Roferon-A® [Interferon alfa-2a]
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Antiviral and antitumor agent
Roferon-A - interferon alpha-2a - highly purified protein containing 165 amino acids, with a molecular mass of about 19,000 daltons. It is obtained by recombinant DNA technology using a genetically engineered E. coli strain, whose DNA encodes the synthesis of this human protein.
Possesses the properties of natural human alpha interferons. It has an antiviral effect, inducing in cells a state of resistance to viral infections and modulating the immune system's response to neutralize the virus or destroy the cells infected by them. The main mechanism of antitumor activity of Roferon-A is not yet known. In human tumor cells treated with Roferon-A (HT29 cells), DNA, RNA and protein synthesis is significantly reduced. Roferon-A has antiproliferative effects on a number of human tumors.in vitro and inhibits the growth of some xenografts of human tumors in nude mice.In vivo The antiproliferative activity of Roferon-A was studied in such tumors as mucoid carcinoma of the mammary gland and adenocarcinoma of the blind and transversely intestine, as well as the prostate gland. The degree of antiproliferative activity varies.
Many effects of interferon alfa-2a, partially or completely disappear when it is tested on animals. In rhesus monkeys, which had previously been administered interferon alpha-2a, significant activity against vaccinia virus was induced.
Neoplasms of the lymphatic system and blood system: hairy cell leukemia, myeloma, skin T-cell lymphoma, chronic myeloid leukemia, thrombocytosis in myeloproliferative diseases, low-grade non-Hodgkin's lymphoma.
Solid tumors: Kaposi's sarcoma in AIDS patients without anamnestic indications of opportunistic infections, advanced renal cell carcinoma, metastatic melanoma, melanoma after surgical resection (tumor thickness> 1.5 mm) in the absence of lymph node disease and distant metastasis.
Viral diseases: chronic active hepatitis B in adults with viral replication markers, i.e. positive for HBV-DNA, DNA polymerase or HBeAg; chronic hepatitis C (hepatitis "neither A nor B") in adults who have antibodies to hepatitis C virus or HCV RNA in serum and an increase in the activity of alanine aminotransferase (ALT) without signs of hepatic decompensation (Child-Pugh class A) genital warts.
1 syringe tube with 0.5 ml (one dose) contains interferon alpha-2a, not containing human serum albumin (Roferon-A RBA, or "solution without albumin") - 3 million IU.
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Dosage and Administration
Roferon-A should be administered subcutaneously or intramuscularly. Subcutaneous administration is especially recommended for patients with thrombocytopenia (platelet count less than 50,000 / μL) or for patients with a risk of bleeding.
Hairy cell leukemia.
Initial dose: 3 million IU daily for 16-24 weeks. In case of intolerance, the daily dose is reduced to 1.5 million IU and / or reduce the frequency of administration to three times a week.
Maintenance dose: 3 million IU 3 times a week. With intolerance - 1.5 million IU 3 times a week.
Duration of treatment: for 6 months, after which, in the presence of a positive effect, it is continued, and in the absence, it is canceled. The treatment was carried out up to 20 months in a row. The optimal duration of Roferon-A therapy for hairy cell leukemia has not been established.
At 3 million IU 3 times a week. Depending on the individual tolerance, the dose can be increased weekly until the maximum tolerated dose (9-18 million IU) is reached 3 times a week.
Treatment according to this scheme can be continued indefinitely, if the disease does not progress or the drug intolerance does not develop.
Cutaneous T-cell lymphoma (CTCL).
Roferon-A may have an effect in patients with progressive cutaneous T-cell lymphoma, including refractory to traditional therapy or not suitable for its implementation.
Initial dose: patients, from the age of 18, should be administered Roferon-A s / c or / m for 12 weeks, gradually bringing the daily dose to 18 million IU. It is recommended to increase the dose as follows: 1-3 days IU / day for 1–3 days, 9 million IU / day for 4–6 days, 18 million IU / day for 7–84 days.
Maintenance dose: s / c or / m 3 times a week at the maximum dose tolerated by the patient, but not exceeding 18 million IU.
Duration of treatment: patients should receive the drug for at least 8 weeks, preferably 12 weeks, after which, if there is a positive effect, the therapy is continued, if it is not, it is stopped. The treatment was carried out up to 40 months in a row. The optimal duration of treatment with Roferon-A in CTCL has not been established. Patients who respond positively to treatment should continue for at least 12 months to maximize the chance of achieving complete remission and increase the likelihood of long-term remission.
Attention:approximately 40% of patients with CTCL cannot achieve an objective antitumor effect. Partial remission is usually observed within 3 months of treatment, complete - 6 months, but sometimes 12 months of therapy is required to achieve the best effect.
Chronic myeloid leukemia (CML).
Roferon-A is indicated for the treatment of patients in the chronic stage of chronic myeloid leukemia, positive for Philadelphia chromosome. Whether he cures this disease is unclear.
Roferon-A leads to hematological remission in 60% of patients in the chronic stage of CML, regardless of previous therapy. In 2/3 of these patients, complete hematological remission is still maintained 18 months after the start of treatment.
Unlike cytotoxic chemotherapy, interferon alpha-2a can lead to stable cytogenetic remission lasting more than 40 months.
Dosing recommendations: Patients aged 18 years or older of Roferon-A should be injected with a sc or intramuscular for 8-12 weeks. The following scheme is recommended for gradually increasing the dose: 1–3 day - 3 million IU / day, 4–6 day - 6 million IU / day, 7–84 day - 9 million IU / day. Duration of treatment: patients should receive the drug for at least 8 weeks, preferably 12 weeks, after which, if there is a positive effect, therapy is continued (until complete hematological remission is reached, but not longer than 18 months).
All patients with complete hematological remission should continue treatment with 9 million IU daily (optimal dose) or 9 million IU 3 times a week (minimum dose) to achieve cytogenetic remission as soon as possible.The optimal duration of treatment for chronic myeloid leukemia has not been established, but there are observations of cytogenetic remissions lasting 2 years after the start of treatment.
Efficacy, safety and optimal doses of Roferon-A for children with CML have not been established.
Thrombocytosis associated with myeloproliferative diseases.
Thrombocytosis often accompanies chronic myeloid leukemia and is the main symptom of essential thrombocytopenia. Clinically severe thrombocytosis is manifested by a high incidence of severe thrombotic diathesis.
Roferon-A for several days reduces the number of platelets, reduces the frequency of concomitant thrombohemorrhagic complications and does not have leukemic potential. Therefore, in the treatment of patients with excessive thrombocytosis in chronic myeloid leukemia and other myeloproliferative diseases, the use of non-leukogenic therapy Roferon-A is recommended.
In the case of thrombocytosis in chronic myeloid leukemia, the following dose increase scheme is recommended: 1–3 day - 3 million IU / day, 4–6 day - 6 million IU / day, 7–84 day - 9 million IU / day. The duration of treatment is 8 weeks, preferably not less than 12 weeks, after which, if there is a positive effect, the therapy is continued, in the absence of hematological parameters, it is stopped.
In the case of thrombocytosis, for myeloproliferative diseases (except for chronic myeloid leukemia), the following dose increase scheme is recommended: 1–3 day - 3 million IU / day, 4–30 day - 6 million IU / day.
Duration of treatment: a well-tolerated dose of 1–3 million IU 2-3 times a week is usually sufficient to maintain the platelet count. For each patient, the maximum tolerated doses are selected individually.
Low-grade non-Hodgkin's lymphoma.
When prescribed in addition to chemotherapy (with or without radiation therapy), Roferon-A prolongs relapse-free survival and progression-free survival.
Dosing recommendations: as maintenance therapy after standard chemotherapy (with or without radiation therapy) n / a dose of 3 million IU 3 times a week for 12 months. Treatment with Roferon-A should be started as early as possible with the improvement of the patient's condition (usually 4-6 weeks after chemotherapy and radiation therapy).
Roferon-A can also be administered simultaneously with traditional chemotherapy regimens (for example, with a combination of cyclophosphamide, prednisolone, vincristine, and doxorubicin), sc or i / v, 6 million IU / m2 from day 22 to day 26 of each 28-day cycle. In this case, Roferon-A treatment is started simultaneously with chemotherapy.
