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Important Safety Information for Makena (hydroxyprogesterone caproate injection)

Makena should not be used in women with any of the

Indication

Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of

Reducing Risk with Makena®

Makena helps you get closer to term

What is Makena?

Makena, pronounced Ma-keen-a, is a hormone medicine (progestin) prescribed to lower the risk of having another preterm baby in women who are pregnant with one baby, and who’ve unexpectedly delivered one baby too early (before 37 weeks) in the past.6

Makena is a weekly injection (given every 7 days) by your healthcare provider either at their office or in your home.6

You can start Makena between 16 weeks and 20 weeks, 6 days of your pregnancy, depending on your healthcare provider’s direction.6

Is Makena right for you?

In a clinical study, taking Makena significantly lowered the rate of preterm birth compared to moms who did not take Makena.6

If you answer “yes” to all of the questions below, talk with your healthcare provider to see if Makena could help you reduce your risk of another preterm birth.5

  • Have you unexpectedly delivered a baby preterm (less than 37 weeks gestation, or more than 3 weeks too early) before?
  • Was your preterm birth due to preterm labor or your water breaking?
  • Are you currently pregnant with one baby?

While there are many causes for preterm birth, the safety and benefits of Makena have been demonstrated only in women who’ve unexpectedly delivered their baby prior to 37 weeks of pregnancy. Makena is not meant for use in women with multiple gestations or other risk factors for preterm birth.6

Start the conversation with your healthcare provider with this useful guide >
Watch Kate talk about her Makena experience

“Looking back, Makena gave me hope that I had a better chance of delivering Olivia full term.”
—Kate, mom of a 35-week preemie

Watch Kate’s story (8:10)

Makena administration options

Subcutaneous auto-injector icon
  • Designed so you never see the needle
  • Given in the back of the upper arm under the surface of the skin with a shorter, thinner needle
  • Full dose delivered in about 15 seconds
Intramuscular injection option for Makena
  • Given into your hip (upper outer area of your buttocks) into the muscle with a longer needle
  • Full dose delivered over the course of one minute or longer
Learn more about what to expect when receiving your injections by Makena Auto-Injector

Learn more about what to expect when receiving your injections by Makena Auto-Injector.

Watch video (8:57)
Our commitment is to help ensure that Makena is affordable for all prescribed moms. Find out more >

Makena therapy schedule

Makena is an injection given by a healthcare provider6:

  • In the healthcare provider’s office, or
  • At home during a home healthcare visit (if covered by your insurance)

With both Makena injection options, therapy starts between 16 weeks and 20 weeks, 6 days of your pregnancy, depending on your healthcare provider’s direction. You will receive 1 injection each week (every 7 days) until week 37 (your last injection could be as late as 36 weeks, 6 days) or until you deliver your baby, whichever happens first.6

Home injections by healthcare professionals

Weekly injections of Makena may be administered in your home by a trained healthcare professional, if approved by your insurance plan. Find out more >

Lyn talks about her experience with preterm birth

“Receiving the weekly injections of Makena is giving me the peace of mind knowing that I’m doing everything I can to help prolong this pregnancy.”
—Katie, mom of a 34-week preemie

Is Makena safe?

You and your healthcare provider should consider the benefits and risks of therapy with Makena prior to deciding if Makena is right for you.

Makena should not be used if you6:

  • Have now or have had a history of blood clots or other blood clotting problems
  • Have now or have had a history of breast cancer or other hormone-sensitive cancers
  • Have unusual vaginal bleeding not related to your current pregnancy
  • Have yellowing of skin due to liver problems during your pregnancy
  • Have liver problems, including liver tumors
  • Have uncontrolled high blood pressure

Before you receive Makena, tell your healthcare provider if you6:

  • Have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena
  • Have diabetes or prediabetes
  • Have epilepsy
  • Have migraine headaches
  • Have asthma
  • Have heart problems
  • Have kidney problems
  • Have depression
  • Have high blood pressure

Tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

What are the possible side effects?

For moms: Makena may cause serious side effects, including6:

  • Blood clots—Symptoms of a blood clot may include leg swelling, redness in your leg, a spot on your leg that is warm to the touch, or leg pain that worsens when you bend your foot
  • Allergic reactions—Symptoms of an allergic reaction may include hives, itching, or swelling of the face
  • Depression
  • Yellowing of your skin and the whites of your eyes

The most common adverse reactions observed with Makena were injection site pain (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.6

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).6

For babies: In a follow-up study, children between the ages of 2 and 5 years old were evaluated for development in various physical, mental, and social measures. The results were comparable to children born to non-Makena-treated moms.7

Watch Lyn talk about her experience with Makena

“Makena gave the extra protection to reduce the chance of preterm birth, and it was something that I really wanted to do for my daughter.”
—Lyn, mom of a 36-week preemie

Watch Lyn's story (7:41)

Makena gives moms an extra layer of support. Find out how >

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.

Indication

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.

Indication

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. 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.

References: 1. Long-term health effects of premature birth. March of Dimes website. https://www.marchofdimes.org/baby/long-term-health-effects-of-premature-birth.aspx. Last reviewed October 2013. Accessed January 12, 2018. 2. American College of Obstetricians and Gynecologists Committee on Obstetric Practice, Society for Maternal-Fetal Medicine. Committee opinion no. 579: Definition of term pregnancy. Obstet Gynecol. 2013;122(5):1139-1140. 3. Preterm (premature) labor and birth. American College of Obstetricians and Gynecologists website. FAQ087. https://www.acog.org/Patients/FAQs/Preterm-Premature-Labor-and-Birth. Published November 2016. Accessed January 12, 2018. 4. Why at least 39 weeks is best for your baby. March of Dimes website. https://www.marchofdimes.org/pregnancy/why-at-least-39-weeks-is-best-for-your-baby.aspx. Last reviewed September 2013. Accessed February 21, 2018. 5. Preterm labor and premature birth. March of Dimes website. https://www.marchofdimes.org/pregnancy/preterm-labor-and-premature-birth.aspx. Last reviewed October 2014. Accessed January 12, 2018. 6. Makena® (hydroxyprogesterone caproate injection) prescribing information. AMAG Pharmaceuticals, 2018. 7. Northen AT, Norman GS, Anderson K, et al. Follow-up of children exposed in utero to α-hydroxyprogesterone caproate compared with placebo. Obstet Gynecol. 2007;110(4):865-872.

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