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(medroxyprogesterone acetate injectable suspension) Contraceptive Injection
Read this Patient Information carefully before you decide if Depo-Provera CI is right for you. This information does not take the place of talking with your gynecologist or other healthcare provider who specializes in women's health. If you have any questions about Depo-Provera CI, ask your healthcare provider. You should also learn about other birth control methods to choose the one that is best for you.
What is the most important information I should know about Depo-Provera CI?
Depo-Provera CI can cause serious side effects, including:
- Use of Depo-Provera CI may cause you to lose calcium stored in your bone and decrease your bone mass. The longer you use Depo-Provera CI, the greater your loss of calcium from your bones. Your bones may not recover completely when you stop using Depo-Provera CI.
- If you use Depo-Provera CI continuously for a long time (for more than 2 years), it may increase the risk of weak, porous bones (osteoporosis) that could increase the risk of broken bones, especially after menopause.
- You should not use Depo-Provera CI for more than two years unless you cannot use other birth control methods.
- It is not known if your risk of developing osteoporosis is greater if you are a teenager or young adult when you start to use Depo-Provera CI. (See “What are the possible side effects of Depo-Provera CI?”).
Depo-Provera CI is intended to prevent pregnancy. Depo-Provera CI does not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs).
What is Depo-Provera CI?
Depo-Provera CI is a progestin hormone birth control method that is given by injection (a shot) to prevent pregnancy.
How well does Depo-Provera CI work?
Your chance of getting pregnant depends on how well you follow the directions for taking your Depo-Provera CI. The more carefully you follow the directions (such as returning every 3 months for your next injection), the less chance you have of getting pregnant.
In clinical studies, about 1 out of 100 women got pregnant during the first year that they used Depo-Provera CI.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
How should I take Depo-Provera CI?
- Depo-Provera CI is given by your healthcare provider as a shot into your muscle (intramuscular injection). The shot is given in your buttock or upper arm 1 time every 3 months. At the end of the 3 months, you will need to return to your healthcare provider for your next injection in order to continue your protection against pregnancy.
- To make sure that you are not pregnant before you take
Depo-Provera CI, the first injection should be given only:
- during the first 5 days of a normal menstrual period, or
- within the first 5 days after giving birth, if you are not breastfeeding, or
- at the 6th week after giving birth, if you are feeding your baby only breastmilk.
- Depo-Provera CI may be given at other times than those listed above, but you will likely need to have a pregnancy test first to show that you are not pregnant.
- During treatment with Depo-Provera CI, you should see your healthcare provider every year for a blood pressure check and other healthcare needs.
Who Should Not Use Depo-Provera CI?
Do not use Depo-Provera CI if you:
- are pregnant or think you might be pregnant
- have bleeding from your vagina that has not been explained
- have breast cancer now or in the past, or think you have breast cancer
- have had a stroke
- ever had blood clots in your arms, legs or lungs
- have problems with your liver or liver disease
- are allergic to medroxyprogesterone acetate or any of the other ingredients in Depo-Provera CI. See the end of this leaflet for a complete list of ingredients in Depo-Provera CI.
What should I tell my healthcare provider before taking Depo-Provera CI?
Before taking Depo-Provera CI, tell your healthcare provider if you have:
- risk factors for weak bones (osteoporosis) such as bone disease, use alcohol or smoke regularly, anorexia nervosa, or a strong family history of osteoporosis
- irregular or lighter than usual menstrual periods
- breast cancer now or in the past, or think you have breast cancer
- a family history of breast cancer
- an abnormal mammogram (breast X-ray), fibrocystic breast disease, breast nodules or lumps, or bleeding from your nipples
- kidney problems
- high blood pressure
- had a stroke
- had blood clots in your arms, legs or lungs
- migraine headaches
- epilepsy (convulsions or seizures)
- depression or a history of depression
- any other medical conditions
If you are breastfeeding or plan to breastfeed, Depo-Provera CI can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Depo-Provera CI.
