Recombinant interferon alpha-2b is a highly purified water-soluble protein with a molecular weight of 19,300 da.
It has an antiproliferative effect on tumor cells, and also has antiviral and immunomodulatory effects. The action of interferon alpha-2b is manifested by its binding to specific receptors on the surface membrane of the cell and initiating a complex of sequential intracellular reactions associated with the induction of a number of enzymes and the implementation of cellular functions, namely: suppression of viral replication in an infected cell and a decrease in the proliferation of tumor cells; with the implementation of immunomodulatory processes (increased phagocytic activity of macrophages, increased specific cytotoxicity of lymphocytes to target cells).
The preparation is used in complex therapy in adults and children with:
The preparation is used in the form of a solution. solution of laferobion is administered intravenously (drip), intramuscularly, subcutaneously, intradermally, intraperitoneally, intravesically, rectally, intranasally, subconjunctivally.
Laferobion 100,000 IU for intranasal administration
SARS in children, including newborns
Intranasally, 4-6 drops in each nasal passage 3-6 times a day for 3-5 days; dosage of the preparation for newborns - 20,000-50,000 IU / ml, for other children - 100,000 IU / ml. It is permissible to introduce into the nasal passages (alternately) cotton turundas moistened with Laferobion's solution for 10-15 minutes.
SARS in adults
Intranasally, 0.25 ml of Laferobion solution (100,000 ME / ml) in each nasal passage 6-8 times a day. Before use, the administered Laferobion solution should be heated in a syringe (use a syringe without a needle) to body temperature, the rest of the solution should be stored in the refrigerator, protecting it from bacterial contamination.
Acute diarrheal syndrome in newborns
Rectally in the form of daily microclysters containing 100,000 IU of Laferobion for 3–7 days.
Acute intestinal infections in young children with symptoms of hypocoagulation
Rectally at a dose of 10,000 IU / kg 3 times with an interval of 48 hours.
Purulent-septic diseases, peritonitis, multiple abscesses of the abdominal cavity
IV, 2-4 million ME once a day; total dose per course - 12-16 million IU; expediently simultaneous endolymphatic administration of the preparation in the same dose - 2-4 million IU 1 time per day.
Herpetic keratoconjunctivitis: instillation of 2-3 drops of Laferobion solution (1 million ME in 5 ml of isotonic solution) every 2 hours for 7-10 days; as the symptoms of the disease disappear, the preparation can be used less often.
Laferobion for parenteral administration
Acute viral hepatitis B
IM administration of 1 million ME (in severe cases - 2 million ME) 2 times a day for 10 days. Further, depending on the clinical status of the patient, the course of treatment can be extended to 2-3 weeks according to this scheme or carried out at a dose of 1 million IU 2 times a week for several weeks.
Chronic viral hepatitis B
In / m introduction of 3-4 million IU 3 times a week for 2 months.
Chronic viral hepatitis C
S / c administration of 3 million IU 3 times a week (every other day) in combination with ribavirin or as monotherapy (in the presence of contraindications or in case of intolerance to ribavirin). The course of treatment is 3-4 months, after which HCV RNA is determined. The therapy is continued in case of a negative result (HCV RNA was not detected).
With monotherapy, the course of treatment with Laferobion is 12-18 months, in combination with ribavirin - 6 months; with genotype 1 of the virus and a high level of viral DNA in the blood serum 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, taking into account such aggravating factors as age over 40 years, male gender, progressive fibrosis.
Herpetic infections
Shingles: daily 1 million IU / m + 2 million ME in 5 ml of isotonic sodium chloride s / c in several points around the rash zone. The duration of treatment is 5-7 days.
Skin herpetic eruptions: daily intramuscular or subcutaneous (around the focus) administration of the preparation at a dose of 2 million IU; treatment can be combined with topical application (applications) on herpetic papules.
Genital herpes: daily intramuscular injection at a dose of 2 million IU in combination with local application of the preparation in the form of applications to the area of the rash.
Laryngeal papillomatosis: s / c 3 million IU / m2 3 times a week (every other day) for 6 months or more.
The dose is adjusted taking into account the tolerability of the preparation, treatment begins after surgical removal (using a laser) by the tumor tissue.
Multiple sclerosis
In / m 1 million ME 2-3 times a day for 10-15 days, followed by the introduction of 1 million ME 1 time per week for six months.
Malignant melanoma: as an adjunct to surgical treatment and for the induction of remission, 20 million IU / m2 per day are administered intravenously (infusion over 20 minutes), 5 times a week for 4 weeks. Supportive therapy - n / a 10 million IU / m2 3 times a week for 48 weeks.
With the development of severe side effects, namely: with granulocytopenia (granulocytes 500 / mm3), an increase in serum ALT / ASAT levels (5 times higher than the upper limit of the norm), the preparation is stopped until the indicators normalize. The treatment is resumed at half the dose. If the preparation intolerance persists and the number of granulocytes decreases to 250 / mm3 or the activity of ALT and / or AST in the blood serum increases (10 times higher than the upper limit of the norm), the preparation is canceled.
Uveal melanoma: (when treated with Laferobion in combination with tumor photodestruction and beta-application) - parabulbar daily 1 million IU of the preparation (diluted in 1 ml of water for injection) for 10 days; repeated 10-day injections are carried out twice every 20 days; the general course of treatment is 48 weeks. The need for repeated courses in 45 days is not excluded.
Renal cell carcinoma: IM, 3 million ME, daily for 10 days; the total dose for a course of treatment is 30 million IU; repeated courses are carried out at intervals of 3-5 weeks for six months, and then at intervals of 1.5-2 months during the year.
As an induction therapy, 10 million IU / m2 (up to 18 million IU / m2 / day) are administered intramuscularly or subcutaneously. These doses are achieved by increasing the previous dose every 3 days by 3 million IU / m2 (the first 3 days - 3 million IU / m2, the second 3 days - 6 million IU / m2, the next 3 days - 9 million IU / m2 and then until a dose of 18 million IU / m2 is reached). Dose adjustment is carried out taking into account the tolerability of the preparation. With good tolerance, the maximum dose is 36 million IU / m2, the duration of induction therapy is 3 months, after which the question of discontinuing the preparation or continuing treatment in the presence of remission or stabilization of the condition is decided. With maintenance therapy, the preparation is administered in the same doses 3 times a week for at least 6 months.
Superficially localized bladder cancer: intravesical instillation at a dose of 30-50 million IU weekly for 8-12 weeks. In case of carcinoma in situ, 60-100 million IU is administered per instillation weekly for 12 weeks. Before the administration of the preparation, the patient should refrain from taking fluids for 8 hours; before the administration of the preparation, it is necessary to empty the bladder. Laferobion is injected with a sterile syringe through a catheter into the bladder cavity, where it should be for 2 hours, while every 15 minutes the patient should change the position of the body (for better contact of the preparation with the bladder mucosa), after 2 hours the bladder must be emptied.
Ovarian cancer: intraperitoneally during surgery and in the next 5 days in the drainage - 5 million IU; further administration of Laferobion - i / m, 3 million IU for 10 days between courses of chemotherapy; the total course dose of Laferobion is 90 million IU. Subsequent courses can be prescribed at intervals of 2-3 months for 1-1.5 years: 3 million IU daily for 10 days.
Breast cancer: i / m daily for 10 days, 3 million IU. Repeated courses are carried out during the year at intervals of 1.5-2 months, and then - 2-3 months (depending on the clinical status); it is advisable to alternate courses of therapy with Laferobion with courses of chemotherapy or radiation therapy.
Kaposi's sarcoma against the background of HIV infection: injected intramuscularly daily for 10 days at 3 million IU; the treatment is combined with chemotherapy with prospidin; repeated courses - once a month for six months or intravenously drip for 30 minutes - 50 million ME (30 million ME / m2) daily for 5 consecutive days or with an interval of 1 day, after which it is necessary to take a break less than 9 days before the start of the next 5-day course. This mode of administration can last an unlimited period, except in cases of rapid progression of the disease or severe preparation intolerance.
Chronic myeloid leukemia: inject s / c at 5 million IU / m2 per day daily until complete hematological remission is achieved (the number of leukocytes in the peripheral blood is no more than 10 109 / l) or for 18 months; when complete hematological remission is achieved, therapy is continued until complete cytogenetic remission occurs (in some patients it is achieved only 1–2 years after the start of therapy). Treatment should be started as early as possible. When the number of leukocytes is above 50 109 / l, treatment can be started with hydroxyurea in a standard dose, and then proceed to the use of Laferobion.
Hairy cell leukemia: i / m or s / c at 2-3 million IU / m2 until the state of remission is achieved, then - 3 times a week every other day. The duration of treatment is an average of 12 months. The dose is adjusted taking into account the tolerability of the preparation.
Non-Hodgkin's lymphomas: injected intramuscularly or subcutaneously at 5 million IU / m2 3 times a week (in addition to chemotherapy) or 3 million IU 3 times a week for 12-18 months (as maintenance therapy when remission is achieved due to chemotherapy).
Basal cell carcinoma: 10 million IU (dissolved in 1 ml of water for injection) - into the base and deep into the tumor (using a 1 ml syringe).
If the area of the tumor lesion is less than 2 cm2, 0.15 ml of the preparation solution (1.5 million IU) is injected 3 times a week (every other day) for 3 weeks; the total dose should not exceed 13.5 million IU.
With a lesion area of 2-10 cm2 - the dose of the preparation is 0.5 million IU / cm2 (the first injection is at least 1.5 million IU), administered 3 times a week (every other day) for 3 weeks; treatment of one lesion site is carried out at the same time; in the absence of positive dynamics (assessment of the appearance, size of the lesion, degree of hyperemia, biopsy data), after 2-3 months of treatment, the question of surgical treatment of the disease is considered.
T-cell lymphoma (fungal mycosis) in the ulceration stage: injected intradermally (into the superficial layer of the dermis, below the spot or ulcer), 1-2 million IU (dissolved in 0.5 ml of water for injection) 3 times a week for 4 weeks ; before the introduction, the affected area is treated with a cotton swab with alcohol. The solution of the preparation is injected with a thin needle (30 gauge), using a 1 ml syringe; during the injection, the needle should be almost parallel to the surface of the body, a deeper SC injection should be avoided.
The solution is prepared immediately before its introduction. As a solvent, water for injection is used (if the solution is prepared for subcutaneous, intradermal or intradermal administration), while water for injection is taken at the rate of 1 ml per injected dose of the preparation (which ensures the isotonicity of the administered solution ).
If the solution of the preparation is prepared for intra-abdominal or intravesical administration, 0.9% isotonic solution of sodium chloride is used as a solvent (which is taken from the calculation of obtaining the required concentration of Laferobion in solution of at least 0.3 million IU / ml).
Preparation and implementation of intravenous infusion of the preparation
30 minutes before the start of the infusion of Laferobion, an infusion of 0.9% isotonic sodium chloride solution (at a rate of 200 ml / h) is carried out and it is completed immediately before the administration of the preparation.
To prepare the infusion solution, Laferobion is first dissolved in water for injection (at the rate of 1 ml of water per administered dose of the preparation), then the required amount of the preparation (dose in 1 ml of aqueous solution) is taken and added to 50 ml of 0.9% isotonic solution of sodium chloride. The prepared solution is injected intravenously drip for 30 minutes. After the end of the introduction of Laferobion, the infusion of 0.9% isotonic sodium chloride solution (at a rate of 200 ml / h) should be continued for 10 minutes.
