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Tysabri, |Tysabri

Tysabri

Generic Name: natalizumab (nat ta LIZ yoo mab)
Brand Names: Tysabri

What is natalizumab?

Natalizumab is a monoclonal antibody that affects the actions of the body"s immune system.

Natalizumab is used in to treat relapsing forms of multiple sclerosis.

Natalizumab may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about natalizumab?

Natalizumab is available only to select patients through a restricted-use program called the TOUCH Prescribing Program. To receive this medication, you must be enrolled in this program and meet all requirements. You will be interviewed before receiving each dose of this medicine to make sure you still meet these requirements.

Call your doctor at once if you develop any signs of infection such as fever, chills, sore throat, cough, stuffy nose, redness, pain, swelling, or painful urination.

What should I discuss with my healthcare provider before receiving natalizumab?

Natalizumab is available only to select patients through a restricted-use program called the TOUCH Prescribing Program. To receive this medication, you must be enrolled in this program and meet all requirements. You will be interviewed before receiving each dose of this medicine to make sure you still meet these requirements.

Before receiving natalizumab, tell your doctor if you have:

• HIV or AIDS;

• herpes or shingles;

• leukemia, lymphoma; or

• if you have had a recent organ transplant;

• if you are using any steroid medicines; or

• if you are being treated with chemotherapy or radiation.

If you have any of these conditions, you may not be able to receive natalizumab, or you may need a dosage adjustment or special tests during treatment.

How is natalizumab given?

Natalizumab is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting every 4 weeks. The medicine must be given slowly through an IV infusion, and can take up to 1 hour to complete.

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

After you receive natalizumab, your caregivers may want to watch you for at least 1 hour in case you have any type of reaction to the medication. An allergic reaction can occur up to 2 hours after your infusion.

What happens if I miss a dose?

Contact your doctor if you miss a dose of natalizumab.

What happens if I overdose?

What should I avoid while receiving natalizumab?

Natalizumab can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

Do not receive a vaccine or flu shot while you are being treated with natalizumab, unless your doctor has told you to.

Natalizumab side effects

• signs of infection such as fever, chills, body aches, flu symptoms, sore throat, cough, redness, pain, swelling, or painful urination;

• sudden change in your vision, balance, strength, or mental state;

• easy bruising or bleeding, unusual weakness;

• white patches or sores inside your mouth or on your lips;

• vaginal itching or discharge;

• tooth pain, gum pain or swelling; or

• flare of herpes infection (cold sores, blisters or lesions of the genital or anal area).

Other, less serious side effects are more likely to occur, such as:

• headache;

• joint or muscle pain;

• stomach pain;

• depression;

• painful menstrual cramps; or

• drowsiness, tiredness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect natalizumab?

Before receiving natalizumab, tell your doctor if you are taking any other medicines, especially those that may affect the immune system such as:

• interferon (Roferon, Intron, Rebetron, Alferon, Avonex, Rebif, Betaseron, or Actimmune);

• cyclosporine (Neoral, Sandimmune, Gengraf);

• sirolimus (Rapamune), tacrolimus (Prograf);

• basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);

• mycophenolate mofetil (CellCept);

• azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel); or

• if you are receiving chemotherapy or radiation treatments.

If you are using any of these drugs, you may not be able to receive natalizumab, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect natalizumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist has additional information about natalizumab written for health professionals that you may read.

What does my medication look like?

Natalizumab is available with a prescription under the brand name Tysabri as an injection. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication.

• 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.