Discover Tyruko: Uses, Dosage, Side Effects, & Warnings

Tyruko is a biosimilar medication of natalizumab, indicated for the treatment of relapsing forms of multiple sclerosis (MS) and Crohn's disease in adults. It is designed to be highly similar to reference medicine, offering a more accessible treatment option for patients while maintaining comparable efficacy and safety profiles.

Tyruko received FDA approval on August 24, 2023, with indications identical to the reference drug, Tysabri. However, It has not been approved for usgae under 18 years of age.

Indication And Uses

Tyruko is prescribed as a standalone therapy for treating various forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It serves to induce and maintain clinical response and remission in Crohns disease (CD) patients experiencing moderate to severe symptoms and inflammation who have had an inadequate response to conventional CD therapies and TNF- inhibitors. However, it's important to note that Tyruko, like other natalizumab products, carries an increased risk of progressive multifocal leukoencephalopathy (PML). Physicians must carefully evaluate the potential benefits of Tyruko against this risk when initiating and continuing treatment.

Dosage And Administration

Tyruko is typically administered as a 300 mg intravenous infusion over the course of one hour, given every four weeks. It's important not to administer Tyruko as an intravenous push or bolus.

After preparation, the Tyruko solution must be administered within four hours. Patients should be closely observed during all infusions. Following the infusion, patients should be monitored for one hour after the completion of the first 12 infusions. For patients who have not exhibited hypersensitivity reactions after 12 infusions, subsequent infusions should be observed according to clinical judgment.

In the treatment of Crohns disease (CD), Tyruko should be discontinued in patients who have not experienced therapeutic benefit within 12 weeks of induction therapy. Additionally, in patients unable to discontinue chronic concomitant steroids within six months of initiating therapy, Tyruko should be discontinued.

Side-Effects

The most common adverse reactions observed with Tyruko include:

For Multiple Sclerosis (MS):

• Fatigue
• Arthralgia (joint pain)
• Urinary tract infection
• Headaches
• Lower respiratory tract infection
• Gastroenteritis
• Vaginitis
• Depression
• Pain in extremity
• Abdominal discomfort
• Diarrhea
• Rash

For Crohns Disease (CD):

• Headache
• Upper respiratory tract infections
• Nausea
• Fatigue

It's important to note that while these side effects are common, not all patients will experience them. Additionally, patients should report any unexpected or severe side effects to their healthcare provider promptly.

Warnings And Precautions

• Tyruko increases the risk of progressive multifocal leukoencephalopathy (PML), a viral brain infection, particularly in those with John Cunningham Virus (JCV) antibodies, extended treatment duration, or prior immunosuppressant use. It's available only through a restricted program due to this risk.
• Life-threatening infections, liver injury, and severe hypersensitivity reactions may occur. Regular monitoring and immediate medical attention for symptoms are essential. Notify your doctor if you experience any infection symptoms like fever, chills, sore throat, cough, congestion, redness, discomfort, swelling, or painful urination.
• Avoid concomitant use with certain medications in Crohn's disease and discontinue Tyruko if hypersensitivity reactions occur.
• Severe hypersensitivity reactions, including anaphylaxis, may arise from Tyruko. If such reactions occur, discontinue its use permanently..
• In some cases, Tyruko can cause symptoms of Thrombocytopenia, characterized by low platelet counts. Your doctor will perform routine blood tests to monitor for bleeding issues.

Tyruko: What You Need to Know Before Use

It's essential to have a thorough discussion with your doctor about potential risks associated with Tyruko, particularly if you have a history of infections, liver disease, or any drug allergies. Additionally, if you are pregnant, planning pregnancy, or breastfeeding, it's crucial to consult with your healthcare provider to assess the potential risks and benefits of using Tyruko during this time.

Participation in the Tyruko Risk Evaluation and Mitigation Strategy (REMS) Program is vital. This program is designed to ensure the safe and appropriate use of Tyruko by providing education and monitoring to patients and healthcare providers. As part of this program, it may be necessary to undergo John Cunningham Virus (JCV) antibody testing.

This testing helps assess the risk of progressive multifocal leukoencephalopathy (PML), a serious brain infection associated with the use of Tyruko. By participating in the Tyruko REMS Program and undergoing JCV antibody testing, patients can be better informed about their individual risk factors and ensure that Tyruko is used safely and effectively.

Tyruko: What You Can Expect After Use

Tyruko can weaken your immune system, making you more susceptible to getting sick, including potentially severe or life-threatening infections. You'll need regular blood tests and may require additional tests like brain scans or spinal taps if there are signs of a brain infection. Your doctor will monitor you closely every 3 to 6 months for signs of serious infection and may continue to check you for several weeks after you stop taking the medication. It's important to inform any healthcare provider treating you that you're using Tyruko. Your doctor will reassess your treatment every 6 months and decide whether to continue your medication for another 6 months.

Interactions and Storage

Inform your doctor of all medications you're taking, especially immunosuppressants. Store Tyruko vials in the refrigerator at 2 degrees to 8 degrees celsius and use for four hours. Do not freeze or shake the medication. If unused within this duration, discard the solution.

Frequently Asked Questions (FAQs)

What activities should I refrain from while undergoing Tyruko treatment?

While receiving Tyruko, it's important to steer clear of individuals who are ill or have infections. If you notice any signs of infection, promptly inform your doctor. Additionally, ensure you maintain all scheduled appointments with your doctor.

What are the consequences of an overdose?

The safety of doses exceeding 300 mg has not been sufficiently assessed. However, as this medication is administered by a healthcare provider in a clinical environment, the likelihood of an overdose is minimal.