Tisagenlecleucel – Uses, Dosage, Side Effects, Interaction

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 17 min read
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Tisagenlecleucel is a CD19-directed genetically modified autologous T cell immunotherapy or a CAR-T cell therapy for B-cell acute lymphoblastic leukemia. It was granted approval by FDA in August 2017 under the market name Kymriah. Tisagenlecleucel is an immune cellular therapy that involves autologous T cells...

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বাংলা রোগী নোট এখনো যোগ করা হয়নি। পোস্ট এডিটরে “RX Bangla Patient Mode” বক্স থেকে সহজ বাংলা সারাংশ যোগ করুন।

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Article Summary

Tisagenlecleucel is a CD19-directed genetically modified autologous T cell immunotherapy or a CAR-T cell therapy for B-cell acute lymphoblastic leukemia. It was granted approval by FDA in August 2017 under the market name Kymriah. Tisagenlecleucel is an immune cellular therapy that involves autologous T cells that are collected from each individual patient and genetically engineered to express a specific protein called a chimeric antigen receptor...

Key Takeaways

  • This article explains Mechanism of action in simple medical language.
  • This article explains Indications in simple medical language.
  • This article explains Contraindications in simple medical language.
  • This article explains Dosage in simple medical language.
Educational health guideWritten for patient understanding and clinical awareness.
Reviewed content workflowUse writer and reviewer profiles for stronger trust.
Emergency safety firstUrgent warning signs are highlighted below.

Seek urgent medical care if you notice

These warning signs are general safety guidance. Local emergency numbers and clinical judgment should always come first.

  • Severe symptoms, breathing difficulty, fainting, confusion, or rapidly worsening illness.
  • New weakness, severe pain, high fever, or symptoms after a serious injury.
  • Any symptom that feels urgent, unusual, or unsafe for the patient.
1

Emergency now

Use emergency care for severe, sudden, rapidly worsening, or life-threatening symptoms.

2

See a doctor

Book a professional medical evaluation if symptoms persist, worsen, recur often, affect daily activities, or occur in a high-risk patient.

3

Learn safely

Use this article to understand possible causes, tests, treatment options, prevention, and questions to ask your clinician.

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Definition

Tisagenlecleucel is a CD19-directed genetically modified autologous T cell immunotherapy or a CAR-T cell therapy for B-cell acute lymphoblastic leukemia. It was granted approval by FDA in August 2017 under the market name Kymriah. Tisagenlecleucel is an immune cellular therapy that involves autologous T cells that are collected from each individual patient and genetically engineered to express a specific protein called a chimeric antigen receptor (CAR) that specifically targets CD19 antigens. Modified T cells are infused back into the patient’s body. These CD19-directed chimeric antigen receptors (CD19 CAR-T cells) direct the T cells to target and kill leukemia cells that express CD19 on the cell surface.

In a multicenter clinical trial involving pediatric and young adult patients with relapsed or refractory B-cell precursor ALL, the overall remission rate within three months of treatment was 83 percent.[rx]

Mechanism of action

Tisagenlecleucel is a CD19-directed genetically modified autologous T cell immunotherapy that involves genetically modified autologous T cells isolated from each individual patient. The reprogramming of the patient’s T cells uses a lentiviral vector to encode an anti-CD19 chimeric antigen receptor (CAR). The CAR is comprised of a murine single-chain antibody fragment (scFv) specific for CD19, followed by a CD8 hinge and transmembrane region that is fused to the intracellular signaling domains from 4-1BB (CD137) and CD3 zeta.[rx] These intracellular costimulatory signaling domains increase the expansion, longer-term persistence, and potency of CAR T cells[rx]; the CD3 zeta component is critical for initiating T-cell activation and antitumor activity, while 4-1BB enhances the expansion and persistence of tisagenlecleucel.rx] Upon binding to CD19-expressing cells, the CAR transmits a signal to promote T-cell expansion, activation, target cell elimination, and persistence of the tisagenlecleucel cells.[rx]

Tisagenlecleucel demonstrates efficacy in re-inducing remission in patients with refractory B-cell precursor acute lymphoblastic leukemia. The sole purpose of the therapy is to eliminate CD19-expressing malignant and normal cells with specificity and an increased chance of remission.

