AMAG has completed enrollment for PROLONG (Progestin’s Role in Optimizing Neonatal Gestation), an international clinical trial of Makena to reduce the risk of recurrent preterm birth in its indicated population.
The trial is designed to be sufficient size (more than 1,700 women) to detect outcome differences in neonatal morbidity and mortality. The data collected through PROLONG is expected to provide a platform for secondary analysis. A detailed description of the clinical trial is available on ClinicalTrials.gov.
Makena® (hydroxyprogesterone caproate injection)
Makena helps reduce the risk of preterm birth in the indicated patient population.
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® (hydroxyprogesterone caproate injection)
- Do not use Makena (hydroxyprogesterone caproate injection) 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
- 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)