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Depo-Provera CI and certain other medicines may affect each other, causing serious side effects. Sometimes the doses of other medicines may need to be changed while you are taking Depo-Provera CI.
Some medicines may make Depo-Provera CI less effective at preventing pregnancy, including those listed below.
Especially tell your healthcare provider if you take:
- medicine to help you sleep
- medicine for seizures
- an antibiotic
- medicine for HIV (AIDS)
- St. John's wort
Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider or pharmacist before you first start taking Depo-Provera CI or when you get a new medicine.
Follow your healthcare provider's instructions about using a back-up method of birth control if you are taking medicines that may make Depo-Provera CI less effective.
What are the possible side effects of Depo-Provera CI?
Depo-Provera CI can cause serious side effects, including:
- Effect on the bones: See ”What is the most important
information I should know about Depo-Provera CI?”. Teenage years are the most
important years to gain bone strength. The decrease in calcium in your bones is
of most concern if you are a teenager or have the following problems:
- bone disease
- an eating disorder (anorexia nervosa)
- a strong family history of osteoporosis
- you take a drug that can lower the amount of calcium in your bones (drugs for epilepsy or steroid drugs)
- you drink a lot of alcohol (more than 2 drinks a day)
- you smoke
If you need a birth control method for more than 2 years, your healthcare provider may switch you to another birth control method instead of using Depo-Provera CI. If you continue using Depo-Provera CI, your healthcare provider may ask you to have a bone test, especially if you have other risks for weak bones.
When Depo-Provera CI is stopped, your bones may start to regain calcium. However, in a study of teenage girls who used Depo-Provera CI for more than 2 years, their hip bones did not completely recover by 5 years after they stopped using Depo-Provera CI. Taking calcium and Vitamin D and exercising daily may lessen the loss of calcium from your bones.
- increased risk of breast cancer. Studies of women who have used different forms of contraception found that women under 35 years of age who first used Depo-Provera CI within the previous 4 to 5 years may have a slightly increased risk of developing breast cancer.
- blood clots in your arms, legs, lungs, and eyes
- a pregnancy outside of your uterus (ectopic pregnancy). Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death.
- allergic reactions. Severe allergic reactions have been reported in some women using Depo-Provera CI.
- loss of vision or other eye problems
- migraine headaches
- convulsions or seizures
- liver problems
Call your healthcare provider right away if you have:
- sharp chest pain, coughing up blood, or sudden shortness of breath (indicating a possible clot in the lung)
- sudden severe headache or vomiting, dizziness or fainting, problems with your eyesight or speech, weakness, or numbness in an arm or leg (indicating a possible stroke)
- severe pain or swelling in the calf (indicating a possible clot in the leg)
- sudden blindness, partial or complete (indicating a possible clot in the blood vessels of the eye)
- unusually heavy vaginal bleeding
- severe pain or tenderness in the lower abdominal area
- persistent pain, pus, or bleeding at the injection site
- yellowing of the eyes or skin
- difficulty breathing
- swelling of the face, mouth, tongue or neck
The most common side effects of Depo-Provera CI include:
- irregular vaginal bleeding, such as lighter or heavier menstrual bleeding, or continued spotting
- weight gain. You may experience weight gain while you are using Depo-Provera CI. About two-thirds of the women who used Depo-Provera CI in the clinical trials reported a weight gain of about 5 pounds during the first year of use. You may continue to gain weight after the first year. Women who used Depo-Provera CI for 2 years gained an average of 8 pounds over those 2 years.
- abdominal pain
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of Depo-Provera CI. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other information should I know before choosing Depo-Provera CI?
- Pregnancy. When you take Depo-Provera CI 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-Provera CI if you are pregnant. However, Depo-Provera CI taken by accident during pregnancy does not seem to cause birth defects.
- Nursing Mothers. Although Depo-Provera CI can be passed to the nursing baby in the breast milk, no harmful effects on babies have been found. Depo-Provera CI does not stop the breasts from producing milk, so it can be used by nursing mothers. However, to minimize the amount of Depo-Provera CI that is passed to the baby in the first weeks after birth, you should wait until your baby is 6 weeks old before you start using Depo-Provera CI for birth control.
