Decitabine

Decitabine is a prescription medication used for the treatment of myelodysplastic syndromes. 

• Decitabine is available under various brand names: Dacogen

Common side effects of Decitabine include:

• fever, and
• other signs of infection

Serious side effects of Decitabine include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• chills,
• sore throat,
• mouth sores,
• red or swollen gums,
• skin sores,
• easy bruising,
• unusual bleeding,
• purple or red spots under the skin,
• pale skin,
• cold hands and feet,
• cough with mucus,
• chest pain, and
• shortness of breath

Rare side effects of Decitabine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Powder for injection

• 50 mg/vial

Myelodysplastic Syndromes

Adult dosage

• 3-day regimen: 15 mg/m² IV infusion over 3 hr repeated every 8 hours for 3 days; repeat every 6 weeks; repeat cycles every 6 weeks upon hematologic recovery (ANC at least 1,000/μL and platelets at least 50,000/μL) for a minimum of 4 cycles; a complete or partial response may take longer than 4 cycles; delay and reduce dose for hematologic toxicity  
• 5-day regimen: 20 mg/m² IV infusion over 1 hr every day for 5 days, repeat cycle every 4 weeks upon hematologic recovery (ANC at least 1,000/μL and platelets at least 50,000/μL) for a minimum of 4 cycles; a complete or partial response may take longer than 4 cycles

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Decitabine has severe interactions with no other drugs.
• Decitabine has serious interactions with the following drugs:
  • palifermin
  • ropeginterferon alfa 2b
• Decitabine has moderate interactions with the following drugs:
  • acalabrutinib
  • cholera vaccine
  • dengue vaccine
  • dichlorphenamide
  • ethotoin
  • fingolimod
  • hydroxyurea
  • ponesimod
  • siponimod
  • sipuleucel-T
• Decitabine has minor interactions with the following drugs:
  • maitake
  • taurine
  • vitamin A
  • vitamin E

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Decitabine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Decitabine?”

Cautions

• Use caution in renal/hepatic impairment
• Fatal and serious myelosuppression occurs in treated patients; myelosuppression (anemia, neutropenia, and thrombocytopenia) is the most frequent cause of dose reduction, delay, and discontinuation; manage toxicity using dose delay, dose-reduction, growth factors, and anti-infective therapies as needed; myelosuppression and worsening neutropenia may occur more frequently in first or second treatment cycles, and may not necessarily indicate progression of underlying MDS
• Therapy can cause fetal harm when administered to a pregnant woman; based on the mechanism of action, the drug alters DNA synthesis and is expected to result in adverse reproductive effects; advise men with female partners of childbearing potential to avoid fathering a child while receiving treatment and for 3 months following the last dose; counsel patients of childbearing potential to use effective contraception during this time
• Bone marrow suppression may occur (dose limiting); dose adjustment may be necessary

Pregnancy & Lactation

• Based on findings from human data, animal studies, and the mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; limited published data on use throughout the first trimester during pregnancy describe adverse developmental outcomes including major birth defects (structural abnormalities); advise pregnant women of the potential risk to the fetus
• Based on findings of decitabine in animals, male fertility may be compromised by treatment; the reversibility of effect on fertility is unknown
• Conduct pregnancy testing of females of reproductive potential prior to initiating treatment
• Advise females of reproductive potential to avoid pregnancy and use effective contraception while receiving therapy and for 6 months following the last dose
• Advise males with female partners of reproductive potential to use effective contraception while receiving treatment and for 3 months following the last dose
• Lactation
  • There are no data on the presence of drugs or metabolites in human milk, their effects on the breastfed child, or on milk production; because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in a nursing child, advise lactating women to avoid breastfeeding during treatment and for at least 1 week after the last dose.