Alfaferon - Instructions For Use, Price, Analogues, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Alfaferon

Alfaferon: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Alfaferone

ATX code: L03AB01

Active ingredient: interferon alpha (Interferon alfa)

Manufacturer: Alfa Wassermann, SpA (Italy)

Description and photo update: 2019-10-07

Alfaferon is an interferon preparation, which is a mixture of various subtypes of natural alpha-interferon from human donor blood leukocytes.

Release form and composition

Dosage form - solution for injection: transparent, colorless or light yellow (in ampoules made of neutral transparent glass with a volume of 1 ml with a black line or break point, 1 ampoule in a plastic pallet, 1 pallet in a cardboard box and instructions for the use of Alfaferon).

Composition of 1 ml solution:

• active substance: human alpha leukocyte interferon - 1 million ME (International units), 3 million ME or 6 million ME;
• auxiliary components: water for injection, potassium dihydrogen phosphate, potassium chloride, sodium hydrogen phosphate dodecahydrate, sodium chloride.

Pharmacological properties

Pharmacodynamics

Interferon alpha has an immunomodulatory, antiproliferative and antiviral effect.

The immunomodulatory effect is realized through direct stimulation of the activity of macrophages and NK cells (natural killer cells) and is carried out in this way: macrophages are involved in the presentation of antigen to immunocompetent cells, and NK cells are involved in the body's immune response to tumor cells.

The antiproliferative activity of the drug is manifested through the activation of the p53 protein.

The antiviral effect of Alfaferon is due to its ability to bind on the surface of still uninfected cells with specific receptors. As a result, their resistance to the penetration of viruses increases. Specific enzymes are formed, including oligoadenylate synthetase, which activates endoribonuclease, which destroys viral RNA and thereby prevents its replication, and protein kinase, which phosphorylates protein eIF-2 (eukaryotic translation initiation factor). In this case, eIF-2 forms an inactive complex with the eIF2B factor and, as a consequence, disrupts intracellular protein synthesis. The result of protein kinase activation is the induction of another cellular enzyme - RNase, which destroys RNA, which causes blockage of intracellular protein synthesis, death of the virus and host cells infected with the virus.

Alfaferon induces the formation of proteins, the so-called interferon-stimulated genes, which are involved in the destruction of viruses and prevent the multiplication of viruses through the activation of the p53 protein, and it, in turn, destroys cells infected with the virus through the mechanism of apoptosis.

Interferon alpha activates the immunoproteasome and molecules of the major histocompatibility complex MHC I and MHC II. The immunoproteasome helps T cells recognize and destroy cells infected with the virus. Due to the increased expression of the MHC I and MHC II genes, the presentation of viral peptides to cytotoxic T cells and T helper cells, respectively, improves. Helper T cells produce cytokines that coordinate the interaction of cells in the immune system.

Thus, the direct action of Alfaferon is directed not at viruses, but at cells not yet infected with a virus, which causes a number of changes in them, which provide the cells with the ability to resist the virus.

Pharmacokinetics

Intravenous (iv) administration of interferon alfa provides a rapid creation of a high concentration in the blood, however, within 24 hours, it decreases below the minimum detectable value (<0.01%). With the subcutaneous (s / c) and intramuscular (i / m) method of administration of Alfaferon, the concentration in the blood remains longer.

After i / m administration, interferon alpha is absorbed almost completely. The maximum plasma concentration (C _max) reaches within 1–6 hours. For 6–12 hours, a stable level of the substance in the plasma is maintained, after which it begins to gradually decrease, until complete elimination after 18–36 hours.

With subcutaneous administration, Alfaferon is slowly absorbed through the lymphatic vessels.

Interferon alpha in the minimum concentration is found in the cerebrospinal fluid, in a small amount penetrates the blood-brain barrier.

The drug circulating in the blood is filtered by the glomeruli of the kidneys, after which it undergoes proteolytic degradation by lysosomal enzymes to amino acids and is reabsorbed in the proximal tubules of the kidneys. A small amount of unchanged interferon alpha and degradation products (peptides) are excreted in the urine. The half-life (T _1/2) is about 6 hours.

In patients with normal renal and hepatic function, there is no significant accumulation of the drug, even with prolonged treatment.

