Decitabine

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.

• 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 the extra caution in patients with renal and hepatic impairment.

Care should be exercised in the handling of MYLODEC. MYLODEC injections should not be opened or broken. Store vials at 25°C (77°F); excursions permitted to 15 to 30°C (59­-86°F).

Drug interaction findings along with decitabine have not been conducted. In vitro findings in human liver microsomes suggest that decitabine is unlikely to inhibit or induce the cytochrome P450 enzymes. In vitro metabolism findings have suggested that decitabine is not a substrate for human liver cytochrome P450 enzymes. As plasma protein binding of decitabine is negligible (<1 percent), interactions due to displacement of more highly protein bound drugs from plasma proteins are not expected.