Indications

  • Tisagenlecleucel is indicated for use in individuals aged 25 years and younger with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
  • It is also used to treat adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
  • Tisagenlecleucel is also indicated in adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.[rx]
  • For adult patients with relapsed or refractory (r/r) large B-cell lymphoma after 2 or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma (NOTE: This drug not indicated for the treatment of patients with primary central nervous system lymphoma).
  • Tisagenlecleucel is indicated for the treatment of those under 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse; or adults with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.[rx][rx]
  • Refractory Diffuse Large B Cell Lymphoma (DLBCL)
  • Refractory Follicular Lymphoma
  • Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
  • Relapsed Follicular Lymphoma
  • Refractory B-cell precursor acute lymphoblastic leukemia
  • Relapsed B cell precursor Acute lymphoblastic leukemia
  • Tisagenlecleucel is a CAR T cell therapy for relapsed or refractory large B-cell lymphoma and diffuses large B-cell lymphoma.

In May 2022, the indication in the US was updated to include the treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Use in Cancer

Tisagenlecleucel is approved to treat:

Tisagenlecleucel is only available as part of a special program called Kymriah REMS (Risk Evaluation and Mitigation StrategiesExit Disclaimer).

This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, a confirmatory trial(s) must show that tisagenlecleucel provides a clinical benefit in these patients. Tisagenlecleucel is also being studied in the treatment of other types of cancer.

Contraindications

  • a bad infection
  • pregnancy
  • resolved hepatitis B
  • reactivation of hepatitis B infection

Dosage

Strength: See Drug Leveling

Acute Lymphoblastic Leukemia

Prior to infusing this drug:

  • Lymphodepleting chemotherapy: Fludarabine (30 mg/m2 IV daily for 4 days) and cyclophosphamide (500 mg/m2 IV daily for 2 days starting with the first dose of fludarabine); infuse tisagenlecleucel 2 to 14 days after completion of the lymphodepletion chemotherapy.

Tisagenlecleucel:
Up to 25 years:

  • Body weight 50 kg or less: 0.2 to 5 x 10(6) chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight
  • Body weight above 50 kg: 0.1 to 2.5 x 10(8) CAR-positive viable T cells
  • Base the dosage on the patient’s weight at the time of leukapheresis.
  • Administer this drug via IV infusion within 30 minutes of thawing at 10 to 20 mL per minute (adjusted as appropriate for smaller children and smaller volumes); the infusion bag volume ranges from 10 to 50 mL.
  • Pre-medicate patients with acetaminophen and diphenhydramine or another H1-antihistamine approximately 30 to 60 minutes prior to infusion of this drug; avoid using corticosteroids at any time except in the case of a life-threatening emergency.
  • For patients up to 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

Lymphoma

Prior to infusing this drug:

  • Lymphodepleting chemotherapy: Fludarabine (25 mg/m2 IV daily for 3 days) and cyclophosphamide (250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine)
  • Alternate lymphodepleting chemotherapy: Bendamustine 90 mg/m2 IV daily for 2 days if a patient experienced a previous Grade 4 hemorrhagic cystitis with cyclophosphamide or demonstrates resistance to a previous cyclophosphamide containing regimen; infuse tisagenlecleucel 2 to 11 days after completion of the lymphodepleting chemotherapy.
  • Lymphodepleting chemotherapy may be omitted if a patient’s white blood cell (WBC) count is less than or equal to 1 x 10(9)/L within 1 week prior to tisagenlecleucel infusion.
  • Dose: 0.6 to 6 x 10(8) CAR-positive viable T cells

Pediatric Dose

Acute Lymphoblastic Leukemia

Prior to infusing this drug:
Lymphodepleting chemotherapy: Fludarabine (30 mg/m2 IV daily for 4 days) and cyclophosphamide (500 mg/m2 IV daily for 2 days starting with the first dose of fludarabine); infuse tisagenlecleucel 2 to 14 days after completion of the lymphodepletion chemotherapy.

