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Kymriah

Generic Name: tisagenlecleucel (TIS a JEN lek LOO sel)
Brand Names: Kymriah

What is Kymriah?

Kymriah (tisagenlecleucel) is an immunotherapy medicine used to treat a certain type of acute lymphoblastic leukemia in people who are up to 25 years old.

Kymriah is given after other treatments have failed.

Kymriah is made from your own white blood cells, removed from a small amount of blood drawn from your body.

Kymriah is available under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Important information

A serious side effect of Kymriah is called cytokine release syndrome, which causes fever, chills, trouble breathing, vomiting, and other symptoms. Your caregivers will have medication available to quickly treat this condition if it occurs.

Kymriah can also cause life-threatening nerve problems. Tell your caregivers or seek emergency medical attention if you have problems with speech, problems with thinking or memory, confusion, or a seizure.

Kymriah side effects

Get emergency medical help if you have signs of an allergic reaction to Kymriah: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

A serious side effect of Kymriah is called cytokine release syndrome (CRS). Tell your caregivers right away if you have signs of this condition: fever, chills, trouble breathing, body aches, vomiting, diarrhea, or feeling light-headed. Your caregivers will have medication available to quickly treat CRS if it occurs.

Also tell your caregivers or seek emergency medical attention if you have signs of life-threatening nerve problems: problems with speech, problems with thinking or memory, confusion, or a seizure.

Also call your doctor at once if you have:

  • headaches, unusual tiredness;

  • tremors, anxiety, agitation;

  • unusual thoughts or behavior;

  • trouble speaking or understanding what is said to you; or

  • signs of infection - fever, chills, flu symptoms, mouth sores, skin sores, easy bruising or bleeding, cough, trouble breathing.

Common Kymriah side effects may include:

  • nausea, vomiting, diarrhea, loss of appetite;

  • fever;

  • headache, confusion, feeling tired;

  • bleeding; or

  • fast heartbeats.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side Effects (complete list)

Before taking this medicine

To make sure Kymriah is safe for you, tell your doctor if you have ever had:

  • hepatitis B or C;

  • HIV (human immunodeficiency virus); or

  • if you have received a vaccine in the past 2 weeks.

Women may need pregnancy testing before receiving this medicine. You may also need to use birth control to prevent pregnancy during and shortly after treatment with Kymriah and chemotherapy.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

If you receive Kymriah during pregnancy, your baby's blood may need to be tested after it is born. This is to evaluate any effects the medicine may have had on the baby.

It is not known whether tisagenlecleucel passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

How is Kymriah given?

Your care providers will use an intravenous (IV) needle to draw your blood for collecting the white blood cells. The cells are then frozen and sent to a laboratory where they are made into tisagenlecleucel. This could take 3-4 weeks.

About 2 to 14 days before Kymriah is given, you will be pre-treated with chemotherapy to help prepare your body for tisagenlecleucel.

Just before you receive Kymriah, you will be given other medications to help prevent serious side effects or allergic reaction.

Once your body is ready to receive tisagenlecleucel, your care providers will inject the medicine into a vein through an IV.

For at least 4 weeks, plan to stay near the hospital or clinic where you received Kymriah. Avoid being so far away that it takes you longer than 2 hours to travel back to the hospital.

Serious and sometimes fatal infections may develop after the injection. Call your doctor right away if you have fever, chills, easy bruising, unusual bleeding, or other signs of infection.

This medicine can cause you to have a false positive screening test for HIV (human immunodeficiency virus). Tell any doctor who treats you that you are using Kymriah.

Using Kymriah may increase your risk of developing other types of cancer, or causing your leukemia to come back. Your doctor will need to check your progress for the rest of your life.

If you have ever had hepatitis B, Kymriah can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

Kymriah dosing information

Usual Adult Dose of Kymriah for Acute Lymphoblastic Leukemia:

Up to Age 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

Duration of Therapy: Infuse this drug 2 to 14 days after completion of lymphodepleting chemotherapy.

Comments:
-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.

Use: Treatment of patients up to age 25 with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

Usual Pediatric Dose for Acute Lymphoblastic Leukemia:

-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

Duration of Therapy: Infuse this drug 2 to 14 days after completion of lymphodepleting chemotherapy.

Comments:
-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.

Use: Treatment of patients up to age 25 with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

What happens if I miss a dose?

Call your doctor for instructions if you miss any of your chemotherapy treatment, or if you miss a dose of your medications to prevent side effects of Kymriah.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving Kymriah?

This medicine can cause weakness, drowsiness, confusion, problems with memory or coordination, and seizures. Avoid driving or operating machinery for at least 8 weeks after you are treated with Kymriah.

Do not donate blood, an organ, or any tissues or cells from your own body.

Do not receive a "live" vaccine while using Kymriah, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect Kymriah?

Other drugs may interact with tisagenlecleucel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Kymriah.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Kymriah only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2017 Cerner Multum, Inc. Version: 1.02.

Date modified: December 03, 2017
Last reviewed: November 01, 2017

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