Index of drugs

Treatment of patients with diagnosed recurrent multiple sclerosis (SR) defined in clinical trials as 2 or more exacerbations (relapses) over the last three years without signs of disease progression between relapses (the drug slows down disability and reduces recurrence) and patients who there has been a single case of demyelination with an active inflammatory process whose severity qualifies for treatment with intravenous corticosteroids if an alternative diagnosis has been ruled out and there is a high risk of developing clinically definite multiple sclerosis. The drug should be discontinued in patients who develop progressive MS.

1 amp-syringe. or 1 injection. semi-automatic contains 30 μg (6 million IU) of Interferon beta-1a.

Interferons are cytokines that mediate antiviral, antiproliferative and immunomodulatory activity. The drug exerts biological effects by binding to specific receptors on the surface of human cells. This binding initiates a complex cascade of intracellular reactions that lead to the expression of numerous interferon-induced gene products and markers, such as: MHC Class I, Mx protein, 2 '/ 5'-oligoadenylated synthetase, ß₂- microglobulin and neopterin. The exact mechanism of action of the drug in multiple sclerosis is not known. The bioavailability of the intramuscular drug is approximately 40%. The strongest effect occurs after 5-15 h. T_0,5 is 10 hours.

Hypersensitivity to natural or recombinant interferon beta or excipients. Severe depression and / or suicidal thoughts. Begin treatment in pregnant women.

Particularly cautiously used in patients with past or present depressive disorder, especially with suicidal ideation (these patients should be closely monitored during therapy and treated appropriately, discontinuation of interferon beta therapy should be considered, patients should be informed that symptoms of depression should be immediately reported to the physician and / or suicidal thoughts); with a history of convulsive seizures treated with anti-epileptic drugs, especially if epilepsy is not adequately controlled by the use of anti-epileptic drugs; with severe renal failure; with severe liver impairment or in patients using hepatotoxic drugs; with severe myelosuppression; with heart disease, e.g. angina pectoris, congestive heart failure, arrhythmia (flu-like symptoms associated with treatment with beta interferon may worsen the health of patients with heart disease). During treatment, in addition to routine tests required to monitor patients with multiple sclerosis, it is recommended to determine the number of leukocytes with smears, platelet counts and blood biochemistry tests, including liver function tests. Patients should be monitored for symptoms of liver damage. Patients with bone marrow suppression may require increased control of whole peripheral blood with differential diagnosis of platelets. If thrombotic microangiopathy (TMA) is diagnosed, treatment should be initiated immediately (including consideration of plasma exchange) and immediate discontinuation of interferon beta is recommended. Clinical signs of TMA include: thrombocytopenia, newly diagnosed hypertension, fever, symptoms with o.u.n. (eg confusion and paresis) and renal dysfunction. In the event of clinical signs of TMA, platelet count, blood lactate dehydrogenase and renal function should be performed; it is also necessary to perform a blood smear for the presence of erythrocyte fragments. Due to the risk of nephrotic syndrome, it is recommended to periodically monitor for early signs or symptoms, such as edema, proteinuria or impaired renal function, especially in patients at high risk of renal disease. It is necessary to quickly treat the nephrotic syndrome. Consider discontinuation of interferon beta-1a.Interferon beta-1a neutralizing antibodies may be produced during treatment, which may be associated with decreased efficacy. The safety and efficacy of the medicine in children <16 years has not been established (only limited data are available for adolescents aged 12-16 years, but no recommendation on posology).

Starting treatment in pregnant women is contraindicated (there is a risk of spontaneous abortion). Women of childbearing potential should use contraception. If the patient becomes pregnant or plans to become pregnant during treatment with interferon beta-1a, discontinuation of treatment should be considered. In patients with frequent relapses, the risk of a severe relapse after discontinuation of interferon beta-1a due to pregnancy should be considered prior to treatment, relative to the potential for an increased risk of spontaneous abortion. There are no data on the secretion of interferon beta-1a in breast milk. Due to the risk of serious side effects in breast-fed infants, a decision should be made whether to discontinue breast-feeding or discontinue the drug.

