2018-02-02T17:43:00+03:00

Proven effectiveness of interferon alpha 2b

The world first learned about interferon, a natural protein in the human body, in 1957, when scientists Alik Isaacs and Jean Lindenmann discovered the phenomenon of interference, a complex mechanism biological processes, thanks to which the body is able to fight various diseases. But in the last century they probably did not suspect that this protein would become the main component of many medicines.

Interferons are proteins that are produced by body cells when viruses invade them. Thanks to them, genes responsible for the synthesis of protective intracellular molecules are activated, which provide an antiviral effect by suppressing the synthesis of viral proteins and preventing its reproduction. In other words, these proteins (they are also called cytokines) in our body act as powerful defenders who guard our health and keep a strict vigil so that, if necessary, we can immediately repel the attack of viruses and defeat the disease.

To protect the body infected with viruses, interferon is produced by almost all cells of our body. In addition, its formation can be stimulated not only by viruses, but also by bacterial toxins, so this protein is also effective against some bacterial infections. Thus, we can conclude that this cytokine is a very important component of the human immune system. Without it, humanity would have been defeated long ago by numerous viruses and bacteria.

Types of interferons

Interferons are divided into three types: alpha, beta and gamma, which are produced by different cells.

• Interferon alpha activates the so-called natural killer cells - leukocytes, which destroy viruses, bacteria and other “enemy” agents.
• Interferon beta is produced in fibroblasts, epithelial cells and macrophages, which absorb infectious agents.
• Interferon gamma is produced by T-lymphocytes, its main function, like other types, is the regulation of immunity.

How has the effectiveness of interferon been proven for ARVI?

As is known, in their activities, when prescribing therapy, doctors rely on their experience and an already established system of knowledge. But medicine is developing rapidly: every year new effective treatment methods are developed around the world and new drugs are patented. Therefore, there was a need to systematize the latest achievements and discoveries in medicine, resulting in clinical guidelines and standards of care. These documented algorithms are based on proven clinical experience, describe the necessary instructions for diagnosis, treatment, rehabilitation, disease prevention and help the doctor make decisions on the choice of treatment tactics in a given situation.

For example, regarding the provision of medical care children on the problem of ARVI and influenza, the development group consists of approximately 40 people and includes leading Russian specialists in the field of infectious diseases from various institutions and departments. It is logical that experts pay special attention medical drugs, which are able to cope with diseases as quickly as possible and at the same time have a minimum of side effects. Now we are talking about drugs containing interferon, which help fight ARVI in adults and children.

As mentioned above, their ability to fight viruses was discovered during the study of interference by scientists Isaacs and Lindenmann. They described interferon as “a protein, much smaller than immunoglobulins, that is produced by the body's cells after infection with live or inactivated viruses; capable of inhibiting the growth of a variety of viruses in doses that are non-toxic to cells.” Today it is known that these proteins can be produced by almost all cells of the body in response to the introduction of foreign information, regardless of its etiology (viruses, fungi, bacteria, intracellular pathogens, oncogenes). And their main biological effect lies in the processes of recognition and removal of this foreign information. In other words, these protective molecules “know how” to gently and accurately destroy viruses that have occupied cells, without damaging the cells themselves. This has been confirmed by numerous scientific studies.

As for the methods of using drugs containing interferons, it is necessary to mention some nuances. One of the main problems of interferon therapy is to “deliver” the effective dose of the drug without causing negative consequences. In some cases, intramuscular or intravenous administration drugs containing interferon leads to side effects in the form of fever, chills, headache and other undesirable effects. These symptoms are not critical for the body and soon disappear, but during the treatment process they cause discomfort.

Minimize side effects interferon therapy or to do without them altogether was made possible by the use of suppositories containing interferon alfa-2b. According to scientific research, rectal application recombinant human interferon in the first days of the disease, ARVI reduces the duration of fever, fights the runny nose and allows you to quickly defeat the disease 2. Intranasal use of drugs (when the medicine is applied to the nasal mucosa) containing interferon alfa-2b complements the treatment and ensures the optimal effect of therapy. One of the drugs that is suitable for fighting influenza and other acute respiratory viral infections at any stage of the disease is VIFERON. It is available in the form of suppositories (candles), gel and ointment.

Brief instructions for use and tolerability of drugs containing interferon alfa-2b

Who can take VIFERON drugs:

• adults;
• children from the first days of life;
• pregnant women from the 4th week of gestation.

Recognition by the scientific community

Interferon alfa-2b (VIFERON) is included in three federal standards of medical care as a recommended drug for the treatment of influenza and ARVI, as well as in three Federal Protocols for the treatment of these diseases. 1 If we take into account not only influenza and ARVI, but also other diseases, then the number of standards and recommendations regarding this drug is even greater - interferon (VIFERON) is included in 30 federal standards for the provision of medical care to adults and children, approved by the Ministry of Health of the Russian Federation, as well as in 21 Protocol ( Clinical guidelines) providing medical care to adults, including pregnant women, and children.

The principle of action of the drug

Human recombinant interferon alpha-2b, which is part of the drug VIFERON, has antiviral, immunomodulatory properties and suppresses the replication of RNA and DNA viruses. Antiviral therapy against influenza can be started at any phase of the disease. This will help improve the condition and prevent the development of complications 2. The drug VIFERON includes generally recognized highly active antioxidants: in suppositories these are vitamins E and C, in ointments - vitamin E, in gel - vitamin E, citric and benzoic acids. Against the background of such antioxidant support, an increase in the antiviral activity of interferons is noted.