Kaposi's sarcoma with AIDS.
The optimal dosing regimen of Roferon-A has not been established.
The likelihood that patients with Kaposi sarcoma on the background of AIDS will respond positively to therapy if they have no opportunistic infections, symptoms of group B (weight loss more than 10%, temperature above 38 ° C in the absence of a known focus of infection, night-time). sweat), and the initial number of T4-lymphocytes exceeds 200 cells / mcl.
Initial dose: Patients aged 18 years and older should be injected with a sc or i / m for 10–12 weeks, gradually bringing the daily dose to at least 18 million IU, and, if possible, to 36 million IU. It is recommended to increase the dose according to the following scheme: 1-3 days IU / day for 1–3 days, 9 million IU / day for 4–6 days, 18 million IU / day for 7–9 days, with tolerance they increase the dose by 10–84 days to 36 million IU / day.
Maintenance dose: s / c or / m in the maximum dose tolerated by the patient, but not more than 36 million IU 3 times a week.
The frequency of remission in patients with Kaposi's sarcoma on the background of AIDS, who received Roferon-A at a daily dose of 3 million IU, was less than when prescribing the recommended doses.
Duration of treatment: to determine the response to treatment, the dynamics of the tumor should be documented.Patients should receive the drug for at least 10 weeks, preferably 12 weeks, after which, if there is a positive effect, the therapy is continued, if it is not, it is stopped. Usually, the effect begins to appear after 3 months of treatment. The treatment was carried out up to 20 months in a row. The optimal duration of treatment for Roferon-A Kaposi's sarcoma with AIDS has not been established. If there is a clinical effect, treatment should be continued until the tumor disappears.
Note: after discontinuation of Roferon-A therapy, Kaposi’s sarcoma often recurs.
Launched renal cell carcinoma.
In patients with tumor recurrence or metastases, the best therapeutic effect was observed when large doses of Roferon-A (36 million IU / day) were administered as monotherapy or moderate doses of Roferon-A (18 million IU 3 times a week) in combination with vinblastine, compared with with monotherapy with moderate doses of Roferon-A 3 times a week. In patients who received small doses of Roferon-A (2 million IU / m2 / day), no effect of treatment was observed.
The combination of Roferon-A with vinblastine leads to a slight increase in the frequency of mild or moderate leukopenia and granulocytopenia compared with monotherapy.
Initial dose: s / c or / m for 8-2 weeks, gradually bringing the daily dose to 18 million IU, and, if possible - to 36 million IU. A dose of 36 million IU is recommended to enter the / m. A gradual increase in the dose according to the following scheme is recommended: (n / a or v / m) 1-3 days IU / day, 4–6 day –9 million IU / day, 7–9 day –18 million IU / day, with tolerability, the dose is increased by 10–84 days to 36 million IU / day.
Maintenance dose: at the maximum dose, but not more than 36 million IU 3 times a week.
Duration of treatment: patients should receive the drug for at least 8 weeks, preferably 12 weeks, after which, if there is a positive effect, the therapy is continued, if it is not, it is stopped. The treatment was carried out up to 16 months in a row. The optimal duration of treatment for advanced renal cell carcinoma has not been established.
Combination therapy with Roferon-A and vinblastine.
Combination therapy gives a general remission rate of about 20%, slows the progression of the disease and lengthens the overall survival of patients with advanced kidney cancer.
Dosing: Roferon-A (s / c or v / m) - in 1 week - 3 million IU 3 times a week, in 2 weeks - 9 million IU 3 times a week, then - 18 million IU 3 times a weeks
During this period, vinblastine should be administered intravenously, in accordance with the instructions of the manufacturer, at a dose of 0.1 mg / kg body weight 1 time in 3 weeks. If the patient does not tolerate a dose of 18 million IU, it can be reduced to 9 million IU 3 times a week.
The duration of treatment is 3–12 months or until the onset of disease progression. In case of complete remission, treatment can be stopped 3 months after its occurrence.
