Dacogen is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Dacogen injection is used to treat myelodysplastic syndromes (certain types of blood or bone marrow cancer).

Dacogen may also be used for purposes not listed in this medication guide.

Dacogen affects your immune system. You may get infections more easily. Call your doctor if you have unusual bruising or bleeding, or new signs of infection (fever, chills, cough, sore throat, trouble breathing).

Before receiving a Dacogen injection, tell your doctor if you have liver or kidney disease.

Do not use Dacogen if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. If a man fathers a child while using decitabine, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 2 months after you stop receiving this medicine. You should not breast-feed while you are receiving this medicine.

Before taking this medicine

To make sure Dacogen is safe for you, tell your doctor if you have ever had:

• kidney disease; or

• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

Decitabine can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Dacogen if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Dacogen.

Decitabine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because decitabine can harm an unborn baby.

You should not breastfeed while using Dacogen and for at least 2 weeks after your last dose.

Dacogen is given as an infusion into a vein. A healthcare provider will give you this injection.

In most cases, a Dacogen injection is given every 8 hours for 3 days. This 3-day treatment is usually repeated every 6 weeks at least 4 times.

You may be given other medications to prevent nausea or vomiting while you are receiving Dacogen.

Decitabine affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Usual Adult Dose for Myelodysplastic Syndrome:

TREATMENT REGIMEN OPTION 1:
15 mg/m2 IV over 3 hours; repeat every 8 hours for 3 days; repeat this cycle every 6 weeks; patients may be premedicated with standard antiemetic therapy

If hematologic recovery (ANC 1,000/mcL or greater and platelets 50,000/mcL or greater) from a previous treatment cycle requires more than 6 weeks, then the next cycle should be delayed and dosing temporarily reduced by following this algorithm:
-Recovery requiring more than 6, but less than 8 weeks: Delay dosing for up to 2 weeks and temporarily reduce the dose to 11 mg/m2 IV every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) when restarting therapy
-Recovery requiring more than 8, but less than 10 weeks: Assess patient for disease progression (by bone marrow aspirates); in the absence of progression, the dose should be delayed up to 2 more weeks and then reduced to 11 mg/m2 IV every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) when restarting therapy, then maintained or increased in subsequent cycles as clinically indicated

TREATMENT REGIMEN OPTION 2:
20 mg/m2 IV over 1 hour; repeat daily for 5 days; repeat this cycle every 4 weeks; patients may be premedicated with standard antiemetic therapy

If myelosuppression is present, subsequent treatment cycles should be delayed until there is hematologic recovery (ANC 1,000/mcL or greater and platelets 50,000/mcL or greater)

Comments:
-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.
-Perform complete blood and platelet counts prior to each cycle and as needed to monitor response and toxicity.
-Perform liver chemistries and serum creatinine prior to initiation of therapy.

Use: For the treatment of myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of 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

To make sure Dacogen is safe for you, tell your doctor if you have ever had:

• kidney disease; or

• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

Decitabine can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Dacogen if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Dacogen.

Decitabine may affect fertility (ability to have children) in men. However, it is important to use birth control to prevent pregnancy because decitabine can harm an unborn baby.

You should not breastfeed while using Dacogen and for at least 2 weeks after your last dose.

Call your doctor for instructions if you miss an appointment for your Dacogen injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Get emergency medical help if you have signs of an allergic reaction to Dacogen: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fever, chills, sore throat;

• mouth sores, red or swollen gums, skin sores;

• easy bruising, unusual bleeding, purple or red spots under your skin;

• pale skin, cold hands and feet; or

• cough with mucus, chest pain, feeling short of breath.

Common Dacogen side effects include:

• fever or other signs of infection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with decitabine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.