Help Reduce the Risk of Preterm Birth with Makena™ (hydroxyprogesterone caproate injection)

Give your patients the first and only FDA-approved therapy demonstrated to reduce the risk of preterm birth for women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.¹

Makena is 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 of preterm birth

Makena is classified Pregnancy Category B¹. Studies in pregnant women have shown that Makena does not increase the risk of abnormalities when administered during the second and third trimesters of pregnancy

–	There are no adequate and well-controlled studies of Makena use in women during the first trimester of pregnancy

A follow-up study assessed children at a mean of 4 years (ages 2-5 years) using the Ages & Stages Questionnaire, which evaluates child development by various physical, mental, and social measures²

–	The proportion of children whose scores met the screening threshold for developmental delay in each developmental domain was similar for each treatment group

Once-weekly intramuscular injection by a healthcare provider¹

Click here to learn more about the benefits of FDA-approved Makena

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.

References: 1. Makena™ (hydroxyprogesterone caproate injection) prescribing information, Ther-Rx Corporation, 2011. 2. Northen AT, Norman GS, Anderson K, et al. Follow-up of children exposed in utero to 17 α-hydroxyprogesterone caproate compared with placebo. Obstet Gynecol. 2007;110:865-872.