ROFERON-A MONOTHERAPY

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

Initial dosage:

Roferon-A should 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 maintenance therapy with 3 million IU Roferon-A three times a week for an additional six months or longer to consolidate the complete response. The optimal duration of treatment has not yet been determined but a therapy of at least 12 months is advised.

Note:

The majority of patients who relapse after adequate treatment with Roferon-A alone do so within four months of the end of treatment.

- FOLLICULAR NON-HODGKINS LYMPHOMA

Roferon-A prolongs disease-free and progression-free survival when used as adjunctive treatment to CHOP-like chemotherapy regimens in patients with advanced (high tumour burden) follicular non-Hodgkin's lymphoma. However, the efficacy of adjunctive interferon alfa-2a treatment on overall long-term survival of these patients has not yet been established.

Dosage Recommendation:

Roferon-A should be administered concomitantly to a conventional chemotherapy regimen (such as the combination of cyclophosphamide, prednisone, vincristine and doxorubicin) according to a schedule such as 6 million IU/m2 given subcutaneously from day 22 to day 26 of each 28-day cycle.

- ADVANCED RENAL CELL CARCINOMA

COMBINATION WITH VINBLASTINE

Therapy with Roferon-A in combination with vinblastine induces overall response rates of approximately 17-26%, delays disease progression, and prolongs overall survival in patients with advanced renal cell carcinoma.

Dosage recommendation:

Roferon-A should be given by subcutaneous injection at a dose of 3 million IU three times weekly for one week, 9 million IU three times weekly for the following week and 18 million IU three times weekly thereafter. Concomitantly vinblastine should be given intravenously according to the manufacturer's instructions at a dose of 0.1 mg/kg once every 3 weeks.

If the Roferon-A dosage of 18 million IU three times per week is not tolerated the dose may be reduced to 9 million IU three times per week.

Treatment should be given for a minimum of three months, up to a maximum of 12 months or until the development of progressive disease. Patients who achieve a complete response may stop treatment three months after the response is established.

COMBINATION WITH BEVACIZUMAB (AVASTIN)

Dosage recommendations:

9 MIU sc three times weekly until disease progression or up to 12 months.

Roferon-A therapy may be initiated with a lower dose (3 or 6 MIU), the recommended dose of 9 MIU should however be reached within the first 2 weeks of treatment.

If the Roferon-A dosage of 9MIU three times per week is not tolerated, the dosage may be reduced to a minimum dosage of 3 MIU three times per week.

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