Dacogen

Dacogen is a prescription medication used to treat myelodysplastic syndrome. This is a group of conditions in which the bone marrow makes blood cells that are misshapen. The bone marrow cannot produce enough healthy blood cells. Dacogen belongs to a group of drugs called hypomethylation agents. These work by helping the bone marrow produce normal blood cells. It also works by killing abnormal cells in the bone marrow.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects include lowered blood cell counts, tiredness, fever, and nausea.

Dacogen is a prescription medication used to treat myelodysplastic syndrome. This is a group of conditions in which the bone marrow makes blood cells that are misshapen. The bone marrow cannot produce enough healthy blood cells.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

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Common side effects include the following:

• tiredness
• fever
• nausea
• cough
• petechiae (red dots on your skin)
• constipation
• diarrhea
• high blood sugar

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No Dacogen drug interactions have been identified. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Dacogen including the following:

• low platelet count (thrombocytopenia). Tell your doctor right away if you have any unusual bleeding, such as nosebleeds, or bruising under your skin.
• low white blood cell count (neutropenia). A low white blood cell count can cause you to get infections, which may be serious. Serious illness or death can happen if an infection is not treated right away when white blood cell counts are very low. Tell your doctor right away if you have any of the following signs or symptoms of an infection:
  • fever
  • shortness of breath
  • pain or burning during urination
  • chills
  • cough
• low red blood cell count (anemia). Tell your doctor if you have any of these symptoms of anemia during treatment with Dacogen:
  • feeling weak, tired, or you get tired easily
  • you look pale
  • you feel short of breath

It is recommended to avoid pregnancy while receiving treatment with Dacogen and for I month afterward and to use effective contraception during this time.

It is recommended for men not to father a child while receiving treatment with Dacogen, and for 2 months afterward. During these times, men with female partners of childbearing potential should use effective contraception.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Dacogen, there are no specific foods that you must exclude from your diet.

Before receiving a dose of Dacogen,

• tell your doctor and pharmacist if you are allergic to Dacogen or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have kidney or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are using Dacogen. You should use birth control to prevent pregnancy in yourself or your partner during your treatment with Dacogen and for 2 months afterwards. Talk to your doctor about birth control methods that will work for you. If you or your partner becomes pregnant while using Dacogen, call your doctor. Dacogen may harm the fetus.
• tell your doctor if you are breastfeeding.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Dacogen may cause harm to an unborn baby.

It is recommended to avoid pregnancy while receiving treatment with Dacogen and for I month afterward and to use effective contraception during this time.

It is recommended for men not to father a child while receiving treatment with Dacogen, and for 2 months afterward. During these times, men with female partners of childbearing potential should use effective contraception.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Dacogen crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Dacogen.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Treatment Regimen - Option 1

• The starting dose of Dacogen is 15 mg/m2 by IV (into the vein) infusion over 3 hours repeated every 8 hours for 3 days. This cycle should be repeated every 6 weeks.
• Dosing and/or duration may be adjusted according to adverse effects that may occur.

Treatment Regimen - Option 2

• The starting dose of Dacogen is 20 mg/m2 by IV (into the vein) infusion over 1 hour repeated daily for 5 days. This cycle should be repeated every 4 weeks.
• Dosing and/or duration may be adjusted according to adverse effects that may occur.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.