WARNING

Natalizumab is a medication used to treat certain autoimmune diseases, such as multiple sclerosis and Crohn’s disease. While it can be effective in managing these conditions, there are some risks associated with taking Natalizumab injections. Here are the key risks:

• Progressive Multifocal Leukoencephalopathy (PML): The most serious risk associated with Natalizumab is the development of PML, a rare and potentially fatal brain infection. PML is caused by the reactivation of a virus called the JC virus. Regular monitoring is necessary to minimize the risk of PML.
• Immune Suppression: Natalizumab works by suppressing the immune system, which can increase the risk of developing other infections. This includes serious infections such as meningitis and opportunistic infections.
• Allergic Reactions: Some individuals may experience allergic reactions to Natalizumab, ranging from mild symptoms like rash and itching to severe reactions like difficulty breathing, swelling, or anaphylaxis. Immediate medical attention is required if a severe allergic reaction occurs.
• Liver Damage: Rare cases of liver damage have been reported in patients taking Natalizumab. Regular liver function tests are necessary to monitor for any signs of liver problems.
• Other Potential Side Effects: Other less common side effects of Natalizumab include headache, fatigue, nausea, joint pain, and depression. These side effects vary in severity and occurrence among individuals.

It is important to note that the risks and benefits of Natalizumab should be carefully considered and discussed with a healthcare professional. Close monitoring and adherence to the prescribed treatment plan can help minimize the risks associated with this medication.

Why is this medication prescribed?

Natalizumab injection is prescribed for the treatment of certain autoimmune diseases, primarily multiple sclerosis (MS) and Crohn’s disease. Here’s how Natalizumab is used in each condition:

• Multiple Sclerosis (MS): Natalizumab is approved for the treatment of relapsing forms of MS. It is used to reduce the frequency of relapses and delay the progression of physical disability. Natalizumab works by preventing immune cells from crossing the blood-brain barrier and entering the central nervous system, where they cause inflammation and damage to the myelin sheath, a protective covering around nerve fibers.
• Crohn’s Disease: Natalizumab is also used in the treatment of moderate to severe Crohn’s disease. It is prescribed for individuals who have not responded to or cannot tolerate other medications, such as corticosteroids, immunomodulators, or tumor necrosis factor (TNF) inhibitors. Natalizumab works by blocking immune cells from entering the intestines, reducing inflammation and symptoms associated with Crohn’s disease.

How should this medicine be used?

Natalizumab is administered as an intravenous (IV) infusion, which means it is given directly into a vein. Here are the general guidelines for using Natalizumab:

• Administration: Natalizumab is administered by a healthcare professional in a clinical setting, such as a hospital or infusion center. It is not intended for self-administration at home.
• Dosage: The dosage of Natalizumab is determined by the prescribing healthcare professional based on the individual’s condition and response to treatment. The typical recommended dose is 300 milligrams (mg) given as a single infusion once every 4 weeks.
• Preparation: The healthcare professional will prepare the Natalizumab infusion and ensure the correct dosage. They may mix the medication with a compatible infusion solution before administering it.
• Infusion Process: The Natalizumab infusion is given slowly over a period of approximately one hour. The infusion rate may be adjusted based on the individual’s tolerance and any potential side effects.
• Monitoring: During and after the infusion, the individual will be monitored closely for any adverse reactions or side effects. This may include vital sign measurements and assessments of overall well-being.
• Regular Schedule: Natalizumab infusions are typically scheduled every 4 weeks. It is important to follow the prescribed treatment plan and not miss any scheduled infusions unless directed by a healthcare professional.

It is crucial to consult with a healthcare professional for specific instructions on how to use Natalizumab. They will provide detailed guidance on the administration process, including any additional precautions or considerations that may apply to the individual’s situation.

Other uses for this medicine

Natalizumab is primarily used for the treatment of multiple sclerosis (MS) and Crohn’s disease. However, there are no other approved uses for Natalizumab. It is important to consult with a healthcare professional for the most up-to-date information on approved uses.

What special precautions should I follow?

