Instructions for Laferon-Pharmbiotek lyophilized powder for solution for injection 1000000 IU vial No. 10
Composition
active ingredient: recombinant human interferon alpha-2b;
1 vial contains 1 million, 3 million, 5 million, 6 million, 9 million or 18 million IU of recombinant human interferon alfa-2b;
excipients: sodium chloride, dextran 70, potassium dihydrogen phosphate, sodium hydrogen phosphate anhydrous.
Dosage form
Lyophilisate for solution for injection.
Main physicochemical properties: lyophilized powder or porous mass of white color, hygroscopic.
Pharmacotherapeutic group
Immunostimulants. Interferon alpha-2b. ATX code L03A B05.
Pharmacological properties
Pharmacodynamics.
Recombinant human interferon alpha-2b is a highly purified, water-soluble protein with a molecular weight of 19,300 daltons.
Laferon-PharmBiotech®, like natural leukocyte interferon, has three main types of biological activity: immunomodulatory, antiviral, and antitumor.
The mechanism of action of the drug Laferon-PharmBiotec® is based on the fact that interferon, binding to the corresponding receptors of the body's cells, induces a complex of intracellular mechanisms, which leads to the appearance of enzymes that prevent virus replication, increase the phagocytic activity of macrophages, specific cytotoxicity of lymphocytes to target cells, and inhibit the proliferation of metastasizing cells.
Pharmacokinetics.
Data is missing.
Indication
Laferon-PharmBiotec® 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 infection in children, including newborns, acute diarrheal syndrome in newborns, acute intestinal infections in young children with hypocoagulation phenomena);
– acute and chronic septic diseases of viral and bacterial nature, including disseminated forms of acute and chronic sepsis;
– herpetic infections of various localization: shingles, multiple skin herpetic rashes; genital herpetic infection; herpetic keratoconjunctivitis and keratouveitis, acute herpetic stomatitis in children;
– chronic urogenital chlamydiosis;
– nervous system lesions with mono- and polyradicular pain syndromes;
– multiple sclerosis;
– laryngeal papillomatosis;
– melanoma of the skin and eye; kidney, bladder, ovarian, breast cancer; Kaposi's sarcoma, myeloma; chronic myeloid leukemia, hairy cell leukemia, non-Hodgkin's malignant lymphomas, basal cell carcinoma; T-cell lymphoma of the skin (mycosis fungoides).
Contraindication
– Hypersensitivity to interferon alfa-2b or to other components of the drug;
– severe diseases of the cardiovascular system (including heart failure in the decompensation stage, recent myocardial infarction, severe arrhythmia);
– severe renal or hepatic dysfunction, including due to metastases;
– epilepsy and/or CNS dysfunction (including functional);
– chronic hepatitis with decompensated cirrhosis of the liver;
– chronic hepatitis in patients who are undergoing or have recently undergone treatment with immunosuppressive drugs, except for a short course of corticosteroid therapy;
– autoimmune hepatitis or a history of autoimmune disease; transplant recipients after immunosuppressive therapy;
– pre-existing thyroid disease, if it is not controlled by traditional treatments;
– the presence of severe visceral disorders in patients with Kaposi's sarcoma;
– psoriasis, sarcoidosis, if the potential benefit does not outweigh the potential risk;
– combination of the drug Laferon-PharmBiotec® with telbivudine;
– pregnancy (the safety of the drug during pregnancy has not been established).
Children and adolescents
Presence or history of a severe mental condition, especially severe depression, suicidal thoughts or suicide attempts.
Combination therapy with ribavirin
When using the drug Laferon-PharmBiotec® and ribavirin as part of combination therapy for chronic hepatitis C, also see information on contraindications for ribavirin.
Interaction with other medicinal products and other types of interactions
Since interferon alpha alters cellular metabolism, there is a potential for modification of the action of other drugs. It may alter oxidative metabolic processes, which should be considered when co-administering drugs that are metabolized by this pathway (cimetidine, phenytoin, warfarin, theophylline, aminophylline, diazepam, propranolol). Theophylline serum concentrations should be monitored and the dosage regimen adjusted if necessary.
