Hydroxyprogesterone (Injection)

Hydroxyprogesterone caproate injection is a synthetic progestin hormone. It is used in pregnant women to help reduce the risk of preterm birth (giving birth before 37 weeks of pregnancy). This medicine is given only to pregnant women who are carrying one baby and who have previously had a preterm delivery of one baby.

This medicine must be given only by or under the direct supervision of your doctor.

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.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it will provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare provider know if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or packaging ingredients carefully.

Pediatric

Hydroxyprogesterone caproate injection is not approved for children younger than 16 years of age. Safety and effectiveness have not been established in this age group.

Geriatric

There is no information available about how age affects the effects of hydroxyprogesterone caproate injection in older patients. This medicine should not be used in elderly women.

Breast Feeding

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

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could happen. In such cases, your doctor may adjust the dose or take other precautions. Inform your healthcare provider if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around meal times or with specific types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may impact the use of this medicine. Be sure to inform your doctor if you have any other medical conditions, 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 closely monitored while using this medicine.

Along with its necessary effects, this medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor or nurse right away 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 gets used to the medicine. Your health care professional may also be able to suggest ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 happen in some patients. If you notice any other effects, talk to your healthcare professional.

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

Pharmacologic Class: Hydroxyprogesterone

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.