INTERFERON BETA-1A (Interferon beta-1a)

     Description : Recombinant human interferon beta? 1a, generated mammalian cells (culture cells of Chinese hamster ovary). The specific activity of anti-over 200 million IU / mg (1 ml containing 30 µ g of interferon beta? 1 and with 6 million IU antiviral activity). There glikozilirovannom in the form of 166 amino acid residues and complex carbohydrate fragment related to the nitrogen atom. On Amino acid sequence identical to the natural (natural) human interferon beta.

     Pharmacology : anti-drugs operation, ummunomodulating, antiproliferativnoe.

Associated with specific receptors on the surface of cells of the human body and triggers a complex cascade mezhkletochnyh interaction leading to interferon- resulting expression of gene products and multiple markers, including histocompatibility complex class I, Mh protein, 2 ', 5'- oligoadenilatsintetazy, beta2- microglobulin and neopterina.

Bullets biological activity (neopterin, beta2- mikroglobulin etc.) determined from healthy donors and patients after injecting doses of 15-75 ug. The concentration of these markers increased during 12 h after and remained elevated for 4-7 days. Peak biological activity typically observed after 48 h after injection. The exact relationship between plasma levels of beta interferon? One and a concentration belkov- markers, which it induces the synthesis, is not yet known.

It stimulates the activity supressornyh cells increased production interleykina? 10 and transform rostovogo factor beta providers with multiple sclerosis and immunosupressornoe antiinflammatory effect. Interferon beta? 1 and reliably reduces the frequency of exacerbations and the rate of progression of irreversible neurological disorders in remittiruyuschem type of MS (slowed growth in the number and size of focal cerebral destruction on the MRT). The treatment may be accompanied by the appearance of antibodies to interferon beta? A 1. They reduced their activity in vitro (neutralizing antibodies) and the biological effects (clinical efficacy) in vivo. In two years of treatment antibodies found in 8% of patients. For others, after 12 months of treatment in serum antibodies appear in 15% of patients.

Mutagennogo actions were detected. Data for the study of carcinogenicity in animals and humans lacking. The study of reproductive function in makak- Rh receiving interferon beta? 1 and in doses exceeding 100 times MRDCH, some animals there cessation of ovulation and lowering serum progesterone (effects were reversible). U monkeys receiving doses of 2 times more than the recommended weekly, these changes were found.

Introduction pregnant monkeys dose 100 times greater than MRDCH not accompanied by acts teratogennogo actions and the negative impact on the development of a fetus. However, the dose of 3-5 times higher than the recommended week, was aborted (with 2-fold excess of a weekly dose of the fetus was not). Information on the impact on the reproductive function of the missing persons.

Pharmacokinetic studies of interferon beta? 1 and in patients with multiple sclerosis were not conducted.

In healthy volunteers pharmacokinetic parameters dependent on the path of : when in / m in a dose of 60 µ g C max was 45 IU / ml was achieved through the 3-15 hour, T1 / 2 to 10 h; When S / S to a max-30 IU / mL time for achieving 3-18 h, T1 / 2 - 8.6 hours While in bioavailability / m introduction was 40% with S /-to 3 times lower. There is little evidence of possible infiltration in breast milk are not available.

     Application : Retsidiviruyuschy multiple sclerosis (at least two relapses of neurological dysfunction over 3 years and the absence of a continuous progression of the disease between relapses).

     Contraindications : Giperchuvstvitelnost (incl. to natural or recombinant beta interferon, whey human albumin), expressed depression and / or the presence of suicidal thoughts, epilepsy (with insufficient funds protivoepilepticheskih), pregnancy, breast-feeding.

     Restrictions apply to : Age 16 (safety and efficacy of not identified).

     Application of pregnancy and breastfeeding : Protivopokazano pregnancy. At the time of treatment should stop breastfeeding.

     Side Effects : According platsebo- controlled study with the / m in a dose of 30 µ g 1 every week, if observed in 2% of cases and more (in parentheses% occurrence in the placebo group).

Grippopodobny Syndrome-61% (40%), usually at the beginning of treatment, including headache 67% (57%), mialgiya 34% (15%), fever 23% (13%), shivers 21% (7%), fatigue 21% (13%).

From the nervous system and sensory organs : insomnia 19% (16%), dizziness 15% (13%), malaise 4% (3%), fear (usually single at the beginning of treatment) 4% (2%), suicidal tendencies 4 % (1%), convulsions 3% (0%), the speech 3% (0%), down from hearing 3% (0%), ataxy 2% (0%).

From the cardiovascular system and blood (blood, hemostasis) : Anemia 8% (3%), eosinophilia 5% (4%), vazodilatatsiya 4% (1%), reducing gematokrita 3% (1%), feel.

From the respiratory system : the development of upper respiratory infections 31% (28%), sinusitis 18% (17%), dyspnoea 6% (5%), ear 6% (3%).

For part of the digestive tract : nausea 33% (23%), diarrhea 16% (10%), neuralgia 11% (7%), anorexia 7% (6%).

Allergic reactions : urticaria 5% (2%), hypersensitivity reactions 3% (0%).

Other : 24% syndrome (20%), incl. arthralgia 9% (5%), pain in the abdomen 9% (6%), chest pains 6% (4%); development infections 11% (6%), including Herpes zoster 3% (2%), Herpes simplex 2% (1%); Causes muscles 7% (6%); Local reaction to the introduction of 4% (1%), incl. inflammation 3% (0%), ekhimoz 2% (1%); Alopecia 4% (1%); vaginitis 4% (2%), higher ACT 3% (1%), ovary cyst 3% (0%) , nevus 3% (0%).

     Networking : Compatible with corticosteroid and AKTG. Not recommended simultaneous application of mielosupressivnymi drugs, including cytostatica (possible additive effect). A careful balance of funds clearance to a large extent depends on the system tsitohroma R450 (ANTIEPILEPTICS drugs, some antidepressants, etc.).

     Dosing and Administration : W / m, and 30 µ g 1 once a week under the supervision of a doctor (possibly in the same time of day, the same day, they have weekly injections). The duration of treatment is determined by a physician.

     Precautions : Be wary designate patients with mild depressive state convulsant syndrome by the kidney and liver failure, severe mielosupressiey. There is a need for careful monitoring of patients with heart diseases, including strokes, congestive heart failure, arrhythmia. In the course of treatment is recommended to control of blood cell, including the number of platelets and leykotsitarnuyu formula, as well as a biochemical analysis of blood (including liver enzymes). With signs of bone marrow suppression needs more careful monitoring of blood.

Women of childbearing age should be informed of the ability of interferon beta? One cause abortion and the need to use appropriate measures of contraception. To use caution during the drivers of vehicles and people, professions related to high concentration. To reduce the appearance grippopodobnogo syndrome injections before and during the 24 hours after it possible to use analgetikov- antipiretikov.

In case of progressive forms of MS treatment should stop.

     Special instructions : The duration of treatment has not been determined (experience more than two months of no). Solution prepared using the attached syringe with the solvent.

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