Treatment of patients over 18 years of age with moderate to severe plaque psoriasis in the absence of the effect of the treatment or in the presence of contraindications or intolerance dianabol steroids to other methods for systemic therapy or phototherapy.
Treatment of children aged 12 to 18 years with moderate to severe plaque psoriasis in the absence of the effect of the treatment or in the presence of contraindications or intolerance to other methods for systemic therapy or phototherapy.
Treatment of patients over 18 years of age with active psoriatic arthritis (PsA) as monotherapy or in combination with methotrexate.
– Clinically significant hypersensitivity to ustekinumab or any excipient product;
– Children under the age of 12 years (as indicated by “plaque psoriasis”), up to 18 years (as indicated by “psoriatic arthritis”);
– Pregnancy and lactation;
– Serious infectious disease acute phase, including tuberculosis;
– Malignant neoplasm.
– Chronic or recurrent parasitic dianabol steroids and infectious diseases of viral, fungal or bacterial origin.
– Malignant tumors in anamnesis.
– Older age.
Use during pregnancy and lactation
During the study drug was administered to animals in a dose of 45 times the recommended clinical dose for humans, while there was no evidence of teratogenicity effects, birth defects or developmental delays. However, the results from animal studies are not always applicable to humans.
It is unknown whether ustekinumab is when used in pregnant women result in adverse effects on the fetus or affect reproductive function. There are no adequate and well-controlled studies in pregnant women have been conducted.
It is not recommended to use the drug during pregnancy, effective methods of contraception during and for 15 weeks after treatment with the drug should be used.
Studies in monkeys showed that ustekinumab is excreted in breast milk. It is not known whether the drug is absorbed systemically after absorption. Because many drugs and immunoglobulins are excreted in human milk and because the can cause adverse reactions in infants, should decide to breast-feed while taking this drug, or the abolition of ustekinumab therapy.
Dosing and Administration
Preparation dianabol steroids is intended for subcutaneous injection.
The recommended dose is 45 mg. Making a second injection 4 weeks after the first application, then every 12 weeks. In patients weighing more than 100 kg of the drug is recommended at a dose of 90 mg.
In case of failure of therapy for 28 weeks is recommended to consider the appropriateness of the drug.
Patients who have clinical efficacy in the application every 12 weeks expressed enough, increase the dose to 90 mg every 12 weeks. In such case the dosing regimen is not effective, the dose should be administered 90 mg every 8 weeks.
The resumption of treatment
was shown, that the resumption of therapy according to the scheme: a second injection 4 weeks after the first application, and then every 12 weeks, is effective and safe.
The recommended dose is 45 mg. Making a second injection 4 weeks after the first application, then every 12 weeks. In patients weighing more than 100 kg of the drug it is recommended to use a dose of 90 mg.
Use of the leads to a significant weakening of the histological manifestations of psoriasis, including hyperplasia and proliferation of epidermal cells. These data are consistent with clinical efficacy.
Patients with psoriasis and / or psoriatic arthritis ustekinumab not significantly affect the ratio of immune cells circulating in the blood, including a memory cell and non-activated T-cells and cytokine concentration in blood. Concentration of systemic inflammatory markers in patients receiving ustekinumab, is within normal limits, and performance differ slightly in patients taking the drug dianabol steroids , compared with the placebo group.