Index of drugs

Rheumatoid arthritis: Treatment (in combination with methotrexate) of moderate to severe rheumatoid arthritis in adults in cases where the use of anti-rheumatic disease-modifying medicinal products, including Methotrexate (unless contraindicated), is insufficient. It can be used on its own if you have methotrexate intolerance or if further treatment with methotrexate is not appropriate. Treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. The drug, used alone or in combination with Methotrexate, slowed down the progression associated with damage to joint structure, as demonstrated by X-ray examination and improved physical fitness.Juvenile idiopathic arthritis: Treatment of polyarticular arthritis (with or without rheumatoid factor) and developed oliguria arthritis in children and adolescents from 2 years of age, in cases of insufficient response to methotrexate or confirmed methotrexate intolerance. Treatment of psoriatic arthritis in adolescents from the age of 12 years, in cases of insufficient response to methotrexate or confirmed methotrexate intolerance. Treatment of arthritis against tendonitis in adolescents from the age of 12 in the case of insufficient response or confirmed intolerance to traditional treatment. The drug has not been tested in children under the age of 2.Psoriatic arthritis: Treatment of active and progressive psoriatic arthritis in adults in cases where previous use of disease-modifying anti-rheumatic drugs was insufficient. Ethanercept has been shown to improve physical performance in patients with psoriatic arthritis and to slow the damage of peripheral joints, confirmed in X-ray in patients with polyarticular symmetrical subtype of the disease.Ankylosing spondylitis: Treatment of adult patients with severe active ankylosing spondylitis in cases of inadequate response to conventional therapy.Axial spondyloarthritis: Treatment of adults with severe form of axial spondyloarthritis without radiological changes with objective signs of inflammation, including increased C-reactive protein (CRP) and / or changes in magnetic resonance imaging that have shown insufficient response to non-steroidal anti-inflammatory drugs.Psoriasis (plaque): Treatment of adults with moderate to severe plaque psoriasis who have not responded to treatment or have contraindications for treatment or show intolerance to other forms of systemic therapy, including cyclorsporine, methotrexate or ultraviolet A light using psoralen (PUVA).Plaque psoriasis in children and adolescents: Treatment of children and adolescents from 6 years of age with chronic, severe form of plaque psoriasis, which inadequately respond to previous treatment or show lack of tolerance to other systemic therapies or phototherapy.

1 pre-filled syringe (1 ml) contains 50 mg etanercept. 1 pre-filled pen contains 50 mg of etanercept. 1 vial contains 25 mg of etanercept. 1 vial (for use in children) contains 10 mg of etanercept.

An immunosuppressant, an inhibitor of tumor necrosis factor alpha (TNF-α). The mechanism of action of etanercept lies in the competitive inhibition of the association of TNF with its surface cellular TNFR receptors and thus preventing the TNF-mediated cellular response, which in turn makes TNF biologically inactive. Etanercept may also modulate biological responses controlled by other molecules (e.g., cytokines, adhesion molecules or proteinases) that are induced or regulated by TNF. Etanercept is slowly absorbed from the site of subcutaneous injection, reaching peak blood levels approximately 48 hours after a single dose. The absolute bioavailability is 76%.It is assumed that when administered twice a week, steady-state etanercept concentrations are approximately 2-fold higher than when administered once. Etanercept undergoes slow removal from the body. T_0,5 is about 70 hours.

Hypersensitivity to etanercept or other components of the preparation. Septicemia or the threat of sepsis. Treatment with the preparation should not be initiated in patients with active infections, including chronic or local infections.

