Skip to main content

Teclistamab Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 25, 2023.

Applies to teclistamab: subcutaneous solution.

Warning

Subcutaneous route (Solution)

Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving teclistamab-cqyv. Initiate treatment with teclistamab-cqyv step-up dosing schedule to reduce risk of CRS. Withhold teclistamab-cqyv until CRS resolves or permanently discontinue based on severity.Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life-threatening reactions, can occur with teclistamab-cqyv. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment. Withhold teclistamab-cqyv until neurologic toxicity resolves or permanently discontinue based on severity. Because of the risk of CRS and neurologic toxicity, including ICANS, teclistamab-cqyv is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TECVAYLI REMS

Serious side effects of Teclistamab

Along with its needed effects, teclistamab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking teclistamab:

More common

Incidence not known

Other side effects of Teclistamab

Some side effects of teclistamab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to teclistamab: subcutaneous solution.

Cardiovascular

-Hemorrhage includes conjunctival hemorrhage, epistaxis, hematoma, hematuria, hemoperitoneum, hemorrhoidal hemorrhage, lower gastrointestinal hemorrhage, melena, mouth hemorrhage, and subdural hematoma.

-Hypertension includes both essential hypertension and hypertension.

-Cardiac arrhythmias include atrial flutter, cardiac arrest, sinus bradycardia, tachycardia, sinus tachycardia, supraventricular tachycardia, and ventricular tachycardia.[Ref]

Very common (10% or more): Hypotension (18%), hemorrhage (12%), hypertension (12%), cardiac arrhythmia (16%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (25%), diarrhea (21%), constipation (18%), vomiting (12%)

Uncommon (0.1% to 1%): Hemoperitoneum[Ref]

General

-The most common adverse reactions with a frequency of 20% or more were pyrexia, cytokine release syndrome, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea.

-The most common life-threatening and fatal laboratory abnormalities with a frequency of 20% or more were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets.[Ref]

Genitourinary

-Urinary tract infection includes cystitis, cystitis Escherichia, cystitis Klebsiella, Escherichia urinary tract infection, urinary tract infection and bacterial urinary tract infection.[Ref]

Very common (10% or more): Urinary tract infection (11%)[Ref]

Hematologic

Very common (10% or more): Decreased lymphocyte count (92%), decreased white blood cell (86%), decreased neutrophil count (84%), decreased platelet count (71%), decreased hemoglobin (67%)

Frequency not reported: Neutropenia[Ref]

-Febrile neutropenia occurred in less than 10% patients using this drug.[Ref]

Hepatic

Frequency not reported: Hepatic failure[Ref]

Immunologic

Very common (10% or more): Cytokine release syndrome (72%), hypogammaglobulinemia (11%)[Ref]

-Hypogammaglobulinemia includes both hypogammaglobulinemia and hypoglobulinemia.[Ref]

Local

Very common (10% or more): Pain (15%), injection site reaction (37%)[Ref]

-Injection site reaction includes application site erythema, injection site bruising, injection site cellulitis, injection site discomfort, injection site erythema, injection site hematoma, injection site induration, injection site inflammation, injection site edema, injection site pruritus, injection site rash, injection site reaction, and injection site swelling.

-Pain includes ear pain, flank pain, groin pain, oropharyngeal pain, pain in jaw, toothache, and tumor pain.[Ref]

Musculoskeletal

Musculoskeletal pain includes arthralgia, back pain, muscle discomfort, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, and pain in the extremities.[Ref]

Very common (10% or more): Musculoskeletal pain (44%), bone pain (16%)[Ref]

Metabolic

Very common (10% or more): Edema (13%), decreased appetite (11%)

Frequency not reported: Hypercalcemia[Ref]

Edema includes peripheral edema and swelling, facial edema, fluid overload, and fluid retention.[Ref]

Other

-Viral infections including adenovirus, hepatitis B virus (HBV), cytomegalovirus (CMV), varicella zoster virus (VZV), and herpes simplex virus (HSV) have been reported in less than 10% of patients using this drug.

-Fatigue includes asthenia and fatigue.[Ref]

Very common (10% or more): Decreased albumin (68%), increased alkaline phosphatase (42%), decreased phosphorus (38%), increased Gamma-glutamyl transferase (37%), decreased sodium (35%), increased aspartate aminotransferase (34%), decreased calcium (31%), increased creatinine (30%), chills (16%), fatigue (33%), pyrexia (76%)

Common (1% to 10%): Sepsis, general physical health deterioration

Frequency not reported: Viral infections[Ref]

Renal

Acute kidney injury includes both acute kidney injury and renal impairment.[Ref]

Very common (10% or more): Acute kidney injury (11%)

Uncommon (0.1% to 1%): Acute renal failure[Ref]

Respiratory

-Pneumonia includes COVID-19 pneumonia, enterobacter pneumonia, lower respiratory tract infection, metapneumovirus pneumonia, pneumocystis jirovecii pneumonia, pneumonia adenoviral, pneumonia klebsiella, pneumonia moraxella, pneumonia pneumococcal, pneumonia pseudomonal, pneumonia respiratory syncytial viral, pneumonia staphylococcal, and pneumonia viral.

-Upper respiratory tract infections include bronchitis, influenza like illness, nasopharyngitis, pharyngitis, respiratory tract infection, bacterial respiratory tract infection, rhinitis, rhinovirus infection, sinusitis, tracheitis, upper respiratory tract infection, and viral upper respiratory tract infection.

-Cough includes allergic cough, productive cough, and upper-airway cough syndrome.[Ref]

Very common (10% or more): Pneumonia 24%, upper respiratory tract infection (26%), hypoxia (18%), cough (15%)

Common (1% to 10%): COVID-19[Ref]

Nervous system

Very common (10% or more): Headache (25%), motor dysfunction (16%), sensory neuropathy (15%), encephalopathy (13%)

Frequency not reported: Immune effector cell-associated neurotoxicity syndrome (ICANS), seizure, Guillain-Barré syndrome[Ref]

-Motor dysfunction includes cogwheel rigidity, dysgraphia, dysphonia, gait disturbance, hypokinesia, muscle rigidity, muscle spasms, muscular weakness, peroneal nerve palsy, psychomotor hyperactivity, tremor and sixth nerve paralysis.

-Sensory neuropathy includes dysesthesia, hypoesthesia, hypoesthesia oral, neuralgia, paresthesia, paresthesia oral, peripheral sensory neuropathy, sciatica and vestibular neuronitis.

-Encephalopathy includes agitation, apathy, aphasia, confusional state, delirium, depressed level of consciousness, disorientation, dyscalculia, hallucination, lethargy, memory impairment, mental status changes and somnolence.[Ref]

Frequently asked questions

References

1. Product Information. Tecvayli (teclistamab). Janssen Biotech, Inc. 2022.

2. Product Information. Tecvayli (teclistamab). Janssen-Cilag Pty Ltd. 2023;3.230113.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.