Tocilizumab - it is a recombinant humanized monoclonal antibody directed against interleukin 6 receptor, obtained in Chinese hamster ovary (CHO) cells with the use of genetic engineering technology. Tocilizumab was first introduced to the market in 2005 by the Japanese Pharmaceutical and Medical Products Agency. It is the world's first and so far the only drug in its class that inhibits the biological effects of IL-6. In our country, the drug is available in the form of injections as part of the drug program.

Composition of tocilizumab

Tocilizumab (RoActemra 20 mg / mL): concentrate for solution for infusion.

  • Active ingredient: Each vial contains 80/200 / 400mg of tocilizumabin 4/10/20 ml (20 mg / mL).
  • Excipients: sucrose, polysorbate 80, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.

How tocilizumab works

Tocilizumab has the ability to bind specifically to soluble (sIL-6R) and to the plasma membrane (mIL-6R) receptor for IL-6. As a result, it blocks signal transduction to the target cell, inhibiting the pro-inflammatory activity of interleukin 6.

Use of tocilizumab

Tocilizumab has been used to treat adult patients with severe, active, progressive rheumatoid arthritis (RA) who have not yet been treated with MTX.

In addition, the drug is used in the treatment of active juvenile idiopathic arthritis with generalized onset (sJIA). It is also used to treat adult patients with moderate to severe active rheumatoid arthritis (RA) who have had an insufficient response or intolerance to treatment with one or more disease-modifying anti-rheumatic drugs (DMARDs) or factor inhibitors. tumor necrosis (anti-TNF).

Tocilizumab can be used as monotherapy in cases of intolerance to methotrexate or in patients for whom continued treatment with methotrexate is not of benefit.

Indications for the use of tocilizumab

The drug is recommended for:

  • treating adults with progressive rheumatoid arthritisarthritis (RA),
  • treatment of juvenile idiopathic arthritis,
  • treatment of T-cell therapy induced cytokine release syndrome (CRS)
  • and to treat infection caused by COVID-19.

Contraindications to the use of tocilizumab

Do not use the drug if you are allergic to tocilizumab or any of the modules listed in the formulation.

Contraindication to the use of the drug is severe infections such as tuberculosis or hepatitis B.

Dosage of tocilizumab

The drug should be used as prescribed by the doctor. Therapy should only be given by a physician experienced in treating the disease in question.

Precautions

Special caution is advised in patients with liver disease (hepatitis, cirrhosis), as cytokines such as interleukin 6 (IL-6) inhibit the expression of hepatic cytochrome P450 enzymes, leading to a reduction in the expression of enzymes CYP1A2, CYP2C9, CYP2C19 and CYP3A4.

In addition, before using the drug, pay attention to hematological parameters. Mostly in RA patients, neutrophil and platelet counts should be checked every 4 to 8 weeks after starting treatment and then as directed by your he althcare professional.

You should also pay attention to central demyelinating disorders and parameters of lipid metabolism, as patients using tocilizumab tend to:

  • increased total cholesterol value,
  • low-density lipoprotein (LDL) fraction,
  • high-density lipoprotein fraction.

When using the drug, special care should be taken in patients:

  • with the risk of malignant neoplasm and recurrent infections,
  • with chronic infections
  • or with coexisting diseases such as diverticulitis, intestinal ulceration, diabetes, interstitial lung disease, hypertension.

Live and live weakened (attenuated) vaccines should not be given during tocilizumab treatment.

Side effects of tocilizumab

Tocilizumab can primarily cause:

  • upper respiratory tract infection,
  • nasal inflammation,
  • pharyngitis,
  • mouth ulcer,
  • cellulitis,
  • pneumonia,
  • cold sores,
  • shingles,
  • stomach ache,
  • conjunctivitis,
  • gastritis,
  • rash,
  • pruritus,
  • hives,
  • headache,
  • dizziness,
  • increase in hepatic transaminases and total bilirubin levels,
  • weight gain,
  • hypertension,
  • leukopenia,
  • neutropenia,
  • peripheral edema,
  • as well as diverticulitis.

Interaction with other drugs and diseases

In order to avoid undesirable ailments, inform the doctor about all medications that are currently or recently used, as well as about medications that the patient is going to use.

You should also inform your doctor about your current he alth condition, about any diseases or additional ailments you are struggling with.

When starting or ending treatment with tocilizumab, patients should be monitored who are taking individually dose-titrated medications that are metabolized by enzymes (CYP4503 A4, 1A2, or 2C9) as the doses of individual medications may need to be increased to maintain adequate levels. healing effect.

Tocilizumab and pregnancy and breastfeeding

Before taking the drug, inform your doctor if you are pregnant or breastfeeding. The use of tocilizumab during pregnancy and while breast-feeding is generally not recommended.

Storage of tocilizumab

The tocilizumab solution for infusion should be used immediately after first opening and reconstitution. If the product is not used immediately, storage should not be longer than 24 hours at 2 ° C to 8 ° C.

Unopened vials should be stored in the refrigerator according to the expiry date.

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