Tysabri Warnings and Precautions
Some people who have a history of shingles, an organ transplant, or a certain brain infection may not be able to receive Tysabri. Precautions with this prescription medication also include warnings of potential complications that may occur, such as liver damage, serious allergic reactions, and a weakened immune system. Also, women who are pregnant or breastfeeding should talk to their doctor before receiving this drug.
What Should I Tell My Healthcare Provider?Talk with your healthcare provider prior to receiving Tysabri® (natalizumab) if you have:
- Liver disease, such as hepatitis, cirrhosis, or liver failure
- A weakened immune system due to human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), leukemia, lymphoma, or any other cause
- A fever or infection (including long-lasting infections, such as shingles)
- A history of progressive multifocal leukoencephalopathy (PML), a rare infection of the brain
- Had an organ transplant
- Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
- Pregnant or thinking of becoming pregnant.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Specific Warnings and Precautions With TysabriSome warnings and precautions to be aware of prior to receiving this drug include the following:
- Tysabri can increase the risk for a serious brain infection called progressive multifocal leukoencephalopathy (PML). PML can cause severe disability and death. Your chances of getting PML are higher the longer you receive Tysabri and if you take other medicines that weaken your immune system (immunosuppressants). Contact your healthcare provider right away if you experience any possible signs of PML, such as:
- Weakness on one side of the body
- Vision problems
- Difficulty thinking or remembering things
- Personality changes.
- If you develop PML during treatment, you will need to stop using Tysabri. You should know that there have been reports of a condition called immune reconstitution inflammatory syndrome (IRIS) occurring in some people who stopped taking Tysabri after developing PML. IRIS occurs when the immune system recovers too quickly, causing a severe inflammatory response, which can make your symptoms worse. IRIS may resolve on its own, or may need to be treated.
- Because of the risks associated with Tysabri, it is only available through a special program called the Touch® program. You, your healthcare provider, and the infusion center where you receive your dose must be enrolled in this program. The Touch program ensures you understand the risks and benefits of receiving Tysabri. Your healthcare provider will help you enroll in this program, and will talk to you about Tysabri treatment.
- Your healthcare provider will monitor your response to treatment and determine if you should continue receiving this drug after three months of treatment, again after six months of treatment, and every six months thereafter.
- There have been reports of serious allergic reactions from the Tysabri intravenous infusion. These reactions usually occur within two hours after starting the dose (which takes about an hour to give). Tell your healthcare provider immediately if you experience possible symptoms of an infusion reaction during or any time after your infusion. Some of the possible symptoms may include:
- Fever and chills
- Flushing (sudden warmth and redness of the face, neck, and chest)
- Breathing problems, such as shortness of breath or wheezing
- Chest pain
- Low blood pressure (hypotension), which could cause dizziness or fainting.
- This medication weakens your immune system, which can increase your risk for infections, including potentially serious infections. Contact your healthcare provider right away if you develop signs of an infection, such as:
- Body aches
- Problems urinating (including difficulty urinating, painful urination, or blood in the urine).
- Tysabri has been reported to cause liver damage. Your healthcare provider may choose to check your liver function with a blood test, especially if you develop any signs of liver problems. Let your healthcare provider know if you have signs of liver problems, such as:
- Yellowing of the skin or whites of the eyes (jaundice)
- Dark urine
- Extreme tiredness
- Pain in the upper-right area of the abdomen (stomach).
- Talk to your healthcare provider before getting any type of vaccination or immunization during Tysabri treatment, as vaccinations may be less effective. You could also become infected with the bacteria or viruses used to make "live" vaccines (see Tysabri Drug Interactions).
- Tysabri may react with a few other medications (see Tysabri Drug Interactions for more information).
- Tysabri passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see Tysabri and Breastfeeding).
- Tysabri is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Tysabri and Pregnancy).