Avonex - description of the drug, instructions for use, reviews

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Manufacturers: Pierre Fabre Ltd

Active ingredients

• Interferon beta-1a

Disease class

• Multiple sclerosis

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Antiproliferative
• Antiviral
• Immunomodulatory

Pharmacological group

• Antiviral (except HIV) drugs
• Interferons

Lyophilisate for the preparation of solution for injection Avonex (Avonex)

Instructions for medical use of the drug

Indications for use

- treatment of patients suffering from relapsing multiple (multiple) sclerosis, characterized by at least two relapses over the previous three-year period with no signs of disease progression between relapses; - treatment of patients who have had a case of demyelination as a result of an active inflammatory process that required intravenous corticosteroids, with the exclusion of any other diagnosis other than multiple sclerosis.

Release form

lyophilisate for preparing a solution for intramuscular administration 30 mcg; glass bottle (bottle) with a solvent in a syringe and needles, tray 4, cardboard pack 1.

Pharmacodynamics

Interferons are natural proteins produced by eukaryotic cells in response to viral infection and other biological factors. Interferons are cytokines that are mediators of the antiviral, antiproliferative and immunomodulatory systems of the body. Interferon beta is synthesized by various types of cells, including fibroblasts and macrophages. Natural beta-interferon and the drug Avonex (interferon beta-1a) exist in glycosylated form and contain a single complex hydrocarbon fragment linked to the N atom. Glycosylation of proteins affects their stability, activity, biodistribution and half-life. 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 of the human body and trigger a complex cascade of intercellular interactions, leading to interferon-mediated expression of numerous gene products and markers, such as major histocompatibility complex class I, Mx protein, 2 '/5'-oligoadenylate synthetase, b-2-microglobulin and neopterin. The presence of some of these compounds was detected in the serum and cellular blood fractions of patients receiving the drug Avonex. After intramuscular administration of 1 dose of the drug, the content of these compounds in the serum remained elevated for 4–7 days. It is unknown whether the mechanism of action of Avonex in the treatment of multiple sclerosis is related to the triggering of the biological interactions described above, because The pathophysiology of multiple sclerosis has not yet been sufficiently studied. The effect of the drug in the treatment of multiple sclerosis was assessed in a strictly controlled study conducted in patients with relapsing forms of multiple sclerosis. It was shown that the total number of patients who experienced progression of disability (as determined by the Kaplan-Meier table) at the end of the second year of the study was 35% with placebo and 22% with Avonex. In order to compare the effectiveness of different doses of the drug, a double-blind randomized study was conducted on 802 patients suffering from multiple (multiple) sclerosis with relapses. The study did not reveal statistically significant differences between the 30 and 60 mcg doses in clinical parameters and general MRI parameters. It was also found that the use of the drug Avonex for 1 g leads to a reduction in the frequency of relapses within a year by 1/3. The effectiveness of the drug in the treatment of multiple sclerosis was shown in a strictly controlled study in the treatment of patients with symptoms of demyelinating disease. In the group of patients receiving placebo, the relapse rate over two and three years was 39 and 50%, respectively, while in the group receiving Avonex, these figures were 21 and 35%. The above data show that Avonex slows the progression of disability and reduces the incidence of relapses.

Pharmacokinetics

The pharmacokinetics of interferon beta-1a was studied based on measurements of the antiviral activity of interferon. After a single intramuscular injection, peak levels of antiviral activity are achieved in plasma in the period from 5 to 15 hours. T1/2 is about 10 hours. The bioavailability of the drug is approximately 40%.

Use during pregnancy

Due to the potential risk of adverse reactions, the use of Avonex during pregnancy is contraindicated. Due to the potential risk of adverse reactions in an infant, Avonex is contraindicated for use during lactation.

Contraindications for use

Known hypersensitivity to natural or recombinant interferon beta, human serum albumin or any other component of the drug; pregnancy period; lactation period; severe depression; the appearance of suicidal thoughts; epilepsy that is difficult to respond to drug therapy; age less than 16 years.

