VIDAZA® Treatment for MDSa

Dosing Recommendations1

Your guide to dosing

First treatment cycle

Recommended starting dose (regardless of haematological baseline values):1

  • 75 mg/m2 of body surface area, daily for 7 days
  • Injected subcutaenously
  • Rest period of 21 days (28 day cycle)

Subsequent treatment cycle

Patients should be monitored and a dose delay or reduction may be necessary, depending on haematological/renal values.1 Read more about some common side effects of VIDAZA® and how adverse events should be monitored.

Learn more about the importance of continued treatment of VIDAZA® and duration recommendations.

Dose Adjustments

Monitoring

  • Patients should be monitored for haematological response/toxicity and renal toxicities.
  • Patients with severe renal/hepatic impairment should be carefully monitored for adverse events

Haematological toxicity

Definition: The lowest count reached in a given cycle (nadir) if platelets fall below 50 x 109/L and/or absolute neutrophil count (ANC) below 1 x 109/L

Occurence: There is a greater risk of haematological toxicity occurring during the first two cycles, after which they occur with less frequency in patients with restoration of haematological function1

Management: If haematological toxicity occurs after a VIDAZA® treatment cycle, a dose delay or reduction may be necessary, as described in the following algorithms:

Without Reduced Baseline Blood Counts1

Patients without reduced baseline blood counts

*White blood cells (WBC) > 3.0 x 109/L and absolute neutrophil count (ANC) < 1.5 x 109/L, and platelets > 75.0 x 109/L prior to the first treatment†Recovery = counts ≥ nadir count + (0.5 x [Baseline count – nadir count])

  1. VIDAZA® Summary of Product Characteristics, 2011.

Patients with reduced baseline blood counts*1

Patients with reduced baseline blood counts

Following dose adjustments, cycle duration should return to 28 days1

*White blood cells (WBC) < 3.0 x 109/L and absolute neutrophil count (ANC) < 1.5 x 109/L, and platelets < 75.0 x 109/L prior to the first treatment†Recovery = counts ≥ nadir count + (0.5 x [Baseline count – nadir count])

  1. VIDAZA® Summary of Product Characteristics, 2011.

Dose adjustments in patients with renal impairment1

Recommended doses

  • No specific modification to the starting dose is needed in patients with renal impairment (e.g., baseline serum creatinine or blood urea nitrogen ≥2-fold above upper limit of normal or serum bicarbonate <20 mmol/l).
  • Subsequent dose modifications should be based on haematology and renal laboratory values.

Patients with renal impairment

No formal studies in patients with renal impairment have been conducted.

  1. VIDAZA® Summary of Product Characteristics, 2011.
  1. VIDAZA® Summary of Product Characteristics, 2011.
a. MDS-specific Indication

VIDAZA® is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with:

  • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),
  • chronic myelomonocytic leukaemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder
b. AML-specific Indication:

Treatment of adult AML patients who are not eligible for haematopoietic stem cell transplantation with 20-30% blasts and multi-lineage dysplasia, according to the WHO classification. WHO classifies RAEB-T patients with blasts ≥20% to <30% as AML patients.

Disclaimer

This is an international website for VIDAZA® and is intended for healthcare professionals outside the US. The information on this site is not country-specific and may contain information that is outside the approved indications in the country in which you are located.

The information on this website is based on the European Summary of Product Characteristics (SmPC). Please refer to your country-specific website, or contact a Celgene representative in your country for the latest information specific to your country.