Active Ingredient: Polatuzumab vedotin
In combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) it is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
In combination with bendamustine and rituximab it is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 1.8 milligrams polatuzumab vedotin per kilogram of body weight, once every 21 days. This step is repeated 6 times.
The recommended dose of polatuzumab vedotin is 1.8 mg/kg, given as an intravenous infusion every 21 days in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for 6 cycles. Polatuzumab vedotin, rituximab, cyclophosphamide and doxorubicin can be administered in any order on Day 1 after the administration of prednisone. Prednisone is administered on Days 1-5 of each cycle. Cycles 7 and 8 consist of rituximab as monotherapy.
Refer to the summary of product characteristics (SmPC) of chemotherapy agents given in combination with polatuzumab vedotin for patients with previously untreated DLBCL.
The recommended dose of polatuzumab vedotin is 1.8 mg/kg, given as an intravenous infusion every 21 days in combination with bendamustine and rituximab for 6 cycles. Polatuzumab vedotin, bendamustine and rituximab can be administered in any order on Day 1 of each cycle. When administered with polatuzumab vedotin, the recommended dose of bendamustine is 90 mg/m²/day on Day 1 and Day 2 of each cycle and the recommended dose of rituximab is 375 mg/m² on Day 1 of each cycle. Due to limited clinical experience in patients treated with 1.8 mg/kg polatuzumab vedotin at a total dose >240 mg, it is recommended not to exceed the dose 240 mg/cycle.
If not already premedicated, premedication with an antihistamine and anti-pyretic should be administered to patients prior to polatuzumab vedotin.
If a planned dose of polatuzumab vedotin is missed, it should be administered as soon as possible and the schedule of administration should be adjusted to maintain a 21-day interval between doses.
The infusion rate of polatuzumab vedotin should be slowed or interrupted if the patient develops an infusion-related reaction. Polatuzumab vedotin should be discontinued immediately and permanently if the patient experiences a life-threatening reaction.
There are different potential dose modifications for polatuzumab vedotin in patients with previously untreated DLBCL and those who are relapsed or refractory.
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