Pulmonary infiltrates, pneumonitis, and pneumonia (in some cases fatal) have been observed more frequently with the use of shosaikoto (a Chinese herbal medicine) in combination with interferon alpha.
When using the drug in combination with chemotherapeutic drugs (cytarabine, doxorubicin, teniposide, cyclophosphamide), the risk of developing life-threatening toxic effects (their severity and duration) increases.
Synergism of side effects (with respect to white blood cell counts) has been described with the combined administration of interferon alfa and zidovudine. In patients receiving these drugs simultaneously, the incidence of neutropenia was higher than in those treated with zidovudine alone.
Also see the instructions for medical use of ribavirin if Laferon-PharmBiotec® is administered in combination with ribavirin to patients with chronic hepatitis C.
A clinical study of the combination of telbivudine, 600 mg daily, with pegylated interferon alfa-2a, 180 mcg once weekly by subcutaneous administration, showed that this combination is associated with an increased risk of developing peripheral neuropathy. The mechanism of development of this reaction is unknown. Moreover, the safety and efficacy of telbivudine in combination with interferons for the treatment of chronic hepatitis B have not been demonstrated. Therefore, the combination of Laferon-PharmBiotec® with telbivudine is contraindicated.
Application features
Laferon-PharmBiotec® should be used under the supervision of a physician. Patients should be informed about the benefits of this therapy and possible adverse reactions.
If the side effect does not subside or worsens, the dose of the drug is reduced to 50% or treatment is discontinued. Depending on the individual sensitivity and the prescribed dose of the drug, patients may experience a slowed psychomotor reaction rate - drowsiness, weakness, increased fatigue.
Fever
Since fever may occur as part of the flu-like syndrome that is common during interferon therapy, other causes of persistent fever should be ruled out.
It is recommended to use the drug against the background of antihistamine and antipyretic therapy.
The need for adequate hydration
When treating with the drug, it is necessary to ensure adequate hydration of the body, since some patients experience hypotension associated with dehydration.
Hypersensitivity reactions
If an immediate hypersensitivity reaction develops (urticaria, angioedema, bronchospasm, anaphylaxis), the drug should be discontinued immediately and appropriate measures taken. Transient rash does not require discontinuation of therapy.
Mental and central nervous system (CNS) disorders
Some patients have experienced serious CNS side effects, particularly depression, suicidal ideation and suicide attempts, during and after treatment with interferon alfa-2b, and even after treatment has been discontinued, mainly within the next 6 months. Among children and adolescents treated with interferon alfa-2b in combination with ribavirin, suicidal ideation and suicide attempts were observed much more often than in adults (2.4% versus 1%), during treatment and within 6 months after treatment. As in adults, other psychiatric side effects (e.g., depression, emotional lability, and drowsiness) also occurred in children and adolescents. Other CNS effects, including aggressive behavior (sometimes directed against others, such as thoughts of murder), bipolar disorder, mania, confusion, and mental status changes, have been observed with interferon alfa. Patients should be closely monitored for any signs or symptoms of psychiatric disorders. If such symptoms appear, the physician should consider the potential seriousness of these undesirable effects and decide on the need for adequate treatment. If symptoms of psychiatric disorders persist or worsen or suicidal thoughts or aggressive behavior towards others occur, it is recommended to discontinue treatment with Laferon-PharmBiotec® and provide the patient with appropriate psychiatric care.
Patients with clinical or anamnestic data on severe mental conditions
If treatment with interferon alfa-2b is prescribed as necessary for adults with clinical or anamnestic data on severe psychiatric conditions, it is started only after appropriate individual diagnosis and therapeutic treatment of the psychiatric condition.
The use of interferon alfa-2b in children and adolescents with clinical or anamnestic data of severe psychiatric conditions is contraindicated.
HCV-infected patients who use drugs (alcohol, cannabis, etc.) are at increased risk of developing psychiatric disorders or exacerbation of existing psychiatric disorders during treatment with interferon alfa. If treatment with interferon alfa is necessary for these patients, the presence of concomitant psychiatric diseases and the possibility of using other substances should be carefully analyzed, assessed and adequately regulated before starting therapy. If necessary, an interdisciplinary approach is used with the involvement of a psychiatrist or a narcologist to assess, treat and monitor the patient's condition. The patient's condition should be carefully monitored during therapy and even after discontinuation of treatment and timely prescribed means to correct the relevant conditions. During treatment with the drug, alcohol consumption should be excluded.
Coinfection with HIV and hepatitis C virus
Patients co-infected with HIV and receiving highly active antiretroviral therapy (HAART) may be at increased risk of lactic acidosis. Caution should be exercised when adding Laferon-PharmBiotec® and ribavirin to HAART. Patients receiving Laferon-PharmBiotec® and ribavirin in combination therapy and zidovudine may be at increased risk of developing anemia.
Co-infected patients with cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death. Additional use of alpha interferons, alone or in combination with ribavirin, increases the above risk in this category of patients.
HCV/HBV coinfection
Cases of hepatitis B reactivation (some with severe consequences) have been reported in patients coinfected with hepatitis B and C viruses treated with interferon. The incidence of such reactivation was low. All patients should be tested for hepatitis B before initiating treatment with interferon for hepatitis C. Patients coinfected with hepatitis B and C should be monitored and treated in accordance with current clinical guidelines.
Thyroid disorders
Thyroid disorders, including hypothyroidism or hyperthyroidism, have been reported uncommonly in adult patients treated with interferon alfa-2b for hepatitis C (2.8% of patients in clinical trials). Thyroid dysfunction was controlled with appropriate conventional therapy. The mechanism by which Laferon-PharmBiotec® may affect thyroid status is unknown. Before prescribing the drug for a long time at doses of 3 million IU and above, a thyroid function test is recommended. The drug can be started provided that the level of thyroid-stimulating hormone (TSH) is within normal limits. If changes in TSH levels are detected, appropriate therapy should be carried out. Treatment with Laferon-PharmBiotec® can be started provided that the TSH content can be maintained at a normal level. During treatment, it is also advisable to monitor the TSH level. If symptoms of thyroid dysfunction appear during treatment with Laferon-PharmBiotec®, it is necessary to determine the TSH level. In the presence of thyroid dysfunction, treatment with this drug can be continued if the TSH level can be maintained at a normal level. After discontinuation of therapy, thyroid function impaired as a result of drug administration is not restored.
Additional thyroid monitoring, specifically for children and adolescents
In children and adolescents on long-term treatment with interferon drugs, thyroid function should be monitored every 3 months (for example, TSH levels should be determined).
Laboratory studies
All patients should have a complete peripheral blood count, including complete blood count and biochemical blood tests, including determination of electrolytes, calcium, liver enzymes, bilirubin, and creatinine, before and regularly during treatment. Serum albumin and prothrombin time should be closely monitored in all patients receiving the drug.
During the treatment of patients with chronic hepatitis B or C, the following laboratory monitoring schedule is recommended: 1, 2, 4, 8, 12, 16 weeks and then once every two months throughout the entire course of treatment. If ALT increases to a value that is twice or more higher than the value that was before the start of therapy, treatment with Laferon-PharmBiotec® can be continued, provided that signs of liver failure do not appear. In this case, ALT, prothrombin time, alkaline phosphatase, albumin and bilirubin should be determined every 2 weeks.
In patients with malignant melanoma, liver function and leukocyte count (differential white blood cell count) should be monitored weekly during remission induction and monthly during maintenance therapy.
In myeloma disease, periodic monitoring of kidney function is necessary.
