INTRON A is indicated for the treatment of high tumour burden Follicular Lymphoma as adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen.

Subtype:

Follicular Lymphoma (FL)

License:

EMA

Class:

Interferons

Newly Diagnosed

SmPC: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000281/WC500034679.pdf

1. Approved Labelling

Intron A is indicated for the treatment of high tumor burden Follicular Lymphoma as adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen. High tumor burden is defined as having at least one of the following: bulky tumor mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10%, pyrexia > 38°C for more than 8 days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukemia.

2. Treatment Regimen

Treatment must be initiated by a physician experienced in the management of the disease.

Adjunctively with chemotherapy, interferon alpha 2b may be administered subcutaneously, at a dose of 5 million IU three times a week (every other day) for a duration of 18 months. CHOP-like regimens are advised, but clinical experience is available only with CHVP (combination of cyclophosphamide, doxorubicin, teniposide and prednisolone). 

3. AE/Warnings

Please see section 4.4 of the SmPC.

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