Up to 25 years:

  • Body weight 50 kg or less: 0.2 to 5 x 10(6) chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight
  • Body weight above 50 kg: 0.1 to 2.5 x 10(8) CAR-positive viable T cells
  • Base the dosage on the patient’s weight at the time of leukapheresis.
  • Administer this drug via IV infusion within 30 minutes of thawing at 10 to 20 mL per minute (adjusted as appropriate for smaller children and smaller volumes); the infusion bag volume ranges from 10 to 50 mL.
  • Pre-medicate patients with acetaminophen and diphenhydramine or another H1-antihistamine approximately 30 to 60 minutes prior to infusion of this drug; avoid using corticosteroids at any time except in the case of a life-threatening emergency.
  • For patients up to 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse

Dose Adjustments

MANAGEMENT OF CYTOKINE RELEASE SYNDROME (CRS): Identify CRS based on clinical presentation; evaluate and treat other causes of fever, hypoxia, and hypotension.
If CRS is Suspected, Treat Based on CRS Severity:

  • Prodromal Syndrome (low-grade fever, fatigue, anorexia): Observe in person; exclude infection; administer antibiotics per local guidelines if neutropenic; provide symptomatic support.
  • Overt CRS (one or more of the following: high fever, hypoxia, mild hypotension): Administer antipyretics, oxygen, IV fluids, and/or low-dose vasopressors as needed.

Severe or Life-Threatening CRS (one or more of the following: hemodynamic instability despite IV fluids and vasopressor support; worsening respiratory distress including pulmonary infiltrates, increasing oxygen requirement including high-flow oxygen and/or need for mechanical ventilation; rapid clinical deterioration):

  • Administer high doses or multiple vasopressors, oxygen, mechanical ventilation, and/or other supportive care as needed.
  • Administer tocilizumab: 12 mg/kg IV over 1 hour (if the patient weighs less than 30 kg) OR 8 mg/kg IV over 1 hour (maximum dose: 800 mg; if the patient weighs 30 kg or greater).

Resistant CRS (no clinical improvement in 12 to 18 hours, or worsening at any time despite prior management):

  • Administer multiple vasopressors, oxygen, mechanical ventilation, and/or other supportive care as needed.
  • Administer methylprednisolone 2 mg/kg as an initial dose, then 2 mg/kg per day until vasopressors and high-flow oxygen are no longer needed, then taper quickly.
  • If no response to steroids within 24 hours, repeat the administration of tocilizumab at 12 mg/kg IV over 1 hour (if the patient weighs less than 30 kg) OR 8 mg/kg IV over 1 hour (maximum dose: 800 mg; if the patient weighs 30 kg or greater).
  • If no response to the second dose of tocilizumab within 24 hours, consider a third dose of tocilizumab or pursue alternative measures for CRS treatment.

Administration Advice:

  • Delay the infusion of this drug if a patient has unresolved serious adverse reactions (e.g., pulmonary reactions, cardiac reactions, hypotension) from preceding chemotherapies, active uncontrolled infection, active graft versus host disease (GVHD), or worsening of leukemia burden following lymphodepleting chemotherapy.
  • Do not wash, spin down, and/or re-suspend this drug in new media prior to infusion.
  • Consult the manufacturer’s product information for additional administration instructions.

Side Effects

The Most Common

  • constipation
  • stomach pain
  • back pain
  • nasal congestion
  • decreased appetite
  • weight loss
  • unusual bleeding or bruising, blood in urine, red or tarry black bowel movements, vomiting blood or material that looks like coffee grounds
  • fever, chills, or other signs of infection
  • weakness, feeling tired, or shortness of breath
  • decreased urination frequency or amount
  • swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
  • difficulty swallowing
  • rash
  • hives
  • itching

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

Rare

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

Drug Interaction

Pregnancy and Lactation

US FDA pregnancy category: Not assigned.

Pregnancy

There are no available data on KYMRIAH use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with KYMRIAH to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if KYMRIAH has the potential to be transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia. Therefore, KYMRIAH is not recommended for women who are pregnant, and pregnancy after KYMRIAH administration should be discussed with the treating physician. Report pregnancies to Novartis Pharmaceuticals Corporation at 1-888-669-6682. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically
recognized pregnancies are 2% to 4% and 15% to 20%, respectively.

