Skip to main content

What is the Tysabri Touch Prescribing Program?

Medically reviewed by Kristianne Hannemann, PharmD. Last updated on July 31, 2025.

Official Answer by Drugs.com

The TOUCH Prescribing Program was developed by Biogen and mandated by the FDA specifically to monitor and minimize the risks associated with Tysabri (natalizumab), particularly the risk of 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.

Here’s a simplified overview of what patients and caregivers can expect from initial prescription through ongoing care:

This framework prioritizes continuous risk mitigation, patient safety, and adherence to federal REMS guidelines.

What are the requirements of the TOUCH Prescribing Program?

Enhanced Digital Access: How to Use TOUCH On-Line

TOUCH On-Line streamlines program compliance and simplifies management for all parties. Here’s how patients and healthcare professionals use it:

References

See also:

Related medical questions

Drug information

Related support groups