Tisagenlecleucel suspension for injection
What is this medicine?
TISAGENLECLEUCEL (tis'' a jen" lek loo' sel) is a gene therapy that is made from cells in your immune system. It is used to treat acute lymphoblastic leukemia.
How should I use this medicine?
This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting. This medicine is made from your own immune cells. Your cells will be collected approximately 3 to 4 weeks before the infusion of this medicine.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
loss of balance or coordination
low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
muscle pain or joint pain
signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls
signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired
trouble speaking or understanding
Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):
swelling in your legs and feet
What may interact with this medicine?
Interactions have not been studied.
Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What if I miss a dose?
This does not apply.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
an unusual or allergic reaction to tisagenlecleucel, other medicines, foods, dyes, or preservative
pregnant or trying to get pregnant
What should I watch for while using this medicine?
You may need blood work done while you are taking this medicine.
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you.
Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.
Do not give blood while taking this medicine.
Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.
Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.
November 11, 2017