Other Names: Kymriah™
About this Drug
Tisagenlecleucel is used to treat cancer. It is made using your own T-cells, a type of white blood cell. Your T-cells will be collected via leukopheresis, a procedure that circulates your blood through a machine and removes some of your T-cells. Your collected T-cells are then genetically modified and grown. Tisagenlecleucel contains your modified T-cells and is given to you through the vain (IV).
Possible Side Effects
- Fever when you have low white blood cells
- Infections, including viral, bacterial and fungal
- Changes in your central nervous system can happen. The central nervous system is made up of your brain and spinal cord. You could feel extreme tiredness, agitation, confusion, hallucinations (see or hear things that are not there), have trouble understanding or speaking, loss of control of your bowels or bladder, eyesight changes, numbness or lack of strength to your arms, legs, face, or body, seizures, or coma. If you start to have any of these symptoms let your doctor know right away.
- Decreased level of oxygen
- Low blood pressure
- Increase in heart rate
- Cytokine release syndrome (CRS): Some types of cancer drugs can cause CRS because of the effects of the drug in your body. If this happens you may feel very sick and get a fever, headache, nausea, or feel weak. You may also have changes to your blood pressure. Because of this, your blood pressure and pulse will be checked while you are getting this drug. Tell your doctor or nurse right away if you have any of these symptoms while you are getting this drug: fever, chills, or shaking chills, feeling dizzy or lightheaded, have a headache and/or have nausea of throwing up.
- Decreased appetite (decreased hunger)
- Loose bowel movements (diarrhea)
- Nausea and throwing up (vomiting)
- Changes in your kidney function
- Abnormal bleeding — symptoms may be coughing up blood, throwing up blood (may look like coffee grounds), red or black tarry bowel movements, abnormally heavy menstrual flow, nosebleeds, or any other unusual bleeding.
- Decreased immunoglobulin in your body, which are antibodies and help you fight off infection.
Note: Each of the side effects above was reported in 20% or greater of patients treated with tisagenlecleucel . Not all possible side effects are included above.
Warnings and Precautions
- Cytokine release syndrome (CRS), which can rarely be life-threatening
- Severe changes in your central nervous system, which can very rarely be life-threatening
- Allergic reactions including anaphylaxis are rare but may happen in some patients. Signs of allergic reaction to this drug may be swelling of the face, feeling like your tongue or throat are swelling, trouble breathing, rash, itching, fever, chills, feeling dizzy, and/or feeling that your heart is beating in a fast or not normal way. If this happens, do not take another dose of this drug. You should get urgent medical treatment.
- Low blood cell counts, such as platelets, red and white blood cells, which could last for a long time.
- Severe infections, including viral, bacterial, and fungal, which can very rarely be life-threatening
- Decreased immunoglobulin in your body, which are antibodies and help you fight off infection
- A severe decrease in the number of white blood cells. This may raise your risk of infection.
- This drug may raise your risk of getting a second cancer.
Note: Some of the side effects above are very rare. If you have concerns and/or questions, please discuss them with your medical team.
- This drug may impair your ability to drive or use machinery. Do not drive or use machinery during your treatment and for 8 weeks after treatment.
- Talk to your doctor before receiving any vaccinations during your treatment. Vaccinations are not recommended for 2 weeks prior to treatment, while receiving tisagenlecleucel and after receiving tisagenlecleucel - until your immune system is fully recovered.
- This drug may be present in the saliva, tears, sweat, urine, stool, vomit, semen, and vaginal secretions. Talk to your doctor and/or your nurse about the necessary precautions to take during this time.
Treating Side Effects
- Manage tiredness by pacing your activities for the day. Be sure to include periods of rest between energy-draining activities.
- If you are dizzy, get up slowly after sitting or lying down.
- Keeping your pain under control is important to your well-being. Please tell your doctor or nurse if you are experiencing pain.
- To decrease infection, wash your hands regularly.
- Avoid close contact with people who have a cold, the flu, or other infections.
- Take your temperature as your doctor or nurse tells you, and whenever you feel like you may have a fever.
- To help with decreased appetite, eat small, frequent meals.
- Eat high caloric food such as pudding, ice cream, yogurt and milkshakes.
- To help with nausea and vomiting, eat small, frequent meals instead of three large meals a day. Choose foods and drinks that are at room temperature. Ask your nurse or doctor about other helpful tips and medicine that is available to help lessen or stop these symptoms.
- If you are not able to move your bowels, check with your doctor or nurse before you use enemas, laxatives, or suppositories.
- Drink plenty of fluids (a minimum of eight glasses per day is recommended).
- If you throw up or have loose bowel movements, you should drink more fluids so that you do not become more dehydrated (lack water in the body from losing too much fluid).
- If you get diarrhea, eat low-fiber foods that are high in protein and calories and avoid foods that can irritate your digestive tracts or lead to cramping.
- Ask your doctor or nurse about medicines that are available to help stop or lessen constipation and/or diarrhea.
Food and Drug Interactions
- There are no known interactions of tisagenlecleucel with food and other medications.
- Tell your doctor and pharmacist about all the medicines and dietary supplements (vitamins, minerals, herbs, and others) that you are taking at this time. The safety and use of dietary supplements and alternative diets are often not known. Using these might affect your cancer or interfere with your treatment. Until more is known, you should not use dietary supplements or alternative diets without your cancer doctor's help.
When to Call the Doctor
Call your doctor or nurse if you have any of these symptoms and/or any new or unusual symptoms:
- Fever of 100.5 F (38 C) or higher
- Fatigue that interferes with your daily activities
- Easy bleeding or bruising
- Feeling dizzy or lightheaded
- Confusion and/or agitation
- Trouble understanding or speaking
- Blurry vision or other changes in eyesight
- Numbness or lack or strength to your arms, legs, face, or body
- Headache that does not go away
- Feeling that your heart id beating in a fast or not normal way (palpitations)
- Coughing up yellow, green, or bloody mucus
- Wheezing or trouble breathing
- Lasting loss of appetite or rapid weight loss of five pounds in a week
- Nausea that stops you from eating or drinking and/or is not relieved by prescribed medicines
- Throwing up more than 3 times a day
- No bowel movement in 3 days or when you feel uncomfortable
- Loose bowel movements (diarrhea) 4 times a day or loose bowel movements with lack of strength or a feeling of being dizzy
- Decreased urine, or very dark urine
- Blood in your urine, vomit (bright red or coffee-ground) and/or stools (bright red, or black.tarry)
- Signs of allergic reaction: swelling of the face, feeling like your tongue or throat are swelling, trouble breathing, rash, itching, fever, chills, feeling dizzy, and/or feeling that your heart is beating in a fast or not normal way.
- Signs of cytokine release syndrome such as: fever, chills, or shaking chills, feeling dizzy or lightheaded, have a headache and/or have nausea or throwing up.
- If you think you may be pregnant
- Pregnancy warning: This drug may have harmful effects on the unborn baby. Women of child bearing potential should use effective methods of birth control during your cancer treatment. Let your doctor know right away if you think you may be pregnant.
- Breastfeeding warning: It is not known if this drug passes into breast milk. For this reason, women should talk to their doctor about the risks and benefits of breast feeding during treatment with this drug because this drug may enter the breast milk and cause harm to a breast feeding baby.
- Fertility warning: Human fertility studies have not been done with this drug. Talk with your doctor or nurse if you plan to have children. Ask for information on sperm or egg banking.
New October 2017