Hypertriglyceridemia
Hypertriglyceridemia and exacerbation of hypertriglyceridemia, sometimes severe, have been observed with interferon alpha treatment, therefore monitoring of lipid levels is recommended.
Moderate and severe side effects may require adjustment of the dosage regimen or, in some cases, discontinuation of Laferon-PharmBiotec® therapy. Interferon alpha drugs increase the risk of decompensation of liver function and death in patients with cirrhosis. Discontinuation of treatment with the drug is recommended in patients with chronic hepatitis who develop prolongation of coagulation markers, which may indicate liver failure. Any patient who develops liver function abnormalities during treatment with Laferon-PharmBiotec® should be closely monitored, and therapy should be discontinued if symptoms persist. Liver enzyme levels and liver function should be closely monitored in patients with cirrhosis.
Combination therapy with ribavirin
When performing combination therapy with ribavirin, precautions for ribavirin should be taken into account.
Ribavirin causes serious birth defects when used during pregnancy. Patients taking Laferon-PharmBiotec® in combination with ribavirin should avoid becoming pregnant. Women of childbearing potential should use effective contraception during treatment and for 4 months after treatment. Male patients and their female partners should use effective contraception during treatment and for 7 months after treatment.
Concomitant chemotherapy
The use of interferon alfa in combination with other chemotherapeutic agents (e.g. Ara-C, cyclophosphamide, doxorubicin, teniposide) increases the risk of toxicity, which may be life-threatening. The most common side effects that are life-threatening are mucosal inflammation, diarrhea, neutropenia, renal failure, and electrolyte disturbances. Due to the risk of increased toxicity, careful selection of doses of Laferon-PharmBiotec® is required for concomitant use with chemotherapeutic agents. If Laferon-PharmBiotec® is used together with hydroxyurea, an increase in the frequency and severity of cutaneous vasculitis is possible.
Autoantibodies and autoimmune disorders
Autoantibodies and autoimmune disorders have been reported with alpha interferons. Patients predisposed to autoimmune disorders are at increased risk. Patients with evidence of autoimmune disorders should be monitored closely and the benefit-risk of continued interferon therapy should be re-evaluated. Vogt-Koyanagi-Harada syndrome (VKHS) has been reported in patients with chronic hepatitis C treated with interferon. This syndrome is a granulomatous inflammatory disorder affecting the eyes, auditory system, meninges, and skin. If VKHS is suspected, antiviral therapy should be discontinued and corticosteroid therapy should be considered.
Patients with debilitating diseases
Laferon-PharmBiotec® should be used with caution in patients with chronic debilitating diseases such as a history of pulmonary disease (e.g. chronic obstructive pulmonary disease) and in patients with diabetes mellitus predisposed to ketoacidosis. Patients with coagulation disorders (e.g. thrombophlebitis, pulmonary embolism) or severe myelosuppression should also be closely monitored.
Patients with cardiac disorders
There is no evidence of direct cardiotoxicity of interferon, but there is a possibility that the presence of hyperthermia and chills, which often accompany treatment, may exacerbate existing cardiac diseases. In the presence of a history of chronic heart failure, myocardial infarction and/or previous or existing arrhythmias, treatment with interferon alfa-2b should be carried out under strict medical supervision. In patients with pre-existing cardiac diseases and/or advanced cancer, it is recommended to conduct an ECG before and during the course of treatment. Cardiac arrhythmias (mainly supraventricular) usually respond to conventional therapy, but may require discontinuation of treatment with the drug. There are no data on the use of combination therapy in children and adolescents with a history of cardiac diseases.
Hypotension
Hypotension may occur during treatment with the drug or for up to two days after treatment and may require additional treatment.
