Generic Name: Axicabtagene Ciloleucel (ax i CAB tay jeen sye LO loo sel)
Brand Name: Yescarta
- A very bad health problem called cytokine release syndrome (CRS) has happened with Yescarta (axicabtagene ciloleucel). Sometimes, this has been life-threatening or deadly. This can happen while getting this medicine or within 4 weeks after getting Yescarta. 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 Yescarta. 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 Yescarta:
- It is used to treat a type of lymphoma.
What do I need to tell my doctor BEFORE I take Yescarta?
- If you have an allergy to Yescarta 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 Yescarta 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 Yescarta?
- 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 Yescarta. 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.
- 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.
- Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.
- 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 this medicine.
- Talk with your doctor before getting any vaccines. Some types of vaccines must not be given for at least 6 weeks before starting Yescarta, 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 this medicine.
- If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting Yescarta (axicabtagene ciloleucel). Talk with your doctor.
- This medicine may cause harm to the unborn baby if you take it while you are pregnant.
- Use birth control that you can trust to prevent pregnancy during care and for some time after care ends. Talk with your doctor to see how long to use birth control after you stop this medicine.
- If you get pregnant while taking Yescarta or within several months after the last dose, call your doctor right away.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How is this medicine (Yescarta) 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 Yescarta to help avoid side effects.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
See also: Dosage Information (in more detail)
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 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 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 fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Feeling very tired or weak.
- A fast heartbeat.
- A heartbeat that does not feel normal.
- Feeling confused.
- Feeling very sleepy.
- Not able to focus.
- Trouble speaking.
- Swelling, warmth, numbness, change of color, or pain in a leg or arm.
- Chest pain or pressure.
- Change in how you act.
- Hallucinations (seeing or hearing things that are not there).
What are some other side effects of Yescarta?
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.
- Dry mouth.
- Weight loss.
- Feeling tired or weak.
- Pain in arms or legs.
- Muscle or joint pain.
- Muscle spasm.
- Muscle weakness.
- Back pain.
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.
See also: Side effects (in more detail)
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 Yescarta?
- 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.
- Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Yescarta, please talk with your doctor, nurse, 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 this medicine 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 Yescarta. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. 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 Yescarta.
Review Date: December 6, 2017