Drug test results

VIFERON has gone through a full cycle clinical trials with a wide range various diseases in leading clinics in Russia. The result of the studies was evidence of the therapeutic and prophylactic effectiveness of the drug VIFERON for various infectious and inflammatory diseases in adults and children, including newborns, and pregnant women. It has been scientifically proven that complex composition and the release form provides the drug VIFERON with unique pharmacokinetic characteristics, with prolongation of the action of interferon in the absence of side effects inherent in parenteral preparations of recombinant interferons 3.

For what diseases are interferon-based drugs used?alpha-2 b

The drug VIFERON in the form of suppositories, gel and ointment is used to treat the following diseases:

• ARVI, including influenza;
• herpes;
• papillomavirus infection;
• enterovirus infection;
• laryngotracheobronchitis;
• chronic hepatitis B, C, D, including those complicated by cirrhosis of the liver;
• bacterial vaginosis;
• candidiasis;
• mycoplasmosis;
• ureaplasmosis;
• gardnerellosis.

The use of the drug VIFERON as part of complex antiviral therapy makes it possible to reduce therapeutic doses of antibacterial and hormonal drugs, as well as reduce the toxic effects of this therapy.

General doctor

1. http://www.rosminzdrav.ru, Order of the Ministry of Health Russian Federation, http://www.raspm.ru; http://www.niidi.ru; http://www.pediatr-russia.ru; http://www.nnoi.ru
2. Nesterova I.V. "Interferon preparations in clinical practice: when and how,” “Attending Physician,” September 2017.
3. “VIFERON is a complex antiviral and immunomodulatory drug for the treatment of infectious and inflammatory diseases in perinatology.” (Guide for doctors), Moscow, 2014.

Sources used: http://www.lsgeotar.ru

Suction

With subcutaneous or intramuscular administration of interferon alfa-2b, its bioavailability ranges from 80% to 100%. After administration of interferon alpha-2b, Tmax in blood plasma is 4-12 hours, T1/2 - 2-6 hours. 16-24 hours after administration, recombinant interferon is not detected in blood serum.

Metabolism

Metabolism occurs in the liver.

Alpha interferons can disrupt oxidative metabolic processes, reducing the activity of microsomal liver enzymes of the cytochrome P450 system.

Removal

It is excreted mainly by the kidneys by glomerular filtration.

Overdose

Data on overdose of Altevir® are not provided.

Storage conditions

The drug should be stored out of the reach of children, in accordance with SP 3.3.2-1248-03 at a temperature of 2° to 8°C; do not freeze.

Interaction with other drugs

Drug interactions between Altevir and others medicines not fully studied. Altevir® should be used with caution simultaneously with hypnotics and sedatives, narcotic analgesics and drugs that potentially have a myelosuppressive effect.

When Altevir and theophylline are prescribed simultaneously, the concentration of the latter in the blood serum should be monitored and, if necessary, its dosage regimen should be changed.

When Altevir is used in combination with chemotherapeutic drugs (cytarabine, cyclophosphamide, doxorubicin, teniposide), the risk of developing toxic effects increases.

Side effect

General reactions: very often - fever, weakness (they are dose-dependent and reversible reactions, disappear within 72 hours after a break in treatment or its cessation), chills; less often - malaise.

From the central nervous system: very often - headache; less often - asthenia, drowsiness, dizziness, irritability, insomnia, depression, suicidal thoughts and attempts; rarely - nervousness, anxiety.

From the musculoskeletal system: very often - myalgia; less often - arthralgia.

From the digestive system: very often - loss of appetite, nausea; less often - vomiting, diarrhea, dry mouth, change in taste; rarely - abdominal pain, dyspepsia; a reversible increase in liver enzyme activity is possible.

From the outside of cardio-vascular system: often - decreased blood pressure; rarely - tachycardia.

Dermatological reactions: less often - alopecia, increased sweating; rarely - skin rash, skin itching.

From the hematopoietic system: reversible leukopenia, granulocytopenia, decreased hemoglobin levels, thrombocytopenia are possible.

Other: rarely - weight loss, autoimmune thyroiditis.

Compound

human recombinant interferon alpha-2b 3 million IU

Excipients: sodium acetate, sodium chloride, ethylenediamine tetraacetic acid disodium salt, Tween-80, dextran 40, water for injection.

Directions for use and doses

Apply subcutaneously, intramuscularly and intravenously. Treatment must be started by a doctor. Then, with the doctor’s permission, the patient can administer a maintenance dose independently (in cases where the drug is prescribed subcutaneously or intramuscularly).

Chronic hepatitis B: Altevir® is administered subcutaneously or intramuscularly at a dose of 5-10 million IU 3 times a week for 16-24 weeks. Treatment is stopped after 3-4 months of use in the absence of positive dynamics (according to a study of hepatitis B virus DNA).

Chronic hepatitis C: Altevir® is administered subcutaneously or intramuscularly at a dose of 3 million IU 3 times a week for 24-48 weeks. In patients with a relapsing course of the disease and patients who have not previously received treatment with interferon alfa-2b, the effectiveness of treatment increases with combination therapy with ribavirin. The duration of combination therapy is at least 24 weeks. Therapy with Altevir should be carried out for 48 weeks in patients with chronic hepatitis C and the 1st genotype of the virus with a high viral load, in whom hepatitis C virus RNA is not detected in the blood serum by the end of the first 24 weeks of treatment.

Laryngeal papillomatosis: Altevir® is administered subcutaneously at a dose of 3 million IU/m2 3 times a week. Treatment begins after surgical (or laser) removal of the tumor tissue. The dose is selected taking into account the tolerability of the drug. Achieving a positive response may require treatment for 6 months.

Hairy cell leukemia: the recommended dose of Altevir for subcutaneous administration to patients after or without splenectomy is 2 million IU/m2 3 times a week. In most cases, normalization of one or more hematological parameters occurs after 1-2 months of treatment; it is possible to increase the treatment period to 6 months. This dosage regimen should be followed continuously unless rapid progression of the disease or symptoms of severe intolerance to the drug occur.

Chronic myeloid leukemia: the recommended dose of Altevir as monotherapy is 4-5 million IU/m2 per day subcutaneously daily. To maintain the number of leukocytes, a dose of 0.5-10 million IU/m2 may be required. If treatment allows to achieve control of the number of leukocytes, then to maintain hematological remission the drug should be used at the maximum tolerated dose (4-10 million IU/m2 daily). The drug should be discontinued after 8-12 weeks if therapy does not lead to partial hematological remission or a clinically significant decrease in the number of leukocytes.

Non-Hodgkin's lymphoma: Altevir® is used as adjuvant therapy in combination with standard chemotherapy regimens. The drug is administered subcutaneously at a dose of 5 million IU/m2 3 times a week for 2-3 months. The dose must be adjusted depending on the tolerability of the drug.

Melanoma: Altevir® is used as adjuvant therapy for existing high risk recurrence in adults after tumor removal. Altevir® is administered intravenously at a dose of 15 million IU/m2 5 times a week for 4 weeks, then subcutaneously at a dose of 10 million IU/m2 3 times a week for 48 weeks. The dose must be adjusted depending on the tolerability of the drug.

Multiple myeloma: Altevir® is prescribed during the period of achieving stable remission at a dose of 3 million IU/m2 3 times a week subcutaneously.

Kaposi's sarcoma due to AIDS: the optimal dose has not been established. The drug can be used in doses of 10-12 million IU/m2/day subcutaneously or intramuscularly. If the disease stabilizes or responds to treatment, therapy is continued until tumor regression occurs or drug discontinuation is required.

Kidney cancer: the optimal dose and regimen have not been established. It is recommended to use the drug subcutaneously in doses of 3 to 10 million IU/m2 3 times a week.

Preparation of solution for intravenous administration

Draw up the volume of Altevir solution required to prepare the required dose, add it to 100 ml of sterile 0.9% sodium chloride solution and administer it over 20 minutes.

Product description

Solution for injection is transparent, colorless.

With caution (Precautions)

Use for liver dysfunction

Use for renal impairment

The drug is contraindicated in severe renal and/or liver failure (including those caused by the presence of metastases).

special instructions

Before treatment with Altevir for chronic viral hepatitis B and C, it is recommended to perform a liver biopsy to assess the degree of liver damage (signs of active inflammatory process and/or fibrosis). The effectiveness of treatment of chronic hepatitis C increases with combination therapy with Altevir and ribavirin. The use of Altevir is not effective in the development of decompensated liver cirrhosis or hepatic coma.

If side effects occur during treatment with Altevir, the dose of the drug should be reduced by 50% or the drug should be temporarily discontinued until they disappear. If side effects persist or recur after dose reduction, or disease progression is observed, treatment with Altevir should be discontinued.

If the platelet level decreases below 50x109/l or the granulocyte level below 0.75x109/l, it is recommended to reduce the Altevir dose by 2 times with blood test monitoring after 1 week. If these changes persist, the drug should be discontinued.

If the platelet level decreases below 25x109/l or the granulocyte level below 0.5x109/l, it is recommended to discontinue Altevir® with blood test monitoring after 1 week.

In patients receiving interferon alpha-2b preparations, antibodies that neutralize its antiviral activity can be detected in the blood serum. In almost all cases, antibody titers are low, their appearance does not lead to a decrease in the effectiveness of treatment or the occurrence of other autoimmune disorders.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Release form

Solution for injection is transparent, colorless.
1 ml
human recombinant interferon alpha-2b 3 million IU
Excipients: sodium acetate, sodium chloride, ethylenediamine tetraacetic acid disodium salt, Tween-80, dextran 40, water

Expiration date from date of manufacture

18 months

Indications for use

As part of complex therapy in adults:

With chronic viral hepatitis B without signs of liver cirrhosis;

For chronic viral hepatitis C in the absence of symptoms of liver failure (monotherapy or combination therapy with ribavirin);

With papillomatosis of the larynx;

For genital warts;

For hairy cell leukemia, chronic myeloid leukemia, non-Hodgkin's lymphoma, melanoma, multiple myeloma, Kaposi's sarcoma due to AIDS, progressive kidney cancer.

Contraindications

Heavy cardiovascular diseases history (uncontrolled chronic heart failure, recent myocardial infarction, severe heart rhythm disturbances);

Severe renal and/or liver failure (including those caused by the presence of metastases);

Epilepsy, as well as severe disorders of the central nervous system, especially expressed by depression, suicidal thoughts and attempts (including a history);

Chronic hepatitis with decompensated liver cirrhosis and in patients receiving or recently receiving treatment with immunosuppressants (with the exception of completed short-term treatment with corticosteroids);

Autoimmune hepatitis or other autoimmune disease;

Treatment with immunosuppressants after transplantation;

Disease thyroid gland, which cannot be controlled by generally accepted therapeutic methods;

Decompensated lung diseases (including COPD);

Decompensated diabetes mellitus;

Hypercoagulation (including thrombophlebitis, pulmonary embolism);

Severe myelodepression;

Pregnancy;

Lactation period (breastfeeding);

Hypersensitivity to the components of the drug.

pharmachologic effect

Interferon. Altevir® has antiviral, immunomodulatory, antiproliferative and antitumor effects.

