Linvoseltamab Side Effects

Applies to linvoseltamab: intravenous solution.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Call your doctor at once if you have:

• neurological problems--headache, jerking muscle movements, rigid muscles, feeling restless, numbness and tingling, confusion, problems speaking, muscle spasms, tremors, double vision, changes in handwriting, problems walking, muscle weakness in body or face, hearing loss, burning, throbbing, or stabbing pain;

• signs of infection or low white blood cell counts--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding, shortness of breath, chest pain, painful urination, mouth sores, skin sores, cough; or

• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• muscle or bone pain;

• cough with or without mucus;

• nausea, diarrhea;

• tiredness or weakness;

• headache;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• fever, chills, chest pain, feeling short of breath; or

• abnormal blood tests (low white and red blood cell counts).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

See also:

For healthcare professionals

Applies to linvoseltamab: intravenous solution.

General adverse events

The most common adverse reactions in 20% of patients or more included musculoskeletal pain, cytokine release syndrome, cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea. The most common Grade 3 to 4 laboratory abnormalities occurring in 30% of patients or more included decreased lymphocyte count, decreased neutrophil count, decreased hemoglobin, and decreased white blood cell count.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (10%)

Dermatologic

• Very common (10% or more): Rash (15%)

Rash included acneiform dermatitis, contact dermatitis, drug eruption, erythema, erythematous rash, maculo-papular rash, pruritic rash, and stasis dermatitis.

Gastrointestinal

• Very common (10% or more): Diarrhea (35%), nausea (23%), vomiting (19%), constipation (17%)

Hematologic

• Very common (10% or more): Decreased lymphocyte count (97%), decreased hemoglobin (72%), decreased platelet count (64%), decreased white blood cell count (63%), decreased neutrophil count (62%), grade 3 or 4 decreased neutrophil count (47%), neutropenia (29%)
• Common (1% to 10%): Febrile neutropenia

Hepatic

• Very common (10% or more): Increased AST (61%), increased ALT (46%)
• Common (1% to 10%): Grade 3 or 4 total bilirubin elevation

Immunologic

• Very common (10% or more): Cytokine release syndrome (46%), hypogammaglobulinemia (13%)
• Common (1% to 10%): Infusion-related reactions, antidrug antibodies

Metabolic

• Very common (10% or more): Decreased phosphorus (55%), decreased appetite (15%)
• Uncommon (0.1% to 1%): Tumor lysis syndrome

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain (53%)
• Frequency not reported: Motor dysfunction

Nervous system

• Very common (10% or more): Neurologic toxicity (54%), headache (22%), encephalopathy (18%), sensory neuropathy (13%)
• Common (1% to 10%): Immune effector cell-associated neurotoxicity syndrome (ICANS)

Neurologic toxicities included ICANS, depressed level of consciousness, encephalopathy, and toxic encephalopathy.

Encephalopathy included agitation, amnesia, cognitive disorder, confusional state, delirium, depressed level of consciousness, encephalopathy (including hyperammonemic and toxic encephalopathy), irritability, lethargy, memory impairment, mental status changes, somnolence.

Other

• Very common (10% or more): Serious/opportunistic infections (42%), grade 3 or 4 infections (38%), fatigue (34%), edema (19%), pyrexia (17%), sepsis (10%)
• Common (1% to 10%): Fatal infections
• Frequency not reported: Cytomegalovirus infection, progressive multifocal leukoencephalopathy

Psychiatric

• Very common (10% or more): Insomnia (13%)

Renal

• Very common (10% or more): Increased creatinine (47%), urinary tract infections (16%)
• Common (1% to 10%): Acute kidney injury
• Uncommon (0.1% to 1%): Chronic kidney disease

Respiratory

• Very common (10% or more): Cough (39%), upper respiratory tract infection (35%), pneumonia (28%), dyspnea (21%), COVID-19 (17%), nasal congestion (16%)

Pneumonia included the following types: Atypical, COVID-19, Pneumocystis jirovecii, cytomegaloviral, fungal, influenzal, and viral.

Further information

Linvoseltamab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer