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Viraferon is a brand name for Interferon Alfa-2b. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Chronic Hepatitis B: Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/or fibrosis. Chronic Hepatitis C: Adult patients:…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment must be initiated by a physician experienced in the management of the disease. Not all dosage forms and strengths are appropriate for some indications. Please make sure to select an appropriate dosage form and strength. Medicinal product no longer authorised3 If adverse events develop during the course of treatment with Viraferon for any indication, modify the dosage or discontinue therapy temporarily until the adverse events abate.
If persistent or recurrent intolerance develops following adequate dosage adjustment, or disease progresses, discontinue treatment with Viraferon. At the discretion of the physician, the patient may self-administer the dose for maintenance dosage regimens administered subcutaneously.
Chronic Hepatitis B:
The recommended dosage is in the range 5 to 10 million IU administered subcutaneously three times a week (every other day) for a period of 4 to 6 months. The administered dose should be reduced by 50 % in case of occurrence of haematological disorders (white blood cells < 1,500/mm3, granulocytes < 1,000/mm3, thrombocytes < 100,000/mm3).
Treatment should be discontinued in case of severe leukopaenia (< 1,200/mm3), severe neutropaenia (< 750/mm3) or severe thrombocytopaenia (< 70,000/mm3). For all patients, if no improvement on serum HBV-DNA is observed after 3 to 4 months of treatment (at the maximum tolerated dose), discontinue Viraferon therapy.
Chronic Hepatitis C:
Viraferon is administered subcutaneously at a dose of 3 million IU three times a week (every other day) to adult patients, whether administered as monotherapy or in combination with ribavirin.
Children 3 years of age or older and adolescents:
Interferon alfa-2b 3 MIU/m2 is administered subcutaneously 3 times a week (every other day) in combination with ribavirin capsules or oral solution administered orally in two divided doses daily with food (morning and evening). (See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination therapy.
For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC).
See ribavirin SPC for ribavirin-related undesirable effects if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C. In clinical trials conducted in a broad range of indications and at a wide range of doses (from 6 MIU/m2/week in hairy cell leukaemia up to 100 MIU/m2/week in melanoma), the most commonly reported undesirable effects were fever, fatigue, headache and myalgia.
Fever and fatigue were often reversible within 72 hours of interruption or cessation of treatment. In clinical trials conducted in the hepatitis C population, patients were treated with Viraferon alone or in combination with ribavirin for one year.
All patients in these trials received 3 MIU of Viraferon three times a week. In Table 1 the frequency of patients reporting (treatment related) undesirable effects is presented from clinical trials in naïve patients treated for one year.
Severity was generally mild to moderate. The adverse reactions listed in Table 1 are based on experience from clinical trials and post-marketing. Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100, <1/10); rarely (≥1/10,000, <1/1,000); very rarely (<1/10,000); not known.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1. 4 These undesirable effects have also been reported with Viraferon alone. Cardiovascular (CVS) adverse events, particularly arrhythmia, appeared to […]
For all patients:
Psychiatric and central nervous system (CNS): Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Viraferon therapy, and even after treatment discontinuation mainly during the 6-month follow-up periodand in the follow-up period.
4 % vs 1 %) during treatment and during the 6-month follow-up after treatment. , depression, emotional lability, and somnolence). Other CNS effects including aggressive behaviour (sometimes directed against others), confusion and alterations of mental status have been observed with alpha interferons.
Patients should be closely monitored for any signs or symptoms of psychiatric disorders. If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
If psychiatric Medicinal product no longer authorised5 symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Patients with existence of or history of severe psychiatric conditions:
If a treatment with interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
3). , urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa-2b have been observed rarely during Viraferon therapy. If such a reaction develops, discontinue the medication and institute appropriate medical therapy.
Hypersensitivity to the active substance or to any of the excipients. , uncontrolled congestive heart failure, recent myocardial infarction, severe arrhythmic disorders. - Severe renal or hepatic dysfunction; including that caused by metastases.