How will Depo-Provera CI change my periods?
- Change in normal menstrual cycle. The side
effect reported most frequently by women who use Depo-Provera CI for birth
controls is a change in their normal menstrual cycle. During the first year of
using Depo-Provera CI, you might have one or more of the following changes:
- irregular or unpredictable bleeding or spotting
- an increase or decrease in menstrual bleeding
- no bleeding at all. In clinical studies of Depo-Provera CI, 55% of women reported no menstrual bleeding (amenorrhea) after one year of use and 68% of women reported no menstrual bleeding after two years of use.
- Missed period. During the time you are using Depo-Provera CI for birth controls, you may skip a period, or your periods may stop completely. If you have been receiving your shot of Depo-Provera CI regularly every 3 months, then you are probably not pregnant. However, if you think that you may be pregnant, see your healthcare provider.
Unusually heavy or continuous bleeding is not a usual effect of Depo-Provera CI and if this happens you should see your healthcare provider right away. With continued use of Depo-Provera CI, bleeding usually decreases and many women stop having periods completely. When you stop using Depo-Provera CI your menstrual period will usually, in time, return to its normal cycle.
What if I want to become pregnant?
Because Depo-Provera CI is a long-acting birth control method, it takes some time after your last shot for its effect to wear off. Most women who try to get pregnant after using Depo-Provera CI get pregnant within 18 months after their last shot. The length of time you use Depo-Provera CI has no effect on how long it takes you to become pregnant after you stop using it.
General Information about Depo-Provera CI
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. This leaflet summarizes the most important information about Depo-Provera CI. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about Depo-Provera CI that is written for healthcare providers.
What are the ingredients in Depo-Provera CI?
Active ingredient: medroxyprogesterone acetate
Inactive ingredients: polyethylene glycol 3350, polysorbate 80, sodium chloride, methylparaben, propylparaben, and water for injection. When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
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.
|Method||Typical chance of getting pregnant in 1 year (No. of pregnancies in 100 women)|
|Shot||Less than 1|
|IUD (copper IUD and levonorgestrel IUD)|
|Condom alone (male)||14|
|Diaphragm with spermicides||20|
|Condom alone (female)||21|
|Vaginal sponge or||20 to 40|
|Cervical cap with spermicide|
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:
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.
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?
- If you miss a shot, or wait longer than 14 weeks between shots, you could get pregnant. The longer you wait, the greater the risk of getting pregnant.
- Talk with your healthcare provider to find out when to restart depo-subQ provera 104. You should be tested to be sure you are not pregnant.
- Use another kind of nonhormonal birth control, such as condoms, until you start depo-subQ provera 104 again.
DO NOT TAKE depo-subQ provera 104 IF YOU…
- Are pregnant or might be pregnant
- Have any unexplained vaginal bleeding
- Ever had breast cancer
- Ever had serious blood clots, such as blood clots in your legs (deep venous thrombophlebitis), lungs (pulmonary embolism), heart (heart attack), or head (stroke)
- Have liver disease
- Are allergic to anything in depo-subQ provera 104. (There is a list of what is in depo-subQ provera 104 at the end of this leaflet.)
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:
- Are pregnant or might be pregnant. You should not get depo-subQ provera 104 if you are pregnant.
- Plan to become pregnant in the next year. After you stop getting depo-subQ provera 104, it takes time for your body to be able to get pregnant. It can be as early as 1 week after the last shot wears off. Most likely it will take up to 1 year or longer for you to get pregnant.
- Have breast cancer in your family
- Have an abnormal mammogram (breast X-ray), lumps in your breast, or bleeding from your nipples
- Have irregular, light, or heavy menstrual periods
- Have or had any of the following medical problems:
- Kidney problems
- High blood pressure
- Migraine headaches
- Diabetes, or if it runs in your family
- Heart attack, stroke, or developed blood clots
- Bone disease
- Anorexia nervosa (an eating disorder)
- A strong family history of osteoporosis
- Drug use that can lower the amount of calcium in bones (drugs for epilepsy or steroids)
- Drinking a lot of alcohol or smoking a lot
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.
