Indication
- The treatment of patients with myelodysplastic syndromes (MDS) including:
- Previously treated and untreated
- De novo and secondary MDS
- All French-American-British subtypes (refractory anemia, refractory anemia with
ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with
excess blasts in transformation, and chronic myelomonocytic leukemia) and Intermediate-1,
Intermediate-2, and High-Risk International Prognostic Scoring System groups.
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. 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. Men should be advised not to father a child while receiving treatment
with DACOGEN® and for 2 months following completion of treatment.
In the phase 3 clinical trial, the highest incidences of Grade 3 or Grade 4 adverse
events in the DACOGEN® arm were 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. 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 × 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.
For more information about DACOGEN® please see full Prescribing Information.
Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement
may vary significantly by payor, plan, patient, and setting of care. Actual coverage
and reimbursement decisions are made by individual payors following the receipt
of claims. For additional information, customers should consult with their payors
for all relevant coding, reimbursement, and coverage requirements. It is the sole
responsibility of the provider to select the proper code and ensure the accuracy
of all claims used in seeking reimbursement. All services must be medically appropriate
and properly supported in the patient medical record.
This information is intended for use by our healthcare professionals in the United
States only. Eisai Inc. recognizes the Internet is a global communications medium;
however, laws, regulatory requirements and medical practices for pharmaceutical
products vary from country to country. The Prescribing Information included here
is not appropriate for use outside the United States. This site contains information
about products that may have different product labeling in different countries.
DACOGEN® is a registered trademark used by Eisai Inc. under license
from Astex Pharmaceuticals, Inc., Dublin, CA, U.S.A.
Distributed and marketed by Eisai Inc. CORP74BR6 ©2012
Eisai Inc. All rights reserved.
This site was last modified on : December 19, 2011 at 5:45pm ET