Hypersensitivity to the components of the preparation, pregnancy and lactation, thyroid dysfunction, severe visceral disorders in patients with Kaposi's sarcoma; severe cardiovascular diseases, psoriasis, sarcoidosis, severe liver and / or kidney dysfunction, epilepsy and other diseases of the central nervous system (including functional ones), chronic hepatitis against the background of progressive or decompensated cirrhosis of the liver, chronic hepatitis in patients receiving or recently receiving immunosuppressive therapy (with the exception of a short course of corticosteroid therapy), autoimmune hepatitis, or other autoimmune diseases in history.
When using the preparation, it is most often possible to develop a dose-dependent flu-like syndrome (chills, fever, headache, muscle and joint pain, feeling of fatigue).
Possible side effects: impaired thyroid function, impaired vision, liver function, kidney function, electrolyte balance.
With prolonged courses of therapy, leuko- and thrombocytopenia may develop, hypertension and hypotension, vomiting, arthralgia, confusion, dizziness, ataxia, parasthesias, anxiety and depression, hyperexcitability, drowsiness, alopecia, skin rash, pruritus, hot flashes, tachycardia , cough, nosebleeds, herpetic lesions.
Before prescribing the preparation and during treatment, it is necessary to study the function of the thyroid gland. the preparation begins or continues to be used only under the condition of a normal tthg level in the blood plasma. after the termination of therapy, the function of the thyroid gland, impaired as a result of the administration of the preparation, is not restored.
All patients, before and during therapy, should regularly conduct studies: a detailed analysis of peripheral blood with mandatory qualitative and quantitative determination of white blood counts, biochemical blood tests, including determination of the level of electrolytes, calcium, liver enzymes and creatinine.
With multiple myeloma, periodic monitoring of renal function is necessary.
In all patients receiving the preparation, it is necessary to carefully monitor the level of albumin in the blood serum and prothrombin time.
The preparation is prescribed with caution if there is a history of the following diseases: diabetes mellitus with episodes of ketoacidosis, COPD, bleeding disorders (including pulmonary embolism), severe myelosuppression.
When taking the preparation, it is necessary to ensure adequate hydration of the body; with the development of fever, other causes of its occurrence should be excluded.
With the development of an immediate hypersensitivity reaction (urticaria, angioedema, bronchospasm, anaphylaxis), the preparation should be immediately discontinued and appropriate therapeutic measures should be taken.
With the development of moderate and severe side effects, dose adjustment is necessary, in some cases - preparation withdrawal.
The use of the preparation is discontinued in such cases: lengthening of the period of blood coagulation (in patients with chronic hepatitis), the appearance of a pulmonary syndrome and X-ray detection of infiltrate or impaired lung function, the appearance or increase in visual impairment, thyroid dysfunction (deviation from the normal level of TSH), the level of albumin and indicators of prothrombin time in the blood serum.
Use during pregnancy and lactation. The use of the preparation is contraindicated during this period.
The ability to drive vehicles may decrease due to the development of weakness, drowsiness, impaired consciousness when using the preparation.
The preparation is used with caution in conjunction with opioid preparations, analgesics, hypnotics and sedatives (potentially showing myelosuppressive effect).
With simultaneous use with preparations metabolized by oxidation (including xanthine derivatives - aminophylline and theophylline), the possibility of Laferobion's influence on oxidative metabolic processes should be taken into account. It is necessary to control the level of theophylline in the blood serum, if necessary, adjust the dosage regimen.
When using the preparation in combination with chemotherapy preparations (cytarabine, doxorubicin, teniposide, cyclophosphamide), the risk of developing life-threatening toxic effects (their severity and duration) increases.
With simultaneous use with zidovudine, the risk of developing neutropenia increases.
In a dry, dark place at a temperature of 2-8 ° C.
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