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.
Do not use Makena in women with any of the following conditions:
- Current or history of thrombosis or thromboembolic disorders
- Known or suspected breast cancer, other hormone-sensitive cancer or history of these conditions
- Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
- Cholestatic jaundice of pregnancy
- Liver tumors, benign or malignant, or active liver disease
- Uncontrolled hypertension
- Makena should be discontinued if thrombosis or thromboembolism occurs
- Allergic reactions, including urticaria, pruritus and angioedema, have been reported with use of Makena or with other products containing castor oil
- Women receiving Makena should be monitored if they:
- Are prediabetic or diabetic
- Have conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction
- Have a history of clinical depression; Makena should be discontinued if depression recurs
- Develop jaundice; consider whether benefit of use warrants continuation
- Develop hypertension
Certain pregnancy-related fetal and maternal complications or events were numerically increased in
Makena-treated subjects as compared to placebo subjects, including miscarriage (2.4% vs. 0%) and
stillbirth (2% vs. 1.3%), admission for preterm labor (16% vs. 13.8%), preeclampsia or gestational
hypertension (8.8% vs. 4.6%), gestational diabetes (5.6% vs. 4.6%), and oligohydramnios (3.6% vs. 1.3%)
In a study where the Makena intramuscular injection was compared with placebo, the most
common adverse reactions reported with Makena intramuscular injection (reported incidence in
≥2% of subjects and higher than in the control group) were: injection site reactions (pain [35%],
swelling [17%], pruritus [6%], nodule [5%]), urticaria (12%), pruritus (8%), nausea (6%), and diarrhea (2%)
In studies where the Makena subcutaneous injection using auto-injector was compared with
Makena intramuscular injection, the most common adverse reaction reported with Makena
Auto-Injector use (and higher than with Makena intramuscular injection) was injection
site pain (10% in one study and 34% in another)
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. Makena® (hydroxyprogesterone caproate injection) prescribing information,
AMAG Pharmaceuticals, 2018.
2. Society for Maternal-Fetal Medicine Publications Committee. Progesterone and preterm birth prevention:
translating clinical trials data into clinical practice. Am J Obstet Gynecol. 2012;206(5):376-386.
3. Society for Maternal-Fetal Medicine Publications Committee. The choice of progestogen for
the prevention of preterm birth in women with singleton pregnancy and prior preterm birth.
Am J Obstet Gynecol. 2017;216(3):B11-B13.
4. Northen AT, Norman GS, Anderson K. et al; Follow-up of children exposed in utero to
17 α-hydroxyprogesterone caproate compared with placebo. Obstet Gynecol. 2007;110(4):865-872.
5. American Medical Association. Current Procedural Terminology 2017: Professional Edition.
Chicago, IL: American Medical Association; 2016.
6. American Medical Association. ICD-10-CM: The Complete Official Codebook.
2017 ed. Chicago, IL: American Medical Association; 2016.
7. Practice Management Information Corporation. HCPCS: Health Care Procedure Coding System.
Los Angeles, CA: Practice Management Information Corporation; 2016.
8. Centers for Medicare and Medicaid Services. US Department of Health and Human Services.
Quarterly healthcare common procedure coding system (HCPCS) drug/biological code changes—2017 update.
Baltimore, MD: Centers for Medicare and Medicaid Services; 2017. Transmittal 3776.
©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-00389 02/18