Hydroxyprogesterone caproate injection (non-pregnancy use)

What is this medication?

HYDROXYPROGESTERONE (hye drox ee proe JES ter one) is a female hormone. This medicine is used to treat irregular menstrual bleeding or a lack of menstrual bleeding in women. In some cases, it may be used to treat endometrial cancer.

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, like asthma
• migraine headaches
• seizures
• vaginal bleeding
• an unusual or allergic reaction to hydroxyprogesterone, other hormones, castor oil, benzyl alcohol, other medicines, foods, dyes, or preservatives
• breast-feeding

How should I use this medication?

This medicine is for injection into a muscle. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine 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 doctor or health care professional 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 medicine. Tell your doctor or healthcare professional 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 doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• depressed mood
• increase in blood pressure
• increased hunger or thirst
• increased urination
• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg
• unusually weak or tired
• unusual vaginal bleeding
• yellowing of the eyes or skin

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

• diarrhea
• fluid retention and swelling
• nausea
• pain, redness, or irritation at site where injected

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 drug 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.