Pulmonary infiltrates, pneumonitis, and pneumonia, some of which have been fatal, have been reported in patients receiving interferon alpha. The etiology of these events is unknown. These events have been reported more frequently with the use of shosaikoto (a Chinese herbal medicine) in conjunction with interferon alpha. All patients should have a chest x-ray if they develop fever, cough, shortness of breath, or other respiratory symptoms. Patients should be monitored closely for infiltrates on chest x-ray or signs of pulmonary dysfunction, and interferon alpha should be discontinued if necessary. Although these events have been reported more frequently in patients with chronic hepatitis C receiving interferon alpha, these events have also been reported in patients with cancer receiving interferon alpha. Prompt discontinuation of interferon alpha and corticosteroid therapy resolve the pulmonary adverse events.
Stun, coma, and encephalopathy
In some patients, mainly elderly, who took higher doses of the drug, cases of stunning and coma, including cases of encephalopathy, were observed. These effects are mostly reversible, and complete recovery from them in some patients takes up to three weeks. Seizures are very rare when taking high doses of the drug.
Side effects from the organs of vision
In some cases, after treatment with alpha interferons, side effects from the organs of vision were observed, including retinal hemorrhages, "cotton wool" spots on the retina, serous retinal detachment, obstruction of the retinal artery or vein. All patients should undergo an ophthalmological examination before starting therapy. All patients who complain of decreased visual acuity or visual field restriction and have other ophthalmological symptoms during treatment with Laferon-PharmBiotec® should immediately undergo a complete ophthalmological examination. Periodic ophthalmological examinations during therapy with Laferon-PharmBiotec® are especially recommended for patients with disorders that may be associated with retinopathy, such as diabetes mellitus or arterial hypertension. Treatment with the drug should be discontinued in case of new or worsening of existing ophthalmological disorders.
Dental and periodontal disorders
Dental and periodontal disorders, which may result in tooth loss, have been reported in patients receiving combination therapy with interferon alfa and ribavirin. Dry mouth during long-term combination therapy with interferon alfa and ribavirin may have a damaging effect on the teeth and oral mucosa. Patients should be advised to brush their teeth thoroughly twice daily and to have regular dental check-ups. Patients should be advised to rinse their mouth thoroughly after vomiting.
Patients with psoriasis and sarcoidosis
Given the evidence that interferon alpha exacerbates pre-existing psoriasis and sarcoidosis, patients with these diseases are recommended to use Laferon-PharmBiotec® only if the potential benefit outweighs the potential risk.
Kidney and liver transplant rejection
Preliminary data suggest that interferon alpha therapy may be associated with an increased incidence of kidney transplant rejection. Liver transplant rejection has also been reported with interferon therapy. In patients with organ or bone marrow transplantation, drug immunosuppression may be less effective because interferons stimulate the immune system.
Impact on fertility
Interferon may reduce fertility. Decreased serum estradiol and progesterone concentrations have been reported in women receiving human leukocyte interferon. Therefore, effective contraception should be used in women of reproductive age when using the drug.
Discontinue use of the drug in cases of: prolonged blood clotting time (in patients with chronic hepatitis), manifestations of pulmonary syndrome and radiological detection of infiltrate, appearance or increase in visual impairment, thyroid dysfunction (deviation from the norm of TSH), decreased serum albumin levels and decreased prothrombin time.
The product does not contain preservatives, therefore, to avoid bacterial contamination, it is recommended to use the parenteral solution immediately.
Use during pregnancy or breastfeeding
The use of the drug is contraindicated during pregnancy and breastfeeding (the safety of the drug during pregnancy has not been established).
Ability to influence reaction speed when driving vehicles or other mechanisms
Depending on the dose, regimen, and individual sensitivity to interferon alpha, treatment may be accompanied by drowsiness, weakness, fatigue, and decreased psychomotor speed. The patient should be advised to avoid driving or operating complex machinery.
Method of administration and doses
The solution of the drug Laferon-PharmBiotec® is administered intramuscularly, subcutaneously, intravenously, endolymphally, intraperitoneally, intravesically, rectally, parabulbarly, intranasally.
Acute viral hepatitis B:
– administer intramuscularly 1 million IU (in severe cases – 2 million IU) 2 times a day for 10 days. A similar course can be prolonged to 2–3 weeks depending on the clinical status of the patient or continued by 1 million IU 2 times a week for several weeks.
