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Tisagenlecleucel infusion

Updated 2 Feb 2023 | Tisagenlecleucel


Infusions of tisagenlecleucel.

Drugs List

  • KYMRIAH dispersion for infusion bag
  • tisagenlecleucel dispersion for infusion bag
  • Therapeutic Indications


    Large B-cell lymphoma
    Leukaemia - acute lymphoblastic

    Paediatric and young adults up to and including 25 years with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.

    Adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.


    Whilst the typical dose stated below is given as recommended by the manufacturer, local cancer network protocols and product literature should also be consulted.


    Pre-treatment (lymphodepleting chemotherapy)
    B-cell ALL 30mg fludarabine per metre squared (intravenous) daily for 4 days and 500mg cyclophosphamide per metre squared (intravenous) daily for 2 days starting with the first dose of fludarabine.
    If Grade 4 haemorrhagic cystitis occurs with cyclophosphamide or demonstrated a chemorefractory state to a cyclophosphamide-containing regimen prior to lymphodepleting chemotherapy, then the following pre-treatment should be used: 500mg cytarabine per metre squared (intravenous) daily for 2 days and 150mg etoposide per metre squared (intravenous) daily for 3 days starting with the first dose of cytarabine.

    DLBCL 25mg fludarabine per metre squared (intravenous) daily for 3 days and 250mg cyclophosphamide per metre squared (intravenous) daily for 3 days starting with the first dose of fludarabine.
    If Grade 4 haemorrhagic cystitis occurs with cyclophosphamide or demonstrated a chemorefractory state to a cyclophosphamide-containing regimen prior to lymphodepleting chemotherapy, then the following pre-treatment should be used: 90mg bendamustine per metre squared (intravenous) daily for 2 days. Lymphodepleting chemotherapy may be omitted if the patient�s white blood cell count is less than or equal to 1000 cells per microlitre within 1 week prior to tisagenlecleucel infusion.

    Pre-medication Paracetamol and diphenhydramine should be administered approximately 30 minutes to 1 hour before tisagenlecleucel infusion.

    Tisagenlecleucel infusion
    B-cell ALL patients Patients 50kg and below: 0.2 to 5 x 10 to the power of 6 CAR-positive viable T cells per kg of bodyweight. Patients above 50kg: 0.1 to 2.5 x 10 to the power of 8 CAR-positive viable T cells. DLBCL patients 0.6 to 6 x 10 to the power of 8 CAR-positive viable T cells.


    Pre-treatment (lymphodepleting chemotherapy)
    B-cell ALL
    (See Dosage; Adult)
    Tisagenlecleucel infusion
    B-cell ALL patients
    Children aged 3 to 18: (See Dosage; Adult)


    Tisagenlecleucel should be prepared according to the manufacturer's instructions and using appropriate precautions. It should then be administered by intravenous infusion centrally. If the volume of tisagenlecleucel is less than or equal to 20mL, intravenous push may be used as an alternative method of administration.
    Tisagenlecleucel is strictly for autologous use only.


    Children under 3 years
    Uncontrolled systemic infection
    Within 4 months of stem cell transplant
    Within 6 weeks of live vaccines
    Hepatitis B
    Hepatitis C
    Positive HIV status
    Severe cardiac disorder
    Severe hypotension
    Severe pulmonary disease

    Precautions and Warnings

    Children under 18 years
    Patients over 65 years
    Restricted sodium intake
    CNS leukaemia or lymphoma

