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DACOGEN is indicated for treatment of patients with myelodysplastic syndromes (MDS)
Previously treated and untreated
De novo and secondary
All French-American-British (FAB) subtypes (refractory anemia, refractory anemia
with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia
with excess blasts in transformation, and chronic myelomonocytic leukemia)
Intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System
Important Safety Information
Treatment with DACOGEN is associated with neutropenia and thrombocytopenia. Complete
blood and platelet counts should be performed as needed to monitor response and
toxicity but at a minimum prior to each dosing cycle. After administration of the
recommended dosage for the first cycle, treatment for subsequent cycles should be
adjusted if indicated by dose adjustment guidelines. Clinicians should consider
the need for early institution of growth factors and/or antimicrobial agents for
the prevention or treatment of infections in patients with MDS.
DACOGEN may cause fetal harm when administered to a pregnant woman. Women of childbearing
potential should be advised to avoid becoming pregnant while receiving treatment
with DACOGEN and for 1 month following completion of treatment. Women of childbearing
potential should be counseled to use effective contraception during this time. Men
should be advised not to father a child while receiving treatment with DACOGEN and
for 2 months following completion of treatment. DACOGEN may cause fetal harm. Men
with female partners of childbearing potential should use effective contraception
during this time.
In the phase 3 clinical trial, the highest incidence of Grade 3 or Grade 4 adverse
events in the DACOGEN arm was neutropenia (87%), thrombocytopenia (85%), febrile
neutropenia (23%), and leukopenia (22%). Bone marrow suppression was the most frequent
cause of dose reduction, delay, and discontinuation. Six patients had fatal events
associated with their underlying disease and myelosuppression (anemia, neutropenia,
and thrombocytopenia) that were considered at least possibly related to drug treatment.
Of the 83 DACOGEN-treated patients, 8 permanently discontinued therapy for adverse
events compared to 1 of 81 patients in the supportive care arm.
In the single-arm study, the highest incidence of Grade 3 or Grade 4 adverse events
was neutropenia (37%), thrombocytopenia (24%), and anemia (22%). Seventy-eight percent
of patients had dose delays, the median duration of this delay was 7 days. Hematologic
toxicities and infections were the most frequent causes of dose delays and discontinuation.
Eight patients had fatal events due to infection and/or bleeding that were considered
at least possibly related to drug treatment. Nineteen of 99 patients permanently
discontinued therapy for adverse events.
Other commonly occurring reactions include fatigue, pyrexia, nausea, cough, petechiae,
constipation, diarrhea, and hyperglycemia.
If hematologic recovery from a previous DACOGEN treatment cycle requires more than
6 weeks when administering the 3-day dosing, then the next DACOGEN cycle should
be delayed and dosing temporarily reduced. When administering the 5-day dosing,
the DACOGEN cycle should be delayed until there is hematologic recovery. If the
following nonhematologic toxicities are present, DACOGEN treatment should not be
restarted until the toxicity is resolved: (1) serum creatinine ≥2 mg/dL; (2)
SGPT, total bilirubin ≥2 x ULN; and (3) active or uncontrolled infection.
Because there are no data on use of DACOGEN in patients with renal or hepatic dysfunction,
DACOGEN should be used with caution in these patients.
Please see full Prescribing Information