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Makena

Generic Name: hydroxyprogesterone (hye DROX ee pro JES te rone)
Brand Names: Makena, Prodrox

What is Makena?

Makena (hydroxyprogesterone) 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. This medication 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).

Important information

You should not use Makena if you are allergic to hydroxyprogesterone or castor oil, or if you have unusual vaginal bleeding, liver disease or liver cancer, breast cancer, uterine cancer, uncontrolled high blood pressure, a history of jaundice caused by pregnancy, or a history of stroke, blood clot, or circulation problems.

Before you receive Makena, tell your doctor if you have eclampsia or preeclampsia, kidney disease, high blood pressure, heart disease, migraine headaches, a personal or family history of diabetes, asthma, seizures, depression, or fluid retention.

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.

Before taking this medicine

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

  • unusual vaginal bleeding that has not been checked by a doctor;

  • liver disease or liver cancer;

  • a history of hormone-related cancer such as breast or uterine cancer;

  • severe or uncontrolled high blood pressure;

  • a history of jaundice caused by pregnancy; or

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

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

To make sure Makena is safe for you, tell your doctor if you have:

  • eclampsia or preeclampsia of pregnancy;

  • kidney disease;

  • high blood pressure, heart disease;

  • migraine headaches;

  • a personal or family history of diabetes;

  • asthma;

  • epilepsy or other seizure disorder;

  • depression; or

  • fluid retention.

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.

Hydroxyprogesterone can pass into breast milk, but it is not known whether this could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is Makena given?

Makena is injected into a muscle. A healthcare provider will give you this injection.

The first Makena injection is usually given during the 16th through the 20th week 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 while you are using Makena. Do not miss any scheduled appointments. Every woman should remain under the care of a doctor during pregnancy.

If you store Makena at home, keep the medicine vial in the box it came in. Store in an upright position at room temperature away from moisture, heat, and light.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

The multi-dose vial contains enough medicine for 5 injections. Throw away any medicine left in the vial 5 weeks after the first use.

Makena dosing information

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.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of Makena.

What happens if I overdose?

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

What should I avoid while receiving Makena?

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

Makena side effects

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;

  • signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs; or

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

Common Makena side effects may include:

  • soreness, bruising, or itching where the medicine was injected;

  • nausea, diarrhea; or

  • skin rash or itching.

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.

See also: Side effects (in more detail)

What other drugs will affect Makena?

Other drugs may interact with hydroxyprogesterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about Makena.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Makena only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 2.01. Revision Date: 2016-06-14, 12:03:25 PM.

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