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Tyruko (Natalizumab): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
300 mg/15 mL
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Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Tyruko

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

  • TYRUKO increases your chance (risk) of getting a rare brain infection that usually leads to death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML). If PML happens, it usually happens in people with weakened immune systems.
  • There is no known treatment, prevention, or cure for PML.
  • Your chance of getting PML may be higher if you are also being treated with other medicines that can weaken your immune system, including other treatments for Multiple Sclerosis (MS) and Crohn’s disease (CD). You should not take certain medicines that weaken your immune system at the same time you are taking TYRUKO. Even if you use TYRUKO alone to treat your MS or CD, you can still get PML.
  • Your risk of getting PML is higher if you:
  • have been infected by the John Cunningham Virus (JCV). JCV is a common virus that is harmless in most people but can cause PML in people who have weakened immune systems, such as people taking TYRUKO. Most people who are infected by JCV do not know it or do not have any symptoms. This infection usually happens in childhood. Before you start receiving TYRUKO or during your treatment, your doctor may do a blood test to check if you have been infected by JCV.
  • have received TYRUKO for a long time, especially longer than 2 years.
  • have received certain medicines that can weaken your immune system before you start receiving TYRUKO.
  • Your risk of getting PML is greatest if you have all 3 risk factors listed above. There may be other risk factors for getting PML during TYRUKO treatment that we do not know about yet. Your doctor should discuss the risks and benefits of TYRUKO treatment with you before you decide to receive TYRUKO. See “What are the possible side effects of TYRUKO?”

  • While you receive TYRUKO, and for 6 months after you stop receiving TYRUKO, it is important that you call your doctor right away if you have any new or worsening medical problems that have lasted several days.

    These may be new or sudden and include problems with:

    • thinking
    • eyesight
    • strength
    • balance
    • weakness on 1 side of your body
    • using your arms and legs

Tell all your doctors that you are receiving TYRUKO.

  • Because of your risk of getting PML while you receive TYRUKO, TYRUKO is available only through a restricted distribution program called the TYRUKO REMS Program. To receive TYRUKO, you must talk to your doctor and understand the risks and benefits of TYRUKO and agree to follow all of the instructions in the TYRUKO REMS Program.
  • TYRUKO is only:
  • prescribed by doctors who are enrolled in the TYRUKO REMS Program.
  • given by an infusion nurse from an infusion center that is enrolled in the TYRUKO REMS Program.
  • given to people who are enrolled in the TYRUKO REMS Program.
  • Before you receive TYRUKO, your doctor will:
  • explain the TYRUKO REMS Program to you.
  • have you sign the TYRUKO REMS Patient Enrollment Form.

What is TYRUKO?

TYRUKO is a prescription medicine used to treat adults with:

  • relapsing forms of Multiple Sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. TYRUKO increases the risk of PML. When starting and continuing treatment with TYRUKO, it is important that you discuss with your doctor whether the expected benefit of TYRUKO is enough to outweigh this risk. See “What is the most important information I should know about TYRUKO?”
  • moderate to severe Crohn’s disease (CD). TYRUKO is used:
  • to reduce signs and symptoms of CD.
  • in people who have not been helped enough by, or cannot use the usual CD medicines and medicines called tumor necrosis factor (TNF) inhibitors.

It is not known if TYRUKO is safe and effective in children under 18 years of age.

Who should not receive TYRUKO?

Do not receive TYRUKO if you:

  • have PML.
  • are allergic to natalizumab products or any of the ingredients in TYRUKO. See the end of this Medication Guide for a complete list of ingredients in TYRUKO.

Talk to your doctor before receiving TYRUKO if you have any of these conditions.

What should I tell my doctor before receiving each dose of TYRUKO?

Before you receive TYRUKO, tell your doctor if you:

  • have medical conditions that can weaken your immune system, including:

    • HIV infection or AIDS
    • leukemia or lymphoma
    • an organ transplant
    • other medical conditions that can weaken your immune system

  • have any new or worsening medical problems that have lasted several days. These may be new or sudden and include problems with:

    • thinking
    • eyesight
    • strength
    • balance
    • weakness on 1 side of your body
    • using your arms and legs
  • have had hives, itching or trouble breathing during or after receiving a dose of TYRUKO.
  • have a fever or infection (including shingles or any unusually long lasting infection).

