Natalizumab, Infusion

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KEY POINTS

• This medicine is given by IV to treat Crohn’s disease, or to reduce the frequency of attacks caused by multiple sclerosis.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause a severe brain infection or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: biological response modulator; monoclonal antibody

Generic and brand names: natalizumab, infusion; Tysabri

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a vein) to reduce the frequency of attacks caused by multiple sclerosis (MS). This medicine is also given to treat moderate to severe Crohn’s disease. This medicine is usually given to people after other medicines have not worked.

This medicine can only be given by prescribers, infusion centers, and pharmacies who are registered with a special program. Before receiving this medicine, you may need to have an MRI scan of your brain. You must also be enrolled in the special prescribing program.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A weakened immune system from diseases such as HIV/AIDS, leukemia, lymphoma, or from cancer chemotherapy, organ transplant medicine, radiation therapy, or steroid medicine.
• Progressive multifocal leukoencephalopathy (PML)

Before taking this medicine, you should have an anti-JCV blood test. If the test is positive, you are at risk for progressive multifocal leukoencephalopathy (PML).

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide given to you when you start taking this medicine and each time you receive an infusion.

This medicine is given by a healthcare provider. Keep all appointments for treatment.

This medicine may cause an infusion reaction. Tell your healthcare provider right away if you have:

• Flushing
• Itching
• Chest pain or a fast or pounding heartbeat
• Shortness of breath or wheezing
• Back pain
• Fever and chills
• Nausea
• Skin rashes
• Swelling of the face, mouth, tongue, or throat
• Dizziness or fainting

What should I watch out for?

This medicine increases the risk of progressive multifocal leukoencephalopathy (PML), a brain infection that can lead to death or severe disability. Tell your healthcare provider right away if you have these symptoms while receiving this medicine or within 6 months after treatment:

• Changes in mood or behavior
• Confusion, thinking problems, loss of memory
• Changes in vision, speech, or walking
• Decreased strength or weakness on one side of the body

You need to have exams and blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine also increases the risk of brain infections caused by herpes virus. Contact your healthcare provider right away if you have sudden fever or severe headache.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you develop a fever or ANY other symptoms of infection. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine can cause severe liver problems. Contact your healthcare provider right away if you develop severe tiredness, vomiting, nausea, stomach pain, light-colored bowel movements, dark urine, or yellowing of your eyes and skin.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe depression; thoughts of suicide; new or sudden change in your speech, thinking, eyesight, balance, or strength; confusion; severe headache; unexplained cough, sore throat, or sinus congestion; increased urination or painful urination; fever; trouble breathing; yellowing of your skin or eyes; dark urine; light-colored bowel movements; unusual tiredness or weakness; dizziness or fainting; severe nausea, vomiting, or stomach pain.

Other: Mild headache, diarrhea, mild nausea, menstrual problems, vaginal discharge, joint pain, depression.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Canakinumab (Ilaris)
• Cancer medicines such as cisplatin, doxorubicin (Doxil), hydroxyurea (Droxia, Hydrea), mercaptopurine, vinblastine, and vincristine (Marqibo)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Echinacea
• Immunosuppressants such as azathioprine (Azasan, Imuran), basiliximab (Simulect), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Interferon beta-1a (Avonex, Rebif)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as adalimumab (Humira), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), leflunomide (Arava), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Vaccines

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.