Truxima monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

INN:

Subtype:

Follicular Lymphoma (FL)

License:

EMA

Class:

CD20 monoclonal antibody

R/R

SmPC: https://www.medicines.org.uk/emc/medicine/33201

 1. Approved Labelling

Truxima monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

2. Treatment Regimen

The recommended dose of Truxima monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks.

For retreatment with Truxima monotherapy for patients who have responded to previous treatment with Truxima monotherapy for relapsed/refractory follicular lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks.

3. AE/Warnings

Please see section 4.4 of the SmPC

 

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