    Before initiating treatment screen all patients for HBV, HCV and HIV
    Consider anti-infective prophylaxis in immunocompromised patients
    Cytokine release syndrome may require immunosuppressive treatment
    Sodium content of formulation may be significant
    Advise patient not to drive/operate machinery for 8 weeks after treatment
    Consider premedication with hypouricaemic agent
    Maintain adequate hydration of patient prior / during treatment
    Not suitable for CD19 -ve patients who relapsed on prior anti-CD19 therapy
    Pre-medicate with antihistamines with or without antipyretics
    Treatment to be initiated and supervised by a specialist
    Contains dimethyl sulfoxide (DMSO)
    Administer by IV infusion over 30 minutes
    Consult local policy on the safe use of anti-cancer drugs
    Emergency equipment must be available
    Febrile neutropenia should be treated with broad spectrum IV antibiotics
    For autologous use only
    Record name and batch number of administered product
    Staff: Not to be handled by pregnant staff
    Exclude pregnancy prior to initiation of treatment
    Monitor for signs of cytokine release syndrome daily, for at least 10 days
    Monitor for signs of neurological toxicity
    Monitor patient for signs of serious infection
    Monitor patients for development of second primary malignancies
    Monitor patients for signs of tumour lysis syndrome
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Antibodies to ingredient may develop
    May lead to false positive HIV test result in non-infected individuals
    Advise patient to seek advice at first indications of pregnancy
    Not licensed for all indications in all age groups
    Female: Ensure adequate contraception during treatment
    Advise patient to avoid donating blood, organs, tissues or cells
    Advise patient to remain near a clinical facility for 4weeks after infusion

    Prophylactic use of systemic steroids may interfere with tisagenlecleucel activity, and as such is not recommended. Gloves and glasses should be worn to avoid the transmission of infectious blood-borne diseases. As tisagenlecleucel is strictly for autologous use only, it must be verified before infusion that the patient's identity matches the identifiers on the cassette label and bag label. Febrile neutropenia may be concurrent with CRS, and should be managed with broad spectrum antibiotics, fluids and other supportive care. Ensure tocilizumab is available for each patient prior to infusing tisagenlecleucel for use in the event of cytokine release syndrome. The treatment centre must have access to additional doses of tocilizumab within 8 hours. The risk/benefit of tisagenlecleucel in patients with active CNS leukaemia and active CNS lymphoma has not been established.

    Pregnancy and Lactation


    Tisagenlecleucel is contraindicated during pregnancy. The manufacturer contraindicates the use of tisagenlecleucel in pregnancy. At the time of writing there is no information regarding the use of tisagenlecleucel during pregnancy. It is not known whether tisagenlecleucel crosses the placenta so the potential to cause foetal toxicity (including B-cell lymphocytopenia) is unknown.


    Use tisagenlecleucel with caution during breastfeeding. The manufacturer states that breastfeeding women should be advised of the potential risk to the breast-fed infant. At the time of writing it is not known if tisagenlecleucel is excreted in human breast milk. The manufacturer states that breastfeeding women should be advised of the potential risk to the breast-fed infant.

    Side Effects

    Abdominal distension
    Abdominal pain
    Abnormal INR
    Acute kidney injury
    Alanine aminotransferase increased
    Aspartate aminotransferase increased
    Back pain
    Bacterial infection
    Capillary leak syndrome
    Cardiac arrest
    Cardiac failure
    Cerebral haemorrhage
    Cerebral infarct
    Changes of blood pressure
    Coagulation disorders
    Compartment syndrome
    Cytokine release syndrome
    Decreased appetite
    Dry mouth
    Electrolyte disturbances
    Febrile neutropenia
    Fluid overload
    Fungal infection
    Graft versus host disease
    Histiocytosis haematophagic
    Increase in alkaline phosphatase
    Increased fibrin
    Increased partial thromboplastin time
    Increased serum ferritin
    Influenza-like symptoms
    Intravascular coagulation (disseminated)
    Mouth haemorrhage
    Multiorgan failure
    Night sweats
    Pain - generalised
    Peripheral neuropathy
    Pleural effusion
    Prothrombin time increased
    Pulmonary infiltration
    Pulmonary oedema
    Reduced lymphocyte count
    Reduced neutrophil count
    Reduced platelet count
    Reduction of fibrinogen
    Serum bilirubin increased
    Sleep disorders
    Speech disturbances
    Tumour lysis syndrome
    Viral infection
    Weight loss
    White blood cell count decreased


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management. The following number will direct the caller to the relevant local centre (0844) 892 0111 Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2020

    Reference Sources

    Summary of Product Characteristics: Kymriah cells dispersion for infusion. Novartis Pharmaceuticals Ltd. Revised March 2020.

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