Side effects

The most common side effect of interferons is flu-like syndrome. It manifests itself in the form of weakness, fatigue, muscle pain, fever, chills, headache, nausea. These symptoms are usually more pronounced at the beginning of treatment, and their frequency decreases as treatment continues. To alleviate these symptoms, you can prescribe an analgesic-antipyretic, which should be taken before administration of the drug, and also an additional 24 hours after each injection. Before using any other drug during the course of therapy with Avonex, you should consult a doctor. If your doctor recommends taking an analgesic-antipyretic, you must carefully follow the recommendations and not exceed the recommended dose. During any period of treatment, neurological symptoms similar to exacerbation of multiple sclerosis may occur: episodes of muscle spasms and/or muscle weakness, limiting the possibility of voluntary movements. These episodes are temporarily associated with injections and may recur with subsequent injections. In some cases, they may be accompanied by flu-like symptoms. Other, less common manifestations include: From the skin: alopecia, itching, increased sweating, rash, reactions at the injection site (hyperemia, pain, burning sensation, inflammation, abscess), urticaria, exacerbation of psoriasis. Allergic reactions: anaphylactic reactions, anaphylactic shock. From the gastrointestinal tract: loss of appetite, nausea, diarrhea, vomiting, impaired liver function. From the cardiovascular system: fever, tachycardia, arrhythmia, cardiomyopathy, heart failure, vasodilation. From the hematopoietic system and blood: in rare cases - thrombocytopenia, lymphocytopenia, neutropenia, leukopenia, pancytopenia, decreased hematocrit, transient increase in urea in the blood serum, change in the level of potassium in the blood. From the genitourinary system: menorrhagia, metrorrhagia. From the central nervous system: headache, decreased sensitivity, anxiety, dizziness, insomnia, paresthesia, in rare cases, epilepsy-like seizures, depression, suicidal thoughts, confusion, emotional lability, psychosis, migraine. From the musculoskeletal system: muscle spasms, myalgia, arthralgia, pain in the extremities, neck and back pain, muscle rigidity, transient decrease or increase in muscle tone at the beginning of the course of treatment. From the respiratory system: rhinorrhea, dyspnea, shortness of breath. From the endocrine system: hypothyroidism, hyperthyroidism. From the immune system: hepatitis, incl. autoimmune, in rare cases with the development of liver failure, systemic lupus erythematosus. General body reactions: flu-like symptoms, increased sweating at night, changes in body weight, changes in liver function indicators, chest pain.

