Hydroxyprogesterone Caproate, Injection

________________________________________________________________________

KEY POINTS

• This medicine is given by injection to reduce the risk of preterm birth in some women who have delivered a baby too early in the past.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: hormone

Generic and brand names: hydroxyprogesterone caproate, injection; Makena

What is this medicine used for?

This medicine given by injection (shot) to reduce the risk of preterm birth in some women who have delivered a baby too early in the past.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before using this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to castor oil
• A bleeding or blood-clotting disorder
• Asthma
• Blood clots in your legs, lungs, brain, or eyes
• Breast cancer, uterine, or another hormone-related cancer
• Depression
• Diabetes
• Heart disease or stroke
• High blood pressure
• Liver or kidney problems
• Migraine headaches
• Seizures
• Unexplained vaginal bleeding
• Yellowing of your skin (jaundice) due to liver problems during a pregnancy

How do I use it?

These shots are given into a muscle by a healthcare provider. These shots are given once per week between week 16 and week 37 of your pregnancy or until your baby is born. Keep all your appointments for shots.

What if I miss a dose?

It is very important that you do not miss a dose and that you receive this medicine once a week. If you miss a dose, contact your healthcare provider right away.

What should I watch out for?

This medicine may increase the risk of stillbirth, miscarriage, gestational diabetes, or high blood pressure during pregnancy. Talk with your provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Numbness or weakness in an arm or leg; sudden change in your vision; severe headaches; new or worsening depression; swelling, warmth, redness, or pain in your legs; chest pain or trouble breathing; yellowing of your skin or eyes; severe stomach pain; unusual tiredness or weakness; dark urine; light-colored bowel movements; slurred speech; trouble walking; swelling of the hands, ankles, or feet, or other unexplained swelling; injection site oozing blood or fluid.

Other: Nausea; diarrhea; itching, pain, swelling, itching, bruising, or a hard bump at the injection site.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.