$299.00
Manufacturer: Ukraine
Immunostimulants. Interferon alfa-2b. ATX code L03A B05.
Alfarekin is used in complex therapy for:
- acute and chronic viral hepatitis B (moderate and severe forms);
- chronic hepatitis C;
- acute viral, bacterial and mixed infections (including acute respiratory viral infections in children, including newborns, acute diarrheal syndrome in newborns);
- acute and chronic septic diseases of a viral and bacterial nature, including disseminated forms of acute and chronic sepsis;
- herpetic infections of various localization: herpes zoster, multiple skin herpetic eruptions; genital herpetic infection;
- herpetic keratoconjunctivitis and keratouveitis, acute herpetic stomatitis in children;
- chronic urogenital chlamydia;
- lesions of the nervous system with mono- and polyradicular pain syndromes;
- multiple sclerosis;
- papillomatosis of the larynx;
- melanoma of the skin and eyes; Kaposi’s sarcoma, multiple myeloma; chronic myeloid leukemia, hairy cell leukemia, non-Hodgkin’s malignant lymphomas, namely follicular lymphoma.
Description
Composition
active ingredient : recombinant human interferon alfa-2b, 1 vial contains recombinant human interferon alfa-2b 1 million IU;
excipients: sodium chloride, dextran 70, potassium dihydrogen phosphate, anhydrous sodium phosphate.
Dosage form
Lyophilisate for solution for injection.
Basic physical and chemical properties: lyophilized powder or porous mass of white color, hygroscopic.
Pharmacotherapeutic group
Immunostimulants. Interferon alfa-2b. ATX code L03A B05.
Pharmacodynamics
Alfarecin (interferon) is a dosage form of recombinant human interferon alfa-2b. Recombinant interferon alfa-2b is a highly purified, water-soluble protein with a molecular weight of 19,300 daltons, synthesized by E. coli cells based on a gene encoding a product identical to human interferon alfa-2b using phage-dependent genetically engineered biotechnology. The specific activity of Alfarekin is measured in international units. Release the drug in a lyophilized state.
Alfarecin (interferon), like natural leukocyte interferon, has three main types of biological activity: immunomodulatory, antiviral and antitumor.
The mechanism of action of Alfarecin (interferon) is based on the fact that interferon, by binding to the corresponding receptors of body cells, induces a complex of intracellular mechanisms, causes the appearance of enzymes that prevent viral replication, increase the phagocytic activity of macrophages, the specific cytotoxicity of lymphocytes to target cells, and inhibit the proliferation of metastatic cells.
Indications
Alfarecin (interferon) is used in complex therapy for:
- acute and chronic viral hepatitis B (moderate and severe forms);
- chronic hepatitis C;
- acute viral, bacterial and mixed infections (including acute respiratory viral infections in children, including newborns, acute diarrheal syndrome in newborns);
- acute and chronic septic diseases of a viral and bacterial nature, including disseminated forms of acute and chronic sepsis;
- herpetic infections of various localization: herpes zoster, multiple skin herpetic eruptions; genital herpetic infection; herpetic keratoconjunctivitis and keratouveitis, acute herpetic stomatitis in children;
- chronic urogenital chlamydia;
- lesions of the nervous system with mono- and polyradicular pain syndromes;
- multiple sclerosis;
- papillomatosis of the larynx;
- melanoma of the skin and eyes; Kaposi’s sarcoma, multiple myeloma; chronic myeloid leukemia, hairy cell leukemia, non-Hodgkin’s malignant lymphomas, namely follicular lymphoma.
Contraindications
- hypersensitivity to interferon alfa-2b or other components of the drug;
- severe diseases of the cardiovascular system (including heart failure in the stage of decompensation, recent myocardial infarction, severe arrhythmia);
- severe dysfunction of the kidneys or liver, including in connection with metastases;
- epilepsy and / or other dysfunctions of the central nervous system (CNS) (including functional ones);
- chronic hepatitis with decompensated liver cirrhosis;
- chronic hepatitis in patients who are undergoing or have recently received treatment with immunosuppressive drugs other than a short course of corticosteroids;
- autoimmune hepatitis or a history of autoimmune disease is contraindicated in transplant recipients after immunosuppressive therapy;
- thyroid disease, not controlled by traditional methods of treatment;
- the presence of severe visceral disorders in patients with Kaposi’s sarcoma;
- psoriasis, sarcoidosis, if the potential benefit does not outweigh the potential risk;
- a combination of the drug Alfarekin with telbivudine;
- pregnancy (the safety of the drug during pregnancy has not been established).
Children and teenagers
Severe mental condition, especially severe depression, suicidal thoughts or suicide attempts now or in history.
