FOR YOUR PATIENTS AT RISK FOR ANOTHER
SINGLETON SPONTANEOUS PRETERM BIRTH (<37 WEEKS)

• 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 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 full Prescribing Information for Makena.

References: 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.