Lactation

There is no information regarding the presence of KYMRIAH in human milk, the effect on the breastfed infant, or the effects on milk production. A risk to the breastfed infant cannot be excluded. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for KYMRIAH and any potential adverse effects on the breastfed infant from KYMRIAH or from the underlying maternal condition.

Why is this medication prescribed?

Tisagenlecleucel injection is used to treat certain acute lymphoblastic leukemia (ALL; also called acute lymphoblastic leukemia and acute lymphatic leukemia; a type of cancer that begins in the white blood cells) in people 25 years of age or younger that has returned or is unresponsive to other treatment(s). It is also used to treat a certain type of non-Hodgkin’s lymphoma (a type of cancer that begins in a type of white blood cells that normally fights infection) and follicular lymphoma (FL; slow-growing cancer that begins in the white blood cells) in adults that has returned or is unresponsive after treatment with at least two other medications. Tisagenlecleucel injection is in a class of medications called autologous cellular immunotherapy, a type of medication prepared using cells from the patient’s own blood. It works by causing the body’s immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells, and other substances that cause disease) to fight the cancer cells.

How should this medicine be used?

Tisagenlecleucel injection comes as a suspension (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a doctor’s office or infusion center. It is usually given over a period of up to 60 minutes as a one-time dose. Before you receive your tisagenlecleucel dose, your doctor or nurse will administer other chemotherapy medications to prepare your body for tisagenlecleucel.

About 3 to 4 weeks before your dose of tisagenlecleucel injection is to be given, a sample of your white blood cells will be taken at a cell collection center using a procedure called leukapheresis (a process that removes white blood cells from the body). This procedure will take about 3 to 6 hours and may need to be repeated. Because this medication is made from your own cells, it must be given only to you. It is important to be on time and to not miss your scheduled cell collection appointment(s) or to receive your treatment dose. You should plan to stay within 2 hours of the location where you received your tisagenlecleucel treatment for at least 4 weeks after your dose. Your healthcare provider will check to see if your treatment is working and monitor you for any possible side effects. Talk to your doctor about how to prepare for leukapheresis and what to expect during and after the procedure.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before receiving tisagenlecleucel injection

  • tell your doctor and pharmacist if you are allergic to tisagenlecleucel, any other medications, dimethyl sulfoxide (DMSO), dextran 40, or any other ingredients in tisagenlecleucel injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: steroids such as dexamethasone, methylprednisolone (Medrol), prednisolone, and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have ever had reactions from previous chemotherapy treatments such as breathing problems or irregular heartbeat. Also, tell your doctor if you have or have ever had hepatitis B or C (a virus that infects the liver and may cause severe liver damage), human immunodeficiency virus (HIV), lung, kidney, heart, or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You will need to have a pregnancy test before you start tisagenlecleucel treatment. If you become pregnant while receiving tisagenlecleucel injection, call your doctor immediately. Tisagenlecleucel injection may cause fetal harm.
  • you should know that tisagenlecleucel injection may make you drowsy and cause confusion, weakness, dizziness, and seizures. Do not drive a car or operate machinery for at least 8 weeks after your tisagenlecleucel dose.
  • do not donate blood, organs, tissues, sperm, or cells for transplantation after you receive tisagenlecleucel injection.
  • check with your doctor to see if you need to receive any vaccinations. Do not have any vaccinations without talking to your doctor for at least 6 weeks before starting chemotherapy, during your tisagenlecleucel treatment, and until your doctor tells you that your immune system has recovered.
Doctor visit helper

Prepare before seeing a doctor

A simple rural-patient checklist to help you explain symptoms clearly, ask better questions, and avoid unsafe self-treatment.

Safety note: This is not a prescription or diagnosis. For severe symptoms, pregnancy danger signs, children with serious illness, chest pain, breathing difficulty, stroke-like weakness, or major injury, seek urgent care.

Which doctor may help?

Start with a registered doctor or the nearest qualified health center.

What to tell the doctor

  • Write when the problem started and how it changed.
  • Bring old prescriptions, investigation reports, and current medicines.
  • Write allergies, pregnancy status, diabetes, kidney/liver disease, and major past illnesses.
  • Bring one family member if the patient is weak, elderly, confused, or a child.