- It does not lower the amount of milk you can make.
- It can pass through breast milk into your baby, but it is not harmful.
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?
- Losing calcium from your bones. depo-subQ
provera 104 use may decrease the amount of calcium in your bones. The longer
you use depo-subQ provera 104, the more calcium you are likely to lose. This
increases the risk of your bones weakening if you use depo-subQ provera 104
continuously for a long time (for example, if you use depo-subQ provera 104 for
more than two years). The loss of calcium may increase your risk of
osteoporosis and broken bones, particularly after your menopause.
Calcium is generally added to the bones during teenage years. The decrease of calcium in your bones is of most concern if you are a teenager or have the following risk factors:
- Bone disease
- Anorexia nervosa (an eating disorder)
- A strong family history of osteoporosis
- Drug use that can lower the amount of calcium in bones (drugs for epilepsy or steroids), or
- Drinking a lot of alcohol or smoking a lot
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. When depo-subQ provera 104 is stopped, the calcium in your bones begins to come back. The lost calcium may not return completely once you stop using depo-subQ provera 104. Your healthcare provider may tell you to take calcium and Vitamin D as this may lessen the loss of calcium from your bones.
- Abnormal or very heavy bleeding. If you start having very heavy or very long periods, tell your healthcare provider.
- Liver problems. Your healthcare provider may stop depo-subQ provera 104 if you have liver problems. Some signs of liver problems are yellow skin or eyes, feeling like you have the flu, feeling more tired than usual, and itching. Tell your healthcare provider if you have these symptoms.
- Allergic reaction. Allergic reactions to depo-subQ provera 104 are not common. If you have hives, problems breathing, swelling of the face, mouth, tongue or neck, or just do not feel right after your shot, call your healthcare provider or go to the Emergency Room right away.
- Serious blood clots. Call your healthcare provider
immediately if you:
- Have sharp chest pain, cough blood, or suddenly have trouble breathing
- Have a sudden severe headache with vomiting, blindness or trouble talking, weakness, or numbness in an arm or leg, or get dizzy or faint
- Have swelling or severe pain in your leg
WHAT ARE COMMON SIDE EFFECTS OF depo-subQ provera 104?
The most common side effects are:
- Changes in your monthly periods. You may not know when you will bleed, your periods may not be regular, you may have heavy bleeding, or you may have spotting. You may have more days of bleeding during the first 2 or 3 months after you start depo-subQ provera 104. Over time, you may have less and less bleeding. Many women stop having periods by the end of one year. Your periods will come back eventually after you stop using depo-subQ provera 104.
- Weight gain. In studies, women gained an average of 3 to 4 pounds during the first year they used depo-subQ provera 104. After 2 years of using depo-subQ provera 104, women gained an average of 7 to 8 pounds. Some women gained more, some gained less, some lost, and some stayed the same. Weight changes beyond 2 years of use with depo-subQ provera 104 have not been studied. Women who used a similar birth control product for 5 years gained on average 5 pounds more than women who did not use a hormone contraceptive product.
- Skin reaction where you got the shot. Lumps, skin dimpling, or pain are usually mild and usually don't last long. Scarring is unusual, but may happen. If there is swelling or your skin gets hot, has pus or looks bruised one or more days after your shot, call your healthcare provider.
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?
- Birth control like depo-subQ provera 104 was studied in women for many years. In general, the risk of breast cancer slightly increased or stayed about the same as in women not using birth control like depo-subQ provera 104.
- The risk of cancer of the ovary, liver, or cervix did not change.
- There is a decreased risk of cancer of the uterus (endometrial cancer).
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
Last reviewed on RxList: 2/11/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Depo-Provera Information
Depo Provera - User Reviews
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