4). - Chronic hepatitis with decompensated cirrhosis of the liver. - Chronic hepatitis in patients who are being or have been treated recently with immunosuppressive agents excluding short term corticosteroid withdrawal. - Autoimmune hepatitis; or history of autoimmune disease; immunosuppressed transplant recipients.
- Pre-existing thyroid disease unless it can be controlled with conventional treatment. Children and adolescents: - Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicide attempt.
Combination therapy with ribavirin:
Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Interferon Alfa-2b in European Union.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Relapse patients (adults):
Viraferon is given in combination with ribavirin. Based on the results of clinical trials, in which data are available for 6 months of treatment, it is recommended that patients be treated with Viraferon in combination with ribavirin for 6 months.
Naïve patients:
Adults: The efficacy of Viraferon is enhanced when given in combination with ribavirin. Viraferon should be given alone mainly in case of intolerance or contraindication to ribavirin.
Viraferon in combination with ribavirin:
Based on the results of clinical trials, in which data are available for 12 months of treatment, it is recommended that patients be treated with Viraferon in combination with ribavirin for at least 6 months. , a total of 12 months) in patients who exhibit negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and high pre-treatment viral load.
Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into account in order to extend therapy to 12 months. During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV- RNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
Viraferon alone:
Medicinal product no longer authorised4 The optimal duration of therapy with Viraferon alone is not yet fully established, but a therapy of between 12 and 18 months is advised. It is recommended that patients be treated with Viraferon alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Treatment should be continued in patients who exhibit negative HCV-RNA.
Children and adolescents:
The efficacy and safety of Viraferon in combination with ribavirin has been studied in children and adolescents who have not been previously treated for chronic hepatitis C.
Genotype 1:
The recommended duration of treatment is one year. Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96 %). Virological response is defined as absence of detectable HCV-RNA at Week 12.
Treatment should be discontinued in these patients.
Genotype 2/3:
The recommended duration of treatment is 24 weeks. Virological responses after 1 year of treatment and 6 months of follow-up were 36 % for genotype 1 and 81 % for genotype 2/3/4. Viraferon may be administered using either glass or plastic disposable injection syringes.
Transient rashes do not necessitate interruption of treatment. , urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa-2b have been observed rarely during Viraferon therapy. If such a reaction develops, discontinue the medication and institute appropriate medical therapy.
Transient rashes do not necessitate interruption of treatment. Moderate to severe adverse experiences may require modification of the patient's dosage regimen, or in some cases, termination of Viraferon therapy. Any patient developing liver function abnormalities during treatment with Viraferon must be monitored closely and treatment discontinued if signs and symptoms progress.
Hypotension may occur during Viraferon therapy or up to two days post-therapy and may require supportive treatment. Adequate hydration must be maintained in patients undergoing Viraferon therapy since hypotension related to fluid depletion has been seen in some patients.
Fluid replacement may be necessary. While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out. , chronic obstructive pulmonary disease) or diabetes mellitus prone to ketoacidosis.
, thrombophlebitis, pulmonary embolism) or severe myelosuppression. Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with Viraferon.
The aetiology has not been defined. 5). Any patient developing fever, cough, dyspnea or other respiratory symptoms must have a chest X-ray taken. If the chest X-ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha.
While this has been reported more often in patients with chronic hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha. Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events.
8) including retinal haemorrhages, cotton wool spots, and retinal artery or vein obstruction have been reported in rare instance after treatment with alpha interferons. All patients should have a baseline eye examination. Any patient complaining of changes in visual acuity or visual fields, or reporting other ophthalmologic symptoms during treatment with Viraferon, must have a prompt and complete eye examination.
Periodic visual examinations during Viraferon therapy are recommended particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension. Discontinuation of Viraferon should be considered in patients who develop new or worsening ophthalmological disorders.
Medicinal product no longer authorised6 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses. While these effects are generally reversible, in a few patients full resolution took up to three weeks.
Very rarely, seizures have occurred with high doses of Viraferon. Adult patients with a history of congestive […]