In 10–25% of patients with advanced malignant melanoma, Roferon-A treatment resulted in an objective regression of skin and visceral tumors. When using doses of less than 18 million IU 3 times a week, the therapeutic effect was observed less frequently. Patients who responded to treatment had a longer survival than those who did not.
Initial dose: 18 million IU p / k or / m 3 times a week for 8-12 weeks.
Maintenance dose: 18 million IU (or at the maximum tolerated dose) s / c or / m 3 times a week.
Duration of treatment: patients should receive the drug for at least 8 weeks, preferably for at least 12 weeks, after which, if there is a positive effect, the therapy is continued, if it is not, it is stopped. The treatment was carried out up to 17 months in a row. The optimal duration of treatment for advanced melanoma has not been established.
Melanoma after surgery.
Adjuvant therapy with small doses of Roferon-A increases the length of time without relapse in patients without lymph nodes and distant metastases after resection of melanoma (tumor thickness> 1.5 mm).
Dose: s / c or / m 3 million IU 3 times a week.
The duration of treatment is 18 months, and treatment should be started no later than 6 weeks after surgery.
Chronic viral hepatitis B.
The optimal dosing regimen has not yet been established. Usually prescribed (n / a or v / m) 4.5 million IU 3 times a week for 6 months.
If the content of viral replication or HBe antigen markers has not decreased after a month of treatment, the dose can be increased. Further dose adjustment is carried out depending on the tolerability of the drug. If there is no improvement after 3-4 months, therapy should be interrupted.
Children. In children with chronic hepatitis B, administration of Roferon-A at a dose of up to 10 million IU / m2 is safe, but the effectiveness of this therapy has not been proven.
A warning. The effectiveness of Roferon-A in patients with chronic hepatitis B who are simultaneously infected with the human immunodeficiency virus (HIV) has not been proven.
Chronic viral hepatitis C.
Combination therapy with Roferon-A and ribavirin
The effectiveness of interferon alfa-2a increases if it is prescribed in combination with ribavirin.
Combination therapy with Roferon-A and ribavirin for relapse in adult patients in whom the previous monotherapy with interferon-alpha had a temporary effect.
Roferon-A dosing regimen: (n / a or v / m) 4.5 million IU 3 times a week for 6 months.
Ribavirin dosing regimen: 1000–1200 mg / day in 2 divided doses (during breakfast and dinner) - see ribavirin instructions for use.
Combination therapy with Roferon-A and ribavirin for previously untreated patients with chronic hepatitis C
Roferon-A dosing regimen: (n / a or v / m) 3–4.5 million IU 3 times a week for 6 months (no less).
Ribavirin dosing regimen: see above. If after 6 months of HCV therapy, there is no RNA, and the patient was infected with the genotype I virus and had a high viral load before treatment, the treatment should continue for another 6 months. When deciding whether to continue treatment for up to 12 months, other negative prognostic factors should be considered (age over 40 years, male gender, bridge fibrosis). If, after the first 6 months of treatment, virological remission (HCV RNA below the detection limit) cannot be achieved, then persistent virological remission (HCV RNA below the detection limit 6 months after drug withdrawal) is unlikely.
Used with intolerance to ribavirin or in the presence of contraindications to it.
Initial dose: (s / c or / m) 6 million IU 3 times a week for 3 months.
Maintenance dose: to fix complete remission in patients with normalized serum ALT levels — 3 million IU 3 times a week for another 3–9 months. If after 3 months of treatment serum ALT levels have not returned to normal, treatment should be stopped.
Note. Most cases of disease recurrence after adequate therapy occur no later than 4 months after the end of treatment.
P / C or / m 1–3 million IU 3 times a week for 1–2 months.
The following data is based on the experience of treating patients with a wide variety of malignant diseases, often refractory to previous treatment and in advanced stages, as well as patients with chronic hepatitis B and C. Most cancer patients received doses far exceeding those currently recommended. Perhaps this explains the higher frequency and severity of adverse reactions in this group of patients compared with patients with hepatitis B, in whom the adverse reactions were usually passing, so that 1-2 weeks after the start of treatment, the patients returned to their original state. Increased hair loss may last for several weeks.