Directions for use and doses

V/m. The recommended dose of Avonex is 30 mcg once a week. This dose is contained in 1 ml of the dissolved drug in a bottle and is administered intramuscularly. Increasing the dose does not increase the therapeutic effect. The duration of the course of therapy is determined individually. After 2 years of treatment, the patient should undergo a clinical examination and, on an individual basis, the attending physician may recommend continuing the course of therapy. Avonex should be administered intramuscularly immediately after preparing the solution. Injections of the drug should, if possible, be made at the same time on the same day of the week. The injection site should be changed every week. It is possible for the patient to perform injections themselves with the permission of the attending physician and after training in the method of intramuscular injections. Recommendations for preparing for injection: 1. Dissolution (performed immediately before administering the drug): - holding the Bio-Set by the base, turn the cap and remove it. Do not touch the connection hole; - remove the cap from the syringe filled with solvent by pulling it off without touching the tip. Do not press the piston. — place the bottle with Bio-Set vertically on a smooth surface, align it with the tip of the syringe. Screw the syringe cannula into the Bio-Set clockwise. Following the direction of movement and holding the syringe by the base, sharply push it down so that the tip disappears completely and a click is heard; — slowly pressing on the syringe plunger, introduce the solvent into the bottle; — leaving the syringe connected to the Bio-Set, carefully rotate the bottle until the powder is completely dissolved. The drug should completely dissolve within 1 minute. Shaking the bottle should be avoided, as this may cause foam to form; - press the syringe plunger down all the way to remove all the air in the syringe; — turn the syringe and bottle vertically 180° and slowly pull the plunger so that the drug solution ends up in the syringe; — open the individual packaging of the needle, do not remove the cap from the needle; — holding the filled syringe by the base, separate it from the Bio-Set device by turning it counterclockwise. Do not touch the syringe cannula! — place the needle on the filled syringe, turning it clockwise. Then place the syringe on a flat surface and treat the injection site with a swab soaked in alcohol. 2. Injection: - pull off the protective cap from the needle without rotating it; - turn the syringe over with the needle up, and to remove air, lightly tap on its base so that the bubbles rise to the top. Lightly press the plunger to remove bubbles until no more than a small drop of liquid appears at the end of the needle; - Inject a needle into the muscle and slowly inject the drug, and then remove the syringe with the needle. If necessary, cover the injection site with a bandage. Warnings: To prepare the solution, use the water for injection included in the kit. Do not use other solvents. When connecting the syringe to the Bio-Set, do not take further action until you hear a click. Rapid injection of the solvent may cause foaming, which will make it difficult to draw the drug into the syringe. The drug is not suitable for use if the integrity of the bottle is damaged, and also if the drug solution turns out to be cloudy, colored (a slight yellowish color is allowed) or floating particles are visible in it. The drug does not contain preservatives. Each bottle of the drug is intended for single use only. The solution remaining after administration should be thrown away or destroyed.

Overdose

Due to the method of administration and dosage form, an overdose is unlikely. Treatment: in case of overdose, the patient should be hospitalized for medical observation and symptomatic therapy.

Interactions with other drugs

Special studies on the interaction of the drug Avonex with other drugs, incl. with corticosteroids or ACTH, has not been performed in humans. However, the experience of clinical trials shows that patients with multiple sclerosis can take the drug Avonex together with corticosteroids or ACTH during an exacerbation of the disease. It is known that interferons have the ability to reduce the activity of enzymes associated with liver cytochrome P450. In this regard, caution should be exercised when prescribing Avonex concomitantly with drugs whose clearance is largely dependent on the cytochrome P450 system, such as antiepileptic drugs and antidepressants.

