Safety & Side Effects
VIDAZA® was generally well tolerated in WHO AMLb patients2
VIDAZA® was well-tolerated with WHO-defined AMLb (20-30% blasts)1
- VIDAZA® was given for a median of 8 cycles (range, 1-39); median cycle length: 34 days (15-79 days)1
- Median follow-up (all patients) was 20.1 months (0.03-38.4)1
Patients should be pre-medicated for nausea and vomiting2
“Awareness of the onset, duration and management of adverse events can facilitate treatment, permitting patients to continue therapy for maximum benefit.” -Santini et al. 20103
Adverse events and transfusion requirements: VIDAZA® vs CCR*‡
VIDAZA® significantly improved treatment outcomes vs CCR in patients with WHO-defined AMLb (20-30% blasts)1
Fewer hospital admissions with VIDAZA® vs CCR (3.4 vs 4.3 admissions per patient year, p=0.05) and significantly fewer total number of days in hospital (26.0 vs. 50.9 days per patient-year, p<0.0001)1
Awareness of adverse events is important when treating with VIDAZA®
- VIDAZA® has a well-characterized side effect profile1,4
- Most adverse events (>83%) are transient and resolved during ongoing therapy3
- Patients need pro-active management of adverse events (AEs) to keep them on treatment3,4
Infections and bleeding events are symptoms of underlying AMLb and are common events associated with the disease. They may also be adverse events with VIDAZA® treatment.3
Side effect profile
During the first two cycles, VIDAZA® treatment may result in an initial deterioration of cytopenias2
- After cycle two, cytopenias occur with less frequency in patients with restoration of haematological function
- Patients should be monitored for haematological response and renal toxicities; a delay in starting the next cycle or a dose reduction may be necessary
Administration may be associated with nausea, vomiting and injection site reactions, usually grade 1-2.2
*Conventional care regimens: Best supportive care only (BSC); low-dose ara-C (LDAC); intensive chemotherapy (IC).1
†National Cancer Institute’s Common Toxicity Criteria toxicities based on laboratory data.1
‡In patients with WHO-defined AML (20-30% blasts)
§Among patients with RBC dependence at baseline. Transfusion independence for platelets: CCR 40% vs VIDAZA® 53%, p=0.69.1
- Fenaux P et al. J Clin Oncol 2010. 28:562-569.
- VIDAZA® Summary of Product Characteristics, 2011.
- Santini V et al. Eur J Haematol 2010. 85:130-138.
- Fenaux P et al. Leuk Res 2010. 34. 1410-16.
- Fenaux P et al. Lancet Oncol 2009. 10: 223-232.
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.
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.