HYDROXYPROGESTERONE is a female hormone. This medicine is used in women who are pregnant and who have delivered a baby too early (preterm) in the past. It helps lower the risk of having a preterm baby again. Compare progestins.

What is Makena?

Commonly Used Brand Name(s)Hylutin, Makena, Prodrox

Therapeutic ClassificationsEndocrine-Metabolic Agent

Pharmacologic ClassificationsHydroxyprogesterone




Hydroxyprogesterone caproate injection is a man-made hormone of progestin. It is used in pregnant women to help lower the risk of giving birth too early (preterm birth or giving birth less than 37 weeks of pregnancy). This medicine is given only to pregnant women who are pregnant with one baby and who have had a preterm delivery of one baby in the past.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Proper UseTOP

A doctor or other trained health professional will give you this medicine in a hospital or clinic. This medicine is given as a shot into one of your muscles, usually in the hip area (upper outer area of the buttocks).

This medicine is given once a week (every 7 days). You will begin receiving this medicine between 16 weeks and 0 days of your pregnancy, and 20 weeks and 6 days of your pregnancy.

You will continue to receive this medicine once a week until week 37 (through 36 weeks, 6 days of your pregnancy) of your pregnancy or until you give birth.

It is very important that you do not miss a dose and that you continue to receive this medicine weekly. If you miss a dose, call your doctor.

This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Before UsingTOP

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Hydroxyprogesterone caproate injection is not indicated for children. Safety and efficacy have not been established in children younger than 16 years of age.


Appropriate studies on the relationship of age to the effects of hydroxyprogesterone caproate injection have not been performed in the geriatric population. This medicine should not be used in elderly women.


Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast FeedingTOP

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug InteractionsTOP

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other InteractionsTOP

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical ProblemsTOP

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abnormal or unusual vaginal bleeding or
  • Blood clots, or history of or
  • Breast cancer, active or history of or
  • Cholestasis (bile problem) during pregnancy or
  • Hypertension (high blood pressure), uncontrolled or
  • Liver disease, including tumors or cancer—Should not be used in patients with these conditions.


It is very important that you return to your doctor's office for your weekly shots. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Stop using this medicine and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves; difficulty with breathing; a sudden, severe headache; slurred speech; a sudden, unexplained shortness of breath; a sudden loss of coordination; or vision changes while using this medicine.

This medicine may cause serious allergic reactions. Stop using this medicine and check with your doctor right away if you have a rash, itching, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs after you receive the medicine.

This medicine may cause pain, soreness, itching, swelling, or bruising. Call your doctor right away if you have increased pain or discomfort, oozing of blood or fluid, or swelling at the injection site.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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