Considerations for the Use of Long-Acting and Extended-Release Agents During Pregnancy and Lactation

Long-acting agents hold significant promise for treating and preventing common illnesses, including infections. Pharmacokinetic and safety data during pregnancy and lactation are often unavailable for new drugs; these data are vital to facilitate optimal drug use by pregnant and lactating women and women who may conceive. In this commentary, we summarize the circumstances in which pregnant and lactating women are likely to use and benefit from long-acting agents. We focus on long-acting formulations of small molecules (rather than biologics such as monoclonal antibodies) and on several infections of global importance (human immunodeficiency virus, tuberculosis, malaria, and hepatitis C). We discuss pregnancy pharmacokinetic/pharmacodynamic and potential safety and efficacy considerations pertaining to the use of long-acting agents in pregnancy and lactation. Finally, we summarize existing preclinical and pregnancy pharmacokinetic data that are available (or expected in the near future) for several agents that are under development or approved, and how key research gaps may be addressed.

Automated summary

Long-acting agents show great potential in treating and preventing common illnesses, but there is a lack of pharmacokinetic and safety data for pregnant and lactating women. This commentary provides an overview of the circumstances in which these women are likely to use and benefit from long-acting agents, focusing on small molecule formulations and important global infections. It discusses the pharmacokinetic/pharmacodynamic considerations, as well as the potential safety and efficacy, of using long-acting agents during pregnancy and lactation. The commentary also summarizes available and anticipated pregnancy pharmacokinetic data for several agents under development or approved, and suggests ways to address research gaps.