Very common: headache, flu-like symptoms, fever, chills, excessive sweating. Common: decreased lymphocyte count, decreased white blood cell count, decreased neutrophil count, hematocrit reduction, hyperkalemia, increased urea nitrogen in the blood, muscle spasticity, hypoaesthesia, rhinorrhea, vomiting, diarrhea, nausea, rash, increased sweating, bruises, muscle cramps, neck pain, muscle pain, joint pain, leg pain, back pain, muscle stiffness, musculoskeletal stiffness, lack of appetite, rapid redness, injection site reactions (pain, erythema, bruise), weakness, pain, fatigue, malaise, night sweating, depression, insomnia. Uncommon: decreased platelet count, alopecia, burning sensation at the injection site, uterine haemorrhage, menorrhagia. Rarely: dyspnoea, nephrotic syndrome, glomerulosclerosis. Not known: weight loss, weight gain, abnormal liver function tests, cardiomyopathy, congestive heart failure, palpitations, arrhythmia, tachycardia, pancytopenia, thrombocytopenia, neurological symptoms, syncope, increased tension, dizziness, paresthesia, convulsions, migraine , angioneurotic edema, pruritus, alveolar rash, urticaria, worsening of psoriasis, systemic lupus erythematosus, muscle weakness, arthritis, hypothyroidism, hyperthyroidism, injection site reactions (abscess, reaction, cellulitis, necrosis, bleeding), vasodilatation, anaphylactic reaction, anaphylactic shock, hypersensitivity reactions (angioneurotic edema, dyspnea, urticaria, rash, pruritus rash), hepatic failure, hepatitis, autoimmune hepatitis, suicide attempts, psychosis, anxiety, confusion, instability emotional. After the injection, fainting may occur (usually a single case that occurs at the beginning of treatment and not repeated during subsequent injections) and transient neurological symptoms resembling the symptoms of severity of SR. At any time during treatment, there may be a temporary increase in muscle tone and / or severe muscular weakness preventing any free movement. These symptoms occur for a limited duration depending on the subsequent injections and may recur after subsequent injections. In some cases, these symptoms are associated with the occurrence of flu-like symptoms. During treatment with interferon beta, cases of nephrotic syndrome induced by various types of nephropathy have been reported, including focal segmental glomerulosclerosis with capillary loop (FSGS), minimal change (MCD), membranembold-glomerular nephritis (MPGN) and mesangial glomerulonephritis ( MGN). Thrombotic microangiopathy (TMA) has been reported, including fatal cases; in most cases, TMA occurred in the form of thrombotic thrombocytopenic purpura or haemolytic uremic syndrome. Both TMA and nephrotic syndrome can occur after a few weeks or even several years after starting treatment with beta interferon.Limited data suggest that the safety profile in adolescents aged 12-16 years who take 30 micrograms intramuscularly once a week is similar to that seen in adults.

Treatment with the preparation should be started under the supervision of a doctor who has experience in the treatment of multiple sclerosis. Intramuscularly. Adults: 30 μg once a week. To reduce the incidence and severity of flu-like symptoms, treatment can be started with dose adjustment. If ampoules are used, treatment should be started with 1/4 of the full dose, increasing it at weekly intervals to achieve the full dose (30 μg / week) in 4 weeks. Another dose adjustment is to start with the dose corresponding to approximately 1/2 full dose once a week before increasing it to the full dose. In order to achieve adequate efficacy, after the initial adjustment period, a dose of 30 μg once a week should be achieved and maintained. Once the full dose has been reached, patients may begin to use the pre-filled pen. The disposable AVOSTARTCLIP dose adjustment kit is for use with an amp-syringe only. (With this kit, the dose can be increased by 1/4 or 1/2 of the full dose). No additional benefit was found after administration of 60 μg once a week. Prior to injection and 24 hours after each injection, an antipyretic analgesic is recommended to relieve the flu-like symptoms associated with interferon beta-1a (these symptoms usually occur in the first few weeks). months of treatment). At present, it is not known how long patients should be treated. Clinical assessment should be made after 2 years from the start of treatment. Treatment should be discontinued if the patient develops a progressive process of chronic MS. The recommended area for intramuscular injection using the pre-filled pen is the upper, outer thigh. The injection site should be changed every week.