Makena is a form of progestin, a manmade form of a female hormone called progesterone.

Makena is used to lower the risk of premature birth in a woman who has already had one premature baby. Makena will not stop premature labor that has already begun.

Makena is not for use in women who are pregnant with more than one baby (twins, triplets, etc).

Hydroxyprogesterone may also be used for purposes not listed in this medication guide.

You should not use Makena if you have: uncontrolled high blood pressure, unusual vaginal bleeding, liver disease or liver cancer, jaundice caused by your pregnancy, or if you have ever had circulation problems, a stroke or blood clot, or cancer of the breast, uterus/cervix, or vagina.

Your doctor will need to check your progress on a regular basis while you are using Makena. Do not miss any scheduled appointments. Every woman should remain under the care of a doctor during pregnancy.

Call your doctor at once if you have sudden numbness or weakness, confusion, problems with vision or speech, jaundice (yellowing of the skin or eyes), swelling in your hands or feet, pain or redness in one or both legs, or symptoms of depression (sleep problems, weakness, mood changes).

There are many other drugs that may interact with Makena. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products.

Do not start a new medication during pregnancy without telling your doctor.

Makena is injected under the skin or into a muscle.

A healthcare provider will give you this injection.

The first Makena injection is usually given during the second trimester of pregnancy. The usual dosing schedule is one injection per week until the 37th week or until your baby is born. Follow your doctor's instructions.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments. Every woman should remain under the care of a doctor during pregnancy.

Usual Adult Dose for Premature Labor:

To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth:
250 mg intramuscularly once weekly.
Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation. Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

Usual Pediatric Dose for Premature Labor:

To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth:
16 years and older:
250 mg intramuscularly once weekly.
Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation. Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

You should not be treated with Makena if you are allergic to hydroxyprogesterone or castor oil, or if you have:

• unusual vaginal bleeding that is not related to your pregnancy;

• severe or uncontrolled high blood pressure;

• liver disease or liver cancer;

• jaundice caused by your pregnancy;

• a history of cancer of the breast, uterus/cervix, or vagina; or

• a history of a stroke, blood clot, or circulation problems.

Makena is not approved for use by anyone younger than 16 years old.

Tell your doctor if you have ever had:

• eclampsia or preeclampsia of pregnancy;

• kidney disease;

• high blood pressure, heart disease;

• migraine headaches;

• diabetes (in you or a family member);

• epilepsy or other seizure disorder;

• asthma; or

• depression.

It is not known whether Makena will prevent any medical problems in a newborn baby. Talk to your doctor about your baby's individual risk.

Call your doctor for instructions if you miss an appointment for your Makena injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Makena: hives, itching; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• swelling, oozing, bleeding, or worsening pain where the injection was given;

• jaundice (yellowing of the skin or eyes);

• symptoms of depression (sleep problems, weakness, mood changes);

• swelling in your hands, ankles, or feet;

• increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or

• signs of a blood clot - sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common Makena side effects may include:

• pain, swelling, itching, rash, or a lump where the medicine was injected;

• nausea; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with hydroxyprogesterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.