Special instructions for use

Before starting treatment, patients should be informed about possible side effects associated with the use of the drug. In view of the possibility of spontaneous abortion due to the development of side effects associated with the use of interferon beta, patients should be advised to avoid conception. Avonex, like other interferons, should be used with caution when treating patients suffering from depression or depressive disorders. It is known that when using interferons, depression and suicidal thoughts may occur, and in the group of people suffering from multiple sclerosis, the frequency of such phenomena increases. The occurrence of depressive conditions is possible at any time during treatment with Avonex. If any signs of depression or suicidal thoughts occur, patients should immediately contact their doctor. Such patients must be closely monitored during treatment and, if necessary, appropriate therapeutic measures must be urgently applied. In some cases, it may be necessary to stop using the drug. If a patient develops a progressive form of multiple sclerosis, the drug should be discontinued. Caution is required when prescribing Avonex to patients who have previously suffered from seizures. If patients who have not previously suffered from epilepsy experience epilepsy-like seizures during treatment with the drug, the etiology of the seizures should be established and appropriate anticonvulsant therapy should be prescribed before resuming use of the drug Avonex. Caution should be exercised when prescribing, as well as careful monitoring of patients suffering from severe renal and liver failure, as well as suppression of bone marrow hematopoiesis. When using interferon beta, signs of liver dysfunction were observed, such as an increase in the level of liver enzymes in the blood serum, the development of hepatitis, incl. autoimmune, liver failure. Patients should be carefully monitored for signs of liver dysfunction, especially if interferon is used in conjunction with other hepatotoxic drugs. When using the drug Avonex, the condition of patients with diseases of the cardiovascular system should be carefully monitored: angina pectoris, previous myocardial infarction, decompensated heart failure, arrhythmia. Manifestations of influenza-like syndrome caused by the use of the drug can have a stressful effect on such patients. When using interferons, deviations in laboratory parameters occur, therefore, in addition to routine laboratory tests in patients with multiple sclerosis, during treatment it is recommended to count blood cells (including platelets), determine the leukocyte formula and biochemical blood tests (including liver enzymes). Those patients who have signs of bone marrow suppression may require more thorough blood testing. When using the drug Avonex, interferon-neutralizing antibodies may appear in the blood serum, which reduce the activity of interferon beta-1a, and therefore the clinical effectiveness of the drug. Available data indicate that after 12 months of treatment, antibodies to interferon beta-1a appear in the serum of approximately 8% of patients. Impact on the ability to drive a car or use other machinery. Some undesirable effects of the drug on the central nervous system may affect the ability of patients to drive a car or operate complex machinery. Special studies on the interaction of the drug Avonex with other drugs, incl. with corticosteroids or ACTH, has not been performed in humans. However, the experience of clinical trials shows that patients with multiple sclerosis can take the drug Avonex together with corticosteroids or ACTH during an exacerbation of the disease. It is known that interferons have the ability to reduce the activity of enzymes associated with liver cytochrome P450. In this regard, caution should be exercised when prescribing Avonex concomitantly with drugs whose clearance is largely dependent on the cytochrome P450 system (for example, antiepileptic drugs and antidepressants).

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C (do not freeze).

Best before date

24 months

ATX classification:

L Antineoplastic drugs and immunomodulators

L03 Immunostimulants

L03A Cytokines and immunomodulators

L03AB Interferons

L03AB07 Interferon beta-1a

Composition and release form

in glass bottles with a Bio-Set device (complete with a solvent in a syringe and a needle); 1 set in a sealed plastic tray; There are 4 trays in a cardboard box.

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Pharmacodynamics

Interferons are natural proteins produced by eukaryotic cells in response to viral infection and other biological factors. Interferons are cytokines that are mediators of the antiviral, antiproliferative and immunomodulatory systems of the body. Interferon beta is synthesized by various types of cells, including fibroblasts and macrophages. Natural beta-interferon and the drug Avonex® (interferon beta-1a) exist in glycosylated form and contain a single complex hydrocarbon fragment linked to the N atom. Glycosylation of proteins affects their stability, activity, biodistribution and half-life. The biological properties of Avonex® are determined by the ability of interferon beta-1a to bind to specific receptors on the surface of cells of the human body and trigger a complex cascade of intercellular interactions, leading to interferon-mediated expression of numerous gene products and markers, such as major histocompatibility complex class I, Mx protein, 2'/5'-oligoadenylate synthetase, b-2-microglobulin and neopterin. The presence of some of these compounds was detected in the serum and cellular blood fractions of patients receiving the drug Avonex®. After intramuscular administration of 1 dose of the drug, the content of these compounds in the serum remained elevated for 4–7 days. It is unknown whether the mechanism of action of Avonex® in the treatment of multiple sclerosis is associated with the triggering of the biological interactions described above, because The pathophysiology of multiple sclerosis has not yet been sufficiently studied. The effect of the drug in the treatment of multiple sclerosis was assessed in a strictly controlled study conducted in patients with relapsing forms of multiple sclerosis. It was shown that the total number of patients who experienced progression of disability (as determined by the Kaplan-Meier table) at the end of the second year of the study was 35% with placebo and 22% with Avonex®. In order to compare the effectiveness of different doses of the drug, a double-blind randomized study was conducted on 802 patients suffering from multiple (multiple) sclerosis with relapses. The study did not reveal statistically significant differences between the 30 and 60 mcg doses in clinical parameters and general MRI parameters. It was also found that the use of Avonex® for 1 g leads to a reduction in the frequency of relapses within a year by 1/3. The effectiveness of the drug in the treatment of multiple sclerosis was shown in a strictly controlled study in the treatment of patients with symptoms of demyelinating disease. In the group of patients receiving placebo, the relapse rate over two and three years was 39 and 50%, respectively, while in the group receiving Avonex® these figures were 21 and 35%. The above data show that Avonex® slows the progression of disability and reduces the incidence of relapses.

