77% of patients experienced CRS, which was the most common adverse event with KYMRIAH. Although manageable, severe or life-threatening events have been observed.3

In almost all cases, development of CRS occurred between 1 and 10 days after KYMRIAH infusion (median onset, 3 days), with a median time to resolution of 8 days.

The safety profile of KYMRIAH appears more favourable in the real-world setting as seen in the Center for International Blood and Marrow Transplant Research (CIBMTR) Registry3,4

  • CRS has been effectively managed using an established CRS treatment algorithm1
    • A minimum of 1 dose of tocilizumab and emergency equipment must be available per patient prior to infusion
    • The treatment centre must have access to additional doses of tocilizumab within 8 hours


Hypogammaglobulinaemia and agammaglobulinaemia can occur in patients after KYMRIAH infusion.

  • Immunoglobulin levels should be monitored after treatment with KYMRIAH and managed using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement per age and standard guidelines


The majority of neurological events occurred within 8 weeks following KYMRIAH infusion and were transient.

The safety profile of KYMRIAH appears more favourable in the real-world setting as seen in the CIBMTR Registry5


KYMRIAH has a manageable safety profile, providing the option to administer infusions in either an inpatient or outpatient setting1
Adverse drug reactions observed in the ELIANA (ALL, N=79) and JULIET (DLBCL, N=115) trials1
Chart showing Manageable Safety Profile, Percentage of patients (≥10%) with adverse drug reactions in clinical studies Chart showing Manageable Safety Profile, Percentage of patients (≥10%) with adverse drug reactions in clinical studies

aInfections and infestations presented reflect high level group terms.

bHaemorrhage includes anal haemorrhage, blood urine present, catheter site haemorrhage, cerebral haemorrhage, conjunctival haemorrhage, contusion, cystitis haemorrhagic, duodenal ulcer haemorrhage, disseminated intravascular coagulation, epistaxis, eye contusion, gastrointestinal haemorrhage, gingival bleeding, haematochezia, haemarthrosis, haematemesis, haematuria, haemoptysis, large intestinal haemorrhage, melaena, menorrhagia, mouth haemorrhage, peritoneal haematoma, petechiae, pharyngeal haemorrhage, post procedural haemorrhage, pulmonary haemorrhage, purpura, retinal haemorrhage, traumatic haematoma, tumour haemorrhage, upper gastrointestinal haemorrhage and vaginal haemorrhage.

cHypogammaglobulinaemia includes immunoglobulins decreased, blood immunoglobulin A decreased, blood immunoglobulin G decreased, blood immunoglobulin M decreased, immunodeficiency, immunodeficiency common variable and hypogammaglobulinaemia.

dDelirium includes agitation, delirium, hallucination, hallucination visual, irritability and restlessness.

eSleep disorder includes sleep disorder, insomnia and nightmare.

fHeadache includes headache and migraine.

gEncephalopathy includes depressed level of consciousness, mental status changes, automatism, cognitive disorder, confusional state, disturbance in attention, encephalopathy, somnolence, lethargy, memory impairment, metabolic encephalopathy and thinking abnormal.

hDizziness includes dizziness, presyncope and syncope.

iPeripheral neuropathy includes paraesthesia, peripheral sensory neuropathy, neuropathy peripheral, hyperaesthesia and hypoaesthesia.

jTremor includes dyskinesia and tremor.

kMotor dysfunction includes muscle spasms, muscle twitching, myoclonus and myopathy.

lSeizure includes seizure, generalised tonic clonic seizures and status epilepticus.

mSpeech disorders includes speech disorders, dysarthria and aphasia.

nNeuralgia includes neuralgia and sciatica.

oAtaxia includes ataxia and dysmetria.

pVisual impairment includes vision blurred and visual impairment.

qArrhythmia includes atrial fibrillation, supraventricular tachycardia, tachycardia and ventricular extrasystoles.

rCardiac failure includes cardiac failure, left ventricular dysfunction, cardiac failure congestive and right ventricular dysfunction.

sHypotension includes hypotension and orthostatic hypotension.

tThrombosis includes deep vein thrombosis, embolism, pulmonary embolism, thrombosis, vena cava thrombosis and venous thrombosis.

uCough includes cough, productive cough and upper airway cough syndrome.

vDyspnoea includes dyspnoea, dyspnoea exertional, respiratory distress and respiratory failure.

wOropharyngeal pain includes oral pain and oropharyngeal pain.

xPulmonary oedema includes acute pulmonary oedema and pulmonary oedema.

yAbdominal pain includes abdominal pain, abdominal pain upper and abdominal discomfort.

zRash includes dermatitis, dermatitis acneiform, dermatitis contact, rash, rash maculopapular, rash papular and rash pruritic.

aaAcute kidney injury includes acute kidney injury, anuria, azotaemia, blood creatinine abnormal, blood creatinine increased, renal failure, renal tubular dysfunction and renal tubular necrosis.

bbFatigue includes fatigue and malaise.

ccOedema includes oedema peripheral, generalised oedema, localised oedema, face oedema and peripheral swelling.

ddPain includes pain and pain in extremity.

*Frequency is based on laboratory values. Patients are counted only for the worst grade observed post baseline.

As you monitor all patients who were administered KYMRIAH,
please be vigilant for adverse reactions and manage accordingly1
  1. Kymriah Summary of Product Characteristics. Novartis Pharma AG; 2022.
  2. Borchmann P, Tam CS, Jäger U, et al. An updated analysis of JULIET, a global pivotal phase 2 trial of tisagenlecleucel in adult patients with relapsed or refractory diffuse large B-cell lymphoma. Presented at: 23rd Congress of the European Hematology Association (EHA); June 14-17, 2018; Stockholm, Sweden.
  3. Grupp SA, Maude SL, Rives S, et al. Updated analysis of the efficacy and safety of tisagenlecleucel in pediatric and young adult patients with relapsed/refractory acute lymphoblastic leukemia. Presented at: 60th American Society of Hematology Annual Meeting; December 1-4, 2018; San Diego, CA. Abstract 895.
  4. Pasquini M, Hu ZH, Zhang Y, et al. Real world experience of tisagenlecleucel chimeric antigen receptor (CAR) T-cells targeting CD19 in patients with acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL) using the Center for International Blood and Marrow Transplant Research (CIMBTR) Cellular Therapy (CT) Registry. Clinical Lymphoma, Myeloma & Leukemia. S267; 2019. Abstract CT-298.
  5. Grupp S, Hu ZH, Zhang Y, et al. Tisagenlecleucel chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory children and young adults with acute lymphoblastic leukemia (ALL): real world experience from the Center for International Blood & Marrow Transplant Research (CIBMTR) cellular therapy (CT) registry. Presented at: 61st American Society of Hematology Annual Meeting; December 7-10, 2019; Orlando, FL. Abstract 2619.

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