Makena® (hydroxyprogesterone caproate injection) for preterm birth
Dr. Gandell video on preterm birth

Dr. David Gandell,
discusses preterm birth, its risk factors, and treatment with Makena.

Have you delivered preterm (before 37 weeks) in the past? Listen to an obstetrician to learn more

Dr. Gandell, a practicing obstetrician for 31 years, explains preterm birth, its risk factors, and how Makena® (hydroxyprogesterone caproate injection) may be able to help reduce the risk of recurrent preterm birth.

Makena Patient Assistance video

Do you have patients who are
uninsured? Learn more about
the Patient Assistance Program
that provides eligible moms
Makena free of charge.

Makena Patient Assistance Program for eligible uninsured patients

Eligible uninsured women can reduce their out-of-pocket cost for Makena® (hydroxyprogesterone caproate injection). Learn more about the commitment of AMAG Pharmaceuticals to affordable access to therapy.

Makena patient video

When Kate learned she was at risk
for another preterm birth, she made
a decision with her doctor to start
Makena. Hear her story.

After speaking with her doctor, Kate made a decision to start Makena® (hydroxyprogesterone caproate injection) because she was at risk for another preterm birth. Hear her story.

Kate gave birth to her son, Gabriel, 5 weeks early (35 weeks). When she became pregnant again a year later, she learned she was at risk for another preterm birth and discussed Makena with her healthcare provider.

For your patients who are at risk for another preterm birth (<37 weeks), EVERY WEEK COUNTS

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