Combination therapy with ribavirin
When using Alfarecin (interferon) and ribavirin as part of a combination therapy for chronic hepatitis C, contraindications for the use of ribavirin should also be taken into account.
Dosage and administration
Alfarekin’s solution is administered intramuscularly, subcutaneously, intravenously, endolymphally, rectally, parabulbar, intranasally.
Acute viral hepatitis B:
- inject intramuscularly at 1 million IU (in severe cases – 2 million IU) 2 times a day for 10 days. Such a course can be prolonged up to 2-3 weeks, depending on the clinical status of the patient, or continued at a dose of 1 million IU 2 times a week for several weeks.
Chronic viral hepatitis B:
- inject intramuscularly at 3-4 million IU 3 times a week for 2 months.
Chronic viral hepatitis C:
- inject intramuscularly at 3 million IU 3 times a week for 6 months when using the drug as monotherapy or in combination with nucleoside analogues. After 3-4 months, it is necessary to determine HCV RNA; continue treatment only if HCV RNA is not detected; with monotherapy, the course of treatment is from 12 to 18 months, in combination with ribavirin – 6 months; with genotype 1 and a high content of viral RNA before the start of therapy, in the absence of HCV RNA in the blood serum by the end of 6 months of treatment, combination therapy can be continued for another 6 months, however, such negative factors as age from 40 years, male sex, progressive fibrosis.
Acute respiratory viral infection in children, including newborns:
- inject 2-3 drops intranasally into each nasal passage 3-6 times a day for 3-5 days, dosing the drug for newborns – 20-50 thousand IU / ml, for other children – 100 thousand IU / ml. It is acceptable to introduce into the nasal passages (alternately) cotton turundas moistened with Alfarekin for 10-15 minutes.
Acute respiratory viral infection (including influenza) in adults:
- administer intramuscularly at 1-3 million IU, starting from the 1-2 day of illness for 3 days;
- intranasally, 4-6 drops of Alfarekin solution (100 thousand IU / ml) in each nasal passage 6-8 times a day (before use, the dose of Alfarekin, which is poured, should be heated in a syringe (use a syringe without a needle) to body temperature, the rest store the solution in the refrigerator, protecting from bacterial contamination).
Acute and recurrent pneumonia of viral and viral-bacterial etiology:
Alfarekin is administered intramuscularly at 1 million IU for 5-7 days along with complex treatment (antibacterial, detoxification, anti-inflammatory, etc.).
Acute diarrheal syndrome in newborns:
- rectally in the form of daily microclysters containing 100 thousand IU of Alfarekin for 3-7 days.
Purulent-septic diseases, peritonitis, multiple abdominal abscesses:
- intravenously at 2-4 million IU once a day, the total dose is 12-16 million IU; the expediency of simultaneous endolymphatic administration of the drug in the same dose of 2-4 million IU once a day is not excluded.
Herpes infections:
- herpes zoster: daily 1 million IU intramuscularly + 2 million IU in 5 ml of 0.9% sodium chloride solution subcutaneously at several points around the rash. The duration of treatment is 5-7 days;
- skin herpetic eruptions: daily intramuscular or subcutaneous (around the focus) administration of the drug at a dose of 2 million IU, treatment can be combined with topical application (applications) on herpetic papules; the duration of treatment is determined by the doctor;
- genital herpes infection: daily intramuscular injection at a dose of 2 million IU in combination with local application of the drug in the form of applications in the area of rashes; the duration of treatment is determined by the doctor;
- herpetic keratoconjunctivitis: the introduction of a solution of Alfarekin – 1 million IU in 5 ml of 0.9% sodium chloride solution – under the conjunctiva of the eye, 2-3 drops every 2 hours for 7-10 days with the disappearance of symptoms of the disease, the drug can be administered every 4 hours ; the duration of treatment is determined by the doctor;
- acute herpetic stomatitis in children 250 thousand IU per dose 4 times a day in the form of applications in combination with intranasal administration. Dilute Alfarekin 1 million IU in 4 ml of water for injection, apply 1 ml of solution per 1 application and intranasal administration 2 drops enter intranasally, the rest – after hygienic treatment of the oral mucosa, apply topically in the form of applications. The course of treatment is 7-10 days.
Chronic urogenital chlamydia:
treatment of patients with urogenital chlamydia is carried out in 2 stages:
- Stage 1 – preparatory, which includes the use of enterosorbent, multivitamin preparations in therapeutic doses for 2 weeks. From the 10th day, the immunotropic drug thymalin is prescribed, 10 mg intramuscularly in the evening every other day, 5 injections per course;
- Stage 2 – the main one, during which basic therapy with antibacterial agents is carried out according to the following scheme: the first antibiotic within 5 days after a break that lasted 7 days, patients are prescribed a second antibiotic for 10 days. During the break and after the end of the course of antibiotic therapy, Alfarekin is prescribed 1 million IU intramuscularly 1 time per day in the evening, a total of 10 injections per course.
