Makena

Makena is a prescription hormone medication used in women who are pregnant who have delivered a baby too early (preterm) in the past. Makena is used to lower the risk of delivering a baby too early. Makena belongs to a group of drugs called progestin hormones. These work to reduce the risk of premature birth through a mechanism which is currently not yet fully understood.

This medication is available in an injectable form (in an auto-injector or a vial) to be given directly into a muscle by a healthcare provider, typically once per week. Treatment usually begins between the 16th week and 0 days of pregnancy and 20 weeks and 6 days and will be continued weekly until the 37th week (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

Common side effects of Makena include pain, swelling, and itching at the injection site.

Makena can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Makena affects you.

Makena is a prescription hormone medication used to prevent premature delivery (having a baby too soon) in pregnant women who:

• Are pregnant with one baby
• Have had a preterm delivery of one baby in the past

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Makena. See the “Makena Precautions” section.

Common side effects of Makena include the following:

• injection site pain, swelling, and/or redness
• itching
• nausea
• diarrhea
• fatigue
• dizziness
• headache
• fever
• skin rash

This is not a complete list of Makena side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been conducted by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Makena including the following:

Blood Clots. Tell your doctor immediately if you experience any of the following:

• Leg swelling
• Redness in your leg
• A spot on your leg that is warm to touch
• Leg pain that worsens when you bend your foot

Allergic reactions. Severe and potentially life-threatening allergic reactions are possible during treatment with Makena. Get emergency medical attention immediately if you develop any of the following symptoms of a severe allergic reaction:

• sudden difficulty breathing
• sudden and abnormal swelling of the face, lips, tongue, and/or throat
• hives
• sudden development of a red blister-like skin rash
• sudden drop in blood pressure

Depression. Tell your doctor immediately if you notice a change in your mood. 

Reduced glucose tolerance. Makena can reduce your body's ability to tolerate large amounts of glucose. Be sure to inform your physician if you have diabetes or prediabetes, as this can affect how your body responds to this medication.

Jaundice. Tell your doctor immediately if you notice yellowing of your skin and the whites of your eyes. 

Makena can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Makena affects you.

Do not take Makena if you:

• are allergic to Makena or to any of its ingredients 
• have or suspect you may have breast cancer or any other hormone-sensitive cancers
• have unusual vaginal bleeding due to an unknown cause
• have a medical condition called cholestatic jaundice of pregnancy (yellowing of your skin due to liver problems during your pregnancy)
• have liver tumors or any active liver disease
• have untreated high blood pressure
• have or have a history of blood clots

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Makena, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Makena, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have an allergy to Makena, castor oil, or any of the other ingredients in Makena
• have or have a history of blood clots or other blood clotting problems
• have or have a history of breast cancer or other hormone-sensitive cancers
• have unusual vaginal bleeding not related to your current pregnancy
• have yellowing of your skin due to liver problems during your pregnancy
• have liver problems including liver tumors
• have uncontrolled high blood pressure
• have diabetes or prediabetes
• have heart problems
• have epilepsy
• have asthma
• get migraine headaches
• have or have a history of depression

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

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Makena falls into category B. Makena has been given to women in their second and third trimesters and did not result in harm to the baby. In animal studies, pregnant animals were given this medication and the babies did not show any medical issues related to this medication.

Makena is not intended for use in the first trimester. Treatment usually begins between the 16th week and 0 days of pregnancy and 20 weeks and 6 days and will be continued weekly until the 37th week (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

Tell your doctor if you are breastfeeding or plan to breastfeed.

You will likely discontinue Makena at 37 weeks of pregnancy or upon delivery. Detectable amounts of progestins have been identified in the milk of mothers receiving progestins. Many studies have found no adverse effects of medications similar to Makena on breastfeeding performance, or on the health, growth, or development of the infant.

Use Makena exactly as prescribed.

Makena comes in an injectable form to be given directly into a muscle by a healthcare provider, typically once per week.

Treatment usually begins between the 16th week and 0 days of pregnancy and 20 weeks and 6 days and will be continued weekly until the 37th week (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

You will receive this injection in a clinic or doctor's office. Your doctor will need to check your progress on a regular basis while you are using this medication.

It is very important that you do not miss a dose of Makena and that you continue to receive the medicine once a week. If you miss a dose, talk to your healthcare provider for specific directions on how to get back on schedule.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Makena (auto-injector) is 275 mg administered once weekly in the back of either arm.

The recommended dose of Makena (vial) is 250 mg administered once weekly into the upper, outer area of the buttock. 

Treatment usually begins between the 16th week and 0 days of pregnancy and 20 weeks and 6 days and will be continued weekly until the 37th week (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

If Makena is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.