Have you delivered preterm (before 37 weeks) in the past? Listen to an obstetrician to learn more.

Have you delivered preterm (before 37 weeks) in the past? Listen to an obstetrician to learn more

Dr. Gandell, a practicing obstetrician for 31 years, explains preterm birth, its risk factors, and how Makena may be able to help reduce the risk of recurrent perterm birth.

Meet Kate. Her previous preterm birth put her at risk for another one. Hear her story.

After consultation with her doctor, Kate made a decision to start Makena because she was at risk for another preterm birth. Hear her story

Kate gave birth to her son, Gabriel, 5 weeks early (35 weeks). When she became pregnant again a year later, she learned she was at risk for another preterm birth and discussed treatment to help.

Kate and her healthcare provider discuss how she can reduce her risk for another preterm delivery.

Kate and her healthcare provider discuss her risk for another preterm birth and how she can reduce her risk for another preterm delivery

Once Kate found out she was pregnant again, she scheduled an appointment with her doctor to discuss her risk for another preterm birth and how Makena may help reduce her risk.

Indication

Makena (hydroxyprogesterone caproate injection) is a prescription hormone medicine (progestin) used to lower the risk of preterm birth in women who are pregnant with one baby and who have delivered one baby too early (preterm) in the past. Makena was shown to work based on a lower number of women who delivered babies at less than 37 weeks of pregnancy. There are no studies showing 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.

Important safety information for Makena (hydroxyprogesterone caproate injection)

Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to your current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure.

Before you receive Makena, tell your healthcare provider if you have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.

In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in your urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).

Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of your skin and the whites of your eyes. Call your healthcare provider right away if you think you have symptoms of a blood clot (leg swelling, redness in your leg, a spot on your leg that is warm to touch, or leg pain that worsens when you bend your foot) or symptoms of an allergic reaction (hives, itching, or swelling of the face). The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Makena prescribing information.

Important safety information and Indication
INDICATION
IMPORTANT SAFETY INFORMATION