Makena® (hydroxyprogesterone caproate injection) for preterm birth

Meet Sarah. Hear about the personalized support Makena Care Connection® offered to Sarah.

Meet Sarah. Hear about the personalized support offered to Sarah.

Sarah gave birth to her first son, David, 6 weeks early (34 weeks). After speaking with her doctor, Sarah chose Makena® (hydroxyprogesterone caproate injection) to help reduce her risk of another singleton preterm birth—and Makena Care Connection® to help ensure her medication was continually available and affordable.

Hear Shanise's story

Meet Shanise. Makena Care Connection® helped Shanise with the adherence support she needed. Hear her story.

Meet Shanise. Makena Care Connection® helped Shanise with the adherence support she needed. Hear her story.

Shanise tragically lost her first son, Prince Xavier, when he was born 18 weeks early. When she got pregnant again, her doctor recommended Makena® (hydroxyprogesterone caproate injection) because she was at risk for another singleton preterm birth. Hear how Makena Care Connection supported Shanise so she could focus on her goal of a full-term pregnancy without worrying about medication costs.

Makena Patient Assistance video

Hear how Deb, a nurse practitioner, helped ensure affordable access to treatment for her uninsured patient.

Makena Care Connection® offers personalized support

When Deb, a nurse practitioner, was caring for an uninsured patient who was eligible for Makena, she connected her to Makena Care Connection to ensure affordable access to treatment.

Makena patient video

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

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 with a single baby 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
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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