As for special precautions associated with Natalizumab injection, here are some important considerations:

• Risk of Progressive Multifocal Leukoencephalopathy (PML): Natalizumab increases the risk of developing PML, a rare and potentially serious brain infection caused by the JC virus. Prior to starting Natalizumab, individuals are typically screened for the presence of antibodies to the JC virus. Those who test positive are at higher risk of developing PML. Regular monitoring, including brain imaging and clinical evaluations, is necessary to detect early signs of PML.
• Infections: Natalizumab can increase the risk of infections due to its effects on the immune system. Prior to starting treatment, it is important to inform your healthcare professional about any ongoing infections or a history of frequent infections. Monitoring for signs of infection and promptly reporting any symptoms to your healthcare provider is essential.
• Allergic Reactions: Some individuals may experience allergic reactions to Natalizumab. If you have a known hypersensitivity to Natalizumab or any of its components, it is important to inform your healthcare professional. They will evaluate the risks and benefits before prescribing the medication.
• Vaccinations: It is recommended to be up to date with all vaccinations before starting Natalizumab, as the medication can affect the immune response to vaccines. However, live vaccines should be avoided while receiving Natalizumab due to the potential for increased risk of infections.
• Pregnancy and Breastfeeding: Natalizumab should be used during pregnancy only if the potential benefits outweigh the potential risks. It is important to discuss the risks and benefits with your healthcare professional if you are pregnant or planning to become pregnant. The use of Natalizumab during breastfeeding should also be discussed with a healthcare professional.

These precautions are not exhaustive, and it is essential to consult with a healthcare professional who has access to your complete medical history and can provide personalized guidance and advice based on your specific situation.

What special dietary instructions should I follow?

There are no specific dietary instructions associated with Natalizumab injection. However, it is generally recommended to follow a healthy and balanced diet to support overall well-being and immune function. Eating a variety of fruits, vegetables, whole grains, lean proteins, and healthy fats can contribute to maintaining good health.

What should I do if I forget a dose?

Regarding missed doses of Natalizumab, it is important to contact your healthcare professional for guidance. Since Natalizumab is typically administered by a healthcare professional in a clinical setting, missing a dose may require rescheduling the next infusion appointment. It is crucial to follow the prescribed treatment schedule and not miss any scheduled infusions without consulting your healthcare provider. They can provide specific instructions on how to proceed in the event of a missed dose and ensure continuity of treatment.

What side effects can this medication cause?

Natalizumab injection, like any medication, can cause side effects. While not everyone experiences side effects, it is important to be aware of potential adverse reactions.

Here are some common side effects associated with Natalizumab:

• Headache
• Fatigue
• Nausea
• Joint pain
• Respiratory infections (such as the common cold)
• Urinary tract infections
• Influenza (flu)
• Allergic reactions (ranging from mild to severe)

It is important to note that these side effects may vary in severity and frequency among individuals. Additionally, there are some serious and potentially life-threatening risks associated with Natalizumab, which include:

• Progressive Multifocal Leukoencephalopathy (PML): This is a rare and serious brain infection that can cause significant neurological problems. Regular monitoring is necessary to detect early signs of PML.
• Increased Risk of Infections: Natalizumab suppresses the immune system, making individuals more susceptible to infections, including serious infections like meningitis and opportunistic infections.
• Liver Damage: Rare cases of liver damage have been reported in patients taking Natalizumab. Regular monitoring of liver function is recommended.

If you experience any side effects or have concerns while taking Natalizumab, it is crucial to promptly inform your healthcare professional. They can provide appropriate guidance, evaluate your symptoms, and determine the best course of action.

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

• Storage: Natalizumab should be stored in a refrigerator between 2°C and 8°C (36°F and 46°F). Do not freeze the medication. Keep it in its original packaging until ready for use to protect it from light.
• Disposal: It is recommended to consult with your healthcare professional or pharmacist on the proper disposal of unused or expired Natalizumab. They can provide specific instructions in accordance with local regulations and guidelines.

In case of emergency/overdose

In case of an emergency or suspected overdose, it is important to seek immediate medical attention. Contact your local emergency services or go to the nearest emergency room. Be sure to inform the healthcare professionals about the medication you have taken and provide them with any relevant information.

What other information should I know?

• Regular Monitoring: Regular monitoring, including blood tests, may be necessary to assess your response to Natalizumab and monitor for any potential side effects or complications.
• Medical History: It is important to provide your healthcare professional with a comprehensive medical history, including any past or current infections, allergies, or other medical conditions.
• Medication Interactions: Inform your healthcare professional about all the medications, including over-the-counter drugs, supplements, and herbal remedies, that you are currently taking. Some medications may interact with Natalizumab and require adjustments to your treatment plan.
• Travel Considerations: If you plan to travel, especially internationally, it is essential to plan ahead and ensure you have access to necessary medical care and medication during your trip.

Always follow the instructions provided by your healthcare professional and the medication’s packaging regarding the use, storage, and disposal of Natalizumab. If you have any specific concerns or questions, it is recommended to consult with your healthcare provider or pharmacist for personalized guidance.