Contraindications

Absolute:

• Epilepsy resistant to treatment;
• Severe depression;
• The appearance of suicidal thoughts;
• Pregnancy and lactation period;
• Age up to 18 years – for the solution, up to 16 years – for the lyophilisate;
• Hypersensitivity to natural or recombinant interferon beta, auxiliary components of the drug or human serum albumin.

Carefully:

• Severe renal/liver failure;
• Severe inhibition of bone marrow hematopoiesis;
• History of seizures;
• Depressive disorders;
• Heart diseases (arrhythmia, angina pectoris, congestive heart failure, previous myocardial infarction).

special instructions

Before starting treatment, patients should be informed about possible side effects associated with the use of the drug. In view of the possibility of spontaneous abortion due to the development of side effects associated with the use of interferon beta, patients should be advised to avoid conception. Avonex®, like other interferons, should be used with caution when treating patients suffering from depression or depressive disorders. It is known that when using interferons, depression and suicidal thoughts may occur, and in the group of people suffering from multiple sclerosis, the frequency of such phenomena increases. The occurrence of depressive conditions is possible at any time during treatment with Avonex®. If any signs of depression or suicidal thoughts occur, patients should immediately contact their doctor. Such patients must be closely monitored during treatment and, if necessary, appropriate therapeutic measures must be urgently applied. In some cases, it may be necessary to stop using the drug.

If a patient develops a progressive form of multiple sclerosis, the drug should be discontinued.

Caution is required when prescribing Avonex® to patients who have previously suffered from seizures. If patients who have not previously suffered from epilepsy experience epilepsy-like seizures during treatment with the drug, the etiology of the seizures should be established and appropriate anticonvulsant therapy should be prescribed before resuming use of Avonex®. Caution should be exercised when prescribing, as well as careful monitoring of patients suffering from severe renal and liver failure, as well as suppression of bone marrow hematopoiesis.

When using interferon beta, signs of liver dysfunction were observed, such as an increase in the level of liver enzymes in the blood serum, the development of hepatitis, incl. autoimmune, liver failure. Patients should be carefully monitored for signs of liver dysfunction, especially if interferon is used in conjunction with other hepatotoxic drugs.

When using the drug Avonex®, the condition of patients with diseases of the cardiovascular system should be carefully monitored: angina pectoris, previous myocardial infarction, decompensated heart failure, arrhythmia. Manifestations of influenza-like syndrome caused by the use of the drug can have a stressful effect on such patients. When using interferons, deviations in laboratory parameters occur, therefore, in addition to routine laboratory tests in patients with multiple sclerosis, during treatment it is recommended to count blood cells (including platelets), determine the leukocyte formula and biochemical blood tests (including liver enzymes). Those patients who have signs of bone marrow suppression may require more thorough blood testing.

When using the drug Avonex®, interferon-neutralizing antibodies may appear in the blood serum, which reduce the activity of interferon beta-1a, and therefore the clinical effectiveness of the drug. Available data indicate that after 12 months of treatment, antibodies to interferon beta-1a appear in the serum of approximately 8% of patients.

Impact on the ability to drive a car or use other machinery. Some undesirable effects of the drug on the central nervous system may affect the ability of patients to drive a car or operate complex machinery.

