- CHRONIC MYELOGENOUS LEUKAEMIA

Roferon-A is indicated for the treatment of patients with chronic phase Philadelphia-chromosome positive chronic myelogenous leukaemia. Roferon-A is not an alternative treatment for CML patients who have an HLA-identical relative and for whom allogeneic bone marrow transplantation is planned or possible in the immediate future.

Roferon-A produces haematological remissions in 60% of patients with chronic phase CML, independent of prior treatment. Two thirds of these patients have complete haematological responses which occur as late as 18 months after treatment start.

In contrast to cytotoxic chemotherapy, interferon alfa-2a is able to generate sustained, ongoing cytogenetic responses beyond 40 months. It is still unkown whether Roferon-A can be considered as a treatment with a curative potential in this indication.

Dosage:

It is recommended that Roferon-A should be given by subcutaneous injection for eight to 12 weeks to patients 18 years or more. The recommended schedule is:

 
Days 1-3
 3 million IU daily
 
Days 4-6
 6 million IU daily
 
Days 7-84
 9 million IU daily

Duration of treatment:

Patients should be treated for a minimum of eight weeks, preferably for at least twelve weeks before the physician decides whether or not to continue treatment in responding patients or to discontinue treatment in patients not showing any changes in haematological parameters. Responding patients should be treated until complete haematological response is achieved or for a maximum of 18 months. All patients with complete haematologic responses should continue treatment with 9 million IU daily (optimum) or 9 million IU three times a week (minimum) in order to achieve a cytogenetic response in the shortest possible time. The optimal duration of Roferon-A treatment for chronic myelogenous leukaemia has not been determined, although cytogenetic responses have been observed two years after treatment start.

The safety, efficacy and optimal dosage of Roferon-A in children with CML has not yet been established.

- CUTANEOUS T-CELL LYMPHOMA (CTCL)

Interferon alfa-2a (Roferon-A) may be active in patients with progressive cutaneous T-cell lymphoma and who are refractory to, or unsuitable for conventional therapy.

The optimal dosage has not been established.

Initial dosage:

Roferon-A should be given by subcutaneous injection, and escalated to 18 million IU daily for a total of 12 weeks in patients of 18 years or older. The recommended escalation schedule is as follows:
 
Days 1 to 3;
 3 million IU daily
 
Days 4 to 6;
 9 million IU daily
 
Days 7 to 84;
 18 million IU daily

Maintenance dosage:

Roferon-A should be given by subcutaneous injection three times per week at the maximum dose which is acceptable to the patient, but not exceeding 18 million IU.

Duration of treatment:

Patients should be treated for a minimum of eight weeks and preferably for at least twelve weeks before the physician decides whether to continue treatment in responding patients or to discontinue treatment in non-responding patients. Minimum treatment duration in responding patients should be 12 months in order to maximise the chance to achieve a complete response and improve the chance for a prolonged response. Patients have been treated for up to 4