WHO IS RIGHT FOR DACOGEN?

Specifically approved for both de novo and secondary MDS

INDICATED FOR TREATMENT OF PATIENTS WITH MDS INCLUDING

  • Previously treated and untreated

  • De novo and secondary

    • – All FAB subtypes: RA, RARS, RAEB, RAEB-t, CMML

    • – Intermediate-1, intermediate-2, and high-risk IPSS groups

DACOGEN is approved across a broad spectrum of MDS

PATIENTS AT BASELINE

3-day dosing (N=89) 1

Type of MDS

De novo
Secondary

 

77
12

FAB classification

RA
RARS
RAEB
RAEB-t
CMML

 

12
7
47
17
6

IPSS classification

Intermediate-1
Intermediate-2
High-risk

 

28
38
23

Cytogenetic risk

Good
Intermediate
Poor
Unknown

 

44
14
26
5

Time since diagnosis
(median)

203 days
(range: 14-4669)

 

Previous MDS therapy

Yes
No

 

27
62

Transfusion status

 

    RBCs

    Platelets

Independent
Dependent
Independent
Dependent

 

23
66
69
20

Age (median)

70 years (range: 31-85)

 

Gender

Male
Female

 

59
30

PATIENTS AT BASELINE

5-day dosing (N=99)

FAB classification

RA
RARS
RAEB
RAEB-t
CMML

 

20
17
45
6
11

IPSS classification

Low risk
Intermediate-1
Intermediate-2
High risk

 

1
52
23
23

Time since diagnosis (median)

154 days
(range: 7-3079)

 

Previous MDS therapy

Yes
No

 

27
72

Transfusion status

 

    RBCs

    Platelets

Independent
Dependent
Independent
Dependent

 

33
66
84
15

Age (median)

72 years
(range: 34-87)

 

Gender

Male
Female

 

71
28

*DACOGEN is not indicated in patients with low-risk MDS

NOTE: Patient characteristics based on 2 clinical trials

Diagnosis of MDS in the U.S. Population

  • More than 10,000 new cases are diagnosed annually2
    • 86% in patients ≥60 years of age
  • An estimated 60,000 Americans are living with MDS3
    • Prevalence rates are difficult to define and are likely underestimated

Age-adjusted incidence rate of 3.4 cases per 100,000 people based on SEER data collected from 2001 to 2003 and applied to US Census estimates.

For U.S. Healthcare Professionals

 
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INDICATION:

DACOGEN is indicated for treatment of patients with myelodysplastic syndromes (MDS) including 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 (IPSS) groups

IMPORTANT SAFETY INFORMATION:

Neutropenia and Thrombocytopenia: 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. Myelosuppression and worsening neutropenia may occur more frequently in the first or second treatment cycles, and may not necessarily indicate progression of underlying MDS.
Use in Pregnancy: DACOGEN may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of DACOGEN in pregnant women. If this drug is used during pregnancy, or if a patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while taking DACOGEN
Use in Women of Childbearing Potential: 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.
Use in Men: 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.

Complete blood counts and platelet counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each cycle. Liver chemistries and serum creatinine should be obtained prior to initiation of treatment.

Following the first cycle of DACOGEN treatment, if any of the following non-hematologic 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 times ULN; 3) and active or uncontrolled infection.

Most Commonly Occurring Adverse Reactions: neutropenia, thrombocytopenia, anemia, fatigue, pyrexia, nausea, cough, petechiae, constipation, diarrhea, and hyperglycemia.

Clinically Important Adverse Reactions: 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. For DACOGEN-treated patients, 8 of 83 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.

USE IN SPECIFIC POPULATIONS: Nursing Mothers: Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions from DACOGEN in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Renal and Hepatic Impairment: Because there are no data, DACOGEN should be used with caution in patients with renal or hepatic dysfunction.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800- 438-9927 or FDA at 1-800-FDA1088 (www.fda.gov/medwatch).

Please see accompanying FULL PRESCRIBING INFORMATION

 
References:
  1. Kantarjian H, Issa J-P, et al. Decitabine in MDS. Cancer. 2006;106:1794-1803
  2. Ma X, Does M, Raza A, Mayne ST. Myelodysplastic syndromes: incidence and survival in the United States. Cancer. 2007;109:1536-1542.
  3. Sekeres MA. The epidemiology of myelodysplastic syndromes. Hematol Oncol Clin N Am. 2010;24:287-294.