API- Decitabine

Packaging- Single-Use Vial

Strength- 50mg

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Decitabine is a nucleoside metabolic inhibitor indicated in order to treat patients with myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML).

Dosage and Side Effects

The recommended dose should be administered as an injection into the vein under the supervision of a healthcare practitioner. Your healthcare practitioner will determine what dose is appropriate and how often you need to receive it.

Most common adverse reactions include cough, fatigue, neutropenia, hyperglycemia, thrombocytopenia, nausea, anemia, pyrexia, petechiae, constipation, and diarrhea.

Warning and Precautions

  • Liver chemistries and serum creatinine needs to be obtained before initiation of decitabine 50 mg treatment.
  • Platelet counts and complete blood counts should be performed as required in order to monitor response as well as toxicity, but at a minimum, before each cycle.
  • Women of the childbearing potential should be apprised to avoid becoming pregnant while taking treatment with decitabine 50 mg.
  • Male patients should be apprised not to father a child during treatment with this medication, and for 2-months after finishing the treatment.
  • Following administration of the recommended decitabine dosage for the 1st cycle, treatment for the subsequent cycles need to be adjusted.
  • Myelosuppression and worsening neutropenia may occur a bit frequently in the 1st or 2nd treatment cycles, and may not necessarily show progression of the underlying MDS.
  • Mylodec always should be used with extra caution in patients with renal and hepatic impairment.


Is Decitabine an FDA-approved drug?

The FDA approved the drug Decitabine in 2006.

What are the alternate brands of Decitabine Injection?

  • Xalibo Injection (Dr Reddy’S Laboratories Ltd)
  • Decitex 50mg Injection (Sun Pharmaceutical Industries Ltd)
  • Natdecita 50mg Injection (Natco Pharma Ltd)
  • Decitas 50mg Injection (Intas Pharmaceuticals Ltd)
  • Deczuba 50mg Injection (Glenmark Pharmaceuticals Ltd)
  • Dacogen 50mg Injection (Johnson & Johnson Pvt Ltd)

How does Decitabine work?

As a hypomethylating agent, decitabine works in order to switch off a protein named DNA methyltransferase. This switches on the genes that block the cancerous cells from growing as well as dividing.

From which class of drug Decitabine belongs?

Decitabine belongs to a class of drugs known as DNA demethylating agents.

What are the ingredients of the medicine Decitabine?

The active ingredient in the medicine is Decitabine, and the inactive ingredients are monobasic potassium phosphate (potassium dihydrogen phosphate) and sodium hydroxide.

What are commonly reported side effects of decitabine?

Nausea, fever, vomiting, diarrhea, headache, and lung infection.