Indications for use

Alfaferon is prescribed for the following viral diseases:

• chronic hepatitis C in patients with high activity of liver enzymes, but in the absence of liver failure;
• chronic active hepatitis B in patients with viral replication markers such as HBV-DNA, viral DNA polymerase, or HBeAg;
• genital warts.

The drug is also used in the treatment of such neoplastic processes:

• fungal mycosis;
• non-Hodgkin's lymphoma;
• multiple myeloma;
• chronic myeloid leukemia;
• hairy cell leukemia (tricholeukemia);
• malignant melanoma;
• kidney cancer;
• Kaloshi's sarcoma in patients with AIDS (acquired immunodeficiency syndrome) who do not have a history of opportunistic infections.

Contraindications

Absolute:

• diseases of the thyroid gland that cannot be controlled by standard therapy;
• severe renal and / or liver dysfunction;
• autoimmune hepatitis;
• chronic hepatitis in patients who have recently received or are receiving treatment with immunosuppressants (except for cases of recent withdrawal of short-term glucocorticosteroid therapy);
• chronic hepatitis, complicated by cirrhosis of the liver, with symptoms of liver failure;
• severe diseases of the cardiovascular system (arrhythmia, heart failure);
• epilepsy, severe mental impairment or dysfunction of the central nervous system (currently or in history);
• age up to 18 years;
• lactation period;
• hypersensitivity to any component of the drug.

Relative (Alfaferon should be used with caution, under close medical supervision):

• arterial hypotension;
• recent myocardial infarction;
• oppression of bone marrow hematopoiesis;
• bleeding disorder (including thrombocytopenia);
• pregnancy;
• simultaneous use of narcotic analgesics, sedatives or hypnotics.

Alfaferon, instructions for use: method and dosage

Alfaferon is administered intravenously, intramuscularly or subcutaneously, with genital warts, it is possible to inject the drug directly into the lesion. In thrombocytopenia (platelet count <50,000 / μl), the drug is preferable to inject s / c. High daily doses (≥ 9 million IU) are injected slowly intravenously (over 30-60 minutes), for this the dose is diluted with saline in a volume of 50 ml.

The doctor sets the dosage regimen depending on the type and course of the disease; in the course of treatment, he can change it, taking into account the individual response of the patient.

Recommended dosage regimens for viral diseases:

• chronic hepatitis C: i / m or s / c, 3 million IU three times a week for up to 6 months. If within 16 weeks of regular use of the drug, the activity of hepatic transaminases does not decrease, the drug is canceled. If necessary, Alfaferon is prescribed in combination with ribavirin in the form of capsules (in a daily dose of 1000-1200 mg in 2 divided doses with meals) for at least 6 months. Treatment of patients infected with genotype 1 virus, or previously untreated, or with high initial viremia, or with persistent HCV-RNA clearance for 6 months, the combination therapy is increased to 12 months;
• chronic active hepatitis B: i / m or s / c at 2.5-5 million IU / m ² of body surface three times a week for 4-6 months. If after 1 month the number of viral or HBeAg replication markers does not decrease, the dose of Alfaferon is increased individually for each patient, depending on the tolerance of the drug. In the absence of positive dynamics after 3-4 months, treatment is stopped. The described treatment regimen is also suitable for patients with chronic hepatitis D virus;
• genital warts: s / c, i / m or into the lesion (if it is large, Alfaferon is injected into the base of the damaged area using a thin needle). The required dose depends on the area of the lesion and may be 0.1-1 million IU. When calculating the total single dose, the amount of damage is taken into account, but it should not exceed 3 million IU. Each cycle of therapy consists of three doses per week for a minimum of 3 weeks. Improvement can be seen 4-6 weeks after the start of the first cycle (ie, within a month after the end of treatment). If necessary, repeat the cycle using similar doses.

Recommended dosage regimens for neoplastic processes:

