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.

Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to your current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure.

Before you receive Makena, tell your healthcare provider if you have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.

In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in your urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).

Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of your skin and the whites of your eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.

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.

Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to your current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure.

Before you receive Makena, tell your healthcare provider if you have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.

In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in your urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).

Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of your skin and the whites of your eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.

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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Makena Care Connection®

How does Makena Care Connection provide moms with personalized support?

Makena Care Connection®

Have Questions? Connect with us

mail iconinfo@makenacareconnection.com

phone icon1-800-847-3418 (M-F, 8am-8pm ET)

When you start Makena®, you get more than the medicine. You get personalized resources that are specifically designed to help you throughout your experience with Makena. Think of us as an extra layer of support.

Prescription icon

Prescription support

Helps you get your prescription approved in a timely manner

You’re unique and so are your insurance benefits. Because getting your medicine in a timely manner is important, we’re here to lend a hand. We have a dedicated team who understands the coverage policies for Makena. Our experts can handle the details between your healthcare provider, insurance company, and pharmacy so you receive your Makena when you need it.

Watch Sarah talk about the Makena Care Connection® personalized support

“Having the personalized support from the Makena Care Connection helped me feel like I had someone there to support me throughout my experience.” —Sarah, mom of a 34-week preemie

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Watch Sarah’s story (6:25)
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Education & adherence

Support that helps keep you on track with weekly injections

We understand that moms receiving Makena injections may need some encouragement and support to stick to their weekly injection schedule, and we want to help. This free service offers educational and adherence support to encourage you to make Makena part of your pregnancy and take an active role in your health.

A level of personalized support you can expect:

  • Injection reminders that support weekly therapy
  • Educational materials to address topics during pregnancy
  • Encouragement so you can take an active role in your health
Watch how Shanise was assisted every step of the way

“The Makena Care Connection called me weekly to check in. I felt they were there with me every step of the way.”—Shanise, mom of a 22-week preemie

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See how Shanise was assisted every step of the way (6:27)
Financial assistance icon

Financial assistance

Helps ensure affordable access to Makena

We believe that you should be able to focus on your pregnancy more than the cost of your medication. To support that, AMAG Pharmaceuticals is committed to making sure that Makena-eligible moms have affordable access to Makena. We offer eligible patients* financial assistance.

For commercially insured moms whose health plans cover Makena:
We help lower out-of-pocket costs associated with copays, coinsurance, and deductibles*

For uninsured and commercially underinsured moms:
We offer a free course of therapy*

Watch Nalleli's financial assistance story through Makena Care Connection®

“I was so happy that I was approved for financial assistance. I feel very thankful that my family and I had this opportunity with the Makena Care Connection.”—Nalleli, mom of a 36-week preemie

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See Nalleli's story (6:50)

*Each patient's eligibility is evaluated on an individual basis. To be eligible, patients must meet the FDA-approved indication (pregnant with a single baby, with a history of singleton spontaneous preterm birth <37 weeks).6 In compliance with federal regulations, patients insured by a government-funded program (Medicaid, TRICARE, etc) are not eligible. There are no upper-level income caps.

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Home injections by healthcare professionals

Provides injection administration in the comfort of your home

We can help coordinate Makena injections through a home healthcare organization. Once you’re approved by insurance, you can choose to receive your injections by a healthcare professional in the comfort of your home or another location that’s convenient for you.

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