hydroxyprogesterone injection

What is the most important information I should know about hydroxyprogesterone?

What is hydroxyprogesterone?

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

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

Hydroxyprogesterone 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.

What should I discuss with my healthcare provider before receiving hydroxyprogesterone?

• 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.

Hydroxyprogesterone 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 hydroxyprogesterone will prevent any medical problems in a newborn baby. Talk to your doctor about your baby's individual risk.

How is hydroxyprogesterone given?

Hydroxyprogesterone is injected under the skin or into a muscle.

A healthcare provider will give you this injection.

The first hydroxyprogesterone 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.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while receiving hydroxyprogesterone?

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

What are the possible side effects of hydroxyprogesterone?

• 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 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.

What other drugs will affect hydroxyprogesterone?

Other drugs may affect 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.

Where can I get more information?

Your doctor or pharmacist can provide more information about hydroxyprogesterone.