Enbrel (ethanercept) solution for injections 50 mg/ml. 1ml. №4

Description

Enbrel Composition
active substance: etanercept;

1 ml of solution contains 50 mg of etanercept;

1 pre-filled syringe contains 50 mg etanercept; 1 prefilled pen contains 50 mg of etanercept;

Enbrel excipients: sucrose, water for injection, sodium phosphate dibasic dihydrate, sodium phosphate monobasic dihydrate, L-arginine hydrochloride, sodium chloride.

Dosage form
Injection.

Basic physical and chemical properties: liquid from colorless to yellow or pale brown, transparent or opalescent; may contain a small amount of translucent or white amorphous particles.

Pharmacotherapeutic group
Immunosuppressants, tumor necrosis factor-a inhibitors. Etanercept. ATX code L04A B01.

Pharmacodynamics
Etanercept is a fancy protein of the human tumor necrosis factor receptor and p75Fc, obtained by recombinant DNA technology using mammalian cells (Chinese hamster ovary cells) as an expression system.

Tumor necrosis factor (TNF, TNF) is a cytokine that plays a major role in the development of the inflammatory process in rheumatoid arthritis. Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic arthritis, as well as in the serum and synovial tissue of patients with ankylosing spondylitis. Infiltration of the psoriatic plaque with inflammatory cells, including T cells, leads to an increase in TNF levels at the sites of psoriatic lesions compared to unaffected areas of the skin. Etanercept is a competitive inhibitor of the binding of TNF to its surface cell receptors, and therefore it inhibits the biological activity of TNF. PNS and lymphotoxin are pro-inflammatory cytokines that bind to two cell surface receptors for tumor necrosis factor (TNF): 55 kDa (p55) and 75 kDa (p75). Both RFNPs exist in the body in membrane-bound and soluble forms. Soluble RFNP regulate the biological activity of TNF.

PNS and lymphotoxin exist mainly in the form of homotrimerids, and their biological activity depends on the cross-linking of TNF receptors located on the cell surface. Dimeric soluble receptors, such as etanercept, have a higher affinity for TNF than monomeric receptors, and therefore are significantly more potent competitive inhibitors of the binding of TNF to its cellular receptors. In addition, the use of the immunoglobulin Fc fragment as a binding element in the structure of the dimeric receptor lengthens the half-life from serum.

Enbrel Indications
Rheumatoid arthritis

Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults in cases where the response to basic anti-inflammatory drugs, including methotrexate (in the absence of contraindications), is insufficient.

Enbrel® can be prescribed as monotherapy in case of intolerance to methotrexate or in cases where long-term treatment with methotrexate is impractical.

Also, Enbrel® is indicated for the treatment of severe active and progressive rheumatoid arthritis in adult patients who have not previously received methotrexate therapy.

Juvenile idiopathic arthritis

Treatment of polyarthritis (rheumatoid factor positive or negative) and advanced oligoarthritis in children and adolescents aged 2 years and older who have a known intolerance or insufficient response to methotrexate therapy.

Treatment of psoriatic arthritis in children over 12 years of age with known intolerance or insufficient response to methotrexate therapy.

Treatment of entesitis associated arthritis in children over 12 years of age with known intolerance or insufficient response to conventional therapy.

Psoriatic arthritis

Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Sepsis or the risk of sepsis.
The presence of active infectious processes in patients, including chronic or local infections, at the time of initiation of Enbrel® treatment.
Interaction with other medicinal products and other forms of interaction
Simultaneous use of anakinra

In patients on the background of simultaneous treatment with Enbrel and anakinra, an increase in the incidence of severe infections was observed, compared with patients who received only Enbrel or anakinra (according to anamnesis).

In addition, in a double-blind, placebo-controlled study conducted with the participation of adult patients, on the background of treatment with methotrexate, the drug Enbrel® and anakinra were observed, there was an increase in the incidence of severe infections (7%) and neutropenia compared with patients who received only Enbrel® ( see sections “Peculiarities of use” and “Adverse reactions”).

The combination of Enbrel® and anakinra has not demonstrated increased clinical benefit, therefore it is not recommended for use.

Simultaneous use of abataceptu

In clinical studies, the simultaneous use of abatacept and Enbrel® led to an increase in the incidence of severe adverse reactions. This combination has not demonstrated increased clinical benefit and is therefore not recommended for use.