Real Talk Rx: Tysabri® 

Tysabri® (natalizumab) is the only cell adhesion inhibitor featured in this guide. Cell adhesion inhibitors help prevent T cells and B cells from leaving the bloodstream and entering the brain and spinal cord. These white blood cells normally help fight infection. In MS, they can cross the blood-brain barrier, a protective layer around the brain and spinal cord, and cause inflammation that injures myelin and disrupts nerve messages.

Tysabri is a humanized monoclonal antibody. This means it is a lab-made antibody designed so that most of its structure closely matches antibodies produced by the human body. “Humanized” describes the medication’s structure and does not mean that Tysabri is safer or more effective than other DMTs.

Before treatment, the healthcare team evaluates the following:

• Presence of JCV antibodies
• History of medications that weaken the immune system
• Current infections
• Liver function
• MRI scan results
• Current medications and health conditions
• Treatment risks, benefits, alternatives to Tysabri treatment
• Enrollment in the TOUCH® Prescribing Program

Who Can Take Tysabri?

Tysabri is approved for adults with relapsing forms of MS: 

• Clinically isolated syndrome (CIS)
  
• Relapsing-remitting multiple sclerosis (RRMS)
  
• Active secondary progressive multiple sclerosis (active SPMS)
  

The goal of Tysabri treatment is long-term control of RRMS. It helps reduce relapses and the development of new or enlarging lesions. It does not stop a relapse that has already started or directly relieve current symptoms.

How Does Tysabri Work?

To cross the blood-brain barrier, T cells and B cells use a protein called alpha-4 integrin to attach to blood vessel walls. Tysabri blocks this protein and limits the number of these cells that enter the brain and spinal cord. This helps reduce inflammation, relapses, and new or enlarging lesions seen on MRI.

How Is Tysabri Taken?

Tysabri is given by a trained healthcare professional as an infusion every four weeks. Each infusion takes about one hour. Patients are typically monitored during the infusion and afterward for possible side effects and serious reactions.

Because Tysabri can increase the risk of PML, it is available only through the TOUCH® Prescribing Program. Patients, prescribers, pharmacies, and infusion centers must participate in this safety program. Before each infusion, patients are asked about new health problems and symptoms that could affect whether treatment should continue.

What Does Research Show?

In a major clinical trial, Tysabri was compared with a placebo infusion that did not contain active medication. After one year, people receiving Tysabri had about 68% fewer relapses and far fewer new or enlarging lesions on MRI.

After two years, people receiving Tysabri were less likely to experience continued problems with walking, balance, coordination, or use of their arms and legs than those receiving placebo.

It is important to note that Black participants were underrepresented in Tysabri’s clinical trial, but later research looked specifically at 40 Black or African American participants with early relapsing MS who received Tysabri for up to four years. Researchers found that clinical outcomes, including relapses and disability measures, were generally comparable to those seen in non-Hispanic white participants. Although the study was small, it provides additional information about how Tysabri may work in Black patients with MS.

Possible Side Effects With Cell Adhesion Inhibitor Therapy

• Headache
• Low energy
• Joint pain
• Urinary tract infections
• Respiratory infections
• Stomach discomfort
• Diarrhea
• Rash
• Infusion reactions

Possible Serious Side Effects

Tysabri can increase the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection caused by the JC virus.

The JC virus (JCV) usually remains inactive in the body and causes no symptoms. In people with reduced immune protection, it can become active and cause PML. JCV antibodies are proteins the immune system makes after exposure to the virus. A positive antibody test shows previous exposure. This does not mean the person has PML; however, it helps the healthcare team estimate PML risk during Tysabri treatment.

Serious risks include:

• Progressive multifocal leukoencephalopathy (PML): A rare brain infection that may lead to severe disability or death. The risk may be higher in people who have JCV antibodies, have received Tysabri for a longer period, or previously used medications that weaken the immune system.
• Serious infections: Tysabri may reduce the body’s ability to fight certain infections, including infections affecting the brain and spinal cord.
• Severe infusion reactions: Symptoms may include trouble breathing, swelling, chest discomfort, dizziness, fainting, a rapid heartbeat, rash, or hives.
• Liver injury: Warning signs may include yellowing of the skin or eyes, dark urine, nausea, vomiting, unusual weakness, or pain in the upper-right abdomen.
• Low platelet levels: Platelets help the blood clot. A decrease in platelets may cause unusual bruising, bleeding that is difficult to stop, or small red or purple spots on the skin.

Contact your healthcare team if you develop:

• Fever or chills
• An ongoing cough
• Painful urination
• Unusual bruising or bleeding
• A rash or reaction following an infusion
• New symptoms that continue or become worse

Seek immediate medical treatment for:

• Trouble breathing
• Swelling of the face, lips, tongue, or throat
• Severe rash or hives
• Dizziness or fainting
• Dark urine
• Yellowing of the skin or eyes
• Unusual weakness
• Pain under the right rib cage
• New or worsening weakness on one side of the body
• Vision changes
• Problems with balance or coordination
• Confusion, memory problems, or personality changes

During treatment, the healthcare team continues to check for:

• Infections
• Liver problems
• Infusion reactions
• PML symptoms
• JCV antibodies
• RRMS activity with MRI scans

What Should You Discuss With Your Doctor?

• Why are you recommending Tysabri for my RRMS?
• How often will I receive an infusion?
• What is my current risk for PML?
• Will I need JCV antibody testing before and during treatment?
• How does my previous medication use affect my PML risk?
• How often will I need MRI scans?
• Which symptoms should I report immediately?
• How will we determine whether Tysabri is reducing relapses and new or enlarging lesions?
• Could my other medications, health conditions, or pregnancy plans affect this treatment?
• What happens if my JCV antibody test becomes positive?
• Do I need to stop Tysabri before receiving a vaccine?

What Savings and Support Programs Are Available?

Patients with relapsing multiple sclerosis can find access to Tysabri through several program options. Some of those programs may help lower out-of-pocket medication or infusion costs for eligible patients with private insurance, provide assistance with understanding insurance coverage and financial support options, or help patients locate a TOUCH®-authorized infusion center. Learn more about support and savings for Tysabri.

Key Points

• Tysabri is approved for adults with relapsing forms of MS, including CIS, RRMS, and active SPMS.
• Tysabri is given by a trained healthcare professional as an infusion every four weeks.
• Tysabri blocks alpha-4 integrin, making it harder for T cells and B cells to enter the brain and spinal cord.
• Because Tysabri can increase the risk of PML, it is available only through the TOUCH® Prescribing Program.
• JCV antibody status, previous use of medications that weaken the immune system, and length of Tysabri treatment help the healthcare team evaluate a patient’s risk.
• Patients should contact their healthcare team if an infusion is missed or delayed.

This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking any drug or commencing or discontinuing any course of treatment.