Generic Name: natalizumab, Parenteral Solution

Tysabri

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  • Tysabri
SECTION 1 of 4

Highlights for natalizumab

Parenteral Solution
1

Natalizumab is an injectable drug used to treat multiple sclerosis and Crohn’s disease.

2

Natalizumab is given by a trained doctor or nurse through a needle in your vein once every four weeks.

3

Natalizumab increases your risk of a dangerous condition called progressive multifocal leukoencephalopathy. It’s only available through the TOUCH Prescribing Program. You and your doctor must agree to the program instructions and complete some paperwork before you can get this medication.

4

You’ll receive treatment at an infusion center registered with the TOUCH Prescribing Program. You’ll be monitored during the treatment and for 1 hour after treatment.

5

You may not be able to receive natalizumab if you have a weakened immune system from health conditions, such as HIV, AIDS, leukemia, lymphoma, or an organ transplant.

IMPORTANT INFORMATION

FDA Warning

This drug has a Black Box Warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients to potentially dangerous effects.

Natalizumab increases your risk of progressive multifocal leukoencephalopathy (PML). This is an infection of the brain that usually leads to death or severe disability. Your risk of PML increases the longer you take the drug. It also increases if you take other medications that can weaken your immune system. Because of these risks, you and your doctor must register for the TOUCH Prescribing Program before you can take this drug. Your doctor will monitor you and may need to do tests if you show symptoms of PML.

Severe allergic reaction

This drug may cause a severe allergic reaction, which can include:

  • itching
  • dizziness
  • fever
  • rash
  • nausea
  • flushing
  • trouble breathing
  • chest pain

If you have any of these symptoms, contact your doctor right away.

Infection and disease risk

This drug lowers your immunity, which may increase your risk for infections. Your doctor will check you for symptoms of infection and may do blood tests periodically.

Lowered immunity also increases your risk of developing serious diseases, encephalitis, and meningitis. If you notice sudden fever, severe headache, or if you feel confused after receiving the medication, contact your doctor right away.

May cause liver damage

Natalizumab may cause liver damage. Your doctor may do blood tests to check your liver if you show symptoms of liver damage.

Drug Features

Natalizumab is a prescription drug. It’s an injectable solution that can only be given by a trained healthcare provider in an authorized location.

Why It's Used

Natalizumab is used to treat:

  • relapsing forms of multiple sclerosis
  • moderate to severe Crohn’s disease

How It Works

It’s unclear how natalizumab works in your body.

More Details

How It Works

It’s unclear how natalizumab works in your body. It’s designed to delay movement of potentially damaging immune cells from your blood stream into the parts of your body affected by multiple sclerosis or Crohn's disease.

If you’re taking this medication for multiple sclerosis, the drug prevents these immune cells from entering your brain or spinal cord.

If you’re taking it for Crohn's disease, it prevents these immune cells from entering your gut.

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natalizumab Side Effects

Parenteral Solution

Most Common Side Effects

  • The most common side effects that occur with natalizumab when it’s used to treat multiple sclerosis include:

    • headache
    • fatigue
    • joint pain
    • urinary tract infections
    • pneumonia
    • depression
    • stomach pain
    • diarrhea
    • nausea
    • rash
  • The most common side effects that occur with natalizumab when it’s used to treat Crohn’s disease include:

    • headache
    • fever and chills
    • back pain
    • fatigue
    • pneumonia
    • nausea

Serious Side Effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life threatening or if you think you’re experiencing a medical emergency, call 9-1-1.

  • herpes encephalitis and meningitis. Symptoms may include:

    • sudden fever
    • severe headache
    • confusion
  • liver damage. Symptoms may include:

    • nausea
    • vomiting
    • stomach pains
    • loss of appetite
    • tiredness
    • yellowing of your skin or the whites of your eyes
    • dark urine
  • allergic reaction. Symptoms may include:

    • itching
    • dizziness
    • fever
    • rash
    • nausea
    • flushing
    • trouble breathing
    • chest pain
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Natalizumab doesn’t cause drowsiness.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
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natalizumab May Interact with Other Medications

Parenteral Solution

Natalizumab can interact with other medications, herbs, or vitamins you might be taking. Your healthcare provider will look out for interactions with your current medications. Always be sure to tell your doctor about all medications, herbs, or vitamins you’re taking.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

Pregnant women

Natalizumab is a category C pregnancy drug. That means two things:

  1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
  2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. It isn’t known if natalizumab can harm a fetus. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

If you become pregnant while taking natalizumab, let your doctor know right away. You may need to stop taking it to avoid risks to your baby.

Women who are nursing

Natalizumab can pass through breast milk, but it isn’t known if the amount that does can harm your baby.

You and your doctor should decide if you’ll take natalizumab while breastfeeding.

For Children

The safety and effectiveness of natalizumab haven’t been established in people younger than 18 years.

Allergies

Natalizumab may cause allergic reactions, including severe allergic reactions. Symptoms may include:

  • itching
  • dizziness
  • fever
  • rash
  • nausea
  • flushing
  • trouble breathing
  • chest pain
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How to Take natalizumab (Dosage)

Parenteral Solution

Your doctor will determine a dose that’s right for you based on your individual needs. Your general health may affect your dose. Tell your doctor about all health conditions you have before your doctor or nurse administers the drug to you.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Natalizumab comes with risks if you don’t receive it as prescribed by a doctor.

If You Miss a Dose/Appointment

If you miss a dose, your condition and its symptoms could get worse.

What to Do If You Miss a Dose

Natalizumab is given through a needle in your vein at a registered infusion center. If you have to miss an appointment, contact your doctor or the infusion center to make sure you can reschedule as soon as possible.

How to Tell If the Drug Is Working

You may be able to tell this drug is working for multiple sclerosis if you notice a decrease in flare-up symptoms. These include muscle weakness, vision changes, problems with coordination and balance, and problems with thinking or memory.

You may be able to tell it’s working for Crohn’s disease if you notice improvements in your symptoms, such as less abdominal pain and discomfort.

Natalizumab is a short-term or long-term drug treatment.

Your doctor will evaluate you every 6 months to see if you need to continue treatment.

How Long Does It Take?

You’ll be monitored after receiving this drug. You’ll receive treatment at an infusion center registered with the TOUCH Prescribing Program. You’ll be monitored during the treatment and for 1 hour after treatment.

Clinical Monitoring

Natalizumab can cause damage to your liver, so your doctor may do a blood test to check your liver function after you receive treatment.

Insurance

Many insurance companies will require a prior authorization before they approve the prescription and pay for natalizumab.


Show Sources

Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on April 20, 2015

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Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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