Chronic viral hepatitis B:
– administer intramuscularly 3–4 million IU 3 times a week for 2 months.
Chronic viral hepatitis C:
– administer intramuscularly 3 million IU 3 times a week for 6 months as monotherapy or in combination with nucleoside analogues. The drug should be used for 3–4 months, after which HCV RNA should be determined; then 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 high viral RNA content 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 over 40 years, male gender, progressive fibrosis should be taken into account.
Acute respiratory viral infection in children, including newborns:
– inject intranasally 2–3 drops into each nasal passage 3–6 times a day for 3–5 days; the dosage of the drug for newborns is 20–50 thousand IU/ml, for other children – 100 thousand IU/ml. It is permissible to insert cotton swabs moistened with Laferon-PharmBiotec® into the nasal passages (in turn) for 10–15 minutes.
Acute respiratory viral infection (including influenza) in adults:
– administer 1–3 million IU intramuscularly from day 1–2 of the disease for 3 days;
– intranasally, 4–6 drops of Laferon-PharmBiotec® solution (100 thousand IU/ml) into each nasal passage 6–8 times a day (before use, the dose to be filled should be warmed in a syringe (use a syringe without a needle) to body temperature, the remaining solution should be stored in the refrigerator, preventing bacterial contamination).
Acute and recurrent pneumonia of viral and viral-bacterial etiology:
– Laferon-PharmBiotech® should be administered intramuscularly at 1 million IU for 5–7 days along with comprehensive treatment (antibacterial, detoxification, anti-inflammatory, etc.).
Acute diarrheal syndrome in newborns:
– rectally in the form of daily microenemas containing 100 thousand IU of the drug Laferon-PharmBiotec®, for 3–7 days.
Acute intestinal infections in young children with hypocoagulation phenomena:
– rectally at a dose of 10 thousand IU/kg of body weight three times with an interval of 48 hours.
Purulent-septic diseases, peritonitis, multiple abscesses of the abdominal cavity:
– intravenously 2–4 million IU once a day; total dose 12–16 million IU per course; the feasibility of simultaneous endolymphatic administration of the drug in the same dose (2–4 million IU once a day) is not excluded.
Herpetic infections:
– shingles: daily 1 million IU intramuscularly + 2 million IU in 5 ml of 0.9% sodium chloride solution subcutaneously at several points around the rash area. Duration of treatment 5–7 days;
– cutaneous herpetic eruptions: daily intramuscular or subcutaneous (around the lesion) administration of the drug at a dose of 2 million IU; treatment can be combined with local application (applications) to 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 the rashes; the duration of treatment is determined by the doctor;
– herpetic keratoconjunctivitis: administration of a solution of the drug Laferon-PharmBiotec® – 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 the 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. Laferon-PharmBiotec® 1 million IU diluted in 4 ml of water for injection, use 1 ml of solution per 1 application and intranasal administration: 2 drops administered intranasally, the rest - after hygienic treatment of the oral mucosa, apply locally 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:
– 1st stage – 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 at 10 mg intramuscularly in the evening every other day, the course is 5 injections;
While taking antibacterial agents, it is necessary to use antifungal drugs (nystatin, diflucan, clotrimazole, nizoral) and hepatoprotectors (carsil) in therapeutic doses.
Nervous system damage with mono- and polyradicular pain syndromes:
– intramuscularly at a dose of 1 million IU for a course of 5–10 days in complex treatment.
Laryngeal papillomatosis:
– 3 million IU/m2 subcutaneously 3 times a week (every other day) for 6 months or more; adjust the dose based on drug tolerability. Treatment should be initiated after surgical (laser) removal of tumor tissue.
Multiple sclerosis:
– intramuscularly 1 million IU 2–3 times a day for 10–15 days, followed by the administration of 1 million IU once a week for 6 months.
