Kymriah Side Effects
Generic Name: tisagenlecleucel
Medically reviewed by Drugs.com. Last updated on Sep 1, 2020.
Note: This document contains side effect information about tisagenlecleucel. Some of the dosage forms listed on this page may not apply to the brand name Kymriah.
For the Consumer
Applies to tisagenlecleucel: intravenous suspension
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.
Side effects requiring immediate medical attention
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:
- back pain
- blue lips, fingernails, or skin
- blurred vision
- chest pain or discomfort
- confusion as to time, place, or person
- coughing that sometimes produces a pink frothy sputum
- decreased urine output
- difficult, fast, noisy breathing
- dilated neck veins
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- extreme fatigue
- fast, pounding, or irregular heartbeat or pulse
- holding false beliefs that cannot be changed by fact
- increased sweating
- loss of consciousness
- lower back or side pain
- mood or mental changes
- muscle twitching
- painful or difficult urination
- pale skin
- pounding in the ears
- rapid shallow breathing
- rapid weight gain
- slow or fast heartbeat
- stiff neck
- swelling of the face, arms, fingers, feet, or lower legs
- trembling and shaking of hands
- troubled breathing at rest
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusual excitement, nervousness, or restlessness
- weight gain
- Change in the amount of urine
- cloudy urine
- headache, sudden or severe
- stomach pain
Side effects not requiring immediate medical attention
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:
- decreased appetite
- difficulty in moving
- joint pain
- muscle pain or stiffness
- nasal congestion
- pain in the arms or legs
For Healthcare Professionals
Applies to tisagenlecleucel: intravenous suspension
The most common adverse reactions (incidence greater than 30%) are cytokine release syndrome, hypogammaglobulinemia, infections-pathogen unspecified, prolonged neutropenia, pyrexia, decreased appetite, headache, encephalopathy, bleeding episodes, and hypotension.[Ref]
Very common (10% or more): Cytokine release syndrome (79%), hypogammaglobulinemia (43%)
Common (1% to 10%): Graft versus host disease[Ref]
Very common (10% or more): Infections-pathogen unspecified (41%), pyrexia (40%), viral infectious disorders (26%), fatigue (22%), bacterial infectious disorders (19%), fungal infectious disorders (13%), face edema (10%), peripheral edema (10%), chills (10%)
Common (1% to 10%): Multiple organ dysfunction syndrome[Ref]
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]
Very common (10% or more): Decreased appetite (37%), worsening hypokalemia (27%), worsening hypophosphatemia (19%), fluid overload (10%)
Very common (10% or more): Headache (37%), encephalopathy (34%)
Common (1% to 10%): Tremor, intracranial hemorrhage, seizure
Frequency not reported: Disturbances in consciousness, aphasia[Ref]
Very common (10% or more): Hypotension (31%), bleeding episodes (31%), tachycardia (26%), hypertension (19%)
Common (1% to 10%): Abdominal compartment syndrome[Ref]
Very common (10% or more): Delirium (21%), anxiety (13%)
Frequency not reported: Disorientation, confusion, agitation, mutism[Ref]
Very common (10% or more): Pain in extremity (16%), myalgia (15%), arthralgia (12%), back pain (10%)[Ref]
Common (1% to 10%): Increased blood creatinine[Ref]
Very common (10% or more): Increased AST (28%), acute kidney injury (22%), increased ALT (21%), increased bilirubin (21%)[Ref]
1. "Product Information. Kymriah (tisagenlecleucel)." Novartis Pharmaceuticals, East Hanover, NJ.
Frequently asked questions
- What is the cost of Kymriah?
- How is Kymriah administered?
- What type of drug is Kymriah (tisagenlecleucel)?
More about Kymriah (tisagenlecleucel)
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- Drug class: miscellaneous antineoplastics
- FDA Approval History
Related treatment guides
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.