LAFEROBION (interferon an alpha – 2b recombinant dry)

General characteristics. Structure:

Active ingredient - recombinant interferon alpha 2b the person, with specific activity (1 - 18 106ME. It is received from a clone of E. coliпутём of hybridization of a plasmid about a genome of interferon alpha 2bчеловеческого a leukocyte;
excipients: sodium chloride, dextran-70, potassium dihydrophosphate, dinatrium phosphate dodecahydrate.
Main properties: powder or porous mass of white color; it is hygroscopic. Like natural leukocytic interferon, possesses three main types of biological activity: immunomodulatory, anti-virus and antineoplastic.

Pharmacological properties:

Recombinant interferon alfa-2b-high cleaning soluble protein in water, with a molecular weight of 19 300 дальтон.
Has anti-proliferative effect on tumor cells, and also antiviral and immunomodulatory action.
Deystviyeinterferona alpha 2b is shown by his linkng with specific receptors on a superficial cell membrane and initiation of a complex of the consecutive intracellular reactions connected with induction of a number of enzymes and implementation of cellular functions namely, - with suppression of replication of a virus in the proliferation of tumor cells infected with a kletkeisnizheniye, with implementation of immunomodulatory processes (such as strengthening of phagocytal activity of macrophages, increase in specific cytotoxicity of lymphocytes to target cells).

Indications to use:

Drug is used in complex therapy of adults at:
• an acute and chronic viral hepatitis In (medium-weight and severe forms);
• chronic hepatitis C;
• acute and chronic septic diseases of the virus nature;
• herpes infections of various localization (shingles, multiple skin    herpetic rashes, genital herpes infection);
• throat papillomatosis;
• multiple sclerosis;
• to a malignant melanoma, a uveal melanoma, a nephrocellular carcinoma, superficially localized bladder cancer, cancer of an ovary and mammary gland, Kaposha's sarcoma against the background of HIV infection, a myelosis, a hairy cell leukosis, nekhodzhkinsky lymphoma, a bazalnokletochny carcinoma, the T-cellular lymphoma of skin (fungoid mycosis).

Route of administration and doses:

Drug is used in the form of solution. Laferobiona®vvodyat solution intravenously (kapelno), intramusculary, subcutaneously, vnutrikozhno, intraperitoneally, vnutripuzyrno.
 
About preparation of solution see below.
 
When using drug it is recommended the following schemes of treatment:
 
acute viral hepatitis In: intramusculary on 1 million ME (in hard cases – po2 one million ME) two times a day within 10 days; further taking into account the clinical status of the patient administration of drug can бытьпродленодо 2-3 weeks according to above to the provided scheme or po1 one million ME two times a week within several weeks;
 
chronic viral hepatitis In: intramusculary on 3-4 million ME three times a week within 2 months;
 
chronic hepatitis C: subcutaneously on 3 million ME 3 times a week (every other day) in a combination with ribaviriny or as monotherapy (at contraindications or at intolerance of a ribavirin); drug is used within 3-4 months then carry out HCV RNA definition; further treatment is continued only if NSVNE RNA is revealed; at monotherapy a course of treatment – from 12 to 18 months, in a combination with ribaviriny – 6 months; at a genotype of 1 virus and high content of DNA of a virus prior to therapy, in case of absence in NSVK RNA blood serum to the end of 6 months of treatment, it is possible to continue a combination therapy 6 more months, however at the same time take such negative factors as age into account 40 years, a male, the progressing fibrosis are more senior;
 
herpes infections:
 
shingles: daily 1 million ME intramusculary + 2 million ME in 5 ml of 0.9% of normal saline solution of sodium of chloride subcutaneously in several points around a rash zone; duration of treatment is 5-7 days;
 
skin herpetic rashes: daily intramusculary or subcutaneously (around the center) in a dose of 2 million ME; treatment can be combined with topical administration (applications) on herpetic papules;
 
genital herpes infection: daily intramusculary in a dose of 2 million ME in combination with local use (in the form of applications) on area of rashes;
 
throat papillomatosis: on 3 million ME/sq.m subcutaneously 3 times a week (every other day) within 6 months and more; the dose is adjusted taking into account portability of drug, treatment is begun after surgical (laser) removal of tumoral fabric;
 
