Efleura syringe in autoinjector 60 mg/ml 1 ml, 2 pcs.

Netakimab is a recombinant humanized monoclonal antibody that specifically binds interleukin-17A (IL-17A) found directly in tissues or in blood and other body fluids in therapeutic concentrations. IL-17A is a proinflammatory cytokine whose hyperproduction is predominantly due to the activation of Th17-lymphocytes. In the framework of the innate immunity IL-17A has a protective role.
In chronic immune inflammatory diseases pathological activation of Th17-lymphocytes and IL-17 hyperproduction stimulate T-cell response and increased production of other inflammatory mediators: IL-1, IL-6, tumor necrosis factor alpha (TNF-α), growth factors (G-CSF, GM-CSF) and various chemokines.

Netakimab has a high thermodynamic constant of specific binding to human IL-17A. According to preclinical studies, specific binding of netakimab in normal human tissues is limited to tissues of the lung, thymus, lymph node, tonsils, which is consistent with the data on the expression of IL-17 by cells of these tissues.

Administration of netakimab is not accompanied by statistically significant changes in the level of T-lymphocytes and has no effect on the level and the ratio of immunoglobulins of classes A, G and M.
Specific anti-inflammatory activity of netakimab was demonstrated in in vitro and in vivo tests. Netakimab dose-dependently inhibits IL-17 and TNFα-dependent production of interleukin-6 in cell culture at IC50 40 pM. In a model of collagen-induced arthritis in Javanese macaques (Macaca fascicularis), repeated (once a week for 4 weeks) subcutaneous injection of netakimab is accompanied by a decrease in the severity of inflammatory reaction in joints, which was confirmed by histological examination (articular cartilage remains intact, synovial membranes – without signs of lesions and inflammatory response, synoviocyte proliferation was not noted).

In psoriasis patients use of netakimab is accompanied with decrease of inflammation and hyperkeratosis in the skin, significant decrease of C-reactive protein and CRP level. In patients with active ankylosing spondylitis and psoriatic arthritis against the background of netakimab use there is a decrease of inflammation symptoms in the spine, entheses and joints, as well as a rapid decrease of C-reactive protein concentration, which is a marker of inflammation.

Indications

– Treatment of moderate to severe plaque psoriasis in adult patients when systemic therapy or phototherapy is indicated.

– Treatment of active ankylosing spondylitis in adult patients with insufficient response to standard therapy.

– Treatment of active psoriatic arthritis in monotherapy or in combination with methotrexate in case of insufficient response to standard therapy.

Active ingredient

Composition

How to take, the dosage

The use of Efleura® should be under the supervision of physicians experienced in the treatment of diseases for which Efleura® is indicated. After appropriate training it is possible for the patient to selfadminister the drug under the condition of dynamic monitoring by the attending physician. The drug Efleura® may be used both in inpatient and outpatient settings.

Efleura® is given at a dose of 120 mg in two subcutaneous injections of 1 ml of the drug at a concentration of 60 mg/ml.

The treatment of moderate to severe plaque psoriasis in adult patients when systemic therapy or phototherapy is indicated: The recommended dose of 120 mg as two subcutaneous injections of 1 ml (60 mg) of the drug each is given once weekly at weeks 0, 1 and 2, then once every 4 weeks.

Treatment of active ankylosing spondylitis with insufficient response to standard therapy: The recommended dose is 120 mg as two subcutaneous injections of 1 ml (60 mg) of the drug each. The drug is injected once a week at weeks 0, 1 and 2, then every 2 weeks thereafter.

The treatment of active psoriatic arthritis in monotherapy or in combination with methotrexate if there is an insufficient response to standard therapy: The recommended dose is 120 mg as two subcutaneous injections of 1 ml (60 mg) of the drug each. The drug is injected once a week at weeks 0, 1 and 2, then every 2 weeks until week 10 inclusive. From week 14 onward, the drug is administered at a dose of 120 mg in two subcutaneous injections of 1 ml (60 mg) each once every 4 weeks.

The indication

The single dose

once every 4 weeks, starting at week 6

Ankylosing spondylitis

120 mg

0, 1, 2 weeks

Once every 2 weeks, starting at week 4

Psoriatic arthritis

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120 mg

0, 1, 2 weeks

1 every 2 weeks from week 4 through week 10 inclusive, then

once every 4 weeks from week 14

Interaction

Special Instructions

Contraindications

Side effects

Overdose