Interferon beta-1a

When ATH:
L03AB07

Characteristic.

Recombinant human interferon beta-1a, produced by mammalian cells (the culture of Chinese hamster ovary). Specific antiviral activity - more 200 million IU / mg (1 ml solution contains 30 μg interferon beta-1a, possessing 6 million IU of antiviral activity). There is in glycosylated form, It contains 166 amino acid residues and a complex carbohydrate moiety, linked to the nitrogen atom. Amino acid sequence identical to the natural (natural) human interferon beta.

Pharmacological action.
Antiviral, immunomodulatory, antiproliferative.

Application.

Relapsing Multiple Sclerosis (with at least 2 recurrence of neurological dysfunction for 3 years and there are no signs of continuous progression between relapses).

Contraindications.

Hypersensitivity (incl. to natural or recombinant interferon-beta, human serum albumin), severe depression and / or suicidal thoughts, epilepsy (the lack of effectiveness antiepileptics), pregnancy, lactation.

Restrictions apply.

Age to 16 years (Safety and efficacy have not been determined).

Pregnancy and breast-feeding.

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Side effects.

According to a placebo-controlled study with an intramuscular injection in a dose 30 g 1 once a week, if observed in 2% cases and more (in parentheses % occurrence placebo).

Flu-like syndrome - 61%(40%), usually at the beginning of treatment, incl. headache 67%(57%), myalgia 34%(15%), fever 23%(13%), chills 21%(7%), asthenia 21%(13%).

From the nervous system and sensory organs: insomnia 19%(16%), dizziness 15%(13%), malaise 4%(3%), fainting (usually once at the beginning of treatment) 4%(2%), suicidal tendencies 4%(1%), convulsions 3%(0%), speech disorder 3%(0%), diminished hearing 3%(0%), ataxia 2%(0%).

Cardio-vascular system and blood (hematopoiesis, hemostasis): anemia 8%(3%), eozinofilija 5%(4%), vasodilation 4%(1%), decrease in hematocrit 3%(1%), arrhythmia.

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

From the digestive tract: nausea 33%(23%), diarrhea 16%(10%), dyspepsia 11%(7%), anorexia 7%(6%).

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

Other: pain syndrome 24%(20%), incl. arthralgia 9%(5%), abdominal pain 9%(6%), chest pain 6%(4%); the development of infections 11%(6%)incl. Herpes zoster 3%(2%), Herpes simplex 2%(1%); muscle spasm 7%(6%); local reactions in the injection 4%(1%), incl. inflammation 3%(0%), ecchymosis 2%(1%); alopecia 4%(1%); vaginitis 4%(2%), increase in AST 3%(1%), ovarian cyst 3%(0%), nevus 3%(0%).

Cooperation.

Compatible with corticosteroids and ACTH. Not recommended simultaneous application with myelosuppressive drugs, incl. cytostatics (possible additive effect). Precautions combined with means, clearance of which largely depends on the cytochrome P450 (antiepileptic drugs, Some antidepressants and others.).

Dosing and Administration.

/ M, by 30 g 1 once a week under the supervision of a physician (possible in the same time and the same day of the week, changing the injection site every week). The duration of treatment is determined by a physician.

Precautions.

Be wary appoint patients with mild depressive state, convulsive syndrome, renal and hepatic impairment, severe myelosuppression. Careful monitoring of patients with heart disease, incl. stenokardiey, Congestive heart failure, arrhythmia. In the course of treatment is recommended to monitor blood cell composition, incl. platelet count and leukocyte formula, and conduct blood chemistry (including the determination of liver enzymes). If there are signs of bone marrow suppression, a more careful monitoring of blood parameters.

Women of childbearing age should be informed about the ability of interferon beta 1 cause miscarriage and the need to use adequate contraceptive measures. Be wary of during the drivers of vehicles and people, skills relate to the high concentration of attention. To reduce the severity of flu-like syndrome before injection and during 24 h after it, it is possible to use analgesics-antipyretics.

In the case of progressive forms of multiple sclerosis, treatment should cease.

Cautions.

Duration of treatment is not defined (Experience more, than 2 months of no use). The solution was prepared using the supplied diluent syringe.

Cooperation