• fungal mycosis: s / c or i / m, 3 million IU once a day, then every week the dose is increased (provided that Alfaferon is well tolerated) to a maximum daily dose of 9-12 IU. After 3 months, the patient is transferred to maintenance therapy at a dose of 6 to 12 million IU three times a week;
• non-Hodgkin's lymphoma: i / m or s / c, 5 million IU three times a week for 18 months;
• multiple myeloma: i / m or s / c, 3 million IU three times a week, then every week (provided that the drug is well tolerated) the dose is increased to a maximum of 6-12 million IU three times a week. This regimen can be adhered to indefinitely, except in cases of too rapid progression of the disease or the appearance of signs of Alfaferon intolerance;
• chronic myeloid leukemia: i / m or s / c, 3 million IU daily, every week (provided that the drug is well tolerated) the dose is increased to a maximum daily dose of 9 million IU. After stabilizing the number of leukocytes, the patient can be transferred to maintenance therapy using the optimal dose of Alfaferon three times a week, this regimen can be adhered to indefinitely, except in cases of too rapid progression of the disease or the appearance of signs of intolerance to interferon alpha;
• hairy cell leukemia (tricholeukemia): i / m or s / c 3 million IU three times a week for 6 months. If effective, the treatment is continued until the hematological parameters improve, after reaching their stability, therapy is continued for another 3 months. If there is no positive trend, Alfaferon is canceled;
• malignant melanoma, kidney cancer: s / c or i / m 3 million IU daily, then every week the dose is increased to a maximum daily dose of 6-9 million IU. After 3 months, the patient is transferred to maintenance therapy using the drug in the same dose three times a week for 6 months. In renal cancer, Alfaferon in the indicated dosage regimen can be used in combination with vinblastine (i.v., 0.1 mg / kg once every 21 days);
• sarcoma Galoshi in patients with AIDS: s / c or i / m, 3 million IU daily. With good tolerance, the dose is gradually increased to a maximum daily dose of 9-12 million IU. After 2 months, the patient is transferred to maintenance therapy with Alfaferon at the same dose three times a week.

Side effects

With parenteral administration of interferon alfa, adverse reactions are observed much more often than with other methods of its use.

The following adverse side effects have been reported for systemic organ classes:

• from the cardiovascular system: increase / decrease in blood pressure, arrhythmia (especially in patients with heart disease);
• on the part of the blood and hematopoietic organs: thrombocytopenia, transient leukopenia, granulocytopenia, anemia, eosinophilia;
• from the gastrointestinal tract and liver: abdominal pain, nausea, diarrhea, decreased appetite, vomiting, abnormal liver function;
• from the central nervous system: confusion, drowsiness, irritability, ataxia, depression, dizziness, acute psychosis, changes in electroencephalography;
• on the part of the skin and subcutaneous fat: exfoliative dermatitis, dry skin, itching, skin rash, erythema; in rare cases - alopecia;
• on the part of the organ of vision: visual impairment, edema of the optic nipple;
• others: flu-like symptoms (fever, chills, malaise, headache, asthenia, myalgia, arthralgia), weight loss, increased or decreased thyroid function, hypofunction of the pituitary gland, skin reactions at the injection site.

In clinical studies in patients receiving Alfaferon in combination with ribavirin, the following disorders were observed: shortness of breath, fever, sore throat, chills, cough, fatigue, asthenia, headache, insomnia, increased nervous excitability, hallucinations, depression, dry skin, cutaneous itching, erythema, fungal skin lesions, abdominal pain, dyspepsia, nausea, arthralgia, myalgia, anemia (including hemolytic), polyuria, hyperuricemia, thyroid dysfunction.

Overdose

To date, no cases of Alfaferon overdose have been reported.

special instructions

Before prescribing Alfaferon and regularly during its use, patients should undergo a standard clinical blood test with the obligatory counting of platelets, as well as monitor the level of electrolytes in the blood, blood biochemical parameters, and the functional state of the kidneys and liver.

Careful observation is required for patients with heart disease, especially with arrhythmia (including a history) and after myocardial infarction in the recent past. Before the appointment of Alfaferon and systematically in the course of therapy, they need to conduct an electrocardiographic examination.

In patients with hairy cell leukemia, before starting treatment and periodically during the use of the drug, it is necessary to determine the content of granulocytes, platelets and hemoglobin, as well as hairy cells (including in the bone marrow).

Patients should be warned that interferon preparations cannot be changed without consulting a doctor, since the recommended doses for each agent are different.

Patients should be provided with adequate hydration, especially at the beginning of treatment.

In the event of serious side effects, it is necessary to change the dosage regimen of Alfaferon or cancel it altogether.

Adverse reactions from the central nervous system are usually quickly reversible, but in some cases they completely disappear only after 3 weeks, during which the patient should be under close medical supervision. In severe cases, treatment is interrupted. The most pronounced symptoms are more often observed in older people receiving high doses of Alfaferon.

