WARNING

Tysabri (natalizumab) is a medication primarily used to treat multiple sclerosis (MS) and Crohn’s disease. While it can be effective in managing these conditions, it also poses certain risks that patients should be aware of. Some of the main risks associated with Tysabri include:

• Progressive Multifocal Leukoencephalopathy (PML): This is a rare but serious brain infection caused by the JC virus. PML can lead to severe disability or even death. The risk of developing PML increases with longer duration of Tysabri treatment, prior exposure to the JC virus, and certain other medications.
• Hypersensitivity Reactions: Some individuals may experience allergic reactions to Tysabri, which can range from mild to severe. Symptoms may include rash, itching, swelling, difficulty breathing, or chest tightness.
• Liver Damage: Tysabri has been associated with liver damage in some cases, leading to elevated liver enzymes. Regular monitoring of liver function is recommended while on Tysabri therapy.
• Increased Risk of Infections: Tysabri can suppress the immune system, making patients more susceptible to infections. Serious infections, including opportunistic infections, have been reported in individuals taking Tysabri.
• Other Potential Side Effects: Other less common side effects of Tysabri may include headache, fatigue, joint pain, nausea, and depression.

Due to these risks, Tysabri is typically reserved for patients who have not responded to or cannot tolerate other treatments for MS or Crohn’s disease. Before starting Tysabri therapy, patients should discuss the potential risks and benefits with their healthcare provider and undergo appropriate testing to assess their risk of developing PML. Additionally, regular monitoring is essential to detect any signs of adverse effects early and adjust treatment as needed.

Why is this medication prescribed?

Tysabri (natalizumab) is prescribed primarily for the treatment of multiple sclerosis (MS) and Crohn’s disease. It is typically recommended for individuals who have not responded to or cannot tolerate other available treatments for these conditions.

In the case of MS, Tysabri is used to reduce the frequency of relapses and delay the progression of disability associated with the disease. It works by blocking certain immune cells from entering the brain and spinal cord, where they can cause inflammation and damage to the nerve cells’ protective covering (myelin).

For Crohn’s disease, Tysabri is prescribed to induce and maintain remission in adults with moderate to severe disease who have had an inadequate response to conventional therapies. It helps reduce inflammation in the digestive tract by preventing immune cells from entering the intestinal tissue and causing damage.

How should this medicine be used?

Tysabri (natalizumab) is typically administered by intravenous infusion. The dosage and frequency of Tysabri administration can vary depending on the condition being treated (multiple sclerosis or Crohn’s disease) and the patient’s individual response to the medication. However, here are some general guidelines for the use of Tysabri:

• Dosage: The standard dosage of Tysabri for multiple sclerosis is 300 milligrams infused over approximately one hour once every four weeks. For Crohn’s disease, the dosage is the same, but the frequency may vary based on the treatment regimen prescribed by the healthcare provider.
• Administration: Tysabri is administered by a healthcare professional in a clinical setting, such as a hospital infusion center or a healthcare provider’s office. The medication is delivered intravenously, usually through a vein in the arm.
• Monitoring: Before starting Tysabri treatment, patients will undergo certain tests to assess their risk of developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with Tysabri use. Throughout the course of treatment, regular monitoring is essential to detect any signs of PML or other adverse effects early.
• Duration of Treatment: The duration of Tysabri treatment can vary depending on the individual patient’s response to the medication and the treating healthcare provider’s recommendations. Some patients may continue treatment indefinitely if they are benefiting from Tysabri and tolerating it well, while others may discontinue treatment due to lack of efficacy, intolerance, or safety concerns.

It’s important for patients to follow their healthcare provider’s instructions regarding the use of Tysabri, including the dosage, frequency of administration, and any monitoring requirements. Patients should also report any new or worsening symptoms to their healthcare provider promptly.

Other uses for this medicine

Some of these conditions include:

• Rheumatoid Arthritis: There has been some investigation into the use of Tysabri for the treatment of rheumatoid arthritis (RA), particularly in cases where other conventional therapies have failed. However, its use in RA is not as established as its use in MS and Crohn’s disease.
• Lupus: Tysabri has been studied as a potential treatment for systemic lupus erythematosus (SLE), another autoimmune disease. While early studies have shown some promise, more research is needed to determine its safety and effectiveness in treating lupus.
• Psoriasis: Tysabri has been explored as a treatment option for psoriasis, a chronic autoimmune skin condition. Clinical trials have shown mixed results, and more research is necessary to evaluate its role in managing psoriasis.

What special precautions should I follow?