Special studies on the interaction of the drug Avonex® with other drugs, incl. with corticosteroids or ACTH, has not been performed in humans. However, the experience of clinical trials shows that patients with multiple sclerosis can take Avonex® together with corticosteroids or ACTH during an exacerbation of the disease.

It is known that interferons have the ability to reduce the activity of enzymes associated with liver cytochrome P450. In this regard, caution should be exercised when prescribing Avonex® concomitantly with drugs whose clearance is largely dependent on the cytochrome P450 system (for example, antiepileptic drugs and antidepressants).

Clinical trial results.

The drug Avonex is a dosage form of recombinant interferon beta-1a. It is obtained by synthesis based on the natural sequence of the human gene in mammalian cell culture, therefore it is glycosylated and identical to the natural one. The first results of clinical trials of Avonex were published in 1996 [5], after which the drug was registered for the treatment of multiple sclerosis in the USA in 1996 and in Europe in 1997.

Clinical trials evaluating the effectiveness of Avonex were double-blind, multicenter, randomized, and placebo-controlled. This indicates the high information content and reliability (level I) of the evidence obtained during the research.

The first clinical trial of Avonex used a dose of 30 mcg administered intramuscularly once a week [5]. The study involved patients with definite relapsing-remitting multiple sclerosis (301 people in total), a mild degree of disability on the EDSS scale (from 1 to 3.5 points) and high activity of the process (1 or more exacerbations in the last year or 2 or more exacerbations in the past year). 3 years). The most important result of this clinical trial was the evidence of slowing the progression of irreversible neurological deficits assessed by the EDSS scale.

Subsequently, a clinical trial was conducted in which the effects of two doses of the drug were compared: 30 and 60 mcg, respectively [1]. The study involved 802 patients with relapsing-remitting multiple sclerosis with mild to moderate disability (from 2.0 to 5.5 points on the EDSS scale). The results of this study did not reveal differences in the groups of patients receiving different doses of Avonex, either in clinical or MRI parameters. At the same time, they fully confirmed the previously obtained evidence of the effectiveness of Avonex compared to placebo.

The CHAMPS (Controlled High Risk Avonex Multiple Sclerosis) clinical trial was aimed at assessing the likelihood of developing significant multiple sclerosis after a single episode of isolated neurological deficit (isolated syndrome) during treatment with Avonex at a dose of 30 mcg intramuscularly once a week compared with placebo [3, 4]. The results of a three-year follow-up showed that the likelihood of developing significant multiple sclerosis during treatment with Avonex was 50% lower than in patients receiving placebo. This was confirmed by MRI analysis. During Avonex treatment, MRI signs of pathological process activity were significantly lower. Thus, early therapy with interferon beta-1a slows down the transformation of an isolated neurological syndrome into definite multiple sclerosis.

Avonex was tested in secondary progressive multiple sclerosis [2]. The study involved 436 patients with a degree of disability on the EDSS scale from 3.5 to 6.5 points; observation lasted 2 years. There were no significant differences between the Avonex group and the placebo group in terms of the dynamics of the EDSS scale. However, assessment of the baseline MSFC index (Multiple Sclerosis Functional Composite) over 24 months showed a significant reduction in the rate of progression by 40% during treatment with Avonex compared to the placebo group. Statistically significant positive dynamics in indicators of patients’ physical health-related quality of life were also noted. The main anti-inflammatory effects of the drug confirmed their significance in the later stages of the disease in the form of a significant decrease in the number of contrast-accumulating MRI lesions, as well as a 31% decrease in the frequency of exacerbations and an increase in the proportion of patients without exacerbations.

Interaction

Special studies on the interaction of the drug Avonex® with other drugs, incl. with corticosteroids or ACTH, has not been performed in humans. However, the experience of clinical trials shows that patients with multiple sclerosis can take Avonex® together with corticosteroids or ACTH during an exacerbation of the disease.

