Medroxyprogesterone Injection

Women who use medroxyprogesterone injection may lose more bone mineral density which may increase the risk for osteoporosis and bone fractures. This loss in bone mineral density may not be reversible. It is unknown if early use of medroxyprogesterone injection in adolescence or early adulthood will lead to increase risk of osteoporosis and bone fractures later in life.

Tell your doctor if you or anyone in your family has osteoporosis; if you have or have ever had any other bone disease or anorexia nervosa (an eating disorder); or if you drink a lot of alcohol or smoke a great deal. Tell your doctor if you take any of the following medications: corticosteroids such as dexamethasone, methylprednisolone, and prednisone; or medications for seizures such as carbamazepine, phenytoin, or phenobarbital.

You should not use medroxyprogesterone injection for a long time (e.g., more than 2 years) unless no other method of birth control is right for you or no other medication will work to treat your condition. Your doctor may test your bones to be sure they are not becoming too thin before you continue to use medroxyprogesterone injection.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your health carefully to be sure you do not develop osteoporosis.

Talk to your doctor about the risks of using medroxyprogesterone injection.

Medroxyprogesterone injection is used to prevent pregnancy and to treat endometriosis (a condition in which the type of tissue that lines the uterus (womb) grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Medroxyprogesterone is in a class of medications called progestins. It works to prevent pregnancy by preventing ovulation (the release of eggs from the ovaries). Medroxyprogesterone also thins the lining of the uterus which helps to prevent pregnancy in all women and slows the spread of tissue from the uterus to other parts of the body in women who have endometriosis.

Medroxyprogesterone injection is a very effective method of birth control but does not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) or other sexually transmitted diseases.

Medroxyprogesterone injection comes as a suspension (liquid) to be injected intramuscularly (into the muscle) or subcutaneously (under the skin). It is given once every 12 to 14 weeks by a healthcare provider in an office or clinic.

You must receive your first medroxyprogesterone injection only at a time when there is no possibility that you are pregnant. You should only receive your first injection during the first 5 days of a normal menstrual period, during the first 5 days after you give birth if you are not planning to breast-feed your baby, or during the sixth week after giving birth if you are planning to breast-feed your baby. If you have been using a different method of birth control and are switching to medroxyprogesterone injection, your doctor will tell you when you should receive your first injection.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Before using medroxyprogesterone injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using medroxyprogesterone injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following herbal product may interact with medroxyprogesterone injection: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start using medroxyprogesterone injection. Do not start any of these medications while using medroxyprogesterone injection without discussing with your healthcare provider.
• tell your doctor if you or anyone in your family has or has ever had breast cancer or diabetes. Also tell your doctor if you have or have ever had problems with your breasts such as lumps, bleeding from your nipples, an abnormal mammogram (breast x-ray), or fibrocystic breast disease (swollen, tender breasts and/or breast lumps that are not cancer); unexplained vaginal bleeding; irregular or very light menstrual periods; excessive weight gain or fluid retention before your period; blood clots in your legs, lungs, brain, or eyes; stroke or mini-stroke; migraine headaches; seizures; depression; high blood pressure; heart attack; asthma; or heart, liver, or kidney disease.
• tell your doctor if you think you might be pregnant, you are pregnant, or you plan to become pregnant. If you become pregnant while using medroxyprogesterone injection, call your doctor immediately. Medroxyprogesterone may harm the fetus.
• tell your doctor if you are breast-feeding. You may use medroxyprogesterone injection while you are breast-feeding as long as your baby is 6 weeks old when you receive your first injection. Some medroxyprogesterone may be passed to your baby in your breast milk but this has not been shown to be harmful. Studies of babies who were breast-fed while their mothers were using medroxyprogesterone injection showed that the babies were not harmed by the medication.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using medroxyprogesterone injection.
• you should know that your menstrual cycle will probably change while you are using medroxyprogesterone injection. At first, your periods will probably be irregular, and you may experience spotting between periods. If you continue to use this medication, your periods may stop completely. Your menstrual cycle will probably return to normal some time after you stop using this medication.

You should eat plenty of foods that are rich in calcium and vitamin D while you are receiving medroxyprogesterone injection to help decrease the loss of calcium from your bones. Your doctor will tell you which foods are good sources of these nutrients and how many servings you need each day. Your doctor also may prescribe or recommend calcium or vitamin D supplements.

If you miss an appointment to receive an injection of medroxyprogesterone, call your doctor. You may not be protected from pregnancy if you do not receive your injections on schedule. If you do not receive an injection on schedule, your doctor will tell you when you should receive the missed injection. Your doctor will probably administer a pregnancy test to be sure that you are not pregnant before giving you the missed injection. You should use a different method of birth control, such as condoms until you receive the injection that you missed.

Medroxyprogesterone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• belly pain
• weight gain
• nervousness
• dizziness
• decreased sex drive
• swelling, pain, redness or bruising at site of injection

Some side effects can be serious. The following side effects are uncommon, but if you experience any of them, call your doctor immediately:

• bulging of the eyeballs, double vision, loss of vision, sudden severe headache
• warmth or swelling and pain in an extremity
• severe belly pain
• rash, hives, itching, blistering skin, shortness or breath or feeling like throat is closing, weakness, extreme tiredness
• yellowing of skin or whites of eyes, lower abdominal pain, dark urine, pale stools, extreme tiredness, loss of appetite
• seizures
• swelling of the legs or feet or ankles, weight gain

If you are younger than 35 years old and began to receive medroxyprogesterone injection in the last 4 to 5 years, you may have a slightly increased risk that you will develop breast cancer. Medroxyprogesterone injection may also increase the chance that you will develop a blood clot that moves to your lungs or brain. Talk to your doctor about the risks of using this medication.

Medroxyprogesterone injection may cause meningioma (a type of brain tumor that grows from the meninges, the protective membranes covering the brain and spinal cord). Talk to your doctor about the risks of taking this medication.

Medroxyprogesterone injection is a long-acting birth control method. You might not become pregnant for some time after you receive your last injection. Talk to your doctor about the effects of using this medication if you plan to become pregnant in the near future.

Medroxyprogesterone injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

You should have a complete physical exam, including blood pressure measurements, breast and pelvic exams, and a Pap test, at least yearly. Follow your doctor's directions for self-examining your breasts; report any lumps immediately.

Before you have any laboratory tests, tell the laboratory personnel that you are using medroxyprogesterone.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Depo-Provera^®
• Depo-SubQ Provera 104^®

• Lunelle^® (containing Estradiol, Medroxyprogesterone)^¶

• acetoxymethylprogesterone
• methylacetoxyprogesterone