Interferon alpha-2b, interacting with specific receptors on the cell surface, initiates a complex chain of changes inside the cell, including the induction of the synthesis of a number of specific cytokines and enzymes, and disrupts the synthesis of viral RNA and viral proteins in the cell. The result of these changes is nonspecific antiviral and antiproliferative activity associated with the prevention of viral replication in the cell, inhibition of cell proliferation and the immunomodulatory effect of interferon. Interferon alpha-2b stimulates the process of antigen presentation to immunocompetent cells, has the ability to stimulate the phagocytic activity of macrophages, as well as the cytotoxic activity of T cells and “natural killer” cells involved in antiviral immunity.

Prevents cell proliferation, especially tumor cells. It has an inhibitory effect on the synthesis of some oncogenes, leading to inhibition of tumor growth.

The composition of interferon preparations depends on their release form.

Release form

Interferon preparations have the following release forms:

• lyophilized powder for the preparation of eye and nasal drops, injection solution;
• injection solution;
• eye drops;
• eye films;
• nasal drops and spray;
• ointment;
• dermatological gel;
• liposomes;
• aerosol;
• oral solution;
• rectal suppositories;
• vaginal suppositories;
• implants;
• microenemas;
• tablets (interferon tablets are available under the brand name Entalferon).

pharmachologic effect

IFN drugs belong to the group of drugs with antiviral and immunomodulatory effects.

All IFNs have antiviral and antitumor effects. No less important is their property of stimulating action. macrophages - cells playing important role in initiation.

IFNs contribute to increasing the body's resistance to penetration viruses , and also block reproduction viruses when they penetrate the cell. The latter is due to the ability of IFN to suppress translation of the messenger RNA of the virus .

However, the antiviral effect of IFN is not directed against certain viruses , that is, IFNs are not characterized by virus specificity. This is precisely what explains their versatility and wide range of antiviral activity.

Interferon - what is it?

Interferons are a class with similar properties glycoproteins , which are produced by vertebrate cells in response to exposure various kinds inducers of both viral and non-viral nature.

According to Wikipedia, in order to biologically active substance has been qualified as interferon, it must be of a protein nature and have a pronounced antiviral activity in relation to various viruses , at a minimum, in homologous (similar) cells, “mediated by cellular metabolic processes including RNA and protein synthesis.”

The classification of IFNs proposed by the WHO and the Interferon Committee is based on differences in their antigenic, physical, chemical and biological properties. In addition, it takes into account their species and cellular origin.

Based on antigenicity (antigen specificity), IFNs are usually divided into acid-stable and acid-labile. The acid-fast ones include alpha and beta interferons (they are also called type I IFN). Interferon gamma (γ-IFN) is acid labile.

α-IFN is produced peripheral blood leukocytes (B- and T-type leukocytes), therefore it was previously designated as leukocyte interferon . There are currently at least 14 varieties of it.

β-IFN is produced fibroblasts , which is why it is also called fibroblastic .

The former designation of γ-IFN is immune interferon , it is produced by stimulated T-type lymphocytes , NK cells (normal (natural) killers; from English “natural killer”) and (presumably) macrophages .

Basic properties and mechanism of action of IFN

Without exception, all IFNs are characterized by multifunctional activity against target cells. Their most common property is the ability to induce in them antiviral state .

Interferon is used as a therapeutic and prophylactic agent for various viral infections . A feature of IFN drugs is that their effect weakens with repeated injections.

The mechanism of action of IFN is related to its ability to inhibit viral infections . As a result of treatment with interferon drugs in the patient’s body around source of infection a kind of barrier is formed from resistant to virus uninfected cells, which prevents further spread of infection.

By interacting with still undamaged (intact) cells, it prevents the implementation of the reproductive cycle viruses due to the activation of certain cellular enzymes ( protein kinases ).

The most important functions of interferons are the ability to suppress hematopoiesis ; modulate the body's immune response and inflammation response; regulate the processes of cell proliferation and differentiation; suppress growth and prevent reproduction viral cells ; stimulate the expression of surface antigens ; suppress individual functions B- and T-type leukocytes , stimulate activity NK cells etc..

Use of IFN in biotechnology

Development of synthesis methods and highly efficient purification leukocyte and recombinant interferons in quantities sufficient for the production of drugs, made it possible to use IFN drugs to treat patients diagnosed with viral hepatitis .

A distinctive feature of recombinant IFNs is that they are produced outside the human body.

For example, recombinant interferon beta-1a (IFN beta-1a) are obtained from mammalian cells (in particular, from Chinese hamster ovary cells), and similar in properties interferon beta-1b (IFN β-1b) produced by a member of the Enterobacteriaceae family coli (Escherichia coli).

Interferon inducer drugs - what are they?

IFN inducers are drugs that do not themselves contain interferon, but at the same time stimulate its production.

Pharmacodynamics and pharmacokinetics

The main biological effect of α-IFN is inhibition of viral protein synthesis . The antiviral state of the cell develops within several hours after administration of the drug or induction of IFN production in the body.

However, IFN has no effect on early stages replicative cycle that is, at the stage of adsorption, penetration virus into the cell (penetration) and release internal componentvirus in the process of “undressing” him.

Antivirus action α-IFN appears even when cells are infected infectious RNAs . IFN does not penetrate the cell, but only interacts with specific receptors on cell membranes (gangliosides or similar structures containing oligosugars ).

The mechanism of IFN alpha activity resembles the action of certain glycopeptide hormones . It stimulates activity genes , some of which are involved in coding the formation of products with direct antiviral effect .

β interferons also have antiviral effect , which is associated with several mechanisms of action. Beta interferon activates NO synthetase, which in turn helps to increase the concentration of nitric oxide inside the cell. The latter plays a key role in suppressing reproduction viruses .

