Warning:

Objective tumor responses have not been observed in approximately 40% of patients with CTCL. Partial responses are usually seen within 3 months and complete responses within 6 months, although it may occasionally take more than one year to reach the best response.

- CHRONIC HEPATITIS B

Roferon-A is indicated for the treatment of adult patients with histologically proven chronic hepatitis B who have markers for viral replication, i.e., those who are positive for HBV DNA or HBeAg.

Dosage recommendation:

The optimal schedule of treatment has not been established yet. The dose is usually in the range of 2.5 million IU to 5.0 million IU/m2 body surface administered subcutaneously three times per week for a period of 4 to 6 months.

The dosage may be adjusted according to the patient's tolerance to the medication. If no improvement has been observed after 3-4 months of treatment, discontinuation of therapy should be considered.

Children: up to 10 million IU/m2 has been safely administered to children with chronic hepatitis B. However efficacy of therapy has not been demonstrated.

- CHRONIC HEPATITIS C

ROFERON-A IN COMBINATION WITH RIBAVIRIN

RELAPSED PATIENTS

Roferon-A is given in combination with ribavirin for adult patients with chronic hepatitis C who have previously responded to interferon alpha monotherapy, but who have relapsed after treatment was stopped.

Dosage:

Roferon-A: 4.5 MIU 3 times per week by subcutaneous injection for a period of 6 months.

Dosage of Ribavirin:

Ribavirin dose: 1000 mg to 1200 mg/day in two divided doses (once in the morning with breakfast and once with the evening meal). Please refer to the SmPC for ribavirin for further details on the posology and method of administration of ribavirin.

NAÏVE PATIENTS

The efficacy of interferon alfa-2a in the treatment of hepatitis C is enhanced when combined with ribavirin. Roferon-A should be given alone mainly in case of intolerance or contraindication to ribavirin.

Dosage:

Roferon-A: 3 to 4.5 MIU 3 times per week by subcutaneous injection for a period of at least 6 months. Treatment should be continued for an additional 6 months in patients who have negative HCV RNA at month 6, and are infected with genotype 1 and have high pretreatment viral load.

Dosage of Ribavirin: see above

Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into account in order to extend therapy to 12 months.

Patients who failed to show a virologic response after 6 months of treatment (HCV-RNA below lower limit of detection) do generally not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).

ROFERON-A MONOTHERAPY

Roferon-A monotherapy should be given mainly in case of intolerance or contraindication to ribavirin.

Initial dosage:

Roferon-Ashould be administered at a dose of 3 to 6 million IU by subcutaneous injection three times a week for six months as induction therapy, patient tolerance permitting. In patients who fail to respond after three to four months of treatment, discontinuation of Roferon-A should be considered.

Maintenance dosage:

Patients whose serum ALT has normalised and/or HCV RNA has become undetectable require ma