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Pharmacy and Wellness Review

Article Title

Makena®: A Drug for Reducing the Risk of Preterm Labor

Abstract

Makena®, hydroxyprogesterone caproate, is an intramuscular injection that is U.S. Food and Drug Administration (FDA) approved to reduce the risk of preterm delivery before 37 weeks of pregnancy in pregnant women with a history of spontaneous preterm birth, who are not currently carrying multiple children. One in nine babies born in the United States each year is born prematurely, or before 37 weeks gestation, and mothers who have previously delivered a premature baby are 2.5 times more likely to deliver another baby prematurely. Makena® is administered by a health care professional as a single intramuscular injection to the hip and has a strict window for safe administration. Hydroxyprogesterone caproate has been available as a compounded product for years since the removal of Delalutin® from the market in 2000. The price of Makena® has been a controversial subject since its introduction into the market due to the increase in cost as compared to the compounded injections that have been available in the past.