Downloadable Guides & FAQs

Find resources that provide the support and information you need during your pregnancy to help you get the most from your Makena® (hydroxyprogesterone caproate injection) treatment plan.

Concerned about having another preterm birth?

The Makena patient brochure explains preterm birth, risk factors, how Makena can help reduce the risk of preterm birth, and more.

Makena Patient Education Brochure

Get the conversation started about your risk. View a discussion guide that can help

Watch Heather's video about her Makena experience

Hear why Heather and her healthcare provider chose an FDA-approved product in her fight against recurrent preterm birth

After giving birth to her daughter Astrid 5 weeks early, Heather's doctor told her she was at risk for another preterm birth. Heather and her healthcare provider talked about Makena® (hydroxyprogesterone caproate injection) as a treatment option to help give her second baby a better chance to have more time to develop.

Helpful resources

During pregnancy, every mom has questions or could use some support. Below are resources that contain useful information that could answer your questions.

The Makena Care Connection® is a support program for patients and their healthcare providers that helps ensure patient access to therapy through coordination with pharmacies and financial assistance programs.

To get the prescription process started, the healthcare provider will:

–or–

My Adherence Program is a program designed to help patients stay on track with their Makena treatments. The program includes one-on-one nurse support and educational materials throughout pregnancy.

  • A downloadable PDF is available to help you understand how My Adherence Program provides an extra layer of support during your pregnancy

Expecting mothers can engage in a restorative practice of yoga with everyday household items. View video below.

Watch step-by-step yoga video for expecting mothers

Step-by-step instructional yoga video of restorative poses for expecting mothers.

Stephanie Kinney, a certified yoga instructor, demonstrates a 20 minute sequence of restorative poses for expecting mothers. She shows how you can engage in a restorative practice of yoga with everyday household items. Talk to your healthcare provider before starting any exercise program.

Makena @Home provides women weekly injections of Makena in the comfort of their home (when covered by the patient's insurance). For questions about how Makena is given through Makena @Home, please contact the Makena Care Connection at 1-800-847-3418 or email Makena@sonexushealth.com.

Sidelines provides support for women and their families who are experiencing complicated pregnancies and/or have experienced premature birth. To learn more, visit www.sidelines.org.

Miracle Babies provides support and financial assistance to families with critically ill newborns in the neonatal intensive care unit to enhance the well-being of women, children, and their families through education, prevention, and medical care. To learn more, visit www.miraclebabies.org.

Learn about preterm birth with The Balancing Act

Join the host of The Balancing Act—a Lifetime Television morning show delivering helpful solutions for today's busy on-the-go modern women—as she speaks with real moms of preemies and a Maternal-Fetal Medicine Specialty about preterm birth.

Below are more organizations that support women during pregnancy:

  • National Child & Maternal Health Education Program's Initiative to Reduce Elective Deliveries Before 39 Weeks of Pregnancy: www.nichd.nih.gov
  • The National Association of Nurse Practitioners in Women's Health (NPWH): www.npwh.org
  • The Society for Maternal-Fetal Medicine (SMFM): www.smfm.org
  • Text4Baby: www.text4baby.org

FAQs

The following is a list of frequently asked questions about using Makena® (hydroxyprogesterone caproate injection) to help reduce the risk of preterm birth. Remember, your healthcare provider is always your best source of information.

What is preterm birth?

If you deliver a baby too early—before 37 weeks of pregnancy, or 3 weeks prior to the due date—this is known as preterm birth.1,2 Sometimes preterm births are unexpected or unplanned, though an early delivery may be necessary in some medical situations.1,2

How do I know if I could be at risk for another preterm birth?

Preterm birth can happen to any pregnant woman. But women who've already delivered a baby too early (before 37 weeks)—regardless of the number of weeks early they've delivered—are at a higher risk for having another preterm birth.1,2

Take the quiz to find out if you're at risk

How do I reduce my risk of preterm birth?

While there are no guarantees, you can still take steps to help reduce the chances of your baby being born prematurely.

See the steps

What is Makena?

Makena, pronounced Ma-keen-a, is an FDA-approved hormone medicine (progestin) prescribed to lower the risk of having a preterm baby in women3:

  • Who are pregnant with one baby, and
  • Who've unexpectedly delivered one baby too early (before 37 weeks) in the past

There are no studies showing Makena reduces the number of babies who have serious problems shortly after birth or who die. It is not known whether Makena is safe and effective in women who have other risk factors for preterm birth.