Patients should be carefully monitored for signs and symptoms of infections before, during and after treatment with the product (taking into account that the average_0,5 etanercept is about 70 h, in the range: 7-300 h). When assessing a patient for infection, the patient's exposure to opportunistic infections (eg exposure to endemic mycoses) should be considered. The safety and efficacy of etanercept in patients with chronic infections has not been studied. Caution should be exercised when deciding on the use of the preparation in patients with a history of recurring or chronic infections or with co-morbid conditions that promote the occurrence of infections, such as advanced or non-treatable diabetes. Discontinue administration if a patient develops a serious infection. Before starting treatment, all patients should be examined for both active and inactive (latent) tuberculosis - conduct a detailed medical history with a personal history of tuberculosis or any previous contacts with tuberculosis, and previous and / or current immunosuppressive therapy; perform screening tests, ie a tuberculin skin test and x-ray of the chest wall. The risk of a false negative tuberculin skin test result should be borne in mind, especially in severely ill or immunocompromised patients. Do not start treatment with etanercept if you have tuberculosis. If latent tuberculosis is diagnosed, treatment should be started and the benefit / risk ratio should be assessed before starting etanercept. Patients should be advised to report any symptoms that may suggest tuberculosis, such as persistent cough, wasting and / or weight loss, low fever, both during or after etanercept therapy. Before starting treatment with etanercept, patients should be screened to rule out HBV infection. In the case of a positive HBV test result, consultation with a physician experienced in the treatment of hepatitis B is recommended. Caution should be exercised in patients diagnosed as HBV carriers - be observed for signs and symptoms of active HBV infection. In patients infected with HBV, etanercept should be discontinued and effective antiviral therapy initiated with appropriate supportive care. Caution should be exercised when using etanercept in patients with a history of hepatitis C. Due to the immunosuppressive action of TNF antagonists, the drug may affect the body's defenses against infections and malignant neoplastic processes. Patients undergoing significant exposure to varicella virus should temporarily discontinue etanercept, and should consider antiplatelet and varicella immune globulin as preventive therapy. The safety and efficacy of the preparation in immunosuppressive patients has not been studied. The possibility of developing lymphomas, leukemia or other hematopoetic malignancies or solid tumors in patients treated with TNF antagonists can not be ruled out. Caution should be exercised when deciding on the use of TNF antagonists in patients with a history of malignancies or when deciding whether to continue treatment in patients who develop malignancy. Due to the risk of skin cancer, periodic skin examinations are recommended for all patients, especially those at high risk. Special care should be taken when treating patients with a history of blood dyscrasias (disorder). In the event of signs and symptoms suggestive of a disorder or infection (e.g.persistent fever, sore throat, bruising, bleeding or pallor) complete blood counts should be performed; discontinue etanercept treatment in case of confirmation of discrepancy. The risk / benefit ratio should be carefully assessed, as well as neurological assessment should be performed, prescribing the preparation to patients with demyelinating syndromes o.u.n. in the early phase or in a history or in patients who are at increased risk of developing a demyelinating syndrome. Caution should be used in patients with congestive heart failure (risk of worsening the course of the disease) and in the elderly. Clinical experience with the use of etanercept in patients with impaired renal or hepatic function is limited. Do not use the preparation for the treatment of alcoholic hepatitis. Take caution when using etanercept in patients who have moderate to severe alcoholic hepatitis. In patients with diabetes, it may be necessary to reduce the dose of antidiabetic agents with etanercept. The effect of long-term treatment with the preparation on the development of autoimmune diseases is unknown. Do not give live vaccines at the same time as etanercept. It is recommended, if possible, that patients from the pediatric population should be subjected to all vaccinations required by the applicable guidelines before initiating etanercept therapy. The use of etanercept with anakinra or abatacept is not recommended. The safety profile of etanercept used simultaneously with methotrexate was similar to the safety profile of both drugs used alone (no long-term studies). The safety of long-term use of etanercept in combination with other anti-rheumatic disease-modifying drugs (DMARDs) has not been established. The use of the preparation in combination with other forms of systemic therapy or phototherapy in the treatment of psoriasis has not been evaluated. The preparation is not recommended for the treatment of Wegener's granulomatosis. In the event of a severe allergic reaction or anaphylactic reaction, treatment should be discontinued immediately and appropriate treatment instituted. The needle cover of the pre-filled syringe and pen contains latex, which may cause hypersensitivity reactions in people with hypersensitivity to latex.

Use effective contraception during treatment and for 3 weeks after treatment. The use of etanercept in pregnancy is not recommended. Etanercept crosses the placenta and is detected in the serum of infants. Infants may be at increased risk of infection. In general, live vaccines are not recommended for infants up to 16 weeks after the last dose of etanercept taken by the mother. Etanercept passed into human milk after subcutaneous administration. A choice should be made between stopping breastfeeding or stopping etanercept treatment, taking into account the benefits of breastfeeding to the child and the benefits of treatment for the woman.