Common symptoms: often - flu-like syndrome (lethargy, fever, chills, loss of appetite, muscle and headache, joint pain, sweating). These phenomena usually subside or are eliminated with the simultaneous administration of paracetamol, and their severity during treatment or when changing the dose of Roferon-A tends to decrease, although drowsiness, weakness, or lethargy may occur with continued therapy.
On the part of the digestive tract: often in 2/3 of oncological patients - anorexia, in half - nausea. Quite often - vomiting, change in taste, dry mouth, weight loss, diarrhea, mild or moderate abdominal pain. Rarely - constipation, flatulence, increased peristalsis and heartburn, exacerbation of peptic ulcer, gastrointestinal bleeding, not life-threatening.
Changes in liver function: sometimes - increased levels of ALT, alkaline phosphatase, LDH, bilirubin (as a rule, do not require dose adjustment). Rarely - changes in the activity of transaminases in hepatitis B (this indicates an improvement in the clinical condition of the patient).
Very rarely - severe liver dysfunction, liver failure.
From the side of the central nervous system: sometimes - systemic and non-systemic dizziness, blurred vision, deterioration of mental state, forgetfulness, depression, drowsiness, confusion, behavioral disturbances (anxiety, nervousness) and sleep disturbance. Rarely - severe drowsiness, seizures, coma, impaired cerebral circulation, temporary impotence and ischemic retinopathy, as well as suicidal attempts (in the latter case, the drug must be canceled).
From the peripheral nervous system: sometimes - paresthesia, numbness of the limbs, neuropathy, itching and tremor.
Since the cardiovascular system and respiratory system: quite often - in about 1/5 of oncological patients - transient arterial hypo- and hypertension, edema, cyanosis, arrhythmias, palpitations, chest pains. Rarely - cough, pulmonary edema, pneumonia, small shortness of breath, congestive heart failure, cardiac arrest, respiratory arrest, myocardial infarction. In patients with hepatitis B, cardiovascular disorders are rarely observed.
From the genitourinary system: rarely - deterioration of renal function, acute renal failure (especially in cancer patients with kidney disease in history or with simultaneous treatment with nephrotoxic drugs), electrolyte disturbances (especially during anorexia or dehydration), proteinuria, an increase in the content of cellular elements in urine sediment, increased blood urea nitrogen, as well as serum creatinine and uric acid.
Blood system: quite often, transient leukopenia (rarely requiring dose reduction), in patients with myelosuppression, thrombocytopenia, a decrease in hemoglobin level. Sometimes - thrombocytopenia in patients without myelosuppression. Rarely - a decrease in hemoglobin and hematocrit. The return of severe hematological disorders to baseline was usually observed 7–10 days after stopping treatment with Roferon-A.
On the part of the skin: quite often (in 1/5 of patients) - mild or moderate hair loss, reversible after stopping treatment. Rarely - exacerbation of herpetic eruptions on the lips, rash, itching, dry skin and mucous membranes, nasal discharge and nasal bleeding, exacerbation or manifestation of psoriasis.
Other: rarely, hyperglycemia, reaction at the injection site, autoimmune pathology (vasculitis, arthritis, hemolytic anemia, dysfunction of the thyroid gland, lupus-like syndrome). Very rarely, asymptomatic hypocalcemia.
In rhesus monkeys, who were prescribed doses of the drug significantly higher than those recommended for the clinic, transient menstrual disorders were observed, including prolongation of the menstruation period. The significance of this data for a person has not been established.
Antibodies to interferon: In some patients, after administration of preparations containing a homologous protein, antibodies neutralizing the active protein may form. Therefore, it is likely that antibodies to all interferons, both natural and recombinant, can be detected in a certain part of patients.In some diseases (cancer, systemic lupus erythematosus, shingles) antibodies to human leukocyte interferon can spontaneously occur in patients who have never received interferons before.
In the experiment on mice, the relative immunogenicity of lyophilized Roferon-A increased over time if the drug was stored at 25 ° C. In clinical studies that used lyophilized Roferon-A, stored at 25 ° C, neutralizing antibodies to Roferon-A were detected in about 1/5 of the patients. There is no indication that, in any of the clinical indications, the presence of such antibodies can adversely affect the patient's response to the drug.
