Index of drugs

Plaque psoriasis. Treatment of moderate to severe plaque psoriasis in adults who have failed treatment or are contraindicated, or who have intolerance to other types of systemic therapies, including cyclosporin, Methotrexate (MTX) or PUVA (psilarenum and ultraviolet A).Psoriatic arthritis (PsA). The preparation, either alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults, when the response to previous non-biological therapy with disease-modifying antirheumatic drugs (DMARD) is insufficient.

1 vial or 0.5 ml pre-filled syringe contains 45 mg ustekinumab; 1 vial 1 ml contains 90 mg ustekinumab.

An immunosuppressive drug, an interleukin inhibitor. Ustekinumab is a fully human monoclonal IgG1κ antibody that binds with high specificity to the divisible p40 human cytokine subunit - interleukin: IL-12 and IL-23. Ustekinumab inhibits the bioactivity of human IL-12 and IL-23 by preventing p40 binding to the IL-12Rβ1 protein receptor found on the surface of immune cells. Ustekinumab is unable to attach to interleukin IL-12 or IL-23, which are already attached to IL-12Rβ1 receptors on the surface of cells. Therefore, ustekinumab does not affect complement activity, nor does it participate in cytotoxicity of cells with IL-12 and / or IL-23 receptors. Incorrect regulation of IL-12 and IL-23 is associated with immune-mediated diseases such as psoriasis and psoriatic arthritis. By binding to the p40 interleukin IL-12 and IL-23 subunit p40 subunit, ustekinumab may exhibit clinical effects in psoriasis and psoriatic arthritis by disrupting the Th1 and Th17 cytokine pathways that are key in the pathology of these diseases. After subcutaneous administration of a single 90 mg dose, the average time taken to reach C_max is 8.5 days. The absolute bioavailability of ustekinumab after subcutaneous administration of a single dose was 57.2% in patients with psoriasis. The exact metabolism of ustekinumab has not been known. Median T_0,5 ustekinumab in patients with psoriasis and / or psoriatic arthritis is approximately 3 weeks (range 15-32 days). Median apparent clearance (Cl / F) in patients with b. > 100 kg was about 55% larger compared to patients with ≤100 kg. Median value of apparent volume of distribution (V / F) in patients with bw. > 100 kg was about 37% higher compared to patients with a ≤100 kg. The median of the lowest concentrations of ustekinumab in the serum immediately prior to the Next dose in patients with a higher (> 100 kg) taking 90 mg were comparable to those obtained in patients with less than (≤100 kg) at 45 mg.

Hypersensitivity to the active substance or to any of the excipients. Clinically important, active form of infection (eg active tuberculosis).

Ustekinumab may increase the risk of new infections and reactivate latent infections. Caution is advised when making decisions to use ustekinumab in patients with a chronic infection or with a history of recurrent infections. Before starting treatment, the patient should be examined for tuberculosis infection. The preparation must not be used in patients with active forms of tuberculosis. Before initiating ustekinumab therapy, the latent form of tuberculosis should be initiated. Anti-tuberculosis treatment should also be considered before using the drug in patients with a latent or active form of tuberculosis in which the correct therapeutic procedure can not be confirmed. Patients treated with the product should be closely monitored for signs and symptoms of active tuberculosis during and after treatment. If during the course of treatment the patient develops a serious infection, the patient should be carefully monitored and ustekinumab should be discontinued until the symptoms of infection disappear.Immunosuppressants such as ustekinumab may increase the risk of malignant tumors. Particular care should be taken in patients with a history of malignancy or continuing treatment after developing malignancies. All patients, in particular over 60 years old, patients previously undergoing long-term immunosuppressive therapy or patients previously treated with PUVA, should be monitored for non-melanoma skin cancer. In the event of an anaphylactic or other severe hypersensitivity reaction, treatment should be discontinued immediately and appropriate treatment instituted. It is not recommended to administer live viral or bacterial vaccines (such as BCG) simultaneously with the preparation. No data are available on the secondary transmission of infection by live vaccines in patients receiving the preparation. Before starting the vaccination with a live viral or bacterial vaccine, the treatment should be stopped for at least 15 weeks after the last dose and may be resumed at least 2 weeks after vaccination. During the therapy you can take inactivated vaccines or containing killed microorganisms. Long-term treatment with the preparation does not inhibit the humoral immune response to pneumococcal polysaccharides or tetanus vaccines. The safety and efficacy of the combination of ustekinumab and immunosuppressants, including biological preparations or phototherapy, have not been studied in clinical trials for psoriasis. In clinical trials for psoriatic arthritis, the concomitant use of MTX did not affect the safety and efficacy of the preparation. Particular care should be taken when considering the concomitant use of other immunosuppressants and ustekinumab and when switching from other biological immunosuppressive agents. It is not known whether the preparation affects the immunotherapy of allergies. During observation of the patient during treatment with ustekinumab, particular attention should be paid to the symptoms of erythrodermic psoriasis or exfoliative dermatitis. If these symptoms occur, appropriate treatment should be instituted. The preparation should be discontinued if a drug reaction is suspected. The drug has not been studied in patients with impaired hepatic or renal function. Due to the increased risk of infection, caution should be exercised in elderly patients. The safety and efficacy of the medicine in children and adolescents under 18 has not yet been established.

