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.

Important safety information for Makena

• Makena should not be used 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.

Reference: 1. Makena™ (hydroxyprogesterone caproate injection) prescribing information, Ther-Rx Corporation, 2011.