The U.S. Food and Drug Administration has

approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.

The drug is not intended for use in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for preterm birth.

Makena Patient Information

Read this Patient Information Leaflet before you receive Makena. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is Makena?

Makena is a prescription hormone medicine (progestin) used in women who are pregnant and who have delivered a baby too early (preterm) in the past.

Makena is used in these women to help lower the risk of having a preterm baby again.

Makena is for women who:

• Are pregnant with one baby

• Have had a preterm delivery of one baby in the past

How well does Makena work?

Makena was studied in women who were at risk for having a preterm baby because they had previously given birth to a preterm baby. In the main study, about 37 of 100 women who received Makena gave birth preterm (before 37 weeks of pregnancy), compared to about 55 of 100 women who did not receive Makena. Another study of Makena is going on to see whether Makena reduces the number of babies who have serious problems shortly after birth or who die.

It is not known whether Makena is safe and effective in women who have other risk factors for preterm birth.

It is not known whether Makena is safe and effective in women less than 16 years old.

Makena is not intended for use to stop active preterm labor.