My first baby was born preterm but has developed normally. Am I a candidate for Makena?

Even if your baby has developed normally, you are still at risk for another preterm birth because delivering preterm is a significant risk factor for another preterm birth.1,2 See if Makena is right for you.

Find out if Makena (hydroxyprogesterone caproate injection) is right for you

If you have delivered a baby too early in the past, you are at an increased risk for another preterm birth. Find out if Makena may be right for you.

My first baby was born preterm but was not admitted to the NICU. Am I a candidate for Makena?

Delivering preterm is a significant risk factor for another preterm birth.1,2 Therefore, even if your baby did not require admittance to the NICU (neonatal intensive care unit), you are still at risk for another preterm birth.

What is the active ingredient in Makena?

Makena, or hydroxyprogesterone caproate injection, is a prescription hormone medicine (progestin) used in women who are pregnant and who have delivered a baby too early (preterm) in the past.3

I am afraid of needles, and Makena is a shot. Is it worth it for me to take Makena?

Talk to your healthcare provider about the benefits and risks of Makena. Receiving shots of Makena helps reduce your risk of another preterm birth. The site of the shot is your backside, so you will not have to watch as you are given the injection.3

How do I get a prescription for Makena?

Your healthcare provider will determine if you are a candidate for Makena based on the indication for Makena and your current medical need.

The first step is to work with your healthcare provider to fill out and submit a Makena Prescription Form to the Makena Care Connection. This form serves as your prescription.

Will my health insurance cover Makena?

Makena Care Connection® will work with you, your healthcare provider, and your insurance company to understand your insurance coverage for Makena.

Am I eligible for financial assistance?

If needed, financial assistance with no upper-level income caps is available for eligible insured and uninsured patients.

Eligibility criteria include:

  • Patient meets the FDA-approved indication (pregnant with a singleton with a history of singleton spontaneous preterm birth <37 weeks of gestation)3

In compliance with federal regulations, patients insured by a government-funded program (eg, Medicaid, TRICARE, etc) are not eligible.

What is the Makena Care Connection®?

The Makena Care Connection is a support program for patients and their healthcare providers that helps ensure patient access to therapy through coordination with pharmacies and financial assistance programs.

–or–

What is the My Adherence Program?

My Adherence Program is a program designed to help patients stay on track with their Makena treatments. The program includes one-on-one nurse support and educational materials throughout pregnancy.

  • A downloadable PDF is available to help you understand how My Adherence Program provides an extra layer of support during your pregnancy

What is Makena @Home?

Makena @Home allows patients to receive Makena injections in the privacy of their own home from a trusted provider if covered by their insurance. For questions about how Makena is given through Makena @Home, please contact the Makena Care Connection at 1-800-847-3418 or email Makena@sonexushealth.com.

Indication

Makena (hydroxyprogesterone caproate injection) is a prescription hormone medicine (progestin) used to lower the risk of preterm birth in women who are pregnant with one baby and who have delivered one baby too early (preterm) in the past. Makena was shown to work based on a lower number of women who delivered babies at less than 37 weeks of pregnancy. There are no studies showing Makena reduces the number of babies who have serious problems shortly after birth or who die. It is not known whether Makena is safe and effective in women who have other risk factors for preterm birth.

Important safety information for Makena (hydroxyprogesterone caproate injection)

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. Call your healthcare provider right away if you think you have symptoms of a blood clot (leg swelling, redness in your leg, a spot on your leg that is warm to touch, or leg pain that worsens when you bend your foot) or symptoms of an allergic reaction (hives, itching, or swelling of the face). 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 are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full prescribing information for Makena.

References: 1. American College of Obstetrics and Gynecology. Preterm (premature) labor and birth. http://www.acog.org/~/media/For%20Patients/faq087.pdf?dmc=1&ts=20130207T1252359850. May 2013. Accessed May 5, 2016. 2. March of Dimes. Preterm labor and premature birth. http://www.marchofdimes.org/complications/preterm-labor-and-premature-birth.aspx. March 2016. Accessed May 5, 2016. 3. Makena® (hydroxyprogesterone caproate injection) prescribing information, AMAG Pharmaceuticals, 2016.

Important safety information and Indication
INDICATION
IMPORTANT SAFETY INFORMATION
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