Makena® (hydroxyprogesterone caproate injection)

Healthcare provider discussion guide

Share the following risk factors that you've selected with your healthcare provider

Depending on your risk factors, Makena may or may not be appropriate for you.

When talking with your healthcare provider about your pregnancy and concerns about another preterm birth, being prepared may make the conversation easier. The following are some questions you can discuss with your healthcare provider.

Indication

Makena 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. Another study of Makena is going on to see whether Makena improves 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. 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 may report an adverse event related to AMAG Pharmaceuticals' products by calling 1-877-411-2510 or emailing amag@druginfo.com. If you prefer, you may contact the U.S Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information for Makena.


Marketed by AMAG Pharmaceuticals, Inc. Waltham, MA 02451 ©2018 AMAG Pharmaceuticals, Inc. All rights reserved.
AMAG Pharmaceuticals and Makena are registered trademarks of AMAG Pharmaceuticals, Inc. PP-MKN-US-00392 02/18