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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

IF YOU HAVE HAD A SINGLETON SPONTANEOUS PRETERM BIRTH (BEFORE 37 WEEKS),
YOU ARE AT RISK FOR ANOTHER PRETERM DELIVERY

IF YOU HAVE HAD A SINGLETON SPONTANEOUS PRETERM BIRTH (BEFORE 37 WEEKS), YOU ARE AT RISK FOR ANOTHER PRETERM DELIVERY

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Makena auto-injector device

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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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