Roferon-A is indicated for the treatment of Cutaneous T- Cell Lymphoma. Interferon alfa-2a (Roferon-A ) may be active in patients who have progressive disease and who are refractory to, or unsuitable for, conventional therapy.

Subtype:

Lymphoma, T-Cell, Cutaneous (CTCL)

License:

EMA

Class:

Interferon alpha

R/R

SmPC: https://www.medicines.org.uk/emc/medicine/1730 

1. Approved Labelling 

Roferon-A is indicated for the treatment of Cutaneous T- Cell Lymphoma (CTCL). Interferon alfa-2a (Roferon-A ) may be active in patients who have progressive disease and who are refractory to, or unsuitable for, conventional therapy.

2. Treatment Regimen

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 40 consecutive months. The optimal duration of Roferon-A treatment for CTCL has not been determined.

3. AE/Warnings

Please see section 4.4 of the SmPC

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