What is the Tysabri Touch Prescribing Program?

The Tysabri TOUCH Prescribing Program is a restricted program developed by the manufacturer of Tysabri and the US Food and Drug Administration (FDA) intended to educate healthcare professionals and patients on the risks of using Tysabri, including progressive multifocal leukoencephalopathy (PML).

Tysabri (natalizumab) from Biogen was approved by the US FDA in 2004. It’s an intravenous (IV) injection used to treat adults with Crohn’s disease and adults with relapsing forms of multiple sclerosis.

In 2005, the manufacturer withdrew Tysabri from the market due to some patients developing a serious brain infection known as PML. The US FDA allowed Tysabri to return to the market in 2006, when it has since only been available through a Risk Evaluation and Mitigation Strategy (REMS) called the Tysabri Outreach Unified Commitment to Health (TOUCH) Prescribing Program.

What is a REMS?

A REMS is a program sometimes required by the US FDA to ensure safe use of medications with potentially serious side effects. It helps prevent, monitor, or manage certain side effects through education and actions required by prescribers, dispensers, and/or patients.

What is progressive multifocal leukoencephalopathy (PML)?

Progressive multifocal leukoencephalopathy (PML) is a viral infection in the brain that’s caused by the John Cunningham virus (JC virus). It typically only occurs in people with weak immune systems. This rare infection often leads to severe disability and death. There’s currently no cure for PML.

Signs and symptoms of PML include:

• Clumsiness
• Weakness
• Difficulty walking
• Changes in vision
• Speech difficulty
• Personality changes

Tysabri has been associated with PML, and the risk goes up with the number of infusions a patient receives.

Who must enroll in the TOUCH Prescribing Program?

• Prescribers who want to prescribe Tysabri
• Patients who need to receive Tysabri
• Pharmacies and that dispense Tysabri
• Infusion sites that infuse Tysabri

What is the TOUCH Prescribing Program designed to do?

The TOUCH Prescribing Program is meant to educate patients, prescribers, and dispensers about the risk of PML. It also helps with early diagnosis of PML so that prescribers can stop the medication right away if it occurs.

Additionally, the TOUCH Prescribing Program warns patients and prescribers about using Tysabri together with certain medications that weaken the immune system, and in people who have weakened immune systems. These medications include antineoplastic, immunosuppressant, or immunomodulating agents. A weak immune system is a risk factor for developing PML while taking Tysabri.

What are the requirements of the TOUCH Prescribing Program?

• Prescribers: In order to prescribe Tysabri, prescribers must review and complete the Prescriber Enrollment Form. They must also provide patients with a Medication Guide and educate them on the risks and benefits of the medication. Prescribers must also assess if the patient should continue Tysabri every 6 months. They’re required to submit a form called the TYSABRI Patient Status Report and Reauthorization Questionnaire.

• Patients: To be able to use Tysabri, a patient must review and complete an enrollment form for the TOUCH Prescribing Program. The form contains information about the risks of treatment, including PML. Before each infusion, patients are asked some questions about their health. Patients will need to see their provider at 3 and 6 months after the first infusion, and then every 6 months while taking Tysabri. Additionally, patients need to have a follow-up appointment 6 months after stopping the medication.

• Infusion sites: Infusion sites must participate in a training program and complete an enrollment form. They can only administer Tysabri to patients who are currently enrolled in the TOUCH Prescribing Program, and must provide a Medication Guide to each patient before every infusion. They must also complete a Pre-Infusion Patient Checklist and submit it to the manufacturer, Biogen, within 1 business day of the patient’s visit.

• Certified pharmacies: In order to dispense Tysabri, pharmacies must complete a training program and enrollment form. They can only dispense Tysabri to authorized infusion sites or to the patient’s home for in-home infusion.