Hydroxyprogesterone

Hydroxyprogesterone is a prescription hormone medication used in women who are pregnant who have delivered a baby too early (preterm) in the past. Hydroxyprogesterone is used to lower the risk of delivering a baby too early. Hydroxyprogesterone may also be used to treat amenorrhea (lack of menstruation), advanced uterine cancer, and abnormal bleeding due to an imbalance of the hormones.

Hydroxyprogesterone 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, beginning around the 16th week of pregnancy and up to 20 weeks and 6 days and continuing weekly until the 37th week (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

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

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

Hydroxyprogesterone is a prescription medication used to:

• prevent preterm delivery (having a baby too soon) in pregnant women who are pregnant with one baby and have had a preterm delivery of one baby in the past
• treat amenorrhea (lack of menstruation)
• treat advanced uterine cancer
• treat abnormal bleeding due to an imbalance of the hormones

This medication is also used as a test for estrogen production (made in the body).

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

Hydroxyprogesterone may be found in some form under the following brand names:

• Delta-Lutin

• Duralutin

• Hylutin

• Makena

• Prodrox

Hydroxyprogesterone may cause serious side effects. See the "Drug Precautions" section. 

The most common side effects of hydroxyprogesterone include:

• pain, swelling, itching, bruising or a hard bump at the injection site
• itching
• nausea
• diarrhea
• fatigue
• dizziness
• headache
• fever
• skin rash

Call your healthcare provider if you have the following at your injection site:

• Increased pain over time
• Oozing of blood or fluid
• Swelling

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

These are not all the possible side effects of hydroxyprogesterone. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects or pregnancy complications. You may report side effects to FDA at 1-800-FDA-1088.

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

• theophylline (Theo-24, Elixophyllin, Theolair)
• tizanidine (Zanaflex)
• clozapine (Clozaril, Fazaclo)
• acetaminophen (Tylenol)
• nicotine (Nicotrol)
• efavirenz (Sustiva, in Atripla)
• bupropion (Aplenzin, Fortivo XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL)
• methadone (Methadose, Dolophine)

This is not a complete list of hydroxyprogesterone drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with hydroxyprogesterone 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 hydroxyprogesterone. 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. Hydroxyprogesterone 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. 

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

Do not receive hydroxyprogesterone if you:

• are allergic to hydroxyprogesterone 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 hydroxyprogesterone, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you receive hydroxyprogesterone, tell your healthcare provider if you have:

• An allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in hydroxyprogesterone
• Diabetes or prediabetes
• Epilepsy
• Migraine headaches
• Asthma
• Heart problems
• Kidney problems
• Depression or have a history of depression
• Blood clots or other blood clotting problems or a history 
• Breast cancer or other hormone-sensitive cancers or have a history
• Unusual vaginal bleeding not related to your current pregnancy
• Yellowing of your skin due to liver problems during your pregnancy
• Liver problems including liver tumors
• Uncontrolled high blood pressure

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

Hydroxyprogesterone is intended for use during pregnancy to help prevent giving birth to a baby too soon. Hydroxyprogesterone is not intended for use in the first trimester. Hydroxyprogesterone should be started between weeks 16 and 20 of pregnancy.

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

You will likely stop taking hydroxyprogesterone at 37 weeks of gestation or when the baby is born. This medication, a progestin hormone, is likely to be excreted in breast milk as progestins are known to pass through breast milk in small amounts.

Use hydroxyprogesterone exactly as prescribed.

• Do not give yourself hydroxyprogesterone injections. A healthcare professional will give you the injection into the muscle in your hip area (upper outer area of the buttocks) once a week (every 7 days).
• You will start receiving hydroxyprogesterone injections anytime from 16 weeks and 0 days of your pregnancy up to 20 weeks and 6 days of your pregnancy.
• You will continue to receive hydroxyprogesterone injections once weekly until week 37 of your pregnancy or when your baby is delivered, whichever happens 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 hydroxyprogesterone 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 for each indication is:

• Lowering the risk of delivering a baby too early. The recommended dose range of hydroxyprogesterone is 250 mg to 275 mg administered once weekly into the mucle. In this case, hydroxyprogesterone is typically started around 16 weeks and 0 days of your pregnancy up to 20 weeks and 6 days of your pregnancy. Hydroxyprogesterone is typically continued until the 37th week (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.
• Amenorrhea. The recommended dose is 375 mg administered as a single dose into the muscle or 250 mg administered into the muscle on day 15 of each 28-day cycle for 4 cycles.
• Production of secretory endometrium and desquamation.
  • Not on estrogen therapy: The recommended dose is 250 mg administered into the muscle on day 15 of each 28-day cycle for 4 cycles.
  • Currently on estrogen therapy: The recommended dose is 375 mg administered as a single dose into the muscle or 250 mg administered into the muscle on day 15 of each 28-day cycle until therapy is no longer required.
• To test for endogenous estrogen production. The recommended dose is 250 mg administered into the muscle as a single dose. The dose may be repeated after 4 weeks. 
• Advanced uterine adenocarcinoma. The recommended dose is 1,000 mg administered into the muscle 1 or more times per week (max of 7 doses or 7,000 mg per week). Your healthcare provider will determine how long you will receive this medication. 

Hydroxyprogesterone 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.