Hylutin

Hydroxyprogesterone is a prescription hormone medication used in pregnant women to lower the risk of delivering a baby too early. Hydroxyprogesterone belongs to a group of drugs called progestin hormones. It is not known how progestins work to prevent preterm labor.

Hydroxyprogesterone is a prescription medication used to prevent preterm delivery (having a baby too soon) in pregnant women who:

• Are pregnant with one baby
• Have had a preterm delivery of one baby in the past

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

Hydroxyprogesterone may cause serious side effects, including:

• Blood clots. Symptoms of a blood clot may include:

• 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. Symptoms of an allergic reaction may include:

• Hives
• Itching
• Swelling of the face

Call your healthcare provider right away if you get any of the symptoms above. 

• Depression
• Yellowing of your skin and the whites of your eyes

The most common side effects of hydroxyprogesterone include:

• Pain, swelling, itching, bruising or a hard bump at the injection site
• Hives
• Itching
• Nausea
• Diarrhea

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.

In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received hydroxyprogesterone compared to women who did not receive hydroxyprogesterone, including:

• Miscarriage (pregnancy loss before 20 weeks of pregnancy)
• Stillbirth (fetal death occurring after the 20th week of pregnancy)
• Hospital admission for preterm labor
• Preeclampsia (high blood pressure and too much protein in your urine)
• Gestational hypertension (high blood pressure caused by pregnancy)
• Gestational diabetes
• Oligohydramnios (low amniotic fluid levels)

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.

Hydroxyprogesterone should not be used if you:

• Have now or have had a history of blood clots or other blood clotting problems
• Have now or have had a history of breast cancer or other hormone-sensitive cancers
• Have unusual vaginal bleeding not related to your current pregnancy
• Have yellowing of your skin due to liver problems during your pregnancy
• Have liver problems, including liver tumors
• Have uncontrolled high blood pressure

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
• High blood pressure

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

Hydroxyprogesterone may affect the way other medicines work, and other medicines may affect how hydroxyprogesterone works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medication.

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 21 of pregnancy.

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.

• Do not give yourself hydroxyprogesterone injections. A healthcare professional will give you the injection into 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.

Hydroxyprogesterone comes in ready-to-use vials. There are 5 doses of medicine in each vial. Your healthcare professional should give you only one dose (1 mL) of hydroxyprogesterone as prescribed each week.

Hydroxyprogesterone should be used within 5 weeks after the first use.

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.

The recommended dose of hydroxyprogesterone to prevent preterm delivery is 250 mg (1 mL) once a week.

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.

• Store hydroxyprogesterone at room temperature (59° to 86°F or 15° to 30°C)
• Store hydroxyprogesterone in the original box to protect it from light
• Store the hydroxyprogesterone box upright
• Hydroxyprogesterone should be used within 5 weeks after first use
• Keep hydroxyprogesterone out of the reach of children