Active Ingredient: Brentuximab vedotin
Brentuximab vedotin in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 1.8 milligrams brentuximab vedotin per kilogram of body weight, once every 3 weeks, 6 to 8 doses in total.
The recommended dose in combination with chemotherapy (cyclophosphamide [C], doxorubicin [H] and prednisone [P] [CHP]) is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks for 6 to 8 cycles.
Primary prophylaxis with G-CSF, beginning with the first dose, is recommended for all adult patients with previously untreated sALCL receiving combination therapy.
Refer to the SmPCs of chemotherapy agents given in combination with brentuximab vedotin for patients with previously untreated sALCL.
If the patient’s weight is more than 100 kg, the dose calculation should use 100 kg.
Complete blood counts should be monitored prior to administration of each dose of this treatment.
Patients should be monitored during and after infusion.
The recommended dose of brentuximab vedotin is infused over 30 minutes.
Brentuximab vedotin must not be administered as an intravenous push or bolus. Brentuximab vedotin should be administered through a dedicated intravenous line and it must not be mixed with other medicinal products.
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