection, urinary tract infection, urinary tract infection bacterial, and urinary tract infection enterococcal, and urinary tract infection staphylococcal.
18 MedDRA System Organ Class Adverse reaction Frequency categories (All grades) Any grade (%) Grade 3 or 4 (%) d Sepsis includes sepsis, septic shock, pseudomonal sepsis, streptococcal sepsis, escherichia sepsis, and haemophilus sepsis.
e CMV infection includes cytomegalovirus infection reactivation, cytomegalovirus infection, and cytomegalovirus viraemia and excludes pneumonia cytomegaloviral. f Encephalopathy includes agitation, amnesia, aphasia, cognitive disorder, confusional state, delirium, depressed level of consciousness, encephalopathy, memory impairment, mental status changes, mood altered, somnolence, toxic encephalopathy, and excludes ICANS.
g Pain includes ear pain, flank pain, groin pain, oropharyngeal pain, pain, and toothache. h Motor dysfunction includes dysarthria, dysphonia, gait disturbance, muscle spasm, muscular weakness, and tremor. i Headache includes headache and migraine.
j ICANS is based on adjudicated ICANS which were reported with the terms ICANS, depressed level of consciousness, encephalopathy, and toxic encephalopathy. k Rash includes dermatitis acneiform, dermatitis contact, drug eruption, erythema, rash, rash erythematous, rash maculo-papular, rash pruritic, and stasis dermatitis.
l Oedema includes face oedema, lip oedema, localised oedema, oedema, and oedema peripheral. m Fatigue includes fatigue, lethargy, and malaise. n Infusion related reactions related to […]

EUOfficial regulatory label· Warnings and precautions· revised July 22, 2025[1]

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). CRS is a condition that may be serious or life-threatening.
Clinical signs and symptoms of CRS included, but were not limited to, pyrexia, chills, hypoxia, tachycardia, and hypotension. Administer pretreatment medicinal products (see Table 1) and initiate therapy according to LYNOZYFIC step-up dosing (see Table 2) to reduce the risk of CRS.
All patients should be monitored for signs and symptoms of CRS during and after infusion. All patients should be counselled to seek immediate medical attention should signs or symptoms of CRS occur. For the first step-up treatment dose of LYNOZYFIC, all patients should be instructed to remain with a caregiver within close proximity of the qualified treatment centre for 24 hours after the end of infusion.
For the second step-up treatment dose and subsequent doses, patients should be instructed to remain with a caregiver within close proximity of the qualified treatment centre for 24 hours after the end of infusion: 13 • For the second step-up treatment dose of LYNOZYFIC if the patient experienced CRS with the first step-up treatment dose • For a subsequent dose if the patient experienced Grade 2 CRS with the prior dose.
Patients that experience a first Grade 3 CRS event at any time should be hospitalised for 24 hours after receiving the next dose. At the first sign of CRS, patients should be immediately evaluated for hospitalisation, managed per current practice guidelines, and supportive care should be administered; LYNOZYFIC should be withheld until CRS resolves and the next dose should be modified or LYNOZYFIC should be permanently discontinued based on severity (see Table 3).
Infusion related reaction (IRR) IRR may be clinically indistinguishable from manifestations of CRS. For IRR, interrupt or slow the rate of infusion or permanently discontinue LYNOZYFIC based on severity of reaction (see Table 5). 8).
Clinical signs and symptoms of ICANS may include but are not limited to aphasia, cerebral oedema, confusion, depressed level of consciousness, disorientation, encephalopathy, and seizure. All patients should be monitored for signs and symptoms of ICANS during treatment.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

EUEuropean Union· EMA

Drugs in the same class

Sources & citations