Index of drugs

Treatment of the form of multiple sclerosis with relapses. In clinical trials, this means at least 2 or more relapses of neurological disorders over the past two years. Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without relapsing. In addition, the 44 μg / 0.5 ml dose is used to treat patients with a single demyelinating episode with active inflammation, if other diagnoses are excluded and if patients are at high risk of developing clinically certain multiple sclerosis.

1 amp-syringe. contains 22 μg (6 million IU) or 44 μg (12 million IU) of Interferon beta-1a. The solution contains benzyl alcohol.

Interferons are a group of endogenous glycoproteins with immunomodulatory, antiviral and antiproliferative properties. Interferon beta-1a has the same amino acid sequence as endogenous human interferon beta. It is produced in mammalian cells (Chinese hamster ovary) and is therefore glycosylated like a natural protein. The precise mechanism of action of the preparation in multiple sclerosis is still being investigated. In healthy volunteers, intravenous concentrations of interferon beta-1a show a sharp, multi-exponential decline, and serum concentrations are proportional to its dose. After subcutaneous and intramuscular administration, exposure to interferon beta is equivalent. After multiple subcutaneous injections of the preparation at doses of 22 and 44 μg, C_max usually observed after 8 hours, but it was very variable. Apparent T_0,5 is 50-60 h, which is consistent with the accumulation observed after repeated dosing. Interferon beta-1a is mainly metabolised and excreted by the liver and kidneys.

Hypersensitivity to natural or recombinant interferon beta or excipients. Current severe depressive disorders 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, in epileptic patients with a history of seizures that were insufficiently controlled by treatment; with severe renal failure; with severe liver failure; 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). Close monitoring of patients with severe renal and hepatic impairment as well as patients with severe myelosuppression should be considered. Because of the risk of necrosis at the injection site, it should be checked periodically how the patient administers the medicine, especially if there have been reactions at the injection site. In the event of extensive skin damage, treatment should be discontinued until the skin has healed. Patients with single lesions may continue treatment provided that necrosis is not too extensive. Serum ALT should be measured prior to initiation of therapy, after 1, 3 and 6 months of treatment, and then, if there are no clinical symptoms, studies should be periodically repeated. If the ALT level increases more than 5 times the upper limit of normal, the dose should be reduced, and after normalization of ALT, the dose should be gradually increased. In patients with a history of serious liver disease, clinical signs of active liver disease, alcohol-dependent or with increased ALT (> 2.5 x ULN), special care should be taken at the beginning of treatment. Treatment with the preparation should be discontinued if jaundice or other clinical manifestations of liver dysfunction occur.During the course of treatment, in addition to routine tests required to monitor patients with multiple sclerosis, it is recommended to additionally perform liver function tests, determine the number of leukocytes with smears and determine the number of platelets after 1, 3 and 6 months of treatment, and then if there are no clinical symptoms, periodic repetition of tests. They should be carried out more often when starting treatment with the 44 μg / 0.5 ml preparation. It is recommended to perform basic thyroid function tests at the initial stage of treatment and, if these tests show abnormalities, repeat them every 6-12 months. If the initial test does not indicate abnormal thyroid function, no further routine testing is necessary. However, they should be performed in the event of symptoms suggesting dysfunction of this organ. The preparation has not been studied in patients with primary progressive multiple sclerosis and should not be used in this group of patients. The solution contains 2.5 mg of benzyl alcohol per dose - do not give to premature babies and newborns; The drug may cause poisoning and anaphylactoid reactions in infants and children up to 3 years. If thrombotic microangiopathy (TMA) is diagnosed, treatment should be initiated immediately (including consideration of plasma exchange) and immediate discontinuation of interferon beta therapy 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. If the patient responds poorly to treatment with neutralizing antibodies, the benefit-risk ratio should be considered when continuing treatment with the preparation. The safety and efficacy of the preparation in children under 2 years have not been established. The preparation should not be used in this age group. The solution contains 2.5 mg of benzyl alcohol per dose - do not give to premature babies and newborns; the drug may cause poisoning and anaphylactoid reactions in infants and children up to 3 years of age.

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 prior to initiation of therapy, the risk of a severe relapse should be considered after discontinuation of interferon beta-1a therapy due to pregnancy, 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: neutropenia, lymphopenia, leukopenia, thrombocytopenia, anemia; Headache; inflammation and reactions at the injection site, flu-like symptoms; asymptomatic elevation of transaminases. Common: depression, insomnia; diarrhea, vomiting, nausea; pruritus, rash, erythematous rash, maculopapular rash, alopecia; muscle pain, joint pain; pain at the injection site, fatigue, chills, fever; significant increase in aminotransferases. Uncommon: thyroid dysfunction manifested by hyperthyroidism or hypothyroidism; hepatitis with or without jaundice; necrosis, abscess, infiltration or infection at the injection site; increased sweating; convulsions; vascular retinal disorders (e.g.retinopathy, exudates with the appearance of a bundle of cotton wool in the retina, obstruction of the artery or vein of the retina); thromboembolic events; dyspnoea; urticaria. Rare: thrombotic thrombocytopenic purpura / haemolytic-uremic syndrome, pancytopenia; anaphylactic reactions; hepatic failure, autoimmune hepatitis; suicide attempts; angioneurotic edema, erythema multiforme, skin reactions similar to erythema multiforme, Stevens-Johnson syndrome; medically induced lupus erythematosus; nephrotic syndrome, glomerulosclerosis; connective tissue inflammation at the injection site. Frequency unknown: transient neurological symptoms (ie, decreased sensation, muscle spasms, paresthesia, gait disturbances, muscle and joint stiffness) that may mimic the exacerbation of multiple sclerosis symptoms. The intake of interferons is associated with anorexia, dizziness, anxiety, arrhythmias, vasodilation and palpitations, heavy menstrual bleeding and genital tract bleeding. Higher production of autoantibodies may occur during treatment with interferon beta. The preparation, like other interferons beta, can cause severe liver damage, including acute liver failure. 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 children from 2 to 17 years, taking the medicine three times 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. Subcutaneously.Rebif 22 μg. Adults: 44 μg 3 times a week by subcutaneous injection; 22 μg is recommended for patients who can not tolerate higher doses. At the beginning of treatment, the dose should be gradually increased in order to allow tachyphylaxis and thus reduce side effects.Rebif 44 μg. Adults. In order to enable tachyphylaxis to develop and to reduce side effects, the recommended dosage is as follows: 1-2 weeks: 8.8 μg 3 times per week; 3-4 weeks: 22 μg 3 times a week; from week 5: 44 μg 3 times a week.The first demyelinating episode: 44 μg 3 times a week by subcutaneous injection. Recurrent form of multiple sclerosis: 44 μg 3 times a week by subcutaneous injection; 22 μg is recommended for patients who can not tolerate higher doses. To reduce the flu-like symptoms associated with the medicine, an antipyretic painkiller is recommended before the injection and an additional 24 hours after each injection. It is recommended that patients should be evaluated at least every 2 years for 4 years after starting treatment with the preparation, and the decision on longer treatment should be taken on a case-by-case basis. No clinical or pharmacokinetic studies have been carried out in children and adolescents, however, published data suggest that the safety of interferon beta-1a at 22 μg or 44 μg three times a week as a subcutaneous injection in children from 2 to 17 years similar to those in adults.