Influenza-like symptoms are usually pronounced in the first week of treatment and gradually, as a result of tachyphylaxis, decrease by 2-4 weeks. In rare cases, there is an increase in the intensity of the pain syndrome, which may require discontinuation of the drug. To relieve symptoms such as fever, chills, myalgia, arthralgia and headache, paracetamol is effective. In the clinical practice of using Alfaferon, it has been noted that the severity of influenza-like symptoms decreases if the drug is administered before bedtime.

Some patients experience prolonged asthenia, sometimes requiring discontinuation of therapy.

There have been no reports of serious hypersensitivity reactions, however, the possibility of their development cannot be completely ruled out. In this case, drug treatment is stopped and appropriate therapy is prescribed. Skin rash does not require abolition of Alfaferon.

In patients with hepatitis C during therapy, in some cases (<1%), thyroid dysfunction, such as hyper- or hypothyroidism, requiring standard therapy is observed.

It was reported about an increase in the activity of hepatic transaminases and the subsequent development of seroconversion in patients with active chronic hepatitis B 3 months after the end of therapy. The mechanism of these violations is unknown. In this connection, it is necessary to determine the serum concentration of thyroid-stimulating hormone (TSH) before starting treatment. It is possible to start treatment with interferon alpha only if the TSH is normal. If symptoms occur already during the period of therapy, the use of Alfaferon can be continued, provided that the normal concentration of TSH is maintained. Signs of dysfunction of the thyroid gland, which appeared during therapy with the drug, do not disappear after its cancellation.

The effectiveness of Alfaferon in patients with chronic hepatitis B simultaneously infected with the human immunodeficiency virus (HIV) has not been demonstrated.

With intramuscular injection of the drug, the injection site should be constantly changed.

Women of reproductive age should use reliable methods of contraception during treatment with interferon alfa.

Influence on the ability to drive vehicles and complex mechanisms

Patients receiving Alfaferon in high doses, as well as in the event of adverse reactions from the nervous system, are advised to refrain from performing activities that require quick reactions and increased attention, including driving a car.

Application during pregnancy and lactation

Alfaferon during pregnancy can be used provided that the expected benefit to the mother outweighs the potential risk to the fetus.

Whether the drug passes into breast milk is unknown. If the course of therapy is clinically justified, women are advised to stop lactation and transfer the baby to artificial feeding.

Pediatric use

Studies on the effectiveness and safety of interferon alfa in patients under the age of 18 have not been conducted.

With impaired renal function

Alfaferon is contraindicated in case of severe functional disorders of the kidneys.

For violations of liver function

Alfaferon is contraindicated in case of severe functional disorders of the liver.

Use in the elderly

There is no indication of the need to adjust the dose of Alfaferon for the elderly.

Drug interactions

Alfaferon should not be diluted with 5% dextrose solution. It is forbidden to add any other medicines to the dropper with the drug.

Interferon alpha reduces theophylline clearance and decreases its half-life.

It is recommended to avoid the simultaneous use of ethanol, immunosuppressants and drugs that have a depressing effect on the central nervous system.

When used together, Alfaferon disrupts the metabolism of warfarin, propranolol, phenytoin, cimetidine, diazepam.

Analogs

Alfaferon's analogs are Alfarona, Altevir, Binnoferon Alpha, Interferal, Interal-P, Intron A, Layfferon, Realdiron, Reaferon-EC, Roferon-A.

Terms and conditions of storage

Store at a temperature of 2-8 ° C out of reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Alfaferon

On specialized sites and forums, reviews about Alfaferon are found mainly from patients who received a drug for the treatment of hepatitis. The therapy was combined, therefore, it is difficult for most to assess the properties of this particular agent, however, it indicates that the treatment turned out to be effective. Many people note that at the beginning of the use of the drug, there were undesirable reactions that gradually disappeared as therapy continued, including headache, drowsiness, dizziness, irritability, fever, loss of appetite, nausea, muscle weakness.

The price of Alfaferon in pharmacies

At the moment, the price of Alfaferon is unknown, since the drug is not available on the market. The approximate cost of its analogue, Altevira (ampoules of 1 ml, 5 pcs. In a package), depending on the pharmacy network, may be: dosage of 3 million IU - 1075-1142 rubles, dosage of 5 million IU - 999-1803 rubles, dosage 10 million IU - 1065-1745 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!