Access to MakenaTM

Makena (hydroxyprogesterone caproate injection) fulfills a critical and previously unmet medical need for healthcare providers and high risk moms. The absence of a commercially-available, FDA-approved product means women who could benefit from therapy faced potential barriers to access.

Makena is the first treatment that offers healthcare providers and eligible moms the assurance of knowing that they are prescribing a product that has been rigorously reviewed for safety and efficacy, manufactured in a facility that is compliant with FDA regulations, and is consistent from dose to dose.1

Ther-Rx recognizes the importance of addressing treatment barriers. Ther-Rx established the Makena Care Connection to help facilitate the process of prescribing and obtaining Makena for healthcare providers and patients. The Makena Care Connection is actively processing prescriptions for Makena, and is facilitating access to the patient assistance program for patients who need financial support.

Click here to learn more about our commitment to affordable patient access, product quality and patient safety and ongoing support.

Frequently Asked Questions About FDA-Approved Makena

Access to Makena

What concerns did healthcare providers have about unapproved progesterone formulations before Makena (hydroxyprogesterone caproate injection) became available?

What is the company doing to ensure women have access to Makena now that it is available?

Patient Support Services

Who is eligible for the Makena Patient Financial Assistance Program?

What is the Makena Care ConnectionTM?

Clinical Study of Makena

The FDA based its approval of Makena in part on a study conducted by the National Institute of Child Health and Human Development (NICHD) Maternal Fetal Medicine Units Network. Did the NICHD study use compounded 17P?

Is KV investing in any other clinical studies to learn more about Makena?

About Compounded Medications

What is the difference between FDA-approved medications and compounded drugs?

What is the difference between compounded medications and generic medications?

What is the difference between FDA-approved Makena and compounded 17P?

Visit for additional information regarding Makena.

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 for preterm birth.

Important Safety Information
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%).

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