Very common: infections (including upper respiratory tract infections, bronchitis, cystitis, cutaneous infections), injection site reactions (including bleeding, bruising, erythema, pruritus, pain, swelling). Common: allergic reactions, autoantibody formation, pruritus, fever. Uncommon: severe infections (including pneumonia, cellulitis, infectious arthritis, sepsis, parasitic infections), non-melanoma skin cancer, thrombocytopenia, systemic vasculitis (including vasculitis with the presence of antibodies against neutrophil cytoplasm - ANCA), uveitis, scleritis, interstitial lung disease (including pneumonitis and pulmonary fibrosis), angioneurotic edema, urticaria, rash, psoriasis-like lesions, psoriasis (including new onset or deterioration and pustular psoriasis, mainly on the hands and feet). Rare: tuberculosis, opportunistic infections (including infections: invasive fungal, protozoal, bacterial and atypical mycobacterial andLegionella), lymphoma, melanoma, anemia, leukopenia, neutropenia, pancytopenia, severe allergic / anaphylactic reactions (including angioneurotic edema, bronchospasm), sarcoidosis, convulsions, cases of demyelinating syndromes o.u.n. (e.g., multiple sclerosis) or limited demyelinating syndromes (e.g.optic neuritis and transverse myelitis), exacerbation of congestive heart failure, increased hepatic enzymes, autoimmune hepatitis, vasculitis (including leukocytoclastic vasculitis), Stevens-Johnson syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, lupus erythematosus a chronic, lupus-like syndrome. Very rare: aplastic anemia, cases of peripheral demyelinating polyneuropathy (including Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, multifocal motor neuropathy), toxic epidermal necrolysis. Frequency unknown: listeriosis, reactivation of hepatitis B virus infection, leukemia, Merkel cell carcinoma, macrophage activation syndrome, exacerbation of dermatomyositis. Deaths were observed during treatment with the preparation, which may have been caused by: pancytopenia and aplastic anemia, interstitial lung disease, severe infections. Various cancers (including breast, lung and lymphoma) have been observed. Malignant tumors, sometimes fatal, have been reported in children, adolescents and young people (up to 22 years of age) treated with TNF antagonists (initiation of therapy aged <18 years), including etanercept. The concomitant use of etanercept and anakinra was associated with severe infections and neutropenia. Also, the use of etanercept with abatacept led to an increase in the number of serious side effects. In children and adolescents with juvenile idiopathic arthritis, adverse reactions were similar in frequency and type to the adverse reactions observed in adult patients. Among severe side effects were: chickenpox with signs and symptoms of aseptic meningitis that had disappeared without clinical sequelae, appendicitis, gastroenteritis, depression, personality disorders, skin ulcers, oesophagitis, gastritis, shock septic in the course of group A streptococcus infection, type I diabetes, soft tissue infections and wounds after surgery. There have also been cases of macrophage activation syndrome and cases of inflammatory bowel disease and uveitis, including a very small number of cases indicating a recurrence of adverse reactions after reuse of etanercept. Adverse reactions in children and adolescents with plaque psoriasis were similar to those observed in adult patients with plaque psoriasis.

Subcutaneously.Adults. Rheumatoid arthritis: 25 mg twice a week or 50 mg once a weekŁpsoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis without radiological changes: 25 mg twice a week or 50 mg once a week. Available data indicate that clinical response is usually achieved within 12 weeks of treatment in the above indications. Careful consideration should be given to continuing therapy in patients who have not responded to treatment during this time.Plaque psoriasis: 25 mg twice a week or 50 mg once a week Alternatively, a dose of 50 mg 2 times a week for up to 12 weeks can be used, and then, if necessary, continue to administer a dose of 25 mg 2 times a week or 50 mg once a week. Treatment should be continued until remission, up to 24 weeks. In some patients continuous therapy should be considered for more than 24 weeks. In patients who have not responded to treatment after 12 weeks, discontinue treatment. If re-treatment is indicated, follow the above indications on the length of treatment and use a 25 mg dose twice a week or 50 mg once a week.Children and youth. Juvenile idiopathic arthritis0.4 mg / kg (up to a maximum dose of 25 mg) 2 times a week with intervals of 3-4 days or 0.8 mg / kg. (up to a maximum dose of 50 mg) once per week. Discontinuation of treatment should be considered for patients who are not responding after 4 months of treatment. There were no formal clinical trials in children aged 2 to 3 years.Limited safety data suggest, however, that the safety profile in children aged 2 to 3 is similar to the safety profile in adults and children aged ≥4 years for subcutaneous administration once a week at a dose of 0.8 mg / kg mc. The drug has essentially no use in children aged <2 years in the indication of juvenile idiopathic arthritis.Plaque psoriasis (≥6 years old): 0.8 mg / kg (up to a maximum dose of 50 mg) once a week for up to 24 weeks. Treatment should be discontinued in patients who have no response after 12 weeks of treatment. If it is advisable to re-treat with the preparation, follow the above indications on the length of treatment and use a dose of 0.8 mg / kg. (up to a maximum dose of 50 mg) once a week. The drug has essentially no use in children aged <6 years in the indication of common psoriasis.Special groups of patients: no dose adjustment is required in patients with renal or hepatic impairment or in the elderly (≥65 years).