Hydroxyprogesterone Injection (Non-Pregnancy Use)

What is this medication?

HYDROXYPROGESTERONE (hye drox ee proe JES ter one) treats irregular menstrual cycles. It may also be used to treat uterine cancer. This medication is a progestin hormone.

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. It is given in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

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?

Significant 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 condition will be monitored carefully while you are receiving this medication. Tell your care team if your symptoms do not start to get better or if they get worse.

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
• Change in vision such as blurry vision, seeing halos around lights, vision loss
• Increase in blood pressure
• New or worsening migraines or headaches
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• 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):

• Breast pain or tenderness
• Dark patches of skin on the face or other sun-exposed areas
• Hair loss
• Irregular menstrual cycles or spotting
• 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.