Kymriah Side Effects

Generic name: tisagenlecleucel

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

Note: This document provides detailed information about Kymriah Side Effects associated with tisagenlecleucel. Some dosage forms listed on this page may not apply specifically to the brand name Kymriah.

Applies to tisagenlecleucel: intravenous suspension.

Serious side effects of Kymriah

Along with its needed effects, tisagenlecleucel (the active ingredient contained in Kymriah) 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 Kymriah

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%)

Frequently asked questions

• What is the cost of Kymriah?
• What's the difference between Kymriah and Yescarta?
• What is the survival rate of Kymriah?
• How is Kymriah administered?
• What type of drug is Kymriah (tisagenlecleucel)?

Further information

Kymriah 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