β-IFN activates secondary, effector functions natural killersV , B-type lymphocytes , blood monocytes , tissue macrophages (mononuclear phagocytes) and neutrophilic , which are characterized by antibody-dependent and antibody-independent cytotoxicity.

In addition, β-IFN blocks the release of the internal component virus and disrupts methylation processes RNA virus .

γ-IFN is involved in the regulation of the immune response and regulates the expression inflammatory reactions. Despite the fact that he has independent antivirus And antitumor effect , gamma interferon very weak. At the same time, it significantly enhances the activity of α- and β-IFN.

After parenteral administration, the maximum concentration of IFN is observed after 3-12 hours. The bioavailability indicator is 100% (both after injection under the skin and after injection into the muscle).

The half-life T½ ranges from 2 to 7 hours. Trace concentrations of IFN in blood plasma are not detectable after 16–24 hours.

Indications for use

IFN is intended to treat viral diseases , striking respiratory tract .

In addition, interferon preparations are prescribed to patients with chronic forms hepatitis, and Delta .

For treatment viral diseases and, in particular, IFN-α is used predominantly (both its forms, IFN-alpha 2b and IFN-alpha 2a). The “gold standard” of treatment hepatitis C pegylated interferons alpha-2b and alpha-2a are considered to be. In comparison, conventional interferons are less effective.

Genetic polymorphisms observed in the IL28B gene, which is responsible for encoding IFN lambda-3, cause significant differences in the effect of treatment.

Patients with genotype 1 hepatitis C with common alleles of the specified gene are more likely to achieve longer and more pronounced treatment results compared to other patients.

IFN is also often prescribed to patients with oncological diseases : malignant , pancreatic endocrine tumors , non-Hodgkin's lymphoma , carcinoid tumors ; Kaposi's sarcoma , conditioned; hairy cell leukemia ,multiple myeloma , kidney cancer etc..

Contraindications

Interferon is not prescribed to patients with hypersensitivity to it, as well as to children and adolescents suffering from heavy mental disorders And disorders nervous system , which are accompanied by thoughts of suicide and suicide attempts, severe and protracted.

In combination with antiviral drug Ribavirin IFN is contraindicated in patients diagnosed with severe impairment kidney (conditions in which CC is less than 50 ml/min).

Interferon preparations are contraindicated in (in cases where appropriate therapy does not produce the expected clinical effect).

Side effects

Interferon belongs to the category of drugs that can cause a large number of adverse reactions from various systems and organs. In most cases, they are a consequence of the administration of interferon intravenously, subcutaneously or intramuscularly, but they can also be provoked by other pharmaceutical forms of the drug.

The most common adverse reactions to taking IFN are:

• anorexia;
• nausea;
• chills;
• trembling in the body.

Somewhat less common are vomiting, increased blood pressure, a feeling of dry mouth, hair loss (), asthenia ; nonspecific symptoms reminiscent of flu symptoms ; backache, depressive states , musculoskeletal pain , thoughts of suicide and attempted suicide, general malaise, impaired taste and concentration, increased irritability, sleep disorders (common), arterial hypotension , confusion.

Rare side effects include: pain on the right side of the upper abdomen, rashes on the body (erythematous and maculopapular), increased nervousness, pain and severe inflammation at the injection site of the drug into injection form, secondary viral infection (including infection virus herpes simplex ), increased dryness skin, , pain in the eyes , conjunctivitis , blurred vision, dysfunction lacrimal glands , anxiety, mood lability; psychotic disorders , including increased aggression, etc.; hyperthermia , dyspeptic symptoms , respiratory disorders, weight loss, unformed stools, hyper- or hypothyroidism , hearing impairment (up to its complete loss), the formation of infiltrates in the lungs, increased appetite, bleeding gums, in the extremities, dyspnea , renal dysfunction and development renal failure , peripheral ischemia , hyperuricemia , neuropathy etc..

Treatment with IFN drugs may cause violation reproductive function . Studies in primates have shown that interferon violates menstrual cycle among women . In addition, in women undergoing treatment with IFN-α drugs, the level of .

For this reason, if interferon is prescribed, women of childbearing age should use barrier contraception . Men of reproductive age are also advised to be informed of potential side effects.

In rare cases, treatment with interferon may be accompanied by ophthalmological disorders, which are expressed as hemorrhages in the retina of the eye , retinopathy (including but not limited to macular edema ), focal changes in the retina, decreased visual acuity and/or limited visual fields, disc swelling optic nerves , neuritis of the optic (second cranial) nerve , arterial obstruction or retinal veins .

Sometimes, while taking interferon, they can develop hyperglycemia , symptoms of nephrotic syndrome , . In patients with diabetes mellitus may get worse clinical picture diseases.

The possibility of occurrence cannot be excluded cerebrovascular hemorrhage , erythema multiforme , tissue necrosis at the injection site, cardiac and cerebrovascular ischemia , hypertriglyceridermia , sarcoidosis (or aggravation of its course), Lyell's syndromes And Stevens-Johnson .

The use of interferon in monotherapy or in combination with Ribavirin in isolated cases it can provoke aplastic anemia (AA) or even PAKKM ( complete red bone marrow aplasia ).

There have also been cases where, during treatment with interferon drugs, a patient developed various autoimmune And immune-mediated disorders (including Werlhof's disease And Moschkowitz disease ).

Interferon, instructions for use (Method and dosage)

The instructions for the use of interferons alpha, beta and gamma indicate that before prescribing the drug to the patient, it is recommended to determine how sensitive the patient is to it , which caused the disease.