Questions to ask

  • What is the most likely cause of my symptoms?
  • Which danger signs mean I should go to hospital quickly?
  • Which tests are necessary now, and which can wait?
  • How should I take medicines safely and what side effects should I watch for?
  • When should I come for follow-up?

Tests to discuss

  • Vital signs: temperature, pulse, blood pressure, oxygen saturation
  • Basic physical examination by a clinician
  • CBC, urine test, blood sugar, or imaging only when clinically needed

Avoid these mistakes

  • Do not use antibiotics, steroid tablets/injections, or strong painkillers without proper medical advice.
  • Do not hide pregnancy, kidney disease, ulcer, allergy, or blood thinner use.
  • Do not delay emergency care when danger signs are present.

Medicine safety and first-aid guide

This section is for patient education only. It does not replace a doctor, pharmacist, or emergency care.

Safe first steps

  • Avoid heavy lifting, sudden bending, and prolonged bed rest.
  • Use comfortable posture and gentle movement as tolerated.
  • Discuss physiotherapy, X-ray, or MRI only when clinically needed.

OTC medicine safety

  • For mild back pain, pain-relief medicine may be discussed with a doctor or pharmacist.
  • Avoid repeated painkiller use if you have kidney disease, stomach ulcer, uncontrolled blood pressure, or are taking blood thinners.

Avoid these mistakes

  • Do not start antibiotics without a proper medical decision.
  • Do not use steroid tablets or injections casually for quick relief.
  • Do not delay emergency care because of home remedies.

Get urgent help if

  • Back pain with leg weakness, numbness around private area, loss of urine/stool control, fever, cancer history, or major injury needs urgent care.
Medicine names, dose, and timing must be decided by a qualified clinician or pharmacist after checking age, pregnancy, allergy, other diseases, and current medicines.

For rural patients and family caregivers

Patient health record and symptom diary

Write your symptoms, medicines already taken, test results, and questions before visiting a doctor. This note stays on your device unless you print or copy it.

Doctor to discuss: Orthopedic / spine specialist, physical medicine doctor, or qualified clinician
Tests to discuss with doctor
  • Neurological examination for leg power, sensation, reflexes, and straight leg raise
  • X-ray only if injury, deformity, long-lasting pain, or doctor suspects bone problem
  • MRI discussion if severe nerve symptoms, weakness, bladder/bowel problem, or persistent symptoms
Questions to ask
  • What is the most likely cause of my symptoms?
  • Which warning signs mean I should go to emergency care?
  • Which tests are really needed now?
  • Which medicines are safe for my age, pregnancy status, allergy, kidney/liver/stomach condition, and current medicines?
  • Is physiotherapy, posture correction, or activity modification needed?

Emergency warning signs such as chest pain, severe breathing difficulty, sudden weakness, confusion, severe dehydration, major injury, or loss of bladder/bowel control need urgent medical care. Do not wait for online information.

Safe pathway to proper treatment

Care roadmap for: Tisagenlecleucel – Uses, Dosage, Side Effects, Interaction

Use this simple roadmap to understand the next safe steps. It is educational and does not replace examination by a doctor.

Go to emergency care if you notice:
  • Severe or rapidly worsening symptoms
  • Breathing difficulty, chest pain, fainting, confusion, severe weakness, major injury, or severe dehydration
Doctor / service to discuss: Qualified healthcare provider; specialist depends on symptoms and examination.
  1. Step 1

    Check danger signs first

    If danger signs are present, seek emergency care and do not wait for online information.

  2. Step 2

    Record the symptom story

    Write when symptoms started, severity, medicines already taken, allergies, pregnancy status, and test results.

  3. Step 3

    Visit a qualified clinician

    A doctor, nurse, or qualified healthcare provider can examine you and decide which tests or treatment are needed.

  4. Step 4

    Do only useful tests

    Do tests after clinical assessment. Avoid unnecessary tests, random antibiotics, or repeated medicines without diagnosis.

  5. Step 5

    Follow up and return early if worse

    If symptoms worsen, new warning signs appear, or treatment is not helping, return for review quickly.

Rural patient practical tips
  • Take a written symptom diary and all previous prescriptions/test reports.
  • Do not hide medicines already taken, even herbal or over-the-counter medicines.
  • Ask which warning signs mean urgent referral to hospital.

