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Tyruko

Pronunciation: tie-ROO-koh
Generic name: natalizumab-sztn
Dosage form: injectable injection
Drug class: Selective immunosuppressants

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 1, 2023.

What is Tyruko?

Tyruko (natalizumab-sztn) is an injectable integrin receptor antagonist that is a biosimilar to Tysabri (natalizumab) that may be used to treat adults with relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease) or moderate to severe Crohn's disease (usually after other treatments have been tried).

A biosimilar is a biological product that is like a reference biologic (in this case Tysabri) and for which there are no clinically meaningful differences in terms of safety, purity, and potency. A biosimilar is not considered a “generic” because they are made from living cells rather than chemicals, making them naturally variable, and they are expensive to make. Generic drugs contain identical medicinal ingredients to their reference products and are cheap to make.

Tyruko was FDA-approved on August 24, 2023. It covers all the same indications as the reference product, Tysabri.

Warnings

Tyruko increases the risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually occurs in immunosuppressed people. This can lead to severe disability and death. Risk factors include using presence of John Cunningham Virus (JCV) antibodies, duration of treatment beyond 2 years, and prior use of immunosuppressants. Because of this risk, Tyruko is only available through a restricted distribution program called the Tyruko REMS Program. Call your doctor right away if you have a sudden fever, severe headache, confusion, memory problems, vision changes, eye pain, weakness on one side of your body, or problems with using your arms or legs. These symptoms may start gradually and get worse quickly.

Life-threatening infections, including herpes encephalitis, meningitis, and acute retinal necrosis have occurred in patients receiving natalizumab. Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Significant liver injury, including liver failure requiring transplant, has occurred. Call your doctor at once if you develop any symptoms of liver damage, such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Tyruko can increase your risk of infection. Call your doctor right away if you develop any signs of infection such as fever, chills, sore throat, cough, stuffy nose, redness, pain, swelling, or painful urination.

There is a risk of severe hypersensitivity reactions, such as anaphylaxis, with Tyruko. It should be permanently discontinued if these occur.

Thrombocytopenia (very low platelet counts) can occur with natalizumab. Your doctor will conduct regular blood tests and monitor you for bleeding abnormalities.

In Crohn’s disease, this drug should not be used with concomitant immunosuppressants (such as 6-mercaptopurine, azathioprine, cyclosporine, and methotrexate) or inhibitors of TNF-alpha.

Before taking this medicine

You should not receive Tyruko if you are allergic to natalizumab, or if you have ever had PML.

Your doctor will test you for antibodies to the John Cunningham Virus (JCV). This is a common virus that has infected almost half of the population, although most people are unaware that they have had it. It does not usually cause problems for healthy people but it can be dangerous for those with a weakened immune system.

Tyruko is only available from a certified pharmacy under a special program called the Tyruko REMS Program. You must be registered in the program and understand the risks and benefits of taking this medicine.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

Tyruko can cause harm to an unborn baby and it should not be used while pregnant. Tell your doctor if you are pregnant or plan to become pregnant. Call your doctor right away if you inadvertently become pregnant.

It may not be safe to breastfeed while using Tyruko because it has been detected in human milk. Ask your doctor about any risks.

Tyruko is not approved for use by anyone younger than 18 years old.

Tyruko pregnancy and breastfeeding warnings (more detail)

How is Tyruko administered?

Tyruko is given as an IV infusion into a vein, over one hour, usually once every 4 weeks. A healthcare provider will give you this injection.

The usual dose is 300mg and Tyruko must be given slowly, which is why the  IV infusion can take at least 1 hour to complete. You will be watched closely for at least 1 hour after receiving the infusion, to make sure you do not have an allergic reaction to the medication. An allergic reaction can occur up to 2 hours or longer after your infusion.

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

Tyruko can weaken your immune system. You may get infections more easily, even serious or fatal infections.

You will need frequent blood tests. You may also need a brain scan or spinal tap (lumbar puncture) if you develop signs of a brain infection.

Your doctor must check you every 3 to 6 months for signs of serious infection. Your doctor may also want to check you for several weeks after you stop using this medicine.

Tell any doctor who treats you that you are using Tyruko.

Your doctor will determine every 6 months whether you should continue on treatment, and if so, will authorize treatment for another 6 months.

Detailed Tyruko dosage information

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Tyruko injection.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving Tyruko?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Keep all your regular appointments with your doctor.

What are the side effects of Tyruko?

Get emergency medical help if you have signs of an allergic reaction to Tyruko such as hives, a rash, wheezing, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Some allergic reactions may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy, cold, or sweaty, or if you have chest pain, trouble breathing, or swelling in your face.

Tyruko may cause serious viral infections of the brain or spinal cord that can lead to disability or death. Call your doctor right away if you have any of the following symptoms during treatment with Tyruko or up to 6 months after your last dose (these symptoms may start gradually and get worse quickly):

Also, call your doctor at once if you have:

Common Tyruko side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tyruko side effects (more detail)

What other drugs will affect Tyruko?

Tell your doctor about all your current medicines and any you start or stop using, especially drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

Other drugs may interact with natalizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Tyruko drug interactions (more detail)

Storage

Store unused single-dose vials in the refrigerator between 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date. Do not shake or freeze and protect from light.

Store diluted Tyruko in the refrigerator between 2°C to 8°C (36°F to 46°F) and administer within 4 hours. Discard if not used within this time.

Ingredients

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

Manufacturer

Sandoz Inc.

Popular FAQ

Yes, treatment with Tysabri can weaken your immune system. This may increase your risk of getting an unusual or serious infection. Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML), a rare brain infection. If you have or have had PML, you cannot use Tysabri. Continue reading

You can take Tysabri for as long as you want providing you tolerate it well, have not developed any serious side effects, and Tysabri is still preventing relapses if you have multiple sclerosis (MS) or reducing symptoms, if you have Crohn’s disease. For people with MS, some response is noted at 12 weeks, but it may take up to 2 years for the full effects to be seen. People with Crohn’s disease should discontinue Tysabri if there is no benefit after 12 weeks Continue reading

Tysabri is not chemotherapy, it is a targeted treatment that works by blocking the migration of lymphocytes (a type of immune cell) from the lymph nodes, across the epithelium, and into inflamed tissue. It binds to a receptor that is present on all leukocytes apart from neutrophils and prevents them from binding to their counter receptors. It may also act in several other ways to prevent the further recruitment and inflammatory activity of activated immune cells. Tysabri belongs to the class of medicines known as integrin receptor antagonists. It may also be called a selective immunosuppressant or a monoclonal antibody. Continue reading

Cancer has not been reported as a side effect of Tysabri (natalizumab) in clinical studies. You should tell your doctor if you have cancer now or a history of cancer (for example, leukemia or lymphoma) before you start treatment with Tysabri. Continue reading

More FAQ

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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