Source: European Medicines Agency (EU) Revision Year: 2008 Publisher: SP Europe, 73, rue de Stalle, B-1180 Bruxelles, Belgium
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.
Viraferon is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see section 4.4).
The best way to use Viraferon in this indication is in combination with ribavirin.
Viraferon is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA. The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load. The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).
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.
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).
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.
Treatment should be continued for another 6-month period (i.e., 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:
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.
No case of overdose has been reported that has led to acute clinical manifestations. However, as for any pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs and close observation of the patient is indicated.
3 years.
After reconstitution: An immediate use is recommended. However, the chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Within its shelf-life, for the purpose of transport and/or to facilitate ambulatory use the non-reconstituted product can be kept at or below 25°C for a period up to four weeks before use. If the product is not reconstituted during the four-week period, it cannot be put back in the refrigerator for a new storage period and must be discarded.
24 mg of powder (corresponding to 1 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab. Pack sizes of 1.
Not all pack sizes may be marketed.
Not all dosage forms and strengths are appropriate for some indications. Please make sure to select an appropriate dosage form and strength.
Reconstitution of Viraferon, powder for solution for injection, for parenteral administration: Viraferon is supplied as a powder at strengths of 1 million IU/ml for single-dose use. Vials must be reconstituted with 1 ml of water for injections. The reconstituted solutions are isotonic for parenteral administration.
Proper precautions should be taken during reconstitution to prevent microbial contamination (refer to package leaflet).
Using a sterilised injection syringe and injection needle, inject 1 ml water for injections into the vial of Viraferon. Agitate gently to facilitate complete dissolution of the powder. The appropriate dose can then be withdrawn with a sterile injection syringe and injected.
As for all parenteral medicinal products, inspect the reconstituted solution visually for particulate matter and discoloration prior to administration. The reconstituted solution should be clear and colourless.
Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “How to self inject Viraferon”).
Any unused product must be discarded after withdrawal of the dose.
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