This roadmap is for education. A real diagnosis and treatment plan requires history, examination, and clinical judgment.

RX Patient Help

Ask a health question safely

Write your symptom story. A health professional or site editor can review it before any answer is prepared. This box is not for emergency care.

Emergency first: Severe chest pain, breathing trouble, unconsciousness, stroke signs, severe injury, heavy bleeding, or rapidly worsening symptoms need urgent local medical care now.

Frequently Asked Questions

Mechanism of action Tisagenlecleucel is a CD19-directed genetically modified autologous T cell immunotherapy that involves genetically modified autologous T cells isolated from each individual patient. The reprogramming of the patient's T cells uses a lentiviral vector to encode an anti-CD19 chimeric antigen receptor (CAR). The CAR is comprised of a murine single-chain antibody fragment (scFv) specific for CD19, followed by a CD8 hinge and transmembrane region that is fused to the intracellular signaling domains from 4-1BB (CD137) and CD3 zeta.[rx] These intracellular costimulatory signaling domains increase the expansion, longer-term persistence, and potency of CAR T cells[rx]; the CD3 zeta component is critical for initiating T-cell activation and antitumor activity, while 4-1BB enhances the expansion and persistence of tisagenlecleucel.rx] Upon binding to CD19-expressing cells, the CAR transmits a signal to promote T-cell expansion, activation, target cell elimination, and persistence of the tisagenlecleucel cells.[rx] Tisagenlecleucel demonstrates efficacy in re-inducing remission in patients with refractory B-cell precursor acute lymphoblastic leukemia. The sole purpose of the therapy is to eliminate CD19-expressing malignant and normal cells with specificity and an increased chance of remission. Indications Tisagenlecleucel is indicated for use in individuals aged 25 years and younger with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. It is also used to treat adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Tisagenlecleucel is also indicated in adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.[rx] For adult patients with relapsed or refractory (r/r) large B-cell lymphoma after 2 or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma (NOTE: This drug not indicated for the treatment of patients with primary central nervous system lymphoma). Tisagenlecleucel is indicated for the treatment of those under 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse; or adults with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.[rx][rx] Refractory Diffuse Large B Cell Lymphoma (DLBCL) Refractory Follicular Lymphoma Relapsed Diffuse Large B-cell Lymphoma (DLBCL) Relapsed Follicular Lymphoma Refractory B-cell precursor acute lymphoblastic leukemia Relapsed B cell precursor Acute lymphoblastic leukemia Tisagenlecleucel is a CAR T cell therapy for relapsed or refractory large B-cell lymphoma and diffuses large B-cell lymphoma. In May 2022, the indication in the US was updated to include the treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Use in Cancer Tisagenlecleucel is approved to treat: B-cell acute lymphoblastic leukemia. It is used in children and adults up to 25 years old whose disease is refractory (does not respond to treatment) or has relapsed two or more times. B-cell non-Hodgkin lymphoma (NHL), including the following types: Diffuse large B-cell lymphoma (DLBCL). DLBCL in patients who had follicular lymphoma. High-grade B-cell lymphoma. Follicular lymphoma.¹ It is used in adults whose disease has relapsed or has not gotten better after at least two other types of systemic treatment. Tisagenlecleucel is only available as part of a special program called Kymriah REMS (Risk Evaluation and Mitigation StrategiesExit Disclaimer). This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, a confirmatory trial(s) must show that tisagenlecleucel provides a clinical benefit in these patients. Tisagenlecleucel is also being studied in the treatment of other types of cancer. Contraindications a bad infection pregnancy resolved hepatitis B reactivation of hepatitis B infection Dosage Strength: See Drug Leveling Acute Lymphoblastic Leukemia Prior to infusing this drug: Lymphodepleting chemotherapy: Fludarabine (30 mg/m2 IV daily for 4 days) and cyclophosphamide (500 mg/m2 IV daily for 2 days starting with the first dose of fludarabine); infuse tisagenlecleucel 2 to 14 days after completion of the lymphodepletion chemotherapy. Tisagenlecleucel: Up to 25 years: Body weight 50 kg or less: 0.2 to 5 x 10(6) chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight Body weight above 50 kg: 0.1 to 2.5 x 10(8) CAR-positive viable T cells Base the dosage on the patient's weight at the time of leukapheresis. Administer this drug via IV infusion within 30 minutes of thawing at 10 to 20 mL per minute (adjusted as appropriate for smaller children and smaller volumes); the infusion bag volume ranges from 10 to 50 