Teclistamab Side Effects
Medically reviewed by Drugs.com. Last updated on Dec 12, 2023.
Applies to teclistamab: subcutaneous solution.
Important warnings
This medicine can cause some serious health issues
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
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 5 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause cytokine release syndrome (CRS) and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These may be life-threatening and require immediate attention. Tell your doctor right away if you have agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, coma, confusion, double vision, drowsiness, feeling restless, fever, chills, hallucinations, headache, hearing loss, irritability, jerking movements, mood or mental changes, muscle spasms, nausea, lightheadedness, dizziness, fainting, rigid muscles, seizures, skin rash, stiff neck, tremor, trouble breathing, trouble speaking, unusual tiredness or weakness, or vomiting.
Ask your doctor for a patient wallet card. This card will list the symptoms of cytokine release syndrome and nervous system problems. Carry the card with you at all times during treatment. You will need to show the card to any doctor who treats you.
Check with your doctor right away if you have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech. These could be symptoms of a serious nerve problem.
This medicine may cause serious liver problems. Check with your doctor right away if you have clay colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, stomach pain or tenderness, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.
This medicine may cause serious infections. Check with your doctor right away if you have fever or chills, confusion, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have fast heartbeat, fever, itching, swelling of the face, throat, or tongue, or trouble breathing after receiving this medicine.
This medicine may cause dizziness, confusion, or tremors. Do not drive or do anything else that could be dangerous during and for 48 hours after receiving this medicine until you know how this medicine affects you.
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 side effects
- absence of or decrease in body movement
- agitation
- back pain
- being forgetful
- bladder pain
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody eye
- bloody nose
- bloody or cloudy urine
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- body aches or pain
- chest pain, discomfort, or tightness
- chills
- collection of blood under the skin
- coma
- confusion
- confusion as to time, place, or person
- cough
- coughing up blood
- decreased urine output
- deep, dark purple bruise
- depression
- difficult, burning, or painful urination
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- dryness or soreness of the throat
- ear congestion
- fever
- frequent urge to urinate
- hallucinations
- headache
- hoarseness
- holding false beliefs that cannot be changed by fact
- hostility
- increased menstrual flow or vaginal bleeding
- irritability
- itching, pain, redness, or swelling
- loss of voice
- lower back or side pain
- mood or mental changes
- muscle aches, stiffness, spasm, tightness, or twitching
- nausea and vomiting
- nerve pain
- nervousness
- nosebleeds
- pain in the lower back, bottom, hips, or upper leg
- pain or tenderness around the eyes and cheekbones
- paralysis
- pounding in the ears
- pounding or rapid pulse
- problems with speech or speaking
- prolonged bleeding from cuts
- rapid or irregular heartbeat
- red or dark brown urine
- red or black, tarry stools
- seizures
- shakiness in the legs, arms, hands, feet
- slow or fast heartbeat
- sneezing
- sore throat
- stiff neck
- stuffy or runny nose
- stupor
- sweating
- swelling of the face, ankles, or hands
- tender, swollen glands in the neck
- tingling of the hands or feet
- trembling and shaking of the hands
- trouble breathing
- trouble in swallowing
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusual excitement, nervousness, or restlessness
- unusual weight gain or loss
- voice changes
- weight gain
Incidence not known
- burning, throbbing, or stabbing pain
- clay colored stools
- decreased appetite
- double vision
- jerking movements
- loss of appetite
- pale skin
- stomach pain or tenderness
- trouble speaking
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
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 side effects
- bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- constipation
- diarrhea
- difficulty in moving
- joint pain
- lack or loss of strength
- muscle or bone pain
For healthcare professionals
Applies to teclistamab: subcutaneous solution.
General adverse events
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]
Gastrointestinal
- Very common (10% or more): Nausea (25%), diarrhea (21%), constipation (18%), vomiting (12%)
- Uncommon (0.1% to 1%): Hemoperitoneum[Ref]
Cardiovascular
- Very common (10% or more): Hypotension (18%), hemorrhage (12%), hypertension (12%), cardiac arrhythmia (16%)[Ref]
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]
Genitourinary
- Very common (10% or more): Urinary tract infection (11%)[Ref]
Urinary tract infection includes cystitis, cystitis Escherichia, cystitis Klebsiella, Escherichia urinary tract infection, urinary tract infection and bacterial urinary tract infection.[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
- Very common (10% or more): Musculoskeletal pain (44%), bone pain (16%)[Ref]
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]
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
- 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]
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]
Renal
- Very common (10% or more): Acute kidney injury (11%)
- Uncommon (0.1% to 1%): Acute renal failure[Ref]
Acute kidney injury includes both acute kidney injury and renal impairment.[Ref]
Respiratory
- Very common (10% or more): Pneumonia 24%, upper respiratory tract infection (26%), hypoxia (18%), cough (15%)
- Common (1% to 10%): COVID-19[Ref]
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]
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]
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References
1. (2022) "Product Information. Tecvayli (teclistamab)." Janssen Biotech, Inc.
2. (2023) "Product Information. Tecvayli (teclistamab)." Janssen-Cilag Pty Ltd, 3.230113
Frequently asked questions
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Further information
Teclistamab 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.