Tysabri

The usual recommended adult dose of Tysabri (Natalizumab) is 300 mg given slowly by infusion (over at least 1 hour) into a vein (intravenous infusion) every 4 weeks. The medication will be prepared and given to you by a health care professional, usually in a hospital or a clinic. After you receive your dose of Tysabri (Natalizumab), a health care professional will monitor you for 1 hour for reactions to the medication.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are receiving the medication without consulting your doctor.

It is important that this medication be given exactly as recommended by your doctor. If you miss an appointment to receive Tysabri (Natalizumab), contact your doctor as soon as possible to reschedule your appointment.

You should then continue to receive your dose of Tysabri (Natalizumab) every 4 weeks thereafter.

The safety and effectiveness of this drug when used for longer than 2 years has not been established.

Store unopened vials of Tysabri (Natalizumab) in the refrigerator. Protect from light, and keep out of the reach of children. Do not shake the container or allow it to freeze.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each single-use 15 mL vial, free of preservatives, contains 300 mg of Tysabri (Natalizumab). Nonmedicinal ingredients: polysorbate 80, sodium chloride, sodium phosphate, dibasic, heptahydrate, sodium phosphate, monobasic, monohydrate, and water for injection.

Do not use Tysabri (Natalizumab) if you:

• are allergic to Tysabri (Natalizumab) or any ingredients of Tysabri (Natalizumab)
• have a weakened immune system (e.g., if you have HIV or certain cancers such as Leukemia or lymphomas, or are taking certain medications that can weaken the immune system [immunosuppressants])
• have or have had progressive multifocal leukoencephalopathy (PML), a rare brain infection

There may be an interaction between Tysabri (Natalizumab) and any of the following:

• anti-rejection medications (e.g., Azathioprine, Cyclosporine, mycophenolate, Tacrolimus, Sirolimus, Pimecrolimus)
• BCG
• other biologics (e.g., Abatacept, Adalimumab, Anakinra, Belimumab, Infliximab, Omalizumab)
• cancer medications (e.g., azathioprine, Methotrexate, Vincristine)
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Denosumab
• echinacea
• other MS medications
• Roflumilast
• tretinoin
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Tysabri (Natalizumab). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Tysabri (Natalizumab).

Chronic progressive multiple sclerosis (MS): The safety and effectiveness of using Tysabri (Natalizumab) by people with chronic progressive MS have not been established. Currently, Tysabri (Natalizumab) is only recommended for people with the relapsing-remitting form of MS.

Infections: Tysabri (Natalizumab) may increase the risk of infections. If you notice any signs of an infection such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness, contact your doctor immediately.

Infusion-related reactions: Some people may experience an infusion-related reaction, including headache, dizziness, fatigue, hives, itching, and chills, up to 2 hours after the start of an infusion. If you notice these symptoms, let your doctor know right away.

Kidney function: If you have Kidney Disease or decreased kidney function, discuss with your doctor how Tysabri (Natalizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tysabri (Natalizumab), and whether any special monitoring is needed.

Liver function: Tysabri (Natalizumab) may cause damage to the liver. If you have liver disease or decreased liver function, discuss with your doctor how Tysabri (Natalizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tysabri (Natalizumab), and whether any special monitoring is needed.

If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

Progressive multifocal leukoencephalopathy (PML): Tysabri (Natalizumab) has been associated with an increased risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML), which can lead to disability or death. The risk of developing this infection increases with the length of time Tysabri (Natalizumab) is used.

Signs and symptoms of PML include progressive weakness on one side of the body; clumsiness of limbs; vision disturbances; changes in thinking, memory, and orientation; confusion; and personality changes. Some of the symptoms are similar to MS, so if you develop any of these symptoms or any other unusual symptoms, or if your MS gets worse, contact your doctor immediately. Your doctor should do an MRI scan before you start Tysabri (Natalizumab) to help distinguish a subsequent MS relapse from PML.

Pregnancy: Tysabri (Natalizumab) should not be used during pregnancy unless the benefits outweigh the risks. There have been reports of blood abnormalities in newborns born to women who were treated with Tysabri (Natalizumab) during pregnancy. If you become pregnant while taking Tysabri (Natalizumab), contact your doctor immediately.

Breast-feeding: Tysabri (Natalizumab) passes into breast milk. If you are a breast-feeding mother and are taking Tysabri (Natalizumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Tysabri (Natalizumab) have not been established for children and adolescents less than18 years of age.

Seniors: Safe and effective dosing has not been established for seniors. As they are at a higher risk of developing severe adverse reactions to Tysabri (Natalizumab), seniors should be closely monitored by their physician.