It is known that interferons have the ability to reduce the activity of enzymes associated with liver cytochrome P450. In this regard, caution should be exercised when prescribing Avonex® concomitantly with drugs whose clearance is largely dependent on the cytochrome P450 system, such as antiepileptic drugs and antidepressants.

Directions for use and doses

V/m.

The recommended dose of Avonex® is 30 mcg once a week. This dose is contained in 1 ml of the dissolved drug in a bottle and is administered intramuscularly. Increasing the dose does not increase the therapeutic effect. The duration of the course of therapy is determined individually. After 2 years of treatment, the patient should undergo a clinical examination and, on an individual basis, the attending physician may recommend continuing the course of therapy.

Avonex® should be administered intramuscularly immediately after preparing the solution. Injections of the drug should, if possible, be made at the same time on the same day of the week. The injection site should be changed every week. It is possible for the patient to perform injections themselves with the permission of the attending physician and after training in the method of intramuscular injections.

Recommendations for preparing for injection:

1. Dissolution (performed immediately before administration of the drug):

— holding the Bio-Set by the base, turn the cap and remove it. Do not touch the connection hole;

- remove the cap from the syringe filled with solvent by pulling it off without touching the tip. Do not press the piston.

— place the bottle with Bio-Set vertically on a smooth surface, align it with the tip of the syringe. Screw the syringe cannula into the Bio-Set clockwise. Following the direction of movement and holding the syringe by the base, sharply push it down so that the tip disappears completely and a click is heard;

— slowly pressing on the syringe plunger, introduce the solvent into the bottle;

— leaving the syringe connected to the Bio-Set, carefully rotate the bottle until the powder is completely dissolved. The drug should completely dissolve within 1 minute. Shaking the bottle should be avoided, as this may cause foam to form;

- press the syringe plunger down all the way to remove all the air in the syringe;

— turn the syringe and bottle vertically 180° and slowly pull the plunger so that the drug solution ends up in the syringe;

— open the individual packaging of the needle, do not remove the cap from the needle;

— holding the filled syringe by the base, separate it from the Bio-Set device by turning it counterclockwise. Do not touch the syringe cannula!

— place the needle on the filled syringe, turning it clockwise.

Then place the syringe on a flat surface and treat the injection site with a swab soaked in alcohol.

2. Injection:

— pull the protective cap off the needle without rotating it;

- turn the syringe over with the needle up, and to remove air, lightly tap on its base so that the bubbles rise to the top. Lightly press the plunger to remove bubbles until no more than a small drop of liquid appears at the end of the needle;

- Inject a needle into the muscle and slowly inject the drug, and then remove the syringe with the needle. If necessary, cover the injection site with a bandage.

Warnings: To prepare the solution, use the water for injection included in the kit. Do not use other solvents. When connecting the syringe to the Bio-Set, do not take further action until you hear a click. Rapid injection of the solvent may cause foaming, which will make it difficult to draw the drug into the syringe.

The drug is not suitable for use if the integrity of the bottle is damaged, and also if the drug solution turns out to be cloudy, colored (a slight yellowish color is allowed) or floating particles are visible in it. The drug does not contain preservatives. Each bottle of the drug is intended for single use only. The solution remaining after administration should be thrown away or destroyed.

Control of laboratory parameters.

In addition to the usual laboratory tests that are carried out in patients with multiple sclerosis, during treatment with Avonex it is recommended to monitor the peripheral blood picture with the counting of formed elements (including platelets), determination of the leukocyte formula, and a biochemical blood test (including the activity of liver enzymes). If symptoms of myelodepression are present, more detailed blood testing may be required.

When using the drug Avonex, the following deviations in laboratory test results are possible (most often no additional treatment is required): a decrease in hematocrit, a decrease in the number of circulating lymphocytes, leukocytes, neutrophils and platelets. When using all types of interferons, there may be a transient increase in the level of creatinine, potassium, urea nitrogen, alanine and aspartic transaminases, and a moderate increase in calcium in the urine.