Regarding special precautions for Tysabri, patients and healthcare providers should consider the following:

• Risk of Progressive Multifocal Leukoencephalopathy (PML): Tysabri is associated with an increased risk of PML, a rare but serious brain infection caused by the JC virus. Patients should undergo appropriate testing before starting Tysabri to assess their risk of PML, and regular monitoring is essential during treatment.
• Immunosuppression: Tysabri can suppress the immune system, increasing the risk of infections. Patients should be monitored for signs of infection during treatment, and precautions should be taken to reduce the risk of exposure to infectious agents.
• Hypersensitivity Reactions: Some individuals may experience allergic reactions to Tysabri, including rash, itching, swelling, difficulty breathing, or chest tightness. Patients should report any signs of allergic reactions to their healthcare provider promptly.
• Liver Function Monitoring: Tysabri has been associated with liver damage in some cases, so regular monitoring of liver function is recommended during treatment.
• Other Precautions: Patients should inform their healthcare provider about any other medical conditions they have and any medications they are taking before starting Tysabri. Pregnant or breastfeeding women should discuss the risks and benefits of Tysabri with their healthcare provider, as its safety during pregnancy and breastfeeding is not well established.

Overall, patients should follow their healthcare provider’s instructions carefully and report any new or worsening symptoms promptly during Tysabri treatment.

What special dietary instructions should I follow?

Regarding special dietary instructions for Tysabri, there are typically no specific dietary restrictions associated with its use. However, it’s essential to maintain a balanced and healthy diet to support overall health and well-being.

What should I do if I forget a dose?

If you forget a dose of Tysabri, contact your healthcare provider or infusion center as soon as possible to reschedule your appointment. It’s crucial to maintain the recommended dosing schedule to ensure the effectiveness of the treatment. Do not try to make up for the missed dose by taking extra medication on your own.

What side effects can this medication cause?

Tysabri (natalizumab) can cause various side effects, ranging from mild to severe. Common side effects of Tysabri may include:

• Headache
• Fatigue
• Nausea
• Urinary tract infections
• Joint pain
• Respiratory infections (such as the common cold)
• Rash
• Infusion-related reactions (such as fever, chills, or allergic reactions during or shortly after infusion)

While these side effects are relatively common and often mild, there are also more serious side effects associated with Tysabri use. These include:

• Progressive Multifocal Leukoencephalopathy (PML): This is a rare but serious brain infection caused by the JC virus. PML can lead to severe disability or death and is a significant concern with Tysabri use. The risk of PML increases with longer duration of Tysabri treatment, prior exposure to the JC virus, and certain other factors.
• Hypersensitivity Reactions: Some individuals may experience allergic reactions to Tysabri, which can range from mild to severe. Symptoms may include rash, itching, swelling, difficulty breathing, or chest tightness.
• Liver Damage: Tysabri has been associated with liver damage in some cases, leading to elevated liver enzymes. Regular monitoring of liver function is recommended while on Tysabri therapy.
• Increased Risk of Infections: Tysabri can suppress the immune system, making patients more susceptible to infections. Serious infections, including opportunistic infections, have been reported in individuals taking Tysabri.
• Other Potential Side Effects: Other less common side effects of Tysabri may include depression, dizziness, back pain, and gastrointestinal symptoms such as diarrhea.

It’s essential for patients to be aware of these potential side effects and to promptly report any new or worsening symptoms to their healthcare provider. Regular monitoring and communication with your healthcare team are crucial for managing the risks associated with Tysabri treatment.

What should I know about storage and disposal of this medication?

Storage and disposal of Tysabri:

Storage:

• Tysabri should be stored in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze.
• Protect Tysabri from light by storing it in its original carton until ready for use.
• Do not shake the medication vial.

Disposal:

• Unused or expired Tysabri should be disposed of properly according to local regulations or guidelines provided by your healthcare provider or pharmacist.
• Do not dispose of Tysabri in household trash or pour it down the drain or toilet unless instructed to do so.

In case of emergency/overdose

In case of emergency or overdose with Tysabri, it’s essential to seek medical attention immediately. Contact your healthcare provider, local poison control center, or go to the nearest emergency room. Be sure to bring the Tysabri packaging or medication vial with you to the emergency room if possible.

What other information should I know?

• Infusion: Tysabri is administered by intravenous infusion by a healthcare professional in a clinical setting, such as a hospital infusion center or healthcare provider’s office.
• Monitoring: Regular monitoring is essential during Tysabri treatment to assess for potential side effects, including progressive multifocal leukoencephalopathy (PML) and liver function abnormalities.
• Risk-Benefit Discussion: Before starting Tysabri treatment, discuss the potential risks and benefits with your healthcare provider, including the risk of PML and other serious side effects.
• Informing Healthcare Providers: Make sure to inform all healthcare providers involved in your care that you are receiving Tysabri treatment, including dentists and specialists, as it may affect other treatments or procedures.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of Tysabri treatment with your healthcare provider.
• Medication Interactions: Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as they may interact with Tysabri.
• Patient Support: Utilize resources provided by your healthcare provider or patient support programs offered by the medication manufacturer for additional information and support throughout your Tysabri treatment journey.