Tisagenlecleucel Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 3, 2024.

Applies to tisagenlecleucel: intravenous suspension.

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 may be needed to check for unwanted effects.

This medicine may cause cytokine release syndrome (CRS) and infusion reactions. This may be life-threatening and requires immediate attention. Tell your doctor right away if you or your child has a fever, chills, headache, nausea, lightheadedness, dizziness, fainting, skin rash, trouble breathing, or tiredness or weakness.

Check with your doctor right away if you or your child have seizures, loss of balance, loss of consciousness, confusion, disorientation, difficulty with speaking, or slurred speech. These may be symptoms of serious nerve problems.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Talk to your doctor right away if you have very fast or irregular breathing, a very fast or irregular heartbeat, a rash, fainting, hive-like swellings on the skin, or swelling of the eyelids or around the eyes, face, lips, or tongue.

This medicine can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you or your child are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may increase your risks for hypogammaglobulinemia (immune system problem) and getting other cancers. Talk to your doctor if you have questions about these risks.

This medicine may cause dizziness, confusion, seizures, or decreased alertness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you, for at least 8 weeks after treatment.

While you are being treated with tisagenlecleucel injection, do not have any immunizations (vaccinations) without your doctor's approval. Live virus vaccinations should not be given for at least 6 weeks before start of treatment, during treatment, and until recovery following the last cycle of this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Serious side effects of tisagenlecleucel

Along with its needed effects, tisagenlecleucel 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 tisagenlecleucel:

Other side effects of tisagenlecleucel

Some side effects of tisagenlecleucel 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:

For healthcare professionals

Applies to tisagenlecleucel: intravenous suspension.

General adverse events

The most common adverse reactions (greater than 20%) were cytokine release syndrome (79%), hypogammaglobulinemia (43%), infections-pathogen unspecified (41%), pyrexia (40%), decreased appetite (37%), headache (37%), encephalopathy (34%), hypotension (31%), bleeding episodes (31%), tachycardia (26%), nausea (26%), diarrhea (26%), vomiting (26%), viral infectious disorders (26%), hypoxia (24%), fatigue (25%), acute kidney injury (24%), edema (21%), cough (21%), and delirium (21%).^[Ref]

Immunologic

• Very common (10% or more): Cytokine release syndrome (79%), Grade 3 and Grade 4 hypofibrinogenemia with Grade 3 and 4 CRS (16%), hypogammaglobulinemia (e.g., hypogammaglobulinemia, immunoglobulins decreased, blood immunoglobulin G decreased, blood immunoglobulin A decreased, blood immunoglobulin M decreased) (43%), infections pathogen unspecified (41%), viral infections (26%), bacterial infections (19%), fungal infections (13%)
• Common (1% to 10%): Graft versus host disease
• Frequency not reported: Immunogenicity^[Ref]

Other

• Very common (10% or more): Pyrexia (40%), increased aspartate aminotransferase (28%), hypokalemia (27%), fatigue/malaise (25%), hypophosphatemia pain (18%)
• Common (1% to 10%): Multiple organ dysfunction syndrome^[Ref]

Hematologic

• Very common (10% or more): Prolonged neutropenia (40%), prolonged thrombocytopenia (27%), hypofibrinogenemia with cytokine release syndrome (16%), increased international normalized ratio (13%)
• Common (1% to 10%): Disseminated intravascular coagulation, histiocytosis lymphocytic hemophagocytosis, coagulopathy
• Frequency not reported: Neutropenia, anemia, thrombocytopenia^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (37%), hypophosphatemia (24%), edema (e.g., face edema, generalized edema, localized edema, edema peripheral) (21%), hypokalemia (12%), hyponatremia (11%), weight loss (11%), fluid overload (10%)
• Common (1% to 10%): Tumor lysis syndrome^[Ref]

Nervous system

• Very common (10% or more): Headache/migraine (37%), encephalopathy (e.g., encephalopathy, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, lethargy, mental status changes, somnolence, automatism) (34%), delirium (e.g., delirium, agitation, hallucination, hallucination visual, irritability, restlessness) (21%), chills (10%)
• Common (1% to 10%): Tremor, dizziness, seizure, speech disorder/aphasia/dysarthria, motor dysfunction^[Ref]

Cardiovascular

• Very common (10% or more): Hypotension (31%), tachycardia/sinus tachycardia (26%)
• Common (1% to 10%): Disseminated intravascular coagulation, cardiac arrest, cardiac failure, capillary leak syndrome, thrombosis^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (26%), diarrhea (26%), vomiting (26%), constipation (18%), abdominal pain (16%)
• Common (1% to 10%): Abdominal compartment syndrome^[Ref]

Respiratory

• Very common (10% or more): Hypoxia (24%), cough (19%), pulmonary edema (16%), tachypnea (12%), pleural effusion (10%), nasal congestion (10%)
• Common (1% to 10%): Respiratory distress, respiratory failure, acute respiratory distress syndrome, oropharyngeal pain^[Ref]

Psychiatric

• Very common (10% or more): Delirium (21%), anxiety (13%), sleep disorders/insomnia/nightmare (10%)
• Frequency not reported: Disorientation, confusion, agitation, mutism^[Ref]

Musculoskeletal

• Very common (10% or more): Myalgia (15%), arthralgia (12%), back pain/pain in extremity (10%)
• Common (1% to 10%): Muscle spasms^[Ref]

Renal

• Common (1% to 10%): Acute kidney injury (24%), increased blood creatinine^[Ref]

Hepatic

• Very common (10% or more): Acute kidney injury (e.g., acute kidney injury, anuria, azotemia, renal failure, renal tubular dysfunction, renal tubular necrosis, blood creatinine increased) (24%), increased alanine aminotransferase (21%), increased bilirubin (21%)^[Ref]

Oncologic

• Frequency not reported: Secondary malignancies/cancer recurrence^[Ref]

Ocular

• Common (1% to 10%): Visual impairment/blurred vision

Dermatologic

• Very common (10% or more): Rash/rash maculopapular/rash papular/rash pruritic (16%)

See also:

Frequently asked questions

• What type of drug is Kymriah (tisagenlecleucel)?

Further information

Tisagenlecleucel 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