Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL.

INN:

Subtype:

Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)

License:

EMA

Class:

CD20 monoclonal antibody

Newly Diagnosed

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

1. Approved Labelling

Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL.

2. Treatment Regimen

Prophylaxis with adequate hydration and administration of uricostatics starting 48 hours prior to start of therapy is recommended for CLL patients to reduce the risk of tumour lysis syndrome. For CLL patients whose lymphocyte counts are > 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Truxima to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.

The recommended dosage of Truxima in combination with chemotherapy for previously untreated and relapsed/refractory patients is 375 mg/m2 body surface area administered on day 0 of the first treatment cycle followed by 500 mg/m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total. The chemotherapy should be given after Truxima infusion.

3. AE/Warnings

Please see section 4.4 of the SmPC

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