When storing lyophilized Roferon-A at 4 ° C (recommended storage conditions), no increase in immunogenicity is observed.
When conducting combination therapy with ribavirin - see also side effects of ribavirin.
Hypersensitivity to recombinant interferon alpha-2a or any component of the drug.
Existing or past severe heart disease. There is no indication of a direct cardiotoxic effect of the drug, but there is a possibility that acute, self-extinguishing toxic effects (for example, fever, chills), often accompanying treatment with Roferon-A, may cause exacerbation of existing heart diseases.
Severe dysfunction of the kidneys, liver or myeloid hemopoiesis. Convulsive disorders and / or dysfunction of the central nervous system.
Chronic hepatitis with severe decompensation or cirrhosis of the liver.
Chronic hepatitis, if patients receive or have recently received immunosuppressants, with the exception of short-term treatment with steroids.
Chronic myeloid leukemia, if the patient has an HLA-identical relative and he will have or may have allogeneic bone marrow transplantation in the near future.
When conducting combination therapy with ribavirin - see also contraindications to the use of ribavirin.
Alpha interferons can interfere with oxidative metabolic processes, reducing the activity of hepatic microsomal enzymes of cytochrome P450 systems. This should be considered when simultaneously prescribing drugs that are metabolized by this route.
Described reduced clearance of theophylline after the simultaneous appointment of alpha interferon.
Interferons may enhance the neurotoxic, hematotoxic, or cardiotoxic effects of drugs administered previously or simultaneously with them.
Interactions can be observed after administration of centrally acting drugs.
Pregnancy and Lactation
Men and women who receive Roferon-A should use reliable contraceptive methods.
Use during pregnancy is possible if the expected effect of therapy outweighs the potential risk to the fetus. The issue of stopping breastfeeding or discontinuation of the drug should be decided depending on the importance of treatment for the mother.
Benzyl alcohol can also cross the placenta. When appointing Roferon-A immediately before delivery or cesarean section, one should remember its toxic effect on premature babies.
When conducting combination therapy with ribavirin - see also precautions for ribavirin.
Roferon-A should be prescribed under the supervision of a physician who has experience in treating patients for appropriate indications. Patients should be informed not only about the benefits of this therapy, but also about possible adverse reactions.
In patients with mild or moderate impairment of kidney, liver, or bone marrow, patients should be carefully monitored.
When treating patients with chronic hepatitis with autoimmune diseases in history, caution should be exercised.Each patient, in whom the treatment of interferon-alpha, appears pathological changes in functional liver samples, you need to carefully monitor and, if necessary, cancel the drug.
A thorough periodic neuropsychiatric examination of all patients is recommended (rarely, suicidal attempts are possible in patients, in these cases, therapy is canceled).
Roferon-A should be used with extreme caution in patients with severe myelosuppression, since the drug inhibits the bone marrow, causing a fall in white blood cells (especially granulocytes), platelet counts and, less commonly, hemoglobin levels. This leads to an increased risk of infection and bleeding. It is necessary to closely monitor these changes and to conduct patients detailed blood tests before starting treatment with Roferon-A and regularly during it.
In patients after transplantation (for example, kidney or bone marrow), drug immunosuppression may be less effective because interferons have a stimulating effect on the immune system.
In the presence of clinical symptoms of hyperglycemia, control of blood glucose levels and appropriate monitoring are necessary. Patients with diabetes may require correction of glucose-lowering drugs.
It is not recommended to appoint Roferon-A to newborns (especially prematurely born) and children up to 2 years old, because it contains benzyl alcohol, which can lead to persistent violations of the neuropsychic sphere and multiple organ failure.
When conducting combination therapy with ribavirin - see precautions.
There are no reports of overdose, but repeated administration of large doses of interferon may be accompanied by deep lethargy, lethargy, prostration and coma. Such patients should be hospitalized for monitoring and appropriate supportive measures.
- Brand name: Roferon-A
- Active ingredient: Interferon alfa-2a
- Dosage form: Roferon-A solution for s / c injection, a clear liquid, colorless or light yellow.
- Manufacturer: Hoffmann la roch
- Country of Origin: Switzerland