What are the side effects of DACOGEN (decitabine)?

While you are taking DACOGEN, you may experience side effects. Be sure to tell your healthcare provider how you are feeling during your treatment with DACOGEN.

  • Treatment with DACOGEN is associated with serious, sometimes fatal, blood disorders including:
    • fewer white blood cells (neutropenia and leukopenia), platelets (thrombocytopenia), and/or red blood cells (anemia)
    • fever associated with low white blood cell counts (febrile neutropenia)
    • bone marrow suppression
    • infections
    Your doctor will test and monitor your blood cells before and during treatment with DACOGEN. Your doctor may prescribe medicine to help manage your blood cell counts and/or medicines to prevent or treat infections. Your doctor may need to delay your treatment and/or reduce your dose if you experience certain side effects. Patients should monitor and report any symptoms or fever to their doctor as soon as possible
  • Harm to a fetus when administered to a pregnant woman: Woman of childbearing potential and men with female partners of childbearing potential should use effective contraception and avoid pregnancy while taking DACOGEN
  • Other common side effects including:
    • feeling tired (fatigue)
    • fever (pyrexia)
    • nausea
    • cough - reddish or purplish spots (petechiae)
    • constipation
    • diarrhea
    • high blood sugar (hyperglycemia)
  • DACOGEN should be used with caution if you have kidney or liver problems

Your healthcare provider may need to delay your treatment and/or reduce your dose if you experience certain side effects

What Do Low Blood Cell Counts Mean?

  • A low red blood cell count is called anemia. Red blood cells carry oxygen through your body
  • Anemia means the body has too few red blood cells to carry oxygen
  • This causes the heart to work harder
  • Call your healthcare provider if you have any of the following symptoms, which may be a sign of anemia:
    • Fatigue
    • Weakness
    • Dizziness
    • Cold hands or feet
    • Fast heartbeat
    • Shortness of breath
    • Headache
  • A low white blood cell count is called neutropenia
  • Neutropenia means that there is a low number of neutrophils in your blood. Neutrophils are a type of white blood cell that helps fight infection
  • When your neutrophil level is low, the body has a hard time fighting infection
  • Call your healthcare provider right away if you have any signs or symptoms of infection. Signs and symptoms may include:
    • A fever of 100.5°F or higher
    • Swelling
    • Chills
    • Earache
    • Stiff neck
    • Bloody or cloudy urine
    • Painful or frequent need to urinate
    • Sinus pain or pressure
    • Redness
    • Rash
    • Cough
    • Headache
  • A low platelet count is called thrombocytopenia
  • Platelets help your blood to clot. When your platelet levels are low, you may bruise or bleed more easily
  • Call your healthcare provider if you have any of the following; these may be a sign that your platelet count is low:
    • Bruises, even if you did not bump into anything
    • Small, red spots on your skin
    • Blood in your stool
    • Bowel movements that appear bloody or black
    • Bleeding from your gums or nose
    • Heavy bleeding during your menstrual period or a prolonged period
    • Vaginal bleeding not caused by your period
    • Headaches
    • Changes in your vision

Does DACOGEN Cause Low Blood Cell Counts?

  • In clinical trials, some patients treated with DACOGEN had low blood cell counts including fewer white blood cells (90% neutropenia and 28% leukopenia), platelets (89% thrombocytopenia), and/or red blood cells (82% anemia).
  • Your healthcare provider may do frequent blood tests to monitor your blood counts
  • Low blood cell counts are most common during the first and second treatment cycles
  • In clinical trials, most patients who responded to DACOGEN treatment did so by the fourth cycle, but one patient took longer than 4 treatment cycles to see a response
  • If your blood counts get too low, your healthcare provider may delay and/or reduce your DACOGEN treatment
  • The decision about whether or not to continue treatment will be made by your healthcare provider

INDICATION:

DACOGEN is a prescription medicine indicated for treatment of patients with myelodysplastic syndromes (MDS), including:

Previously treated and untreated MDS
De novo (cause unknown) and secondary (treatment-related) MDS:
  • 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:

Treatment with DACOGEN is associated with serious, sometimes fatal, blood disorders including:
  • fewer white blood cells (neutropenia and leukopenia), platelets (thrombocytopenia), and/or red blood cells (anemia)
  • fever associated with low white blood cell counts (febrile neutropenia)
  • bone marrow suppression
  • infections
Your doctor will test and monitor your blood cells before and during treatment with DACOGEN. Your doctor may prescribe medicine to help manage your blood cell counts and/or medicines to prevent or treat infections. Your doctor may need to delay your treatment and/or reduce your dose if you experience certain side effects. Patients should monitor and report any symptoms or fever to their doctor as soon as possible
Harm to a fetus when administered to a pregnant woman: Women of childbearing potential and men with female partners of childbearing potential should use effective contraception and avoid pregnancy while taking DACOGEN
Other common side effects including:
  • feeling tired (fatigue)
  • fever (pyrexia)
  • nausea
  • cough
  • reddish or purplish spots (petechiae)
  • constipation
  • diarrhea
  • high blood sugar (hyperglycemia)
DACOGEN should be used with caution if you have kidney or liver problems

You are encouraged to report side effects of DACOGEN® (decitabine), please contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA1088 (www.fda.gov/medwatch).

Please see FULL PRESCRIBING INFORMATION