mL. Pre-medicate patients with acetaminophen and diphenhydramine or another H1-antihistamine approximately 30 to 60 minutes prior to infusion of this drug; avoid using corticosteroids at any time except in the case of a life-threatening emergency. For patients up to 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Lymphoma Prior to infusing this drug: Lymphodepleting chemotherapy: Fludarabine (25 mg/m2 IV daily for 3 days) and cyclophosphamide (250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine) Alternate lymphodepleting chemotherapy: Bendamustine 90 mg/m2 IV daily for 2 days if a patient experienced a previous Grade 4 hemorrhagic cystitis with cyclophosphamide or demonstrates resistance to a previous cyclophosphamide containing regimen; infuse tisagenlecleucel 2 to 11 days after completion of the lymphodepleting chemotherapy. Lymphodepleting chemotherapy may be omitted if a patient's white blood cell (WBC) count is less than or equal to 1 x 10(9)/L within 1 week prior to tisagenlecleucel infusion. Dose: 0.6 to 6 x 10(8) CAR-positive viable T cells Pediatric Dose Acute Lymphoblastic Leukemia Prior to infusing this drug: Lymphodepleting chemotherapy: Fludarabine (30 mg/m2 IV daily for 4 days) and cyclophosphamide (500 mg/m2 IV daily for 2 days starting with the first dose of fludarabine); infuse tisagenlecleucel 2 to 14 days after completion of the lymphodepletion chemotherapy. Up to 25 years: Body weight 50 kg or less: 0.2 to 5 x 10(6) chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight Body weight above 50 kg: 0.1 to 2.5 x 10(8) CAR-positive viable T cells Base the dosage on the patient's weight at the time of leukapheresis. Administer this drug via IV infusion within 30 minutes of thawing at 10 to 20 mL per minute (adjusted as appropriate for smaller children and smaller volumes); the infusion bag volume ranges from 10 to 50 mL. Pre-medicate patients with acetaminophen and diphenhydramine or another H1-antihistamine approximately 30 to 60 minutes prior to infusion of this drug; avoid using corticosteroids at any time except in the case of a life-threatening emergency. For patients up to 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse Dose Adjustments MANAGEMENT OF CYTOKINE RELEASE SYNDROME (CRS): Identify CRS based on clinical presentation; evaluate and treat other causes of fever, hypoxia, and hypotension. If CRS is Suspected, Treat Based on CRS Severity: Prodromal Syndrome (low-grade fever, fatigue, anorexia): Observe in person; exclude infection; administer antibiotics per local guidelines if neutropenic; provide symptomatic support. Overt CRS (one or more of the following: high fever, hypoxia, mild hypotension): Administer antipyretics, oxygen, IV fluids, and/or low-dose vasopressors as needed. Severe or Life-Threatening CRS (one or more of the following: hemodynamic instability despite IV fluids and vasopressor support; worsening respiratory distress including pulmonary infiltrates, increasing oxygen requirement including high-flow oxygen and/or need for mechanical ventilation; rapid clinical deterioration): Administer high doses or multiple vasopressors, oxygen, mechanical ventilation, and/or other supportive care as needed. Administer tocilizumab: 12 mg/kg IV over 1 hour (if the patient weighs less than 30 kg) OR 8 mg/kg IV over 1 hour (maximum dose: 800 mg; if the patient weighs 30 kg or greater). Resistant CRS (no clinical improvement in 12 to 18 hours, or worsening at any time despite prior management): Administer multiple vasopressors, oxygen, mechanical ventilation, and/or other supportive care as needed. Administer methylprednisolone 2 mg/kg as an initial dose, then 2 mg/kg per day until vasopressors and high-flow oxygen are no longer needed, then taper quickly. If no response to steroids within 24 hours, repeat the administration of tocilizumab at 12 mg/kg IV over 1 hour (if the patient weighs less than 30 kg) OR 8 mg/kg IV over 1 hour (maximum dose: 800 mg; if the patient weighs 30 kg or greater). If no response to the second dose of tocilizumab within 24 hours, consider a third dose of tocilizumab or pursue alternative measures for CRS treatment. Administration Advice: Delay the infusion of this drug if a patient has unresolved serious adverse reactions (e.g., pulmonary reactions, cardiac reactions, hypotension) from preceding chemotherapies, active uncontrolled infection, active graft versus host disease (GVHD), or worsening of leukemia burden following lymphodepleting chemotherapy. Do not wash, spin down, and/or re-suspend this drug in new media prior to infusion. Consult the manufacturer's product information for additional administration instructions. Side Effects The Most Common constipation stomach pain back pain nasal congestion decreased appetite weight loss unusual bleeding or bruising, blood in urine, red or tarry black bowel movements, vomiting blood or material that looks like coffee grounds fever, chills, or other signs of infection weakness, feeling tired, or shortness of breath decreased