Learn more about preterm birth

  • Learn if you are at risk

    Watch this short video to understand leading risk factors for preterm birth and why every week counts during pregnancy.

Patient story

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    A Mother’s Mind Put At Ease

    “Before talking to my doctor, I didn’t know that having Gabriel unexpectedly at 35 weeks put me at risk for having another preterm birth. I was surprised to learn that I was at risk, but relieved to know that treatment was available to help reduce my risk of another preterm birth.”

    – Kate, mother of two, Rochester, N

 
 

Patient resources to help you achieve a healthy pregnancy

Be your own healthy pregnancy advocate. Learn more about preterm birth and treatment options and how to tell whether you are at risk for preterm birth.  Check back soon to see more patient stories.

 

  • Thumb 1About Preterm Birth

    Learn about preterm birth, risk factors, and more.

    Click here for the Spanish version.

  • Risk Factors of Preterm Birth

    the risk factors of preterm birth and if you’re at risk.

  • Reducing the Risk of Preterm Birth

    about five easy steps you can take to help reduce your risk of preterm birth.

  • Thumb 4About Makena® (hydroxyprogesterone caproate injection)

    Understand more about whether Makena may be right for you.

 

Makena Patient Assistance Program

Lumara Health’s™ financial assistance programs to help ensure affordable access to therapy.

We also provide financial assistance for our other FDA-approved products, including Clindesse® (clindamycin phosphate), Gynazole-1® (Butoconazole Nitrate Vaginal Cream USP, 2%) and Evamist® (estradiol transdermal spray). For more information and to access savings, visit each product’s individual website. Learn More

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® (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 or call 1-800-FDA-1088.

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