Dacogen 50 mg Injection

How Is DACOGEN (decitabine) Given?
Your doctor may perform blood tests before treatment to determine if DACOGEN is right for you. Blood tests may be performed during treatment with DACOGEN to see how well the drug is working and to look for any potential side effects
DACOGEN is given as an intravenous (IV) infusion [in-FYOO-shun]
In an infusion, the medicine is in a plastic bag and flows through a tube into a vein in the body. The flow of the medicine may be controlled by a machine called an IV pump

There are 2 dosing regimens for DACOGEN:
3-day dosing includes:
A 3-hour infusion
Every 8 hours for 3 days
Repeat every 6 weeks

5-day dosing includes:
A 1-hour infusion
Every day for 5 days
Repeat every 4 weeks

Your healthcare provider will determine the dosing regimen that is right for you
Your healthcare provider may need to delay your treatment and/or reduce your dose if you experience certain side effects. Be sure to tell your healthcare provider how you are feeling during your treatment with DACOGEN
With either regimen it is recommended that patients be treated for a minimum of 4 cycles; however, a complete or partial response may take longer than 4 cycles
To get the most out of your DACOGEN treatment, it is important to stay on treatment as long as your healthcare provider recommends
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

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
inflections
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