The method of administration of human leukocyte interferon is determined depending on the diagnosis given to the patient. In most cases, it is prescribed as a subcutaneous injection, but in some cases the drug can be injected into a muscle or vein.

The treatment dose, maintenance dose and duration of treatment are determined depending on the clinical situation and the patient’s response to the therapy prescribed to him.

By “children’s” interferon we mean a drug in the form of suppositories, drops and ointments.

Instructions for the use of interferon for children recommend using this drug both as a therapeutic and as a prophylactic agent. The dose for infants and older children is selected by the attending physician.

For preventive purposes, INF is used in the form of a solution, for the preparation of which distilled or boiled water at room temperature is used. The finished solution is colored red and opalescent. It should be stored refrigerated for no more than 24-48 hours. The drug is instilled into the nose of children and adults.

At viral ophthalmic diseases the drug is prescribed in the form of eye drops.

As soon as the severity of the symptoms of the disease decreases, the volume of instillations should be reduced to one drop. The course of treatment is from 7 to 10 days.

For the treatment of lesions caused by herpes viruses , the ointment is applied in a thin layer to the affected areas of the skin and mucous membranes twice a day, maintaining 12-hour intervals. The course of treatment is from 3 to 5 days (until the integrity of the damaged skin and mucous membranes is completely restored).

For prevention acute respiratory infections and needs to be lubricated with ointment nasal passages . The frequency of procedures during the 1st and 3rd weeks of the course is 2 times a day. It is recommended to take a break during the 2nd week. For preventive purposes, interferon should be used throughout the entire period epidemics of respiratory diseases .

The duration of the rehabilitation course in children who often experience recurrent viral-bacterial infections of the respiratory tract , ENT organs , recurrent infection , caused herpes simplex virus , is two months.

How to dilute and how to use interferon in ampoules?

The instructions for using interferon in ampoules indicate that before use, the ampoule must be opened, water (distilled or boiled) at room temperature must be poured into it up to the mark on the ampoule corresponding to 2 ml.

The contents are gently shaken until completely dissolved. The solution is injected into each nasal passage twice a day, five drops, maintaining intervals of at least six hours between administrations.

IN medicinal purposes IFN is started when the first symptoms appear. flu symptoms . The earlier the patient starts taking it, the higher the effectiveness of the drug.

It is considered the most effective inhalation method(through the nose or mouth). For one inhalation, it is recommended to take the contents of three ampoules of the drug, dissolved in 10 ml of water.

The water is preheated to a temperature of no more than +37 °C. Inhalation procedures are carried out twice a day, maintaining an interval of at least one to two hours between them.

When sprayed or instilled, the contents of the ampoule are dissolved in two milliliters of water and 0.25 ml (or five drops) is administered into each nasal passage three to six times a day. The duration of treatment is 2-3 days.

Nasal drops for children for preventive purposes are instilled (5 drops) twice a day, for initial stage development of the disease, the frequency of instillations increases: the drug should be administered at least five to six times a day every hour or two.

Many people are interested in whether interferon solution can be dripped into the eyes. The answer to this question is yes.

Overdose

Cases of interferon overdose have not been described.

Interaction

β-IFN is compatible with corticosteroid drugs and ACTH. It should not be taken during treatment myelosuppressive drugs , incl. cytostatics (this may cause additive effect ).

Beta-IFN should be administered with caution with agents whose clearance is largely dependent on cytochrome P450 system (antiepileptic drugs , some antidepressants and etc.).

You should not take α-IFN and Telbivudin . The simultaneous use of α-IFN provokes a mutual enhancement of action in relation to. When used together with phosphazide can mutually increase myelotoxicity both drugs (it is recommended to carefully monitor changes in the amount granulocytes And;

at sepsis ;

for the treatment of children viral infections (for example, or);

for treatment chronic viral hepatitis .

IFN is also used in therapy, the purpose of which is the rehabilitation of frequently ill people. respiratory infections children.

The most optimal option for children is nasal drops: when used in this way, interferon does not penetrate the gastrointestinal tract (before diluting the drug for the nose, the water should be heated to a temperature of 37°C).

For infants, interferon is prescribed in the form of suppositories (150 thousand IU). Suppositories for children should be administered one at a time 2 times a day, maintaining 12-hour intervals between administrations. The course of treatment is 5 days. To completely cure a child ARVI As a rule, one course is enough.

For treatment, you should take 0.5 g of ointment twice a day. Treatment lasts on average 2 weeks. Over the next 2-4 weeks, the ointment is used 3 times a week.

Numerous positive reviews about the drug indicate that in this dosage form it has also proven to be an effective treatment stomatitis And inflamed tonsils . Interferon inhalations for children are no less effective.

The effect of using the drug increases significantly if a nebulizer is used to administer it (it is necessary to use a device that sprays particles with a diameter of more than 5 microns). Inhalations through a nebulizer have their own specifics.

First, interferon must be inhaled through the nose. Secondly, before using the device, you must turn off the heating function (IFN is a protein; at temperatures above 37°C it is destroyed).

For inhalation in a nebulizer, the contents of one ampoule are diluted in 2-3 ml of distilled or mineral water(you can also use saline solution for these purposes). The resulting volume is enough for one procedure. The frequency of procedures during the day is from 2 to 4.

It is important to remember that long-term treatment of children with interferon is not recommended, since addiction develops to it and, therefore, the expected effect does not develop.

Interferon during pregnancy

An exception may be cases when the expected benefit of therapy for the expectant mother exceeds the risk of adverse reactions and harmful effects on fetal development.

The possibility of isolating recombinant IFN components in breast milk cannot be ruled out. Due to the possibility of exposure to the fetus through milk, IFN is not prescribed to nursing women.