Avoid using the product during pregnancy. Women of childbearing potential should use effective contraception during treatment and for at least 15 weeks afterwards. The drug should not be used during lactation. The decision to stop breastfeeding during treatment and up to 15 weeks after its completion or discontinuation of the preparation must be made after considering the benefits of breastfeeding and the benefits of using the drug in the mother.

Common: tooth infection, upper respiratory tract infection, nasopharyngeal inflammation, dizziness, headache, mouth and throat pain, diarrhea, nausea, pruritus, back pain, muscle pain, joint pain, fatigue, erythema at the injection site pain at the injection site. Uncommon: cellulitis, shingles, upper respiratory tract infection, hypersensitivity reactions (including rash, urticaria), depression, facial nerve palsy, nasal congestion, pustular psoriasis, exfoliation, injection site reactions (incl. : bleeding, hematoma, induration, swelling and pruritus). Rare: exfoliative dermatitis, severe hypersensitivity reactions (including anaphylactic reaction, angioneurotic edema). Immunosuppressants such as ustekinumab may increase the risk of malignant tumors. In some patients who took the product during clinical trials, skin cancers or other locations appeared. In clinical trials, less than 8% of patients treated with ustekinumab developed antibodies to ustekinumab. There was no apparent association between the production of antibodies to ustekinumab and the appearance of a reaction at the injection site. Most patients with ustekinumab antibodies had neutralizing antibodies.The effectiveness of treatment was lower in patients showing positive results of tests for antibodies against ustekinumab, but the presence of antibodies does not preclude a positive clinical response to treatment.

Subcutaneously. Adults. The preparation should be used under the supervision of a physician experienced in the diagnosis and treatment of psoriasis or psoriatic arthritis.Plaque psoriasis. The recommended dosage is an initial dose of 45 mg, followed by the same dose after 4 weeks, and then every 12 weeks. The possibility of discontinuation of treatment in patients who do not show a clinical response to the 28th week of therapy should be considered. For patients with a body weight of> 100 kg the starting dose is 90 mg, then the same dose after 4 weeks, and then every 12 weeks. It has been proven that in these patients, the 45 mg formulation also shows efficacy. However, for a 90-mg dose, the effectiveness was higher.Psoriatic arthritis (PsA). The recommended dosage is an initial dose of 45 mg, followed by the same dose after 4 weeks and then every 12 weeks. Alternatively, a dose of 90 mg can be used in patients with a body weight of> 100 kg. The possibility of discontinuation of treatment in patients who do not show a clinical response to the 28th week of treatment should be considered. No dose adjustment is necessary in elderly patients. The preparation is used in the form of subcutaneous injections. If possible, areas of skin with psoriasis should be avoided as injection sites. With the consent of the physician and after appropriate training in the field of subcutaneous injection technique, patients can make self-injections of the preparation. However, the doctor should provide adequate patient control.