  • are pregnant or plan to become pregnant. TYRUKO may cause low platelets (thrombocytopenia) and low red blood cells (anemia), in your newborn baby if you take TYRUKO while you are pregnant. It is not known if TYRUKO can cause birth defects.

  • are breastfeeding or plan to breastfeed. TYRUKO can pass into your breast milk. It is not known if the TYRUKO that passes into your breast milk can harm your baby. Talk to your doctor about the best way to feed your baby while you receive TYRUKO.

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medicines that can weaken your immune system. Ask your doctor if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I receive TYRUKO?

  • TYRUKO is given 1 time every 4 weeks through a needle placed in your vein (IV infusion). Each infusion will last about 1 hour.
  • Before each TYRUKO dose you will be asked questions to make sure TYRUKO is still right for you.

What are the possible side effects of TYRUKO?

TYRUKO may cause serious side effects, including:

  • See "What is the most important information I should know about TYRUKO?"
  • Herpes Infections. TYRUKO may increase your risk of getting an infection of the brain or the covering of your brain and spinal cord (encephalitis or meningitis) caused by herpes viruses that may lead to death. Call your doctor right away if you have sudden fever, severe headache, or if you feel confused after receiving TYRUKO. Herpes infections of the eye, causing blindness in some patients, have also occurred. Call your doctor right away if you have changes in vision, eye redness, or eye pain.

  • Liver damage. Symptoms of liver damage can include:

    • yellowing of the skin and eyes (jaundice)
    • nausea
    • vomiting
    • unusual darkening of the urine
    • feeling tired or weak
  • Call your doctor right away if you have symptoms of liver damage. Your doctor can do blood tests to check for liver damage.

  • Allergic reactions, including serious allergic reactions. Symptoms of an allergic reaction can include:

    • hives
    • itching
    • trouble breathing
    • chest pain
    • dizziness
    • wheezing
    • chills
    • rash
    • nausea
    • flushing of skin
    • low blood pressure

  • Serious allergic reactions usually happen within 2 hours of the start of your infusion, but they can happen at any time after you receive TYRUKO.

    Tell your doctor right away if you have any symptom of an allergic reaction, even if it happens after your infusion. You may need treatment if you are having an allergic reaction.

  • Infections. TYRUKO may increase your chance of getting an unusual or serious infection because TYRUKO can weaken your immune system. You have a higher risk of getting infections if you also take other medicines that can weaken your immune system.
  • Low platelet counts. TYRUKO may cause the number of platelets in your blood to be reduced. Call your healthcare provider if you have any of the following symptoms:
  • easy bruising
  • heavier menstrual periods than are normal
  • bleeding from your gums or nose that is new or takes longer than usual to stop
  • bleeding from a cut that is hard to stop
  • small scattered red spots on your skin that are red, pink, or purple

The most common side effects of TYRUKO include:

  • headache
  • feeling tired
  • urinary tract infection
  • joint pain
  • lung infection
  • depression
  • pain in your arms and legs
  • diarrhea
  • vaginitis
  • rash
  • nose and throat infections
  • nausea
  • stomach area pain

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects of TYRUKO. Ask your doctor for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of TYRUKO.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

This Medication Guide summarizes the most important information about TYRUKO. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about TYRUKO that is written for healthcare professionals.

What are the ingredients in TYRUKO?

Active ingredient: natalizumab-sztn.

Inactive ingredients: histidine, L-histidine hydrochloride monohydrate; polysorbate 80, sodium chloride and water for injection.

Manufactured by: Sandoz Inc., Princeton, NJ 08540, US License No. 2003

For more information, go to www.tyruko.com or call 1-800-525-8747.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: BLA 761322 · View the label on DailyMed

Revision date stated in the text: October 2025

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Tyruko

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Integrin Receptor Antagonist
Active ingredient Natalizumab 300 mg/15 mL
Dosage form Injection
Route Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) SANDOZ INC
FDA approval BLA 761322Biologics License Application (BLA) Approved August 24, 2023
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
300 mg/15 mL – 15 ml in 1 vial, single-dose / 1 in 1 carton NDC 61314-543-94

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.