This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.
Brand Names: US
Tysabri
Brand Names: Canada
Tysabri
- A severe brain problem called progressive multifocal leukoencephalopathy (PML) has happened with this drug. It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, depression, change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.
- The risk of PML is raised if you have had a John Cunningham virus (JCV) infection. The risk is also raised if you take this drug for a long time (especially more than 2 years) and if you have taken drugs that can weaken your immune system. Tell your doctor if any of these apply to you. If you have questions, talk with your doctor.
- Watch for side effects of PML while getting this drug and for 6 months after your last dose.
What is this drug used for?
- It is used to treat MS (multiple sclerosis).
- It is used to treat Crohn’s disease.
What do I need to tell my doctor BEFORE I take this drug?
- If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you are allergic to mouse proteins, talk with the doctor.
- If you have had a brain infection called progressive multifocal leukoencephalopathy.
- If you are taking any drugs that suppress your immune system. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
This is not a list of all drugs or health problems that interact with this drug.
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 this drug 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 this drug?
- Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Your doctor may order an MRI scan before you start this drug.
- Some people have had side effects within a few hours of the start of the infusion. Tell your doctor if you have any bad effects during this time.
- You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
- Talk with your doctor before getting any vaccines. Use of some vaccines with this drug may either raise the chance of an infection or make the vaccine not work as well.
- Liver problems have happened with this drug. Sometimes, this has been very bad and a liver transplant has been needed. Talk with the doctor.
- Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
- If you used this drug when you were pregnant, tell your baby’s doctor. Low platelet counts and anemia have happened in newborns when this drug was used during pregnancy.
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, swallowing, 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 a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
- Signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Thoughts of hurting yourself or suicide.
- Depression.
- Dizziness.
- Flushing.
- Shortness of breath.
- Chest pain or pressure or passing out.
- Tooth pain.
- Vaginal itching or discharge.
- Period (menstrual) changes.
- Swelling in the arms or legs.
- Very bad and sometimes deadly infections of the brain or spinal cord caused by herpes viruses have happened with this drug. Call your doctor right away if you have a sudden fever, very bad headache, or feel confused.
- An eye problem caused by herpes viruses has happened with this drug. Sometimes this has been very bad and has led to loss of eyesight in some people. Call your doctor right away if you have a change in eyesight, eye pain, or eye redness.
- Low platelet counts have rarely happened with this drug. Low platelet counts can lead to bleeding that may be life-threatening. Call your doctor right away if you have any unexplained bruising or bleeding.
What are some other side effects of this drug?
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:
- Headache.
- Upset stomach.
- Stomach pain or diarrhea.
- Feeling tired or weak.
- Joint pain.
- Back pain.
- Pain in arms or legs.
- Muscle cramps.
- Signs of a common cold.
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 your national health agency.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
How is this drug best taken?
Use this drug 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.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
How do I store and/or throw out this drug?
- If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
General drug facts
- 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 all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, 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.
Consumer Information Use and Disclaimer
This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.
Last Reviewed Date
2023-09-26
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