Tysabri

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to natalizumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Your doctor or pharmacist can provide more information about natalizumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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• Biogen Idec Inc.

• Elan Pharmaceuticals, Inc.

Before receiving Tysabri, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have any new or worsening medical problems (such as a new or sudden change in your thinking, eyesight, balance, or strength or other problems) that have lasted several days
• have had hives, itching or trouble breathing during or after an infusion of Tysabri 
• have a fever or infection (including shingles or any unusually long lasting infection)
• are pregnant or breastfeeding

Tell your doctor about all of the medicines you are taking, including prescription and non-prescription medicines, vitamins and herbal supplements.

• Tysabri is given once every four weeks through a needle placed in a vein (IV infusion), in a hospital or medical setting.
• The IV infusion usually takes about one hour.
• Following each dose, you will be monitored for side effects and allergic reactions to the medication.
• You must follow all the instructions of the TOUCH Prescribing Program. Before you can begin to receive Tysabri, your doctor or nurse will:
  • explain the TOUCH Prescribing Program to you
  • have you sign the TOUCH Prescriber/Patient Enrollment Form
• Before every Tysabri infusion you will be asked a series of questions to confirm that Tysabri is still right for you.
• Call your doctor who prescribes Tysabri right away to report any medical problems that keep getting worse and last several days.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Specific Drugs

• Mechanism of action in MS not fully elucidated; may involve blockade of α4β1 integrin-mediated leukocyte migration from peripheral blood into CNS.1 5 18

• Binds specifically to α4-subunits of α4β1 and α4β7 integrins expressed on the surface of all leukocytes (except neutrophils) and inhibits α4-mediated adhesion of leukocytes to their counterreceptors, including vascular cell adhesion molecule-1 (VCAM-1).1 5

• May also block α4-mediated cell binding to ligands such as osteopontin and CS-1 of fibronectin.1

• In Crohn's disease, interaction of α4β7 integrin with the endothelial receptor mucosal addressin cell adhesion molecule-1 (MAdCAM-1) implicated as an important contributor to the chronic inflammation of the disease.1 MAdCAM-1 expression found to be increased at active sites of inflammation suggesting that it may play a role in the recruitment of leukocytes to mucosa and contribute to the inflammatory response characteristic of the disease.1

• Mechanism of action in Crohn's disease not fully elucidated; may involve blockade of the interaction of α4β7 integrin receptor with MAdCAM-1 expressed on the vascular endothelium at inflammatory foci.1

• Importance of patients being counseled on and understanding the benefits and risks of natalizumab before the initial prescription is written.1

• Provide natalizumab medication guide to the patient; importance of patient reading the medication guide prior to initiating natalizumab therapy and before each dose of the drug.1 4 (See REMS.)

• Importance of promptly informing clinicians of any new or worsening symptoms that persist over several days.1

• Advise patients that they will need to be evaluated by their prescriber at 3 and 6 months after the first natalizumab infusion and at least once every 6 months during therapy.1

• Importance of informing patients that PML has occurred in patients treated with natalizumab and that PML usually leads to death or severe disability over weeks or months.1 Patients must understand the signs and symptoms and risk of PML and contact their clinician if they develop any symptoms of PML.1

• Importance of promptly informing clinicians of any new or worsening symptoms suggestive of PML (e.g., progressive weakness on one side of the body; clumsiness of limbs; disturbance of vision; changes in thinking, memory, personality, orientation leading to confusion) that have progressed over days to weeks.1 4

• Importance of patients informing all their clinicians that they are receiving natalizumab.1 4

• Importance of discontinuing natalizumab and reporting any symptoms consistent with a hypersensitivity reaction (e.g., urticaria, pruritus, difficulty breathing) that occur during or following IV infusion of the drug.1 4

• Importance of informing patients that natalizumab may increase risk of infection and of informing clinicians if fever or infection (including shingles or any unusually long-lasting infection) occurs.1 4

• Risk of liver injury; importance of contacting clinician if symptoms of hepatotoxicity develop.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1 4

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 4

• Importance of informing patients of other important precautionary information.1 4 (See Cautions.)

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

You must enroll in a prescribing program called TOUCH® in order to begin receiving natalizumab. Your doctor will explain the program and have you sign an enrollment form. Be sure to ask your doctor if you have any questions about the TOUCH® prescribing program. It is very important that you understand and follow all of the instructions for the program.

Your doctor may need to check your brain before you start using this medicine. To do this, you may need to have a test known as a Magnetic Resonance Imaging (MRI) scan.

Natalizumab comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach.
• Loose stools (diarrhea).
• Belly pain.
• Feeling tired or weak.
• Joint pain.
• Back pain.
• Pain in arms or legs.
• Muscle cramps.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Tysabri (natalizumab), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tysabri. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Tysabri.

Review Date: October 4, 2017

Tysabri is a concentrated solution that must be diluted prior to intravenous infusion. Tysabri injection is supplied as 300 mg natalizumab in 15 mL (20 mg/mL) in a sterile, single-use vial free of preservatives.

Tysabri may cause serious viral infections of the brain or spinal cord that can lead to disability or death. Call your doctor right away if you have a sudden fever, severe headache, confusion, memory problems, vision changes, weakness on one side of your body, or problems with using your arms or legs. These symptoms may start gradually and get worse quickly.

Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Call your doctor at once if you develop any symptoms of liver damage, such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

You should also call your doctor right away if you develop any signs of infection such as fever, chills, sore throat, cough, stuffy nose, redness, pain, swelling, or painful urination.

Tysabri is injected into a vein through an IV. A healthcare provider will give you this injection. Tysabri is usually given once every 4 weeks.

Tysabri must be given slowly and the IV infusion can take at least 1 hour to complete. You will be watched closely for at least 1 hour after receiving the infusion, to make sure you do not have an allergic reaction to the medication. An allergic reaction can occur up to 2 hours or longer after your infusion.

Before your first dose, your doctor may recommend an MRI to make sure you do not have any signs of a brain infection.

Tysabri can weaken your immune system. While using this medicine, you may need frequent blood tests. You may also need a brain scan or spinal tap (lumbar puncture) if you develop signs of a brain infection.

It is extremely important that your doctor check you every 3 to 6 months for signs of serious infection. Your doctor may also want to check you for several weeks after you stop using this medicine.

Tell any doctor who treats you that you are using Tysabri.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.