Dacogen

TRANFUSION INDEPENDENCE

Blood transfusions are not long-term treatment solutions for those with myelodysplastic syndromes (MDS).13 Constant red blood cell transfusions may cause iron overload which could lead to fatality if not controlled. Treatment may require several transfusions a month and eventually the body may reject them. Successful treatment with DACOGEN® (decitabine) for Injection may reduce or eliminate the need for those transfusions while receiving this therapy.

In the randomized, controlled phase III trial, all DACOGEN responding patients remained red blood cell (RBC) transfusion free. Beginning with the third treatment cycle, the percentage of responding MDS patients who achieved RBC transfusion independence* increased with each DACOGEN treatment cycle (Table 1).3

Table 1. RBC Transfusion Independence by Cycle (All Patients)3

It is recommended that patients be treated with DACOGEN for a minimum of 4 cycles; however, a complete or partial response may take longer than 4 cycles. Treatment may be continued as long as the patient continues to benefit.

Responding patients receiving DACOGEN demonstrated improved blood cell production.

  • 100% of responding patients (CR + PR) became transfusion independent.
  • 71% of patients with hematologic improvement became RBC transfusion independent.14
  • Fewer patients receiving DACOGEN plus supportive care (20%) were treated with erythropoietic growth factors versus patients receiving supportive care alone (41%).3

* Transfusion independence is defined as no transfusions for at least 8 weeks.
CR = complete response (<5% blasts in bone marrow; no transfusions or growth factors; minimum duration 8 weeks) PR = partial response (50% decrease in bone marrow blast; other reponse criteria same as CR, or a downgrade in the FAB category)15
hematologic improvement = described by magnitude of response (major or minor) and individual responsive cell lines (red blood cells, white blood cells, and platelets).3

References

DACOGEN is indicated for treatment of patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo, and secondary MDS of all FAB subtypes (RA, RARS, RAEB, RAEB-t, CMML) and Intermediate-1, Intermediate-2, and High-Risk IPSS groups.

DACOGEN may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while using DACOGEN. Men should be advised not to father a child while receiving treatment with DACOGEN, and for 2 months afterwards. The most commonly occurring adverse reactions include neutropenia, thrombocytopenia, anemia, fatigue, pyrexia, nausea, cough, petechiae, constipation, diarrhea, and hyperglycemia.

DACOGEN is available by prescription only. Please see the important product information for DACOGEN for more information. This site does not contain everything that is known about DACOGEN. If you would like to know more, talk to your healthcare professional.