What is Tysabri?Tysabri is used to treat relapsing forms multiple sclerosis (MS) to delay the accumulation of physical disability and reduce frequency of clinical exacerbation. It is also used to induce and maintain clinical response and remission of adult patients with moderate-to-severe active Crohn's disease (CD) who are intolerant to conventional therapy. Tysabri does not cure MS or CD.
What is the most important information I should know about Tysabri?Tysabri can increase your chance of getting a rare brain infection--progressive multifocal leukoencephalopathy (PML)--that usually causes death or severe disability, especially if you have a weakened immune system. No one can predict who will get PML, and there is no known treatment, prevention, or cure. Your chance of getting PML may be higher if you are also being treated with other medicines that can weaken your immune system, including other treatments for MS and CD.
Tysabri is only available through a restricted distribution program called the TOUCH™ Prescribing Program. In order to receive TYSABRI, you must talk to your doctor and understand the benefits and risks of TYSABRI and agree to all of the instructions in the TOUCH™ Prescribing Program.
While taking Tysabri, it is important that you call your doctor right away if you get any new or worsening medical problems such as a new or sudden change in your thinking, eyesight, balance, or strength or other problems that have lasted over several days.
The safety of using Tysabri more than 2 years is unknown. Tysabri is only approved for use in patients 18 years old and over.
Who should not take Tysabri?You should not take Tysabri if you have or have had PML or have had a severe allergic reaction to the medication.
What should I tell my doctor before I take the first dose of Tysabri?Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Tysabri. Also talk to your doctor about your complete medical history, especially if you have a weakened immune system, any type of liver problems, or current infections.
What is the usual dosage?The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.
Adults: The dosage is 300 milligrams (mg) via an intravenous (IV) infusion over 1 hour every 4 weeks
Prescribers must be registered in the MS TOUCH Prescribing Program
Adults: The dosage is 300 mg IV infusion over 1 hour every 4 weeks.
** Prescribers must be registered in the CD TOUCH Prescribing Program
If no therapeutic benefit has occurred after 12 weeks of starting treatment with Tysabri, it should be stopped.
If you have Crohn's disease and start Tysabri while taking oral corticosteroids, your doctor will instruct you on how and when to start reducing the steroid dose. If the steroids cannot be tapered off within 6 months of starting Tysabri, the medication should be discontinued.
How should I take Tysabri?Tysabri is administered by a healthcare professional in a hospital or infusion center. No other medication should be injected into the infusion set or mixed with Tysabri.
What are possible food and drug interactions associated with Tysabri?If Tysabri is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Tysabri with the following: immunosuppressant drugs such as 6-MP, azathioprine, cyclosporine, methotrexate.
What are the possible side effects of Tysabri?Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.
Side effects may include: hypersensitivity reactions, infections, liver damage, headache, urinary tract infections, arm and leg pain, vaginitis, fatigue, joint pain, depression, diarrhea, stomach pain
Can I receive Tysabri if I am pregnant or breastfeeding?The effects of Tysabri during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding. Tysabri should be used during pregnancy only if the benefits outweigh the risks. If a woman becomes pregnant while taking Tysabri, she should be enrolled in the Tysabri Pregnancy Exposure Registry.
What should I do if I miss a dose of Tysabri?If you think you might have to miss an infusion appointment, call you doctor to reschedule.
How should I store Tysabri?Tysabri is administered in a hospital or office and will be stored by your healthcare provider.