plus the nadir count (i.e. blood count at recovery Nadir Count + (0.5 x [Baseline count – Nadir count]).
Patients without reduced baseline blood counts (i.e. White Blood Cells (WBC) > 3.0 x 109/l and ANC >1.5 x 109/l, and platelets > 75.0 x 109/l) prior to the first treatment
If haematological toxicity is observed following Vidaza treatment, the next cycle of Vidaza therapy should be delayed until the platelet count and the ANC have recovered. If recovery is achieved within 14 days, no dose adjustment is necessary. However, if recovery has not been achieved within 14 days, the dose should be reduced according to the following table. Following dose modifications, the cycle duration should return to 28 days.
Nadir counts
% Dose in the next cycle, if recovery* is not achieved within 14 days
ANC (x 109/l)
Platelets (x 109/l)
1.0
50.0
50 %
> 1.0
> 50.0
100 %
*Recovery = counts Nadir count + (0.5 x [Baseline count – Nadir count])
Patients with reduced baseline blood counts (i.e. WBC < 3.0 x 109/l or ANC < 1.5 x 109/l or platelets < 75.0 x 109/l) prior to the first treatment
Following Vidaza treatment, if the decrease in WBC or ANC or platelets from that prior to treatment is less than 50 %, or greater than 50 % but with an improvement in any cell line differentiation, the next cycle should not be delayed and no dose adjustment made.
If the decrease in WBC or ANC or platelets is greater than 50 % from that prior to treatment, with no improvement in cell line differentiation, the next cycle of Vidaza therapy should be delayed until the platelet count and the ANC have recovered. If recovery is achieved within 14 days, no dose adjustment is necessary. However, if recovery has not been achieved within 14 days, bone marrow cellularity should be determined. If the bone marrow cellularity is > 50 %, no dose adjustments should be made. If bone marrow cellularity is 50 %, treatment should be delayed and the dose reduced according to the following table:
Bone marrow cellularity
% Dose in the next cycle if recovery is not achieved within 14 days
Recovery* 21 days
Recovery* > 21 days
15-50 %
100 %
50 %
< 15 %
100 %
33 %
*Recovery = counts Nadir count + (0.5 x [Baseline count – Nadir count])
Following dose modifications, the cycle duration should return to 28 days.
Special populations
Renal impairment: No formal studies have been conducted in patients with decreased renal function. Patients with severe organ impairment should be carefully monitored for adverse events. No specific modification to the starting dose is recommended in patients with renal impairment (e.g. baseline serum creatinine or blood urea nitrogen [BUN] 2-fold above upper limit of normal [ULN] or serum bicarbonate less than 20 mmol/l) prior to starting treatment; subsequent dose modifications should be based on haematology and renal laboratory values. If unexplained reductions in serum bicarbonate levels to less than 20 mmol/l occur, the dose should be reduced by 50 % on the next cycle. If unexplained elevations in serum creatinine or BUN to 2-fold above baseline values and above ULN occur, the next cycle should be delayed until values return to normal or baseline and the dose should be reduced by 50 % on the next treatment cycle (see section 4.4).
Hepatic impairment: No formal studies hav |
