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Previously untreated stage III or IV mantle cell lymphoma Clinical criteria: Treatment Phase: Induction treatment The condition must be CD20 positive, AND The treatment must be in combination with rituximab, AND The condition must be previously untreated, AND The condition must be symptomatic, AND The treatment must be for induction treatment purposes only, AND Patient must not receive more than 6 cycles (12 doses) of treatment under this restriction, AND Patient must not be eligible for stem cell transplantation.
Previously untreated stage II bulky or stage III or IV indolent non-Hodgkin's lymphoma Clinical criteria: Treatment Phase: Induction treatment The condition must be CD20 positive, AND The condition must be previously untreated, AND The condition must be symptomatic, AND The treatment must be for induction treatment purposes only, AND The treatment must be in combination with rituximab or obinutuzumab, AND The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction.
Follicular lymphoma Clinical criteria: Treatment Phase: Re-induction treatment The condition must be CD20 positive, AND The condition must be refractory to treatment with rituximab for this condition, AND The condition must be symptomatic, AND The treatment must be for re-induction treatment purposes only, AND The treatment must be in combination with obinutuzumab, AND The treatment must not exceed 6 cycles (12 doses) with this drug under this restriction. The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.
“Bendamustine hydrochloride is an alkylating antitumour agent with unique activity.”
“The elimination half-life t1/2ß after 30 min I.V. infusion of 120 mg/m 2 to 12 subjects was 28.2 minutes.”
Formation of N-desmethyl-bendamustine and gamma-hydroxy-bendamustine by hepatic metabolism involves cytochrome P450 (CYP) 1A2 isoenzyme. In-vitro bendamustine does not inhibit CYP 1A2, CYP 2C9/10, CYP 2D6, CYP 2E1 and CYP 3A4.
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.