Healthcare provider discussion guide

When talking about pregnancy with your healthcare provider, you want to make sure to get the most out of your visit. Here are some questions to help start a conversation about your prior preterm birth experience.

Select the questions you would like to discuss. Click “Print my guide,” then bring the questions to your next appointment.

While there are many causes for preterm birth, the safety and benefits of Makena have been demonstrated only in women who’ve unexpectedly delivered their baby prior to 37 weeks of pregnancy. It’s not meant for use in women with multiple gestations or other risk factors for preterm birth.

If you think you are at risk for a preterm birth due to a history of preterm birth, ask if FDA-approved Makena may be right for you.

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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 Prescribing Information for Makena.

Important Safety Information and Indication
INDICATION
IMPORTANT SAFETY INFORMATION
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If you are enrolled in the Makena Care Connection or My Adherence Program, please note that our contact information has changed. If you have questions or would like to get in touch, please contact us at 1-800-847-3418, or write to us at info@makenacareconnection.com.