Problem Identification: Subcutaneous (SC) formulations for monoclonal antibodies (mAbs) must be evaluated for efficacy and safety in comparison with preexisting IV formulations to identify potential benefits and risks.
Literature Search: This is a systematic review of clinical trials. MEDLINE®/PubMed, EMBASE, Cochrane Library, LILACS (Latin American and Caribbean Health Sciences Literature), and reference lists were searched for relevant studies.
Data Evaluation: Data regarding efficacy and safety were registered in a form designed for this review. Risk of bias was assessed using the Jadad scale.
Synthesis: SC administration of alemtuzumab, trastuzumab, and rituximab presented therapeutic efficacy with similar safety profiles compared to their respective IV formulations, except for the higher prevalence of local adverse events following SC administration.
Implications for Practice: SC mAbs require slow administration (no less than five minutes), and the injection site should be changed at each cycle. Patient guidelines should include information about expected adverse effects, signs or symptoms of side effects requiring emergency care, and how to reduce potential discomfort caused by the injection.