Reducing Risk with Makena Auto-Injector

What is Makena?

Makena helps you get closer to term. Makena, pronounced mah-KEE-na, 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.

Makena is an injection given every seven days by a healthcare provider:

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

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

About Makena Auto-Injector

makena auto injector device

Get to know the delivery device:

  • Designed so you never see the needle
  • Given in the back of the upper arm (triceps area) under the surface of the skin with a short, thin needle
  • Full dose delivered in ~15 seconds
  • No need for private exam room or for you to disrobe
injection site icon

What to expect when receiving therapy:

  • You’ll hear an audible ‘click’ – this is what activates the device
  • While it’s a short, thin needle, it’s still an injection. Some patients may experience a mild to moderate short-term burning sensation
Makena Auto-Injector should always be administered by a healthcare professional. This video can help you understand what to expect when receiving your injections from your healthcare provider with the Makena Auto-Injector.
Watch video (8:04)

When you choose Makena Auto-Injector, you have the opportunity to receive personalized support throughout your pregnancy from Makena Care Connection®. Find out more

Makena therapy schedule

Makena is an injection given by a healthcare provider:

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

Makena 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.

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

“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 right for you?

In a clinical study, taking Makena significantly lowered the rate of preterm birth compared to moms who did not take Makena.8

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.

  • 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.

Start the conversation with your healthcare provider with this useful discussion guide

“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)

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 you:

  • 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 you:

  • 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, including:

  • 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 side effects of Makena included injection site reactions (pain, swelling, itching, bruising, or a hard bump) hives, itching, nausea, and diarrhea.

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).

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.9

“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 more

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IMPORTANT SAFETY INFORMATION

Indication

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

Important Safety Information for Makena
(hydroxyprogesterone caproate injection)

Makena should not be used in women with any of the following: