Active Ingredient: Pixantrone
Pixantrone is indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell lymphomas (NHL).
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
50 - 50 mg per m² of body surface area (BSA)
From 50 To 50 mg per m² of body surface area (BSA) once every 7 day(s)
The recommended dose is 50 mg/m² of pixantrone on days 1, 8, and 15 of each 28-day cycle for up to 6 cycles.
Please note: In the EU recommended dose refers to the base of the active substance (pixantrone). Calculation of the individual dose to be administered to a patient must be based on the strength of the reconstituted solution that contains 5.8mg/ml pixantrone and the dose recommendation of 50 mg/m². In some trials and publications, the recommended dose is based on the salt form (pixantrone dimaleate).
However, the dose has to be adjusted before the start of each cycle based on nadir haematologic counts or maximum toxicity from the preceding cycle of therapy. The amount of pixantrone in milligrams that is to be administered to a patient should be determined on the basis of the patient’s body surface area (BSA).
The BSA should be determined using the institutional standard for BSA calculation and should use a weight measured on day 1 of every cycle.
Some caution is advised in obese patients as data on BSA- based dosing is very limited for this group.
Dose modification and the timing of subsequent doses should be determined by clinical judgement depending on the degree and duration of myelosuppression. For subsequent courses, the prior dose can usually be repeated if white blood cell and platelet counts have returned to acceptable levels.
If on day 1 of any cycle the Absolute Neutrophil Count (ANC) is <1.0 × 109/l or platelet count is <75 × 109/l it is recommended to delay treatment until ANC recovers to ≥1.0 × 109/l and platelet count to ≥75 × 109/l. The tables below are recommended as guides to dosage adjustments for days 8 and 15 of the 28-day cycles.
Dose modifications for hematologic toxicity on days 8 and 15 of any cycle:
| Grade | Platelet count | ANC count | Dose modification |
|---|---|---|---|
| 1-2 | LLN* – 50 × 109/l | LLN – 1.0 × 109/l | No change in dose or schedule. |
| 3 | <50 – 25 × 109/l | <1.0 – 0.5 × 109/l | Delay treatment until recovery to platelet count ≥50 × 109/l and ANC** ≥1.0 × 109/l. |
| 4 | <25 × 109/l | <0.5 × 109/l | Delay treatment until recovery to platelet count ≥50 × 109/l and ANC** ≥1.0 × 109/l. Reduce the dose by 20%. |
* LLN: Lower Limit of the Normal range
** ANC: Absolute Neutrophil Count
Treatment modifications for non-hematologic toxicities:
| Toxicity | Modification |
|---|---|
| Any grade 3 or 4 drug-related non cardiac toxicity other than nausea or vomiting | Delay treatment until recovery to grade 1. Reduce the dose by 20%. |
| Any grade 3 or 4 NYHA* cardiovascular toxicity or persistent LVEF** decline | Delay treatment and monitor until recovery.Consider discontinuation for persistent decline in LVEF** of ≥15% of baseline value. |
* NYHA: New York Heart Association
** LVEF: Left Ventricular Ejection Fraction
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