As a last resort, when the administration of IFN cannot be avoided, the woman is advised not to breastfeed during therapy. To mitigate the side effects of the drug (the occurrence of flu-like symptoms), simultaneous administration with IFN is recommended. .

substance-solution: packs Reg. No.: LSR-007009/08

Clinical and pharmacological group:

Release form, composition and packaging

substance -solution.

bottles (1) - cardboard packs.

Description of the active components of the drug " Interferon alpha-2b»

pharmachologic effect

Interferon. It is a highly purified recombinant protein with a molecular weight of 19,300 daltons. Obtained from an Escherichia coli clone by hybridizing bacterial plasmids with the human leukocyte gene encoding the synthesis of interferon. Unlike interferon, alpha-2a has arginine at position 23.

It has an antiviral effect, which is due to interaction with specific membrane receptors and induction of RNA synthesis and, ultimately, proteins. The latter, in turn, prevent the normal reproduction of the virus or its release.

It has immunomodulatory activity, which is associated with the activation of phagocytosis, stimulation of the formation of antibodies and lymphokines.

Has an antiproliferative effect on tumor cells.

Indications

Acute hepatitis B, chronic hepatitis B, chronic hepatitis C.

Hairy cell leukemia, chronic myeloid leukemia, renal cell carcinoma, Kaposi's sarcoma due to AIDS, cutaneous T-cell lymphoma (mycosis fungoides and Sézary syndrome), malignant melanoma.

Dosage regimen

Administered intravenously or subcutaneously. The dose and treatment regimen are set individually, depending on the indications.

Side effect

Flu-like symptoms: often - fever, chills, pain in bones, joints, eyes, myalgia, headache, increased sweating, dizziness.

From the digestive system: possible loss of appetite, nausea, vomiting, diarrhea, constipation, disturbance taste sensations, dry mouth, weight loss, mild abdominal pain, slight changes in liver function tests (usually normalize after treatment).

From the central nervous system and peripheral nervous system: rarely - dizziness, deterioration of mental activity, sleep disturbance, memory impairment, anxiety, nervousness, aggressiveness, euphoria, depression (after long-term treatment), paresthesia, neuropathy, tremor; in some cases - suicidal tendencies, drowsiness.

From the cardiovascular system: possible - tachycardia (with fever), arterial hypotension or hypertension, arrhythmia; in some cases - disorders of the cardiovascular system, coronary artery disease, myocardial infarction.

From the outside respiratory system: rarely - chest pain, cough, slight shortness of breath; in some cases - pneumonia, pulmonary edema.

From the hematopoietic system: possible slight leukopenia, thrombocytopenia, granulocytopenia.

Dermatological reactions: possible itching, reversible alopecia.

Others: rarely - muscle stiffness; in isolated cases - antibodies to natural or recombinant interferons.

Contraindications

Severe cardiovascular diseases, decompensated liver cirrhosis, severe depression, psychosis, alcohol or drug addiction, increased sensitivity to interferon alpha-2b.

Pregnancy and lactation

Use during pregnancy is possible only if the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

It is not known whether interferon alfa-2b is excreted in breast milk. If it is necessary to use it during lactation, the issue of stopping breastfeeding should be decided.

Women of childbearing age should use reliable contraception during treatment.

Use for liver dysfunction

Contraindicated in decompensated liver cirrhosis. Use with caution in patients with impaired liver function.

Use for renal impairment

Use with caution in patients with impaired renal function.

special instructions

Use with caution in patients with impaired renal, liver, bone marrow hematopoiesis, or with a tendency to suicide attempts.

In patients with diseases of the cardiovascular system, arrhythmia is possible. If the arrhythmia does not decrease or increases, the dose should be reduced by 2 times or treatment should be stopped.

During the treatment period, monitoring of neurological and mental status is necessary.

In cases of severe suppression of bone marrow hematopoiesis, regular examination of the composition of peripheral blood is necessary.

Interferon alfa-2b has a stimulating effect on immune system, therefore should be used with caution in patients prone to autoimmune diseases, due to an increased risk of autoimmune reactions.

Drug interactions

Drug interactions

Interferon alfa-2b inhibits the metabolism of theophylline and reduces its clearance.

Included in the preparations

Included in the list (Order of the Government of the Russian Federation No. 2782-r dated December 30, 2014):

VED

ONLS

ATX:

L.03.A.B.05 Interferon alpha-2b

Pharmacodynamics:

Interferon. It is a highly purified recombinant with a molecular weight of 19,300 daltons. Derived from a clone Escherichia coli by hybridizing bacterial plasmids with the human leukocyte gene encoding the synthesis of interferon. Unlike interferon, alpha-2a is located at position 23.

It has an antiviral effect, which is due to interaction with specific membrane receptors and induction of RNA synthesis and, ultimately, proteins. The latter, in turn, prevent the normal reproduction of the virus or its release.

It has immunomodulatory activity, which is associated with the activation of phagocytosis, stimulation of the formation of antibodies and lymphokines.

Has an antiproliferative effect on tumor cells.

The drug increases the phagocytic activity of macrophages and potentiates the cytotoxic effect of lymphocytes.

Pharmacokinetics:

Penetrates into the systemic bloodstream through the mucous membrane of the respiratory tract, undergoes breakdown in the body, and is partially excreted unchanged, mainly through the kidneys. Local use for the treatment of viral infections provides a high concentration of interferon at the site of inflammation. Metabolized by the liver, the half-life is 2-6 hours.

