Interferon beta-1b has antiviral and immunomodulatory activities. The action of interferon beta-1b in MS is due to binding to high affinity receptors on the cell surface expression of a number and starting proteins with antiviral, antiproliferative and anti-inflammatory action. The therapeutic effect of interferon beta-1b in multiple sclerosis is caused by a shift of cytokine balance in favor of anti-inflammatory cytokines, inhibition of proliferation of white blood cells and the violation of the presentation of autoantigens. An important mechanism of action of interferon beta-1b is to reduce the rate of migration of leukocytes across the blood-brain barrier by reducing the expression of metalloproteinases, which increase the permeability of the blood-brain barrier. Interferon beta-1b decreases the binding ability and expression of the receptors for interferon-gamma, as well as sustanon 300 increasing their disintegration. Thus, interferon beta-1b is an antagonist of interferon-gamma, plays an important role in the pathogenesis of multiple sclerosis. In addition, interferon beta-1b increases the suppressor activity of peripheral blood mononuclear cells and reduces the stability of the T-lymphocytes to apoptosis inducing death of autoreactive clones.
Following subcutaneous administration of interferon beta-1b at the recommended dose of 0.25 mg its serum concentration of low or not detected. In this connection, information about the pharmacokinetics in patients with multiple sclerosis who receive interferon beta-1b at the recommended dose, no. After subcutaneous administration of 0.5 mg of interferon beta-1b maximum plasma levels are about 40 IU / ml after 1-8ch after injection. The absolute bioavailability of interferon beta-1b subcutaneous administration is approximately 50%. With intravenous administration of interferon beta-1b, and clearance half-life of the drug in the serum of approximately 30 ml / min / kg and 5 hours, respectively. The introduction of interferon beta-1b in a day does not increase the plasma levels of the drug, and the pharmacokinetics during the course of therapy, presumably, does not change. With subcutaneous administration of interferon beta-1b at a dose of 0.25 mg every other day levels of biological response markers (neopterin, beta2-microglobulin and immunosuppressive cytokine IL-10) increased significantly compared with baseline after 6-12 hours after the first dose. They peaked at 40-124 hours, and remained elevated for 7 days (168 hours) of the study period. The relationship between the levels of interferon beta-1b or plasma levels of markers and induced sustanon 300 them to me-mechanism of action of interferon beta-1b is not installed in multiple sclerosis.
- reducing the frequency and severity of exacerbations in patients with relapsing-remitting multiple sclerosis;
- for slowing the progression of disease in patients with secondary progressive multiple sclerosis.
- Apply strictly on prescription
- Hypersensitivity to recombinant interferon-beta, or other components of the drug;
- Liver disease in the stage of decompensation;
- Severe depressive illness and / or suicidal thoughts in history;
- Epilepsy (not adequately controlled);
Patients with a history is an indication of depression or seizures, as well as patients receiving anticonvulsants, should be used with caution. The drug should be used with caution in patients with heart failure classification in patients with cardiomyopathy. Care must be taken in the treatment in patients with impaired bone marrow function, Ana, Mia, or thrombocytopenia.
In view of the lack of data on the use, care is needed in the appointment of patients younger than 18 years.
Dosing and Administration
Sustanon 300 is injected subcutaneously every other day at a dose of 8 million. IU. The solution is not shaken, and used immediately. Repeated injections are undesirable in the same area of the skin.Treatment of long-term (multi-year). In controlled clinical trials, the effect of treatment with interferon beta-1b was maintained for 3 years of observations. There are results of clinical trials, in which the duration of treatment in patients with relapsing-remitting and secondary progressive multiple sclerosis was 5 and 3 years respectively.
Treatment is carried out under medical supervision.
Patients should be informed that a side effect of treatment with interferon beta-1b can be depression and suicidal thoughts, when they appear, you should immediately consult a doctor. In rare cases, the condition can lead to suicide attempts. In the presence of depression and suicidal thoughts should immediately discontinue therapy.
Before prescribing interferon beta-1b and treatment with full blood count should be regularly carried out, including the identification of leukocyte and determine the activity. In case of increase of transaminases in the serum should be careful observation and examination of the patient. The drug should be abolished with a significant increase in liver enzymes, or the appearance of symptoms of hepatitis. In the absence of clinical signs of liver damage after normalization of liver enzymes can discuss the issue of resuming therapy under careful control of liver function.
About using sustanon 300 in patients with impaired liver function and kidney do not.
In clinical studies, some patients with multiple sclerosis noted the appearance of serum antibodies neutralizing interferon beta-1b. Effect of antibodies on the clinical efficacy of interferon beta-1b is being studied. The available results are contradictory and do not allow an unambiguous conclusion. No evidence of adverse effect of neutralizing antibodies on slowing the progression of disease in secondary progressive multiple sclerosis has been detected.
In patients treated with interferon beta-1b, described cases necrosis at the injection site. The area of necrosis may be extensive and deep. In case of multiple foci of necrosis treatment with interferon beta-1b should be discontinued prior to complete healing, which can last up to 6 months. If you have a single focus and the absence of extensive necrosis, treatment with interferon beta-1b can be continued.
In order to reduce the risk of necrosis at the injection site, the patient should be advised to: