DEPO-SUBQ PROVERA- medroxyprogesterone acetate injection, suspension 
Pharmacia and Upjohn Company LLC

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Patient Information About

depo-subQ provera 104™
medroxyprogesterone acetate injectable suspension
104 mg/0.65 mL

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT depo-subQ provera 104?

Use of depo-subQ provera 104 may cause you to lose calcium stored in your bones. The longer you use depo-subQ provera 104 the more calcium you are likely to lose. The calcium may not return completely once you stop using depo-subQ provera 104.

Loss of calcium may cause weak, porous bones (osteoporosis) that could increase the risk that your bones might break, especially after menopause. It is not known whether your risk of developing osteoporosis may be greater if you are a teenager when you start to use depo-subQ provera 104.

You should use depo-subQ provera 104 long-term (for example, more than 2 years) only if other methods of birth control are not right for you.

depo-subQ provera 104 does not protect you from HIV (AIDS) and other diseases spread through sex (STDs).

WHAT IS depo-subQ provera 104?

depo-subQ provera 104 is a drug for birth control. It also helps relieve pain related to endometriosis (en-do-ME-tree-OH-sis). Symptoms of endometriosis arise when cells normally inside your uterus grow outside the uterus. The cells respond to menstrual cycle hormones, and may cause painful periods, pelvic pain, and painful sex.

depo-subQ provera 104 contains a hormone called medroxyprogesterone acetate (MPA). It is given as a shot (injection) every 3 months. Three months is the same as 12 to 14 weeks.

HOW WELL DOES depo-subQ provera 104 WORK FOR PREVENTING PREGNANCY?

When you use depo-subQ provera 104 correctly, the chance of getting pregnant is very low. In studies, no women became pregnant during the year they used depo-subQ provera 104 injection.

The list below estimates the chances of getting pregnant using different types of birth control. The numbers are based on typical use. Typical use includes people who use the method correctly and people who use the method incorrectly. The list shows the number of women out of 100 women who will likely get pregnant if they use the method for one year.

MethodTypical chance of getting pregnant in 1 year
(No. of pregnancies in 100 women)
Shot
Implant
Female sterilization
Male sterilization
IUD (copper IUD and levonorgestrel IUD)
Less than 1
Pill5
Condom alone (male)14
Withdrawal19
Diaphragm with spermicides20
Condom alone (female)21
Periodic abstinence25
Spermicides alone26
Vaginal sponge or
Cervical cap with spermicide
20 to 40

HOW WILL I GET depo-subQ provera 104?

depo-subQ provera 104 is given as a shot just under the skin on your thigh or belly. You get it once every 3 months.

For Birth Control:

First Shot:

Your healthcare provider will want to be sure that you are not pregnant before you get your first shot. Normally, you get the shot by the 5th day from the START of your menstrual period. You get it whether or not you are still bleeding.

If you are breast-feeding, you may have your first shot as early as 6 weeks after you deliver your baby.

After the first shot:

It is very important to keep getting depo-subQ provera 104 every 3 months. If you wait more than 14 weeks between shots, you could become pregnant. Your healthcare provider must make sure you are not pregnant before you get your next shot.

When you get your shot, make an appointment for your next shot. Mark it on your calendar.

If you need a birth control method for more than two years, your healthcare provider may ask you to have a test of your bones or ask you to switch to another birth control method before continuing depo-subQ provera 104, especially if you have other risks for weak bones.

For Endometriosis:

If you have regular periods, you get depo-subQ provera 104 the same way as described above for birth control. If your periods have stopped or are not regular, your healthcare provider must test to make sure you are not pregnant before you get your first shot.

It is not recommended that you receive depo-subQ provera 104 for treatment of endometriosis for longer than two years. If your painful symptoms return after stopping treatment, your healthcare provider should ask you to have a test of your bones before restarting treatment.

WHAT IF I MISS A SHOT?

