Kymriah Side Effects

Generic name: tisagenlecleucel

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 2, 2023.

Note: This document contains side effect information about tisagenlecleucel. Some dosage forms listed on this page may not apply to the brand name Kymriah.

Applies to tisagenlecleucel: intravenous suspension.

Warning

Intravenous route (Suspension)

Warning: Cytokine release syndrome and neurological toxicitiesCytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving tisagenlecleucel. Do not administer tisagenlecleucel to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.Neurological toxicities, which may be severe or life-threatening, can occur following treatment with tisagenlecleucel, including concurrently with CRS. Monitor for neurological events after treatment with tisagenlecleucel. Provide supportive care as needed.Tisagenlecleucel is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the KYMRIAH REMS.

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:

More common

Agitation
back pain
bleeding gums
bloody urine
blue lips, fingernails, or skin
blurred vision
chest pain, discomfort, or tightness
chills
confusion as to time, place, or person
cough
coughing that sometimes produces a pink frothy sputum
coughing up blood
decreased urine output
depression
difficult, fast, noisy breathing
dilated neck veins
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
dry mouth
fast, pounding, or irregular heartbeat or pulse
fever
general feeling of discomfort or illness
hallucinations
headache
hoarseness
holding false beliefs that cannot be changed by fact
hostility
increase in heart rate
increased blood pressure
increased menstrual flow or vaginal bleeding
increased sweating
irritability
loss of appetite
loss of consciousness
lower back or side pain
mood or mental changes
muscle, joint, or bone pain
nausea
nervousness
nosebleeds
painful or difficult urination
pale skin
pounding in the ears
problems with speech or speaking
prolonged bleeding from cuts
rapid shallow breathing
rapid weight gain
red or black, tarry stools
red or dark brown urine
seeing, hearing, or feeling things that are not there
seizures
shakiness and unsteady walk
slow or fast heartbeat
stiff neck
sunken eyes
swelling of the face, arms, fingers, feet, or lower legs
trembling and shaking of hands
trouble breathing
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
unusual excitement, nervousness, or restlessness
vomiting
weight gain

Less common

Change in the amount of urine
cloudy urine
headache, sudden or severe
stomach pain
tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

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:

More common

Anxiety
decreased appetite
diarrhea
difficulty in moving
joint pain
muscle pain or stiffness
pain in the arms or legs
stuffy nose

For Healthcare Professionals

Applies to tisagenlecleucel: intravenous suspension.

General

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]