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What is natalizumab?

Natalizumab is a monoclonal antibody that affects the actions of the body’s immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

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

Natalizumab is also used to treat moderate to severe Crohn’s disease in adults. It is usually given after other Crohn’s disease medications have been tried without successful treatment of this condition.

Natalizumab may also be used for other purposes not listed in this medication guide.

Precautions

Instructions

Side-effects

Interactions

Precautions

Natalizumab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines.

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.

You should not receive natalizumab if you have ever had a brain infection called progressive multifocal leukoencephalopathy.

Before receiving natalizumab, tell your doctor if you have:

• HIV or AIDS;
• herpes or shingles;
• leukemia, lymphoma;
• 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 need a dose adjustment or special tests to safely receive this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether natalizumab passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

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.

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Instructions

Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of a natalizumab overdose are unknown.

Contact your doctor if you miss an appointment for your natalizumab innjection.

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Side-effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash, hives, itching; dizziness, fever; nausea, vomiting; feeling flushed; chest pain, difficulty breathing; swelling of your face, lips, tongue, or throat; feeling light-headed or fainting.

Call your doctor at once if you have any of these serious side effects:

• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of infection such as fever, chills, body aches, flu symptoms, sore throat, cough, redness, pain, swelling, or painful urination;
• weakness on one side of the body, loss of balance or coordination;
• 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).

Less serious side effects may include:

• headache;
• joint or muscle pain;
• stomach pain;
• depression;
• painful menstrual cramps; or
• drowsiness, tiredness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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Interactions

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.

This list is not complete and there may be other drugs that can interact with 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.

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