Generic Name: Tisagenlecleucel (tis a jen lek LOO sel)
Brand Name: Kymriah
- A very bad health problem called cytokine release syndrome (CRS) has happened with tisagenlecleucel. Sometimes, this has been life-threatening or deadly. This can happen while getting this medicine or within 4 weeks after getting tisagenlecleucel. Get medical help right away if you have signs like chills; confusion; dizziness; feeling tired or weak; fever; headache; passing out; rash; swelling of the face; trouble breathing; very bad muscle or joint pain; very bad upset stomach, throwing up, or diarrhea; or wheezing.
- Do not take this medicine if you have an infection or any inflammation.
- Nervous system problems have happened after treatment with tisagenlecleucel. Sometimes, these have been very bad or life-threatening. Call your doctor right away if you feel agitated, confused, nervous, or restless. Call your doctor right away if you have anxiety, change in eyesight, dizziness or passing out, hallucinations (seeing or hearing things that are not there), headaches, seizures, shakiness, trouble speaking, or new or worse behavior or mood changes.
- You may only get this medicine through a special program. Talk with your doctor.
Uses of Tisagenlecleucel:
- It is used to treat a type of leukemia.
What do I need to tell my doctor BEFORE I take Tisagenlecleucel?
- If you have an allergy to tisagenlecleucel or any part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
This medicine may interact with other drugs or health problems.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take tisagenlecleucel with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Tisagenlecleucel?
- Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert for at least 8 weeks after getting tisagenlecleucel. If you have any questions, call your doctor or pharmacist.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
- You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
- You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
- If you have had hepatitis B before or carry the virus, talk with your doctor. Drugs like this one can cause the virus to become active. This can lead to very bad and sometimes deadly liver problems.
- Hepatitis and HIV testing will be done before taking tisagenlecleucel.
- Talk with your doctor before getting any vaccines. Some types of vaccines must not be given for at least 2 weeks before starting this medicine, during care, and for some time after care ends.
- This medicine may add to the chance of getting some types of cancer. Talk with the doctor.
- Do not donate blood, organs, or tissues or cells. Talk with your doctor to see when you can do these things after getting tisagenlecleucel.
- This medicine is taken with other drugs. Be sure you know about the warnings, benefits, and risks of these other drugs. Talk with the doctor if you have questions or concerns about any of the drugs.
- If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting this medicine. Talk with your doctor.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using tisagenlecleucel while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How is this medicine (Tisagenlecleucel) best taken?
Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given as an infusion into a vein over a period of time.
- Other drugs may be given before tisagenlecleucel to help avoid side effects.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
- Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Fast breathing.
- Feeling very tired or weak.
- A fast heartbeat.
What are some other side effects of Tisagenlecleucel?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Not hungry.
- Upset stomach or throwing up.
- Loose stools (diarrhea).
- Hard stools (constipation).
- Belly pain.
- Feeling tired or weak.
- Pain in arms or legs.
- Muscle or joint pain.
- Back pain.
- Stuffy nose.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Tisagenlecleucel?
- If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time tisagenlecleucel is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take tisagenlecleucel or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to tisagenlecleucel. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Review Date: December 6, 2017
More about tisagenlecleucel
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Support Group
- En Español
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- Drug class: miscellaneous antineoplastics
Other brands: Kymriah