Tyruko, INN-natalizumab.pdf

What is it?

Tyruko, a biosimilar medicine, is used to treat highly active multiple sclerosis (MS) that isn't adequately controlled by other disease-modifying therapies. It contains the active substance natalizumab.

How does it work?

Natalizumab blocks α4β1 integrin on white blood cells involved in inflammation, potentially reducing nerve damage caused by MS.

Why is it authorized in the EU?

Clinical studies showed Tyruko's structure, purity, and biological activity are highly similar to those of the reference medicine Tysabri. It demonstrated equivalent safety and effectiveness in treating relapsing-remitting MS. The benefits of Tyruko were considered to outweigh its identified risks, leading to its authorization.

How is it used?

Tyruko is administered as a 1-hour infusion every 4 weeks by a doctor experienced in treating MS who has access to MRI scanning capabilities. Monitoring during and after infusions is crucial due to the risk of allergic reactions.

Risks:

Increased infection risk, including progressive multifocal leukoencephalopathy (PML), a serious brain infection.
Risk factors for PML include prolonged treatment duration, immunosuppressant use, and pre-existing antibodies.
Common side effects: urinary tract infections, nasopharyngitis, headache, dizziness, nausea, joint pain, and tiredness.

Safety Measures:

Patient monitoring programs to improve awareness of potential risks.
Educational packs for doctors and patients highlighting safety information.
Special alert cards summarizing key safety information for patients.
* Continuous monitoring of Tyruko's safety profile.