Avonex: instructions for using the medicine, structure, Contraindications

Avonex is a drug for the treatment of multiple sclerosis..

Avonex: indications and dosage

Treatment of the sick, suffering from recurrent multiple (scattered) sclerosis, characterized by at least two relapses during the preceding 3-year period with no evidence of disease progression between relapses. Treatment of the sick, who had a case of demyelination as a result of an active inflammatory process, requiring intravenous administration of corticosteroids, except for the other, than multiple sclerosis, diagnosis.

The start of drug therapy is carried out under the close supervision of a physician., with experience in the treatment of such diseases. Adult. The recommended dose is 30 g (0,5 ml r-RA) 1 once a week. The drug is introduced into / m. At the beginning of treatment, patients are given either a full dose of the drug - 30 g (0,5 ml r-RA), or half dose (to get used to the drug) - 15 g 1 once a week with a further increase to 30 g.

To ensure the necessary effectiveness of the drug, its further administration after the adaptation period should be 30 g (0,5 ml r-RA) 1 once a week during the course of therapy. At the beginning of therapy with Avonex, a manual titrimetric device is used to administer a half dose of the drug to patients.. Strengthening the therapeutic effect in the case of the introduction of the drug in high doses (60 g) 1 once a week not confirmed.

The duration of the course is determined individually and under the supervision of a doctor.. After 2 years of therapy, the patient must undergo a clinical examination and continue the course of treatment as prescribed by the doctor. Avonex injections should, possibly, produce at the same time on the same day of the week. The injection site should be changed every week.

Avonex is in the form of a ready-made solution for injection in syringes.. Before use, the syringe with the drug must be removed from the refrigerator and left at room temperature. (15–30 ° С) for 30 min for heating. Do not use external heat sources to heat the preparation. (e.g. hot water). Check the appearance of the solution. Avonex should not be used if an insoluble precipitate or discoloration occurs.. The syringe with the drug is intended for single use only..

Powder for the preparation of solution for injection Avonex: to prepare the solution for injection, it is necessary to use a ready-made syringe with a solvent. No other solvent is allowed. The contents of the syringe are carefully added to the Avonex vial using the BIO-SET device.. It is necessary to wait for the complete dissolution of the drug.

Avonex: overdose

Cases of overdose with Avonex are unknown.. In case of an overdose, it is necessary to consult a doctor for observation and timely symptomatic therapy..

Avonex: side effects

The most common manifestation of an adverse reaction of interferons is influenza-like syndrome.. Symptoms: myalgia, fever, chills, increased sweating, asthenia, headache and nausea. These symptoms are usually more pronounced at the start of treatment., their frequency decreases with continued therapy with the drug. To alleviate these symptoms, you can prescribe an analgesic-antipyretic, which should be taken before the administration of the drug and additionally after 24 h after each injection. During treatment, neurological symptoms may occur., which are similar to exacerbations of multiple sclerosis: episodes of muscle spasms and/or muscle weakness, limiting the possibility of voluntary movements.

Side effects by frequency of occurrence are classified into such categories: Often (>1/10), often (>1/100, <1/10), infrequently (>1/1000, <1/100), rarely (>1/10 000, <1/1000), rarely <1/10 000), unknown (frequency not determined from data).

