Hydroxyprogesterone Injection (Pregnancy Use)

What is this medication?

HYDROXYPROGESTERONE (hye drox ee proe JES ter one) lowers the risk of preterm labor, or labor that begins before 37 weeks of pregnancy. This medication is a progestin hormone.

This medication is no longer FDA-approved to prevent preterm labor. Studies have shown it does not help prevent preterm labor. Contact your care team with questions.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Makena

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Breast, cervical, uterine, or vaginal cancer
• Depression
• Diabetes or prediabetes
• Heart disease
• High blood pressure
• History of blood clots
• Kidney disease
• Liver disease
• Lung or breathing disease, such as asthma
• Migraine headaches
• Seizures
• Vaginal bleeding
• An unusual or allergic reaction to hydroxyprogesterone, other hormones, castor oil, benzyl alcohol, other medications, foods, dyes, or preservatives
• Breast-feeding

How should I use this medication?

This medication is for injection into a muscle or under the skin. You will receive an injection once every week (every 7 days) as directed during your pregnancy. It is given in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. While this drug may be prescribed for children as young as 16 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your pregnancy will be monitored carefully while you are receiving this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Increase in blood pressure
• Low blood sugar (hypoglycemia)—tremors or shaking, anxiety, sweating, cold or clammy skin, confusion, dizziness, rapid heartbeat
• Worsening mood, feelings of depression
• Yellowing skin or eyes

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Itching or hives
• Nausea
• Pain, redness, or irritation at injection site
• Swelling of the ankles, hands, or feet

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.