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.
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 firstname.lastname@example.org.
If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at
or call 1-800-FDA-1088.
Please see full Prescribing Information for Makena.
1. Long-term health effects of premature birth. March of Dimes website.
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.
Published November 2016. Accessed January 12, 2018.
4. Why at least 39 weeks is best for your baby. March of Dimes website.
Last reviewed September 2013. Accessed February 21, 2018.
5. Preterm labor and premature birth. March of Dimes website.
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.
©2018 AMAG Pharmaceuticals, Inc. All rights reserved. AMAG Pharmaceuticals, Makena,
Makena Care Connection, and the logo design represented in this material are
registered trademarks of AMAG Pharmaceuticals, Inc. PP-MKN-US-00392 02/18