Olokizumab is a humanized containing grafted complementarity determining regions (CDRs) monoclonal antibody of the immunoglobulin (Ig) G4/kappa isotype.
Olokizumab selectively binds to human IL-6 and effectively neutralizes the effects of IL-6 in vivo and in vitro.
Pharmacological properties:
Obtained data indicate that olokizumab does not significantly bind to other molecules of the IL-6 family and does not affect their functioning, nor does it activate the IL-6 signaling pathway.
Source
Mechanism
of action
Olokizumab is a monoclonal antibody which provides a unique mode of action by direct inhibition of IL-6.
действия
олокизумаба
Mechanism
of action
Olokizumab is a monoclonal antibody which provides a unique mode of action by direct inhibition of IL-6.
Source
Indications for use
and contraindications
The world’s first and only registered IL-6 inhibitor for the treatment of rheumatoid arthritis that blocks the cytokine not the receptors
Olokizumab is recommended for patients aged 18 years or older with moderate to severe rheumatoid arthritis in combination with methotrexate and who have an inadequate response to methotrexate or tumor necrosis factor inhibitor (TNFi) therapy.
The safety findings of long-term olokizumab exposure were consistent with IL-6R inhibitors
Convenient dosing regimen, small injection volume
Improving the quality of life of patients
Contraindications
Use with Caution
Therapeutic Indications

  • Treatment of patients aged 18 years or older with moderate to severe rheumatoid arthritis in combination with methotrexate and who have an inadequate response to methotrexate or tumor necrosis factor inhibitor (TNFi) therapy.

  • Pathogenesis-based therapy of cytokine release syndrome in patients with moderate to severe new coronavirus infection (COVID-19).
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  • A history of hypersensitivity to olokizumab or any component of the drug
  • Active infectious diseases (including tuberculosis).
  • Children under 18 years of age.
  • Hereditary fructose intolerance (the drug contains sorbitol).
  • Breastfeeding.
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  • In patients with a history of serious or opportunistic infections; with concomitant diseases and conditions that are risk factors for developing infections (diabetes, renal failure, use of immunosuppressive drugs, elderly age, etc.).
  • In patients exposed to tuberculosis. The risk-benefit ratio of the drug should be evaluated before using Olokizumab in such patients.
  • In patients with a history of diverticulitis or intestinal perforations and other risk factors for intestinal perforation.
  • In patients with hepatic impairment or hepatic failure.
  • Use during Pregnancy and Breastfeeding

Pregnancy: the safety and efficacy of Artlegia during pregnancy are not well established. In animal studies, reproductive toxicity was not ruled out. It is assumed that IL-6 plays an important role in the cervix opening and, possibly, in the delivery of the placenta. Thus, the use of Artlegia may interfere with labor. In particular, an increase in the frequency of difficulty in labor with retained placenta and, in some cases, with significant vaginal bleeding was observed in animals. The significance of this information for humans is not known.

Six pregnancies were reported in clinical studies, in 5 of which patients received concomitant therapy with methotrexate. Out of the 6 cases of pregnancy, 2 pregnancies were terminated by the decision of the patient or physician (abortion), 2 pregnancies ended with the birth of a live child at term (one spontaneous vaginal birth, one delivery by cesarean section), 1 pregnancy was ectopic and therefore was also terminated, and the outcome of 1 pregnancy was a spontaneous abortion (miscarriage).

Before treatment with Artlegia, women of reproductive age should have a pregnancy test. The attending physician should explain in detail the risks of using Artlegia during pregnancy and instruct the patient of childbearing potential about the need to use highly effective methods of contraception and perform regular pregnancy tests during treatment and for at least 6 months after the last dose of Artlegia. In the event that a patient receiving Artlegia becomes pregnant, she should immediately stop using the drug and consult a doctor.

Olokizumab should not be used during pregnancy unless there is a clear clinical need.

Lactation: the penetration of olokizumab into breast milk has not been studied. There are no clinical data on risks for a breastfed baby. Since Artlegia is indicated for use in combination with methotrexate, which is secreted into breast milk, it is recommended to stop breastfeeding when using the drug.

Fertility: There are no clinical data on the effect of olokizumab on human fertility.
During animal studies, no negative effects of olokizumab on fertility in male and female cynomolgus monkeys were found.
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