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What is the Tysabri Touch Prescribing Program?

Medically reviewed by Kristianne Hannemann, PharmD. Last updated on Aug 4, 2023.

Official Answer by Drugs.com

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:

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?

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?

References

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