Indications:

Chronic hepatitis B;

Hairy cell leukemia;

Renal cell carcinoma;

Skin T -cellular lymphoma (mycosis fungoides and Sezary syndrome);

IN viral hepatitis B;

IN viral active hepatitis C;

Chronic myeloid leukemia;

Kaposi's sarcoma due to AIDS;

Malignant melanoma;

- primary (essential) and secondary thrombocytosis;

- transitional form of chronic granulocytic leukemia and myelofibrosis;

- multiple myeloma;

Kidney cancer;

- reticulosarcoma;

- multiple sclerosis;

- prevention and treatment of influenza and acute respiratory viral infection.

I.B15-B19.B16 Acute hepatitis B

I.B15-B19.B18.1 Chronic viral hepatitis B without delta agent

I.B15-B19.B18.2 Chronic viral hepatitis C

I.B20-B24.B21.0 Disease caused by HIV with manifestations of Kaposi's sarcoma

II.C43-C44.C43.9 Malignant melanoma of the skin, unspecified

II.C64-C68.C64 Malignant neoplasm of the kidney other than the renal pelvis

II.C81-C96.C84 Peripheral and cutaneous T-cell lymphomas

II.C81-C96.C84.0 Mycosis fungoides

II.C81-C96.C84.1 Sézary's disease

II.C81-C96.C91.4 Hairy cell leukemia (Leukemic reticuloendotheliosis)

II.C81-C96.C92.1 Chronic myeloid leukemia

Contraindications:

D uncompensated cirrhosis of the liver;

Psychosis;

P increased sensitivity to interferon alpha-2 b;

- severe cardiovascular diseases;

T severe depression;

A alcohol or drug addiction;

- autoimmune diseases;

- acute myocardial infarction;

- severe disorders of the hematopoietic system;

-epilepsy and/or other disorders of the central nervous system;

-chronic hepatitis in patients receiving or recently receiving immunosuppressant therapy (with the exception of short-term pre-treatment with steroids).

Carefully:

-liver diseases;

Z kidney disease;

-violation of bone marrow hematopoiesis;

-tendency to autoimmune diseases;

-tendency to suicide attempts.

Pregnancy and lactation:

FDA Category C recommendation. No safety data available. Do not use! Use during pregnancy is only possible if the potential benefit to the mother outweighs the potential harm to the child.

While using the drug, contraception should be used.

Information about penetration into breast milk No. Do not use during breastfeeding.

Directions for use and dosage:

Administered intravenously or subcutaneously. The dose is set individually depending on the diagnosis and individual indicators sick.

Subcutaneous administration at a dose of 0.5-1 mcg/kg once a week for 6 months. The dose is selected taking into account the expected effectiveness and safety. If after 6 months the virus RNA is eliminated from the serum, then treatment is continued for up to one year. If during treatment there are unwanted reactions, then the dose is reduced by 2 times. When saving unwanted effects or their reoccurrence after changing the dose, treatment is stopped. It is also recommended to reduce the dose if the neutrophil count decreases to less than 0.75×10 9 /l or the platelet count decreases to less than 50×10 9 /l. Therapy is stopped when the number of neutrophils decreases to less than 0.5×10 9 /l or platelets - less than 25×10 9 /l. In cases of severe renal dysfunction (clearance less than 50 ml/min), patients should be under constant monitoring. If necessary, the weekly dose of the drug is reduced. No dose adjustment based on age is required.

Preparation of the solution: the powdery contents of the bottle are dissolved in 0.7 ml of water for injection, the bottle is gently shaken until the powder is completely dissolved. The finished solution should be inspected before administration; If the color changes, it should not be used. For administration, use up to 0.5 ml of solution, the remainder is disposed of.

For the treatment of influenza and ARVI- aerosol for local application 100,000 IU, administered 7 times a day, every 2 hours (daily dose - up to 20,000 IU) in the first two days of the disease, then 3 times a day (daily dose - up to 10,000 IU) for five days or until complete disappearance of symptoms of the disease.

Interferon therapy is carried out against the background of traditional symptomatic therapy, including the use of non-steroidal anti-inflammatory drugs (,) when the temperature rises above 38.5 ° C, antihistamines(diazolin, suprastin, tavegil), antitussives (codelac), mucolytic drugs (cough mixture), restoratives (calcium gluconate, vitamins).

Side effects:

From the outside gastrointestinal tract: decreased appetite, vomiting, constipation, dry mouth, mild abdominal pain, nausea, diarrhea,disturbance of taste, loss of body weight, slight changes in liver function indicators.

From the nervous system: dizziness, sleep disturbance, anxiety, aggressiveness, depression, neuropathy, suicidal tendencies, mental deterioration,memory impairment, nervousness, euphoria, paresthesia, tremor, drowsiness.

From the outside circulatory system: arterial hypotension or hypertension, disorders of the cardiovascular system, myocardial infarction, thrombocytopenia, tachycardia,arrhythmia, ischemic disease heart, leukopenia, granulocytopenia.

From the respiratory system: cough, pneumonia, chest pain,slight shortness of breath, pulmonary edema.

From the outside skin: reversible alopecia, itching.

Others: antibodies to natural or recombinant interferons, muscle stiffness, flu-like symptoms.

Overdose:

No data.

Interaction:

The drug inhibits the metabolism of theophylline.

special instructions:

During the period of use of the drug, it is necessary to monitor the mental and neurological status of the patient.

In patients with diseases of the cardiovascular system, arrhythmia is possible. If the arrhythmia does not decrease or increases, the dose should be reduced by 2 times or treatment should be stopped.

In cases of severe suppression of bone marrow hematopoiesis, regular examination of the composition of peripheral blood is necessary.

Impact on the ability to drive vehicles and other technical devices

The drug in aerosol form does not affect the ability to control vehicles and maintenance of moving mechanisms.

Instructions