rozs_yany sclerosis: intramusculary on 1 million ME 2-3 times a day 10 – 15 days with the subsequent introduction on 1 million ME once a week for half a year;
 
malignant melanoma: in addition to surgical treatment and for remission induction, intravenously on 20 million ME/sq.m (infusion within 20 min.), 5 weekly within 4 weeks; a maintenance therapy – subcutaneously on 10 million ME/sq.m 3 times a week (every other day) within 48 weeks;
 
at development of heavy side effects, namely at decrease in number of granulocytes (less than 500/mm3), increase in ALT/nuclear heating plant (exceeding of an upper side of norm by 5 times), use of drug is stopped before normalization of indicators. Treatment is resumed in a half dose. If the intolerance remains, and the number of granulocytes decreases to 250/mm3 or activity of ALT and/or the nuclear heating plant increases (exceeds an upper side of norm by 10 times), drug is cancelled;
 
at a uveal melanoma: (in case of treatment in combination with photodestruction of a tumor and beta application) the following scheme of treatment is possible: parabulbarno on 1 million ME (divorced in 1 ml of water for injections) daily within 10 days; repeated 10-day introductions carry out in 20 days, twice; the general course - 48 weeks; need of repeated courses in 45 days is not excluded;
 
nephrocellular carcinoma: intramusculary on 3 million ME, daily within 10 days; the general course - 30 million ME, conduct repeated courses with an interval of 3-5 weeks within half a year, then - with an interval of 1.5 - 2 months within a year; as induction therapy on 10 million ME/sq.m (to 18 million ME/sq.m a day) intramusculary or subcutaneously; the specified doses are reached by increase every 3 day by the previous dose on 3 million ME/sq.m (the first 3 days – on 3 million ME/sq.m, the second 3 days – on 6 million ME/sq.m, the third 3 days – on 9 million ME/sq.m etc. to 18 million ME/sq.m); doses adjust taking into account portability of drug; at good tolerance the maximum dose – 36 million ME/sq.m; duration of induction therapy of-3 months then resolve an issue of drug withdrawal or continuation of treatment in the presence of remission or stabilization of a state;
 
at the supporting treatment the drug is administered in the same doses on 3 times a week by not less than 6 months;
 
superficially localized bladder cancer: vnutripuzyrno from 30 million ME to 50 million ME weekly within 8-12 weeks; at a carcinoma of insitupo of 60 million ME - 100 million ME on instillation weekly within 12 weeks; before administration of drug the patient has to abstain from reception of liquid during 8 h; before administration of drug the bubble has to be emptied; the drug is administered the sterile syringe through a catheter in a bladder cavity where it has to be within 2 hours, at the same time by each 15 min. the patient has to change position of a body (for the best soprikasayemost of drug with a mucous membrane of a bladder); in 2 h the bladder should be emptied;
 
ovary cancer: intraperitoneally (in a drainage) during surgical intervention and in the next 5 days on 5 million ME; further - intramusculary on 3 million ME within 10 days between chemotherapy courses; the general course dose - 90 million ME; the subsequent courses (on 3 million ME daily within 10 days) can be appointed at an interval of 2-3 months within 1-1.5 years;
 
breast cancer: intramusculary on 3 million ME, daily within 10 days; repeated courses are conducted within a year with an interval of 1.5-2 months, then 2-3 months (depending on the clinical status); it is reasonable to alternate laferobionoterapiya courses to chemotherapy courses (or radiation therapy);
 
Kaposha's sarcoma against the background of HIV infection: the following schemes of treatment are possible:
 
- intramusculary on 3 million ME daily within 10 days; treatment is combined with chemotherapy Prospidinum; repeated courses - once a month within half a year;
 
