Uses of Hydroxyprogesterone Caproate Injection:

• It delays a baby's birth when it is too early.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Hydroxyprogesterone Caproate Injection?

• If you have an allergy to hydroxyprogesterone, castor oil, or any other part of hydroxyprogesterone caproate injection (makena).
• If you are allergic to hydroxyprogesterone caproate injection (makena); any part of hydroxyprogesterone caproate injection (makena); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have a blood clot, have ever had a blood clot, or have been told you are at risk of getting a blood clot.
• If you have any of these health problems: Liver disease or liver tumors.
• If you have high blood pressure.
• If you have unexplained vaginal bleeding.
• If you have ever had breast cancer or another cancer where hormones make it grow.
• If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.
• If you are pregnant with more than 1 baby.
• If you are not pregnant.

This is not a list of all drugs or health problems that interact with hydroxyprogesterone caproate injection (makena).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take hydroxyprogesterone caproate injection (makena) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Hydroxyprogesterone Caproate Injection?

• Tell all of your health care providers that you take hydroxyprogesterone caproate injection (makena). This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• High blood pressure has happened with hydroxyprogesterone caproate injection (makena). Have your blood pressure checked as you have been told by your doctor.
• This medicine is not approved for use in women who are going through or have been through the change of life (menopause). Talk with your doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
• This medicine is not approved for use in children younger than 16 years of age. Talk with the doctor.
• This medicine is not approved to stop labor that has already started. Talk with your doctor.
• Some very bad pregnancy-related effects may happen more often in women who use hydroxyprogesterone caproate injection (makena). These may include high blood pressure, diabetes, low amniotic fluid levels, miscarriage, and stillbirth. If you have questions, talk with your doctor.

How is this medicine (Hydroxyprogesterone Caproate Injection) best taken?

Use hydroxyprogesterone caproate injection (makena) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Auto-injector shot:

• It is given as a shot into the fatty part of the skin.

Vials:

• It is given as a shot into a muscle.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Low mood (depression).
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Very bad irritation where the shot was given.
• Swelling where hydroxyprogesterone caproate injection (makena) is used.
• Oozing of blood or fluid where the shot was given.
• Yellow skin or eyes.
• Vaginal bleeding that is not normal.
• Blood clots have happened with hydroxyprogesterone caproate injection (makena). Sometimes, these blood clots have been deadly. Call your doctor right away if you have chest, arm, back, neck, or jaw pain or pressure; coughing up blood; numbness or weakness on 1 side of your body, trouble speaking or thinking, change in balance, or change in eyesight; shortness of breath; or swelling, warmth, or pain in the leg or arm.

What are some other side effects of Hydroxyprogesterone Caproate Injection?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain where the shot was given.
• Irritation where the shot is given.
• Upset stomach or throwing up.
• Diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Hydroxyprogesterone Caproate Injection?

• If you need to store hydroxyprogesterone caproate injection (makena) at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about hydroxyprogesterone caproate injection (makena), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.