AMAG Pharmaceuticals is committed to being a part of the solution for reducing the rate of preterm birth

AMAG Pharmaceuticals continues to support healthcare providers and patient advocacy organizations invested in the fight against prematurity. AMAG Pharmaceuticals is dedicated to playing an active role in helping reduce the preterm birth rate through collaboration with healthcare providers to advance patient care, ongoing research and development, and partnering in community educational initiatives.

Makena Care Connection logo

With Makena Care Connection®, you get more than Makena® (hydroxyprogesterone caproate). You’ll get personalized support specifically designed to help you throughout your experience with Makena, including:

  • Administration of weekly injections in your home by a trained healthcare provider, if approved by your insurance plan. Learn more
  • Free educational and adherence support to encourage you to keep Makena part of your pregnancy and take an active role in your health. Learn more
  • Financial assistance to help eligible patients get affordable access to Makena. Learn more

A downloadable PDF is available to help you understand how Makena Care Connection provides an extra layer of support during your pregnancy.

Miracle Babies provides support and financial assistance to families with critically ill newborns in the Neonatal Intensive Care Unit; and to enhance the well-being of women, children and their families through education, prevention and medical care. To learn more, visit www.miraclebabies.org.

Sidelines Laguna Beach, CA

AMAG Pharmaceuticals is a proud corporate partner of Sidelines. Our partnership helps advance the mission of Sidelines of providing support for women and their families experiencing complicated pregnancies and premature births. To learn more about how Sidelines can support your high-risk patients, please visit www.sidelines.org.

Makena patient Amber and her family
Indication

Makena (hydroxyprogesterone caproate injection) 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)
  • 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%)
  • The most common adverse reactions reported in ≥2% of subjects and at a higher rate in the Makena group than in the control group were injection site reactions (pain [35% vs. 33%], swelling [17% vs. 8%], pruritus [6% vs. 3%], and nodule [5% vs. 2%]), urticaria (12% vs. 11%), pruritus (8% vs. 6%), nausea (6% vs. 5%), and diarrhea (2% vs. 1%)

Please see full Prescribing Information for Makena.

Important Safety Information and Indication
INDICATION
IMPORTANT SAFETY INFORMATION
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