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Care During Chemotherapy and Beyond

Tisagenlecleucel

(tis-a-jen-lek-LOO-sel)

Trade Name(s): Kymriah®

Tisagenlecleucel is the generic name for the trade name drug Kymriah®. In some cases, health care professionals may use the trade name Kymriah® when referring to the generic drug name Tisagenlecleucel.

Drug Type: Tisagenleleucel is an anti-cancer immunotherapy drug. This medication is classified as a "Chimeric Antigen Receptor T-Cell (CAR T-Cell) immunotherapy agent." (For more detail, see "How Tisagenleleucel Works" below)

What Tisagenlecleucel Is Used For

  • Acute leukemia if the cancer has relapsed or progressed after standard treatments in both children and young adults up to 25 years old.
  • For adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Tisagenlecleucel Is Given

  • Tisagenlecleucel is made from your own white blood cells. Your white blood cells are collected using an apheresis machine, which will separate the necessary cells from your blood and return these rest of your cells to you through a central venous line. Your cells will then be sent to a manufacturing center to make your dose of tisagenlecleucel.
  • Tisagenlecleucel is given once by IV infusion. You will receive chemotherapy for three days before tisagenlecleucel to prepare your body for the infusion. The chemotherapy will include cyclophosphamide and fludarabine beginning at five days prior to Tisagenlecleucel..
  • You will be given acetaminophen and an antihistamine approximately one hour before the infusion to reduce the risk of infusion related reactions.
  • Because of side effects, tisagenlecleucel must be administered to you while you are hospitalized (as an inpatient) and only certain healthcare facilities can administer tisagenlecleucel.
  • After the tisagenlecleucel infusion, you will need to stay close to where you received the tisagenlecleucel for at least four weeks after the infusion for close monitoring.

Side Effects

Important things to remember about the side effects of Tisagenlecleucel:

  • Tisagenlecleucel side effects are often predictable in terms of their onset, duration, and severity.

The following side effects are common (occurring in greater than 30%) for patients taking Tisagenlecleucel:

A commonly reported side effect with tisagenlecleucel is cytokine release syndrome (CRS). This occurs when your immune system is activated by the tisagenlecleucel treatment and releases proteins called "cytokines" in your body. As a result of this, you may start to experience chills, fevers, low blood pressure, difficulty breathing, or confusion. Sometimes, these symptoms can become life threatening and severe enough that you may need intensive supportive care management and receive tociliuzumab and corticosteroids as needed to treat the cytokine release syndrome. Contact your health care provider immediately if you start to experience any of these symptoms.

Neurological symptoms, including confusion, headaches, dizziness, hallucinations, seizures and anxiety have been reported within 8 weeks of receiving tisagenlecleucel. Onset of neurological toxicity can be concurrent with CRS, following resolution of CRS or in the absence of CRS. You will be closely monitored for these symptoms after receiving tisagenlecleucel by your healthcare team. Sometimes, these symptoms can become severe enough to require supportive care management with medications. Contact your health care provider immediately if you start to experience any of these symptoms or note any changes in behavior.

These are less common side effects (occurring in 10-29%) for patients receiving Tisagenlecleucel:

Note all side effects are listed above. Side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.

When to Contact Your Doctor or Health Care Provider

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

  • Fever of 100.4º F (38º C) or higher, chills (possible signs of infection)
  • Difficulty breathing
  • Confusion
  • Dizziness or lightheadedness
  • Drowsiness or sleepiness

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

  • Nausea (interferes with ability to eat and unrelieved with prescribed medication)
  • Vomiting (vomiting more than 4-5 times in a 24-hour period)
  • Diarrhea (4-6 episodes in a 24-hour period)
  • Unusual bleeding or bruising
  • Black or tarry stools, or blood in your stools
  • Extreme fatigue (unable to carry on self-care activities)

Always inform your health care provider if you experience any unusual symptoms.

Precautions

  • Before starting tisagenlecleucel treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin or products containing aspirin unless your doctor specifically permits this.
  • Do not receive any kind of immunization or vaccination without your doctor's approval while taking tisagenlecleucel.
  • If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.
  • You may experience drowsiness, sleepiness, confusion or dizziness; avoid driving or engaging in tasks that require alertness for 8 weeks after you receive tisagenlecleucel.
  • Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. There have been no animal or human studies with tisagenlecleucel in pregnant women and it is unknown if tisagenlecleucel is transferred to the fetus. If tisagenlecleucel is transferred to the fetus, this may cause fetal toxicity and a decrease in the fetus' white blood cells so it is recommended to avoid tisagenlecleucel if you are pregnant or planning to become pregnant.
  • Do not breast feed while taking tisagenlecleucel.

Self-Care Tips

  • Alert any new health care professional or emergency room worker that you have received tisagenlecleucel is the past. You will be provided with a KYMRIAH® wallet sized card from the manufacturing company informing them of the most common symptoms to monitor for.
  • Wash your hands often.
  • You may be at risk of infection so try to avoid crowds or people with colds and those not feeling well, and report fever or any other signs of infection immediately to your health care provider.
  • Use an electric razor and a soft toothbrush to minimize bleeding.
  • Avoid contact sports or activities that could cause injury.
  • This medication causes some nausea. But if you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also help.
  • Follow regimen of anti-diarrhea medication as prescribed by your health care professional.
  • Eat foods that may help reduce diarrhea (see managing side effects - diarrhea).
  • Get plenty of rest.
  • Maintain good nutrition.
  • Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
  • If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing While Taking Tisagenlecleucel

You will be checked regularly by your doctor while you are taking tisagenlecleucel to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC), immunoglobulin levels as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.

How Tisagenlecleucel Works

Immunotherapy is a relatively new type of cancer therapy that uses the body's own immune system to identify and fight the cancer.

CAR T-Cell therapy is a newly developed immunotherapy treatment that genetically engineers your T-cells to produce special receptors called chimeric antigen receptors (CARs). These CARs let your T-cells recognize cancer cells. After these CAR T-Cells are infused into the patient, they start attack the cancer cells.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

References:

  • Kymriah. Lexicomp Online. [updated 1/10/18]. Lexi-Drugs. Hudson, OH: LexiComp, Inc.
  • Kymriah (tisagenlecleucel) [prescribing information]. East Hanover, NJ: Norvartis Pharmaceuticals Corporation.; [updated 8/2017].

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