urination frequency or amount swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs difficulty swallowing rash hives itching 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 Rare 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 Anxiety decreased appetite diarrhea difficulty in moving joint pain muscle pain or stiffness pain in the arms or legs stuffy nose Drug Interaction DRUG INTERACTION Articaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Articaine. Benzocaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Benzocaine. Benzyl alcohol The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Benzyl alcohol. Bupivacaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Bupivacaine. Butacaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Butacaine. Butamben The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Butamben. Capsaicin The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Capsaicin. Chloroprocaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Chloroprocaine. Cinchocaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Cinchocaine. Cocaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Cocaine. Darbepoetin alfa The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tisagenlecleucel. Diphenhydramine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Diphenhydramine. Dyclonine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Dyclonine. Erythropoietin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Tisagenlecleucel. Ethyl chloride The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Ethyl chloride. Etidocaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Etidocaine. Levobupivacaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Levobupivacaine. Lidocaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Lidocaine. Meloxicam The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Meloxicam. Mepivacaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Mepivacaine. Methoxy The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Tisagenlecleucel. Oxetacaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Oxetacaine. Oxybuprocaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Oxybuprocaine. Peginesatide The risk or severity of Thrombosis can be increased when Peginesatide is combined with Tisagenlecleucel. Phenol The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Phenol. Pramocaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Pramocaine. Prilocaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Prilocaine. Procaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Procaine. Proparacaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Proparacaine. Propoxycaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Propoxycaine. Ropivacaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Ropivacaine. Tetracaine The risk or severity of methemoglobinemia can be increased when Tisagenlecleucel is combined with Tetracaine. Pregnancy and Lactation US FDA pregnancy category: Not assigned. Pregnancy There are no available data on KYMRIAH use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with KYMRIAH to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if KYMRIAH has the potential to be transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia. Therefore, KYMRIAH is not recommended for women who are pregnant, and pregnancy after KYMRIAH administration should be discussed with the treating physician. Report pregnancies to Novartis Pharmaceuticals Corporation at 1-888-669-6682. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Lactation There is no information regarding the presence of KYMRIAH in human milk, the effect on the breastfed infant, or the effects on milk production. A risk to the breastfed infant cannot be excluded. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for KYMRIAH and any potential adverse effects on the breastfed infant from KYMRIAH or from the underlying maternal condition. Why is this medication prescribed?

Tisagenlecleucel injection is used to treat certain acute lymphoblastic leukemia (ALL; also called acute lymphoblastic leukemia and acute lymphatic leukemia; a type of cancer that begins in the white blood cells) in people 25 years of age or younger that has returned or is unresponsive to other treatment(s). It is also used to treat a certain type of non-Hodgkin's lymphoma (a type of cancer that begins in a type of white blood cells that normally fights infection) and follicular lymphoma…

How should this medicine be used?

Tisagenlecleucel injection comes as a suspension (liquid) to be injected intravenously (into a vein) by a doctor or nurse in a doctor's office or infusion center. It is usually given over a period of up to 60 minutes as a one-time dose. Before you receive your tisagenlecleucel dose, your doctor or nurse will administer other chemotherapy medications to prepare your body for tisagenlecleucel. About 3 to 4 weeks before your dose of tisagenlecleucel injection is to be given, a sample…

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