Melanoma of the skin:
– as an adjunct to surgical treatment and for induction of remission, intravenously 20 million IU/m2 (infusion over 20 minutes) 5 times a week for 4 weeks; maintenance therapy – subcutaneously 10 million IU/m2 3 times a week (every other day) for 48 weeks.
If severe side effects develop, namely a decrease in the number of granulocytes (less than 500/mm3), an increase in ALT/AST (5 times the upper limit of normal), the drug should be discontinued until the indicators normalize. Treatment should be resumed at half the dose. If intolerance persists and the number of granulocytes decreases to 250/mm3 or the activity of ALT and/or AST increases (10 times the upper limit of normal), the drug should be discontinued.
Uveal melanoma:
– parabulbar daily 1 million IU for 10 days; repeated 10-day injections are carried out twice after 20 days; the total course is 48 weeks. The need for repeated courses after 45 days is not excluded; treatment with the drug Laferon-PharmBiotec® is combined with photodestruction of the tumor and beta-application.
Kidney cancer:
– as induction therapy, 10 million IU/m2 (up to 18 million IU/m2 per day) intramuscularly or subcutaneously; the indicated doses are achieved by increasing the previous dose by 3 million IU/m2 every 3 days (the first 3 days – 3 million IU/m2, the second 3 days – 6 million IU/m2, the third 3 days – 9 million IU/m2, etc. up to 18 million IU/m2); doses are adjusted taking into account the tolerability of the drug; with good tolerability, the maximum dose is 36 million IU/m2; the duration of induction therapy is 3 months, after which the issue of drug withdrawal or continuation of treatment should be decided in the presence of remission or stabilization of the condition. In maintenance treatment, the drug should be administered in the same doses 3 times a week for at least 6 months.
Bladder cancer:
– intravesically from 30 million IU to 50 million IU weekly for 8–12 weeks; for carcinoma in situ, 60–100 million IU per instillation weekly for 12 weeks. Before administering the drug, the patient should refrain from taking fluids for 8 hours. Before administering the drug, the bladder should be emptied. The drug should be injected with a sterile syringe through a catheter into the bladder cavity, where it should remain for 2 hours, while the patient should change body position every 15 minutes (for better interaction of the drug with the bladder mucosa). After 2 hours, the bladder should be emptied.
Ovarian cancer:
– intraperitoneally during surgery and in the next 5 days – into the drainage – 5 million IU; further administration of the drug Laferon-PharmBiotec® – intramuscularly 3 million IU for 10 days between chemotherapy courses; the total dose of the drug is 90 million IU. Subsequent courses can be prescribed with an interval of 2–3 months for 1–1.5 years: 3 million IU daily for 10 days.
Breast cancer:
– intramuscularly daily for 10 days, 3 million IU per injection. Repeated courses are carried out for 1 year with an interval of 1.5–2 months, and then 2–3 months (depending on the clinical status); it is advisable to alternate courses of therapy with the drug Laferon-PharmBiotec® with courses of chemotherapy (or radiation therapy).
Kaposi's sarcoma: the following treatment regimens are possible:
– intramuscularly daily for 10 days, 3 million IU per injection; treatment is combined with monochemotherapy with prospidin; repeated courses – once a month for 6 months;
– intravenously drip over 30 minutes at 50 million IU (30 million IU/m2) daily for 5 days or with an interval 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 disease:
– intramuscularly daily for 10 days, 3 million IU per injection, repeated courses – once every 1.5–3 months (4–6 times during the year).
Chronic myeloid leukemia:
– subcutaneously 3 million IU/m2 per day daily or once every 2 days, gradually increasing the dose to 5 million IU/m2 per day daily or once every 2 days under the supervision of a physician until complete hematological remission is achieved (the number of leukocytes in peripheral blood is no more than 10×109/l) or for 18 months.
Hairy cell leukemia:
– intramuscularly 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:
– intramuscularly 3 million IU 3 times a week for 12–18 months as maintenance therapy
