Safety & Side Effects
Awareness of adverse events is important when treating with VIDAZA®
- VIDAZA® has a well-characterized side effect profile1,2
- Most adverse events (>83%) are transient and resolved during ongoing therapy1
- Patients need pro-active management of adverse events (AEs) to keep them on treatment1,2
Side effect profile
During the first two cycles, VIDAZA® treatment may result in an initial deterioration of cytopenias
- 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 necessary3
% of patients with grade 3-4 haematological toxicity3
Administration may be associated with nausea, vomiting and injection site reactions, usually grade 1-2.4
- Santini V et al. Eur J haematol 2010. 85: 130-38.
- Fenaux P et al. Leuk Res 2010. 34: 1410-16.
- Fenaux P et al. Lancet Oncol 2009. 10: 223-32.
- 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.
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.