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.

  • 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%)
  • 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)

You may report an adverse event related to AMAG Pharmaceuticals' products by calling 1-877-411-2510 or emailing amag@druginfo.com. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088.

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.

  • 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%)
  • 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)

You may report an adverse event related to AMAG Pharmaceuticals' products by calling 1-877-411-2510 or emailing amag@druginfo.com. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088.

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Resources

Resources for healthcare providers

The resource section is designed to provide you with helpful information, such as forms, clinical resources, and videos for both you and your patients, all in one convenient place.

For medical questions about Makena or to report an adverse event or product complaint:

Contact Medical Affairs

Call AMAG1-877-411-2510 (M-F, 9am-5pm ET)

Select a topic below to learn more

Clinical resources

Meis PJ, et al, 2003
Clinical trial that served as the basis for FDA-approval of Makena

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Society for Maternal-Fetal Medicine (SMFM) Clinical Guideline
Outlines the role of progestogens to reduce the risk of preterm birth

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2017 SMFM Statement Choice of Progestogen
Reaffirms the choice of injectable HPC for certain at-risk women

pdf iconView statement

Bioavailability of Makena Subcutaneous Auto-Injector and Makena Intramuscular Injection Study
Clinical study that showed comparable bioavailability between Makena Auto-Injector dosed subcutaneously (1.1 mL; back of upper arm) and Makena dosed IM (1 mL; gluteus maximus) in a single-dose, open-label, randomized, parallel design bioavailability study in 120 healthy post-menopausal women1

pdf iconView study

Patient resources

HCP icon

Healthcare Provider Discussion Guide

An interactive printable discussion guide that can assist patients in their discussion with a healthcare provider about Makena and reducing the risk of preterm birth.

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Download the Makena patient brochure

Makena Patient Education Brochure

A downloadable brochure that provides educational information on preterm birth, risk factors, and how Makena can help reduce the risk of preterm birth.

Prescribing/purchasing/support resources

Makena Prescription Form

Downloadable form used to prescribe Makena. Information may be typed or written and submitted via fax to Makena Care Connection®.

download pdfDownload

Makena Authorization for Release of Personal Health Information Form

The HIPAA release authorization allows Makena Care Connection to communicate with the healthcare provider, insurer, and specialty pharmacy on the patient’s behalf.

If the patient is not present at the time the prescription is completed, she can complete this form separately and the office or the patient can fax it to Makena Care Connection.

Note: this form does not need to be completed if the patient has already signed Step 2 (Patient Authorization) of the Makena Prescription Form.

Patient Information and Coding Worksheet

Download a worksheet designed to help track verified codes and file with the patient’s chart for quick and easy reference.

download pdfDownload

Makena Billing Guide

Download a guide with billing and coding information to be used when completing the CMS 1500 claim form in addition to FAQs about insurance coverage.

download pdfDownload

Makena Returns Policy

Provides details on the AMAG Pharmaceuticals returns policy for Makena.

download pdfDownload

Makena Care Connection Brochure with Patient Information Sheet

A downloadable brochure for your office, describing the personalized support offered by Makena Care Connection, with an informational sheet to share with your patient about Makena Care Connection support services. Includes Rx support, financial assistance, home injections, and education & adherence.

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Videos

The Makena video gallery has resources for healthcare providers and patients, and covers a variety of topics, including risks associated with preterm birth, treatment of Makena for patients who are at-risk for recurrent preterm birth, patient experiences, and more in-depth information about personalized support provided by Makena Care Connection.

Administering Makena subcutaneously (8:57)

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