- intravenously kapelno within 30 min. on 50 million ME (30 million ME/sq.m) daily within 5 days in a row or at an interval of 1 day then the 9-tidnevny break prior to the beginning of a new 5-tidnevny course is necessary a minimum; such mode can be supported beyond all bounds, except cases of bystry progressing of a disease or the expressed intolerance of drug;
 
chronic мелолейкоз: subcutaneously on 5 million ME/sq.m a day daily before achievement of full hematologic remission (quantity of leukocytes in peripheral blood no more than 10.109/l) or within 18 months; at achievement of full hematologic remission treatment is continued before full cytogenetic remission (at some patients comes only in 1-2 years after an initiation of treatment); treatment is begun as soon as possible; at quantity of leukocytes more than 50.109/l treatment can be begun with a standard dose of hydroxurea, and then to pass to use of Laferobiona®;
 
hairy cell leukosis: intramusculary or subcutaneously daily on 2-3 million ME/sq.m before achievement of remission, then 3 times a week (every other day); the average duration of treatment is-12 months; the dose is adjusted taking into account portability of drug;
 
nekhodzhkinsky lymphoma: intramusculary or subcutaneously on 5 million ME/sq.m 3 times a week (as addition to chemotherapy) or on 3 million ME 3 times a week within 12-18 months (as the supporting treatment at remission owing to the carried-out chemotherapy);
 
bazalnokletochny carcinoma: on 10 million ME (dissolved in 1 ml of water for injections) – in the basis and in a tumor (спомощью the 1 ml syringe); if a defeat zone less than 2 cm2, enter 0.15 ml of solution of drug (1.5 million ME) 3 times a week (every other day) within    3 weeks; the total dose should not exceed 13.5 million ME; if the area of defeat from 2 to 10 cm2, a dose of drug has to make 0.5 million ME/cm2 (but not less than 1.5 million ME in the first injection); enter 3 times a week (every other day) within 3 weeks; treatment of one site of defeat is in one step carried out; in the absence of positive dynamics (the outward, the amount of defeat, extent of reddening given to a biopsy) after 2-3 months of treatment consider a question of surgical treatment of a disease;
 
T-cellular lymphoma (fungoid mycosis): in an ulceration stage: intradermalno (in a derma blanket, spots or ulcers are lower) on 1-2 million ME (dissolved in 0.5 ml of water for injections) 3 times a week within 4 weeks; before introduction the site of defeat is processed a cotton plug with alcohol; solution of drug is entered a fine needle (the 30th caliber), using the 1 ml syringe; during introduction the needle has to be in almost parallel situation to a body surface; it is necessary to avoid deeper – hypodermic introduction.
 
Drug solution preparation.
 
Solution of drug is prepared just before its introduction. As solvent use water for injections (if solution is prepared for hypodermic, intradermal or intramuscular introduction), at the same time waters take at the rate of 1 ml on the entered drug dose (that provides isotonicity of the entered solution).
 
If solution of drug is prepared for intraperitoneal or intravesical introduction, as solvent use 0.9% isotonic solution of sodium of chloride (which, take from calculation that concentration of Laferobiona®v solution made not less, than 0.3 million ME/ml).
 
Preparation and performing intravenous infusion of drug.
 
In 30 min. prior to infusion of Laferobiona®nachinayut infusion of 0.9% of isotonic solution of sodium of chloride (with a speed of 200 ml/hour) also finish it just before administration of drug.
 
For preparation of Laferobion®snachala infusion solution dissolve in water for injections (at the rate of 1 ml of water on the entered drug dose), then select required amount of drug (a dose in 1 ml of aqueous solution) and add 0.9% of isotonic solution of sodium of chloride to 50 ml; the prepared solution is entered intravenously kapelno within 30 min. After the end of introduction Laferobiona®sleduyet to continue infusion of 0.9% of isotonic solution of sodium of chloride (with a speed of 200 ml/hour) within 10 min.

Features of use:

Before purpose of drug and in the course of treatment the research of function of a thyroid gland is necessary. Drug is begun or continues to be applied only under a condition if the TTG level is in norm limits. After the therapy termination the function of a thyroid gland broken as a result of administration of drug is not recovered.
 
All patients before the beginning and regularly during treatment need to carry out the developed analysis of peripheral blood, with an obligatory qualitative and quantitative research of indicators of white blood, and also biochemical analysis of blood, including determination of content of electrolytes, calcium, hepatic enzymes and creatinine.
 
At a multiple myeloma periodic control of function of kidneys is necessary.
 
