Pronunciation:

hye-drox-ee-proe-JES-ter-one KAP-roe-ate

Classifications:

Pharmacologic—

Hydroxyprogesterone

Uses of This Medicine:

Hydroxyprogesterone caproate injection is a man-made progestin hormone. 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.

Before Using This Medicine:

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:

Allergies—

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.

Children—

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

Older adults—

No information is available on the relationship of age to the effects of hydroxyprogesterone caproate injection in geriatric patients. This medicine should not be used in elderly women.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

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 interactions—

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 problems—

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.

• Asthma or
• Depression, history of or
• Diabetes, or family history of or
• Epilepsy or seizures, history of or
• Fluid retention (swelling or edema) or
• Heart problems or
• Hypertension (high blood pressure), controlled or
• Kidney problems or
• Migraine headaches or
• Preeclampsia (high blood pressure during pregnancy and too much protein in urine)—Patients with these conditions should be carefully monitored while receiving this medicine.

Proper Use of This Medicine:

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). It may also be given as a shot under your skin in the back of your upper arm.

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. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

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. Blood tests may be needed to check for unwanted effects.

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 loss of coordination or vision changes while receiving this medicine.

This medicine may cause serious allergic reactions, including angioedema. 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.

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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Pain, itching, or swelling at the injection site

Less common

Small lumps at the injection site

Incidence not known

Anxiety

chest pain

cough

dizziness or lightheadedness

fainting

fast heartbeat

redness, tenderness, or warmth on the skin

troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Hives or welts, itching, skin rash

nausea

Less common

Diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.