While taking antibacterial agents, it is necessary to use antifungal drugs (nystatin, diflucan, clotrimazole, nizoral) and hepatoprotectors (karsil) in therapeutic doses.
Damage to the nervous system with mono- and polyradicular pain syndromes:
- intramuscularly at a dose of 1 million IU for a course of 5-10 days in complex treatment.
Papillomatosis of the larynx:
- 3 million IU/m2 subcutaneously 3 times a week (every other day) for 6 months or more; adjust the dose according to the tolerability of the drug. Treatment should be started after surgical (laser) removal of the tumor tissue.
Multiple sclerosis:
- intramuscularly at 1 million IU 2-3 times a day for 10-15 days, followed by the introduction of 1 million IU once a week for 6 months.
skin melanoma:
- in addition to surgical treatment and to induce remission intravenously at 20 million IU/m2 (infusion for 20 minutes), 5 times a week for 4 weeks maintenance therapy – subcutaneously at 10 million IU/m2 3 times a week (every other day) within 48 weeks.
With the development of severe side effects, namely, with a decrease in the number of granulocytes (less than 500 / mm 3), an increase in the level of alanine aminotransferase (ALT), aspartate aminotransferase (AST) (exceeding the upper limit of the norm by 5 times), stop using the drug until the indicators normalize. Reinstate treatment at half dose. If intolerance persists, and the number of granulocytes decreases to 250 / mm 3 or the activity of ALT and / or AST increases (exceeds the upper limit of the norm by 10 times), the drug should be discontinued.
Uveal melanoma:
- parabulbarno daily, 1 million IU for 10 days, repeated 10-day injections are carried out twice in 20 days; the general course of treatment with Alfarekin is 48 weeks. It is not excluded the need for repeated courses after 45 days of treatment with Alfarekin combined with photodestruction of the tumor and beta-application.
Kaposi’s sarcoma: the following treatment regimens are possible:
- intramuscularly daily for 10 days 3 million IU per injection; treatment is combined with prospidin monochemotherapy; repeated courses – once a month for 6 months;
- intravenous drip over 30 minutes 50 million IU (30 million IU / m2) daily for 5 days or at intervals of 1 day, after which a minimum 9-day break is required before starting a new 5-day course; the duration of treatment is determined by the doctor.
Myeloma:
- intramuscularly, daily for 10 days, 3 million IU per injection, repeated courses – 1 time in 1.5-3 months (4-6 times during the year).
Chronic myeloid leukemia:
- subcutaneously at 3 million IU / m2 per day daily or 1 time in 2 days, gradually increasing the dose to 5 million IU / m2 per day daily or 1 time in 2 days under medical supervision until complete hematological remission is achieved (the number of leukocytes in peripheral blood does not more than 10 × 109/l) or within 18 months.
Hairy cell leukemia:
- intramuscularly at 3 million IU 3 times a week (every other day) for 4-6 weeks. When remission is achieved, maintenance therapy is carried out: 3 million IU every other day for up to 12 months.
Non-Hodgkin’s malignant lymphomas, namely follicular lymphoma:
- intramuscularly at 3 million IU 3 times a week for 12-18 months as maintenance therapy when achieving remission resulting from the use of chemotherapy. In the period of partial remission, the use of other chemotherapy protocols is indicated, followed by therapy with Alfarekin 3 million IU intramuscularly 3 times a week for 18 months.
Preparation of Alfarecin (interferon) solution.
The drug solution is prepared immediately before its use. Use water for injection as a solvent (if the solution is prepared for subcutaneous, intradermal or intramuscular injection). To prepare the solution, the contents of the vial are dissolved in 1 ml of water for injection.
Preparation and conduct of intravenous infusion of Alfarecin (interferon).
30 minutes before the start of the infusion of Alfarekin, start the infusion of 0.9% sodium chloride solution (at a rate of 200 ml / h) and finish it immediately before the administration of the drug. To prepare an infusion solution of Alfarekin, first dissolve in water for injection (at the rate of 1 ml of water for injection, the dose of the administered drug), then select the required amount of the drug and add to 50 ml of a 0.9% sodium chloride solution, the prepared solution is injected intravenously over 30 minutes . After completion of Alfarekin’s input, the infusion of 0.9% sodium chloride solution should be continued at a rate of 200 ml / h for 10 minutes.
Alfarecin (interferon) solution for injection should be used immediately. For intranasal use, the solution is used within 1 day if stored at a temperature of 2 to 8 °C.
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