Subcutaneous Injection of Azacitidine for the Treatment of Acute Myeloid Leukemia

Key Messages

• Evidence from 1 randomized controlled trial suggests that subcutaneous azacitidine prolongs disease-free survival among patients with acute myeloid leukemia who have achieved complete remission and who are ineligible for stem cell transplant.
• The oral and subcutaneous formulations are different pharmacokinetically. The studied regimens are also very different in the dose and treatment duration per cycle. The approved oral regimen is 300 mg once daily for 14 days per 28-day cycle, whereas the studied subcutaneous dose is 50 mg/m2 per day for 5 days per 28-day cycle.
• Given that there is no direct head-to-head comparison between the oral and subcutaneous formulations of azacitidine, there is insufficient evidence to extrapolate conclusions about the clinical effectiveness of oral formulation to the subcutaneous formulation of azacitidine as a maintenance therapy for acute myeloid leukemia.
• For the subcutaneous administration of azacitidine, there are potentially additional health care costs associated with handling hazardous medications and the need for trained personnel for administration. More research is needed to inform decision-making in the context of routes of administration.