DO NOT TAKE depo-subQ provera 104 IF YOU…

BEFORE TAKING depo-subQ provera 104

Your healthcare provider may do a physical examination and check your blood and urine.

Tell your healthcare provider about all your medical conditions.

Most important, tell your healthcare provider if you:

It is important to see your healthcare provider regularly if you have any of these conditions.

Tell your healthcare provider about all the medicines you take. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

WHAT ELSE SHOULD I KNOW ABOUT TAKING depo-subQ provera 104?

Other Birth Control. If you can't take birth control pills or can't use a birth control patch or ring, you may be able to use depo-subQ provera 104. Ask your healthcare provider.

Pregnancy. When you take depo-subQ provera 104 every 3 months, your chance of getting pregnant is very low. You could miss a period or have a light period and not be pregnant. If you miss 1 or 2 periods and think you might be pregnant, see your healthcare provider as soon as possible.

You should not use depo-subQ provera 104 if you are pregnant. However, depo-subQ provera 104 taken by accident during pregnancy does not seem to cause birth defects.

Pregnancy in your tubes (Ectopic Pregnancy). If you have severe pain low in your belly, tell your healthcare provider right away. Infrequently, a baby may start to grow outside the uterus, most often in the tubes.

Nursing a baby. Wait at least 6 weeks after your baby is born to start depo-subQ provera 104. You can use depo-subQ provera 104 if you are nursing.

Blood or urine tests. depo-subQ provera 104 may affect blood or urine test results. Tell your healthcare provider you are taking depo-subQ provera 104 if you are going to have blood or urine tests.

Other medicines. depo-subQ provera 104 may not work as well if you are also taking Cytadren (aminoglutethimide), a cancer medicine. You may need to use another kind of birth control.

WHAT ARE THE MOST SERIOUS RISKS OF depo-subQ provera 104?

WHAT ARE COMMON SIDE EFFECTS OF depo-subQ provera 104?

The most common side effects are:

Women using depo-subQ provera 104 for birth control or endometriosis had these less common side effects: abdominal pain, acne, breast tenderness, being irritable, depression, hot flushes, insomnia, joint pain, lack of energy, less sex drive, painful periods, nausea and sleepiness.

If you feel you are having other side effects, talk with your healthcare provider.

DOES depo-subQ provera 104 CAUSE CANCER?

There have been several studies of women who use birth control like depo-subQ provera 104.

WHAT IF I WANT TO BECOME PREGNANT?

Plan ahead. The effect of depo-subQ provera 104 can last for a long time after you stop getting shots. Although you may be able to get pregnant quickly, it is more likely to take a year or longer after your last shot before you get pregnant.

It's best to see your healthcare provider for a pre-pregnancy check-up. Your healthcare provider may also tell you to take a vitamin called folic acid every day if you are planning to become pregnant.

GENERAL ADVICE ABOUT depo-subQ provera 104

For more information about depo-subQ provera 104, ask your healthcare provider or pharmacist. You can also visit www.depo-subQprovera104.com or call 1-866-554 DEPO (3376). A nurse can answer questions in Spanish or English 24 hours-a-day, 7 days a week.

WHAT IS IN depo-subQ provera 104?

Active ingredient: medroxyprogesterone acetate

Inactive ingredients: methylparaben, propylparaben, sodium chloride, polyethylene glycol, polysorbate 80, monobasic sodium phosphate∙H2O, dibasic sodium phosphate∙12H2O, methionine, povidone, water for shot. When necessary, the pH is adjusted with sodium hydroxide or hydrochloric acid, or both.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com

Rx only

Figure

LAB-0298-7.0
October 2016

Revised: 12/2016
Document Id: 2219a0ef-8b1c-48f8-947b-3be2798a6314
Set id: 390087a6-f3c3-4f0b-a930-79acf412f153
Version: 13
Effective Time: 20161223
 
Pharmacia and Upjohn Company LLC