At all patients receiving drug it is necessary to control carefully albumine level in blood serum and a prothrombin time.
 
With care appoint drug in the presence in the anamnesis of such diseases as a diabetes mellitus with episodes of ketoacidosis and chronic obstructive diseases of lungs, at disturbances of coagulability of blood (including at thrombophlebitises of a pulmonary artery), at the expressed miyelosupressiya.
 
At treatment it is necessary to provide with drug adequate hydration of an organism; at display of fever it is necessary to exclude other reasons of its emergence. 
 
At development of reaction of immediate hypersensitivity (a small tortoiseshell, a Quincke's disease, a bronchospasm, an anaphylaxis) drug it is necessary to cancel and take corresponding measures immediately.
 
Development of heavy and medium-weight side effects demands dose adjustment, and in certain cases treatment cancellations by drug.
 
Use of drug is stopped in cases: lengthenings of a blood clotting time (at patients with chronic hepatitis), manifestations of a pulmonary syndrome and radiological identification of infiltrate or dysfunction of lungs, emergence or aggravation of visual disturbances, dysfunction of a thyroid gland (a TTG level aberration), decrease in level of albumine in blood serum and decrease in indicators of a prothrombin time. 
 
Use during pregnancy and feeding by a breast. During pregnancy and feeding by a breast use of drug is contraindicated.

Side effects:

When using drug the dozozavisimy grippopodobny syndrome (a fever, fervescence, head and muscular pain, a joint pain, feeling of fatigue) is most often possible.
 
Are possible also: dysfunction of a thyroid gland, vision disorder, functions of a liver, kidneys, electrolytic balance.
 
At long courses - a watering can and thrombocytopenia; arterial hypertension and hypotension, vomiting, an arthralgia, confusion of consciousness, dizziness, an ataxy, parasthesias, alarming and depressions, hypererethism, drowsiness, an alopecia, rash on skin, an itch, inflows, tachycardia, cough, nasal bleedings, herpetic defeats can be observed.

Interaction with other medicines:

With care it is necessary to use drug along with opioid medicines, analgetics, somnolent and sedative (potentially rendering myelosuppressive effect).
 
At simultaneous use with the drugs which are metabolized by oxidation (including with derivatives of xanthine Aminophyllinum and theophylline) it is necessary to consider a possibility of influence of Laferobiona®na oxidizing metabolic processes. Concentration of theophylline in blood serum needs to be controlled and if necessary to adjust the dosing mode.
 
At use of drug in a combination with chemotherapeutic drugs (Cytarabinum, doxorubicine, тенипозид, cyclophosphamide) the risk of development of the toxic effects (their weight and duration) menacing for life increases.
 
At simultaneous use with drug the zidovudine raises risk of development of a neutropenia.

Contraindications:

Hypersensitivity to drug components; pregnancy and feeding by a breast; existence at the patient of dysfunction of a thyroid gland; existence of heavy visceral disturbances at patients with Kaposha's sarcoma; serious cardiovascular illness; psoriasis; саркоцидоз; the expressed abnormal liver functions and/or kidneys; epilepsy and other diseases of TsNS (including functional); chronic hepatitis against the background of the progressing or dekompensirovanny cirrhosis; chronic hepatitis at the patients who are receiving or recently receiving therapy by immunodepressants (except for a short course of corticosteroid therapy); autoimmune hepatitis or other autoimmune diseases in the anamnesis.

Storage conditions:

In the dry, protected from light place at a temperature from 2 °C to 8 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Powder for растворадля injections on 1 000 000 ME or on 3 000 000 ME, or on 5 000 000 ME in ampoules No. 5 of Abo No. 10; on 6 000 000 ME in ampoules No. 3 of Abo No. 5; on 9 000 000 ME or 18 000 000 ME in ampoules No. 1 complete with solvent: on 2 ml of water for injections in ampoules respectively or the powder lyophilized for preparation растворадля injections on 1 000 000 ME or 3 000 000 ME, or on 5 000 000 ME in ampoules No. 5 of Abo No. 10; on 6 000 0000 ME in ampoules No. 3 or No. 5; or on 9 000 000 ME or 18 000 000 ME in ampoules No. 1. Ampuli is put in a pack.