• From the side of the blood and lymphatic system Not known: pancytopenia, thrombocytopenia. From the side of the cardiovascular system Often: sensation of heat.Unknown: vasodilation, cardiomyopathy, congestive heart failure, palpitations, arrhythmia, tachycardia.
• From the side of the nervous system Very often: headache², depression, insomnia. Often: muscle spasms, emotional lability. Unknown: neurotic symptoms, syncope, AG, dizziness, paresthesia, convulsions, migraine, suicidal tendencies, psychosis, anxiety, emotional lability.
• From the respiratory system Often: rhinorrhea. Rarely: dyspnoea.
• From the gastrointestinal tract Often: vomiting, diarrhea, nausea².
• On the part of the skin Often: skin rash, increased sweating, reactions at the injection site. Infrequently: alopecia.Unknown: angioedema, itch, blistering rash, hives, exacerbation of psoriasis, abscess at injection site1.
• On the part of the bones and muscles Often: muscle cramps, pain in the neck and back, myalgia², arthralgia, pain in the limbs, muscle stiffness. Unknown: systemic lupus erythematosus, myalgia, arthritis.
• From the endocrine system Not known: hypothyroidism, hyperthyroidism. Metabolic disorder Unknown: anorexia.
• From the immune system Not known: anaphylactic reactions, anaphylactic shock, hypersensitivity reactions (angioedema, labored breathing, hives, skin rash, itch).
• From the side of the liver Not known: hepatic failure, hepatitis, autoimmune hepatitis.
• From the reproductive system Rarely: uterine bleeding, menorragija.
• General disorders. Often: flu-like symptoms, increase in body temperature², chills, increased sweating². Often: pain/erythema/hematoma at injection site, weakness², fatigue², malaise, increased night sweats. Infrequently: burning sensation at the injection site. Unknown: inflammation/necrosis/bleeding reactions at the injection site, neck pain.
• Changes in laboratory parameters Often: decrease in hematocrit, reduced number of lymphocytes, leukocytes, neutrophils in the blood, increase the level of potassium, serum urea nitrogen. Infrequently: decrease in the number of blood platelets. Unknown: increase or decrease in body weight, changes in liver enzymes.

Avonex: Contraindications

Hypersensitivity to natural or recombinant interferon beta, human serum albumin or other components of the drug, pregnancy period, patients with severe depression and/or suicidal tendencies.

Avonex: interactions with other drugs and alcohol

Special studies of the interaction of Avonex with other drugs, including corticosteroids and ACTH preparations, not performed. The results of clinical studies indicate the possibility of the combined use of Avonex with GCS and ACTH during an exacerbation of the disease. Known, that interferons tend to reduce the activity of enzymes of the cytochrome P450 system. In this regard, it is necessary to use Avonex with drugs with caution., the clearance of which largely depends on the cytochrome P450 system, e.g. antiepileptics and antidepressants.

Avonex: composition and properties

Structure: interferon beta-1a.

Avonex: release form

• since. d/p in. r-ra 6 million IU fl., solution. in spr. 1 ml №4 with needles, № 4.
• rr d / in. 6 million IU syringe 0,5 ml, in set. with needles, № 4

Avonex: pharmachologic effect

Interferons are natural proteins, which are produced by eukaryotic cells in response to viral infection and other biological factors. Interferons are cytokines, which are mediators of the antiviral, antiproliferative and immunomodulating system of the body. Interferon beta is synthesized by different types of cells, including fibroblasts and macrophages. Natural interferon and Avonex (interferon beta-1a) exist in a glycosylated state and contain a single complex carbohydrate fragment, bonded to the N atom.

Glycosylation of proteins affects their stability, activity, distribution and T1 / 2. The biological properties of the drug Avonex are determined by the ability of interferon beta-1a to bind to specific receptors on the surface of cells. As a result of this binding, a complex cascade of intercellular interactions is launched., which leads to interferon-mediated expression of numerous gene products and markers, which include class I major histocompatibility complex, protein Mx, 2´/5´- oligoadenylate synthetase, β2-microglobulin and neopterin. The presence of some of these compounds was detected in the serum and cellular blood fractions of patients., using Avonex.

After intramuscular injection of a single dose of the drug, the content of these compounds in the blood serum remains elevated for 4-7 days. The relationship between the mechanism of action of the drug Avonex in the treatment of multiple sclerosis with the launch of biological interactions, described above, unknown, because the pathophysiology of multiple sclerosis is not well understood.

Pharmacokinetic characteristics of the drug Avonex (interferon beta-1a) studied according to the results of measurements of the antiviral activity of interferon. After a single intramuscular injection of the drug, peak levels of antiviral activity are achieved in the period from 5 to 15 no. T1/2 is about 10 no. The bioavailability of the drug is approximately 40%. Bioavailability with i / m administration of the drug in 3 times higher, than with s / c introduction.

Storage conditions: in a place protected from light at a temperature of 2-8 ° C. Do not freeze.

Avonex: general information

• Sales form: on prescription
• Current in-about: Interferon beta-1a
• Manufacturer: Biogen Idek Manufacturing ApS, Denmark/United Kingdom
• Farm. Group: Immunostimulants. Interferons