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Important Safety Information for Makena (hydroxyprogesterone caproate injection)

Makena should not be used in women with any of the

Indication

Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of

Understanding Preterm Birth

What is preterm birth?

In the United States, approximately 1 in 10 babies is born prematurely each year.

But how early is too early?

The goal of a healthy pregnancy is to deliver full term (39 to 40 weeks) to give your baby the time needed to grow and develop.2 For example, your baby’s brain and lungs are still developing during the last weeks of pregnancy.1

Preterm birth is when a baby arrives too early; that’s before 37 weeks of pregnancy, or 3 weeks prior to the baby’s due date.3 Preterm birth can be unexpected or unplanned. Sometimes, a baby needs to be delivered earlier than normal in certain medical situations.4

Preterm birth can happen to any pregnant woman and, in most cases, healthcare providers don’t fully understand what actually causes preterm birth. But moms who have delivered a baby too early (before 37 weeks)—regardless of the number of weeks early they’ve delivered—in the past are at a higher risk for having another preterm birth.5,6

Lyn talks about her experience with preterm birth

Meet Lyn, mom of a 36-week preemie. Because she delivered her son early, she was at risk for another preterm birth. Hear her story.

Watch Lyn’s story (7:41)

Are you aware of the potential risk factors for preterm birth?

Watch video about risk factors for preterm birth

Understand the risk factors for preterm birth. Kate, mom of a 35-week preemie, and her healthcare provider discuss her risk for another preterm birth and how she can reduce her risk for another preterm delivery.

Watch a video on risk factors (6:55)

Talk with your healthcare provider if you are pregnant or planning to get pregnant in the future.

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.

Common risk for preterm birth (check all that apply to you)5:

When you are done, you will get a customized discussion guide to help you talk with your healthcare provider. Depending on your risk factor(s), Makena may or may not be right for you.

You have checked one or more risk factors.
Get your personalized discussion guide below.

Print Discussion Guide Email Discussion Guide

When you are done, you will get a customized discussion guide to help you talk with your healthcare provider. Depending on your risk factor(s), Makena may or may not be right for you.

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.

Indication

Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.

Indication

Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or 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.

References: 1. Long-term health effects of premature birth. March of Dimes website. https://www.marchofdimes.org/baby/long-term-health-effects-of-premature-birth.aspx. Last reviewed October 2013. Accessed January 12, 2018. 2. American College of Obstetricians and Gynecologists Committee on Obstetric Practice, Society for Maternal-Fetal Medicine. Committee opinion no. 579: Definition of term pregnancy. Obstet Gynecol. 2013;122(5):1139-1140. 3. Preterm (premature) labor and birth. American College of Obstetricians and Gynecologists website. FAQ087. https://www.acog.org/Patients/FAQs/Preterm-Premature-Labor-and-Birth. Published November 2016. Accessed January 12, 2018. 4. Why at least 39 weeks is best for your baby. March of Dimes website. https://www.marchofdimes.org/pregnancy/why-at-least-39-weeks-is-best-for-your-baby.aspx. Last reviewed September 2013. Accessed February 21, 2018. 5. Preterm labor and premature birth. March of Dimes website. https://www.marchofdimes.org/pregnancy/preterm-labor-and-premature-birth.aspx. Last reviewed October 2014. Accessed January 12, 2018. 6. Makena® (hydroxyprogesterone caproate injection) prescribing information. AMAG Pharmaceuticals, 2018. 7. Northen AT, Norman GS, Anderson K, et al. Follow-up of children exposed in utero to α-hydroxyprogesterone caproate compared with placebo. Obstet Gynecol. 2007;110(4):865-872.

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