17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Loss of Bone Mineral Density
Advise the patient that the use of depo-subQ provera 104 decreases BMD [see Warnings and Precautions (5.1)].
Arterial and Venous Thromboembolic Disorders
Advise the patient that serious arterial and venous thrombotic events have been seen in women treated with depot medroxyprogesterone acetate (DMPA) [see Warnings and Precautions (5.2)].
Counsel patients on the importance of seeking urgent medical attention if they experience symptoms of anaphylaxis [see Warnings and Precautions (5.5)].
Advise patients to tell their healthcare professional right away if they become pregnant or experience severe abdominal pain to exclude a diagnosis of ectopic pregnancy [see Warnings and Precautions (5.4)].
Advise patients at the beginning of treatment that their menstrual cycle may be disrupted, resulting in irregular and unpredictable bleeding or spotting. Explain that bleeding and spotting irregularities usually decrease to the point of amenorrhea as treatment with depo-subQ provera 104 continues, and does not require other therapy [see Warnings and Precautions (5.11)].
Delayed Return of Ovulation and Fertility
Advise patients that return to ovulation and fertility is likely to be delayed after stopping depo-subQ provera 104 [see Warnings and Precautions (5.8)].
Risks of Breast Cancer
Counsel patients about the possible increased risk of breast cancer in women who use depo-subQ provera 104 [see Warnings and Precautions (5.3)].
Counsel patients about the possible risk of depression and mood disorders. Advise patients with a history of depression or who are receiving treatment for depression to be alert to any mood changes or worsening of their depression. Counsel patients to follow up with their healthcare professional accordingly [see Warnings and Precautions (5.9)].
Risk of Hyperglycemia in Patients with Diabetes
Advise diabetic patients that some patients receiving progestins may exhibit a decrease in glucose tolerance and hyperglycemia [see Warnings and Precautions (5.12)].
Advise patients to seek medical advice if they experience symptoms of liver problems such as jaundice [see Warnings and Precautions (5.13)].
Counsel patients with conditions that may be influenced by fluid retention to inform their healthcare professional if they experience symptoms of fluid retention [see Warnings and Precautions (5.6)].
Injection Site Reactions
Counsel patients on injection site reactions. Advise patients that dimpling or scarring may occur in 1 out of 100 patients [see Warnings and Precautions (5.10)].
Sexually Transmitted Infections
Counsel patients that depo-subQ provera 104 does not protect against HIV infection (AIDS) and other sexually transmitted infections [see Warnings and Precautions (5.14)].
Counsel patients to contact their healthcare professional if they start a medication that is a CYP3A enzyme inducer [see Drug Interactions (7)]. Advise patients that taking a medication that is a CYP3A enzyme inducer may require using a back-up or alternate contraceptive method.
DEPO-SUBQ PROVERA 104®
(deh-poh' sub-cue' pro-ver-ah' one-oh-four)
(medroxyprogesterone acetate injectable suspension)
for subcutaneous use
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 or other treatments for endometriosis pain are not right for you.
Depo-subQ provera 104 does not protect you from HIV (AIDS) and other infections spread through sex (STIs).
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.
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 1 year.
|Method||Typical Chance of Getting Pregnant in 1 year|
(Number of pregnancies in 100 women)
IUD (copper IUD and levonorgestrel IUD)
|Less than 1|
|Condom alone (male)||14|
|Diaphragm with spermicides||20|
|Condom alone (female)||21|
|Vaginal sponge or Cervical cap with spermicide||20 to 40|
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 professional 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 professional 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 professional 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 will 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 professional 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 2 years. If your painful symptoms return after stopping treatment, your healthcare professional should ask you to have a test of your bones before restarting treatment.
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 professional 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 non-hormonal birth control, such as condoms, until you start depo-subQ provera 104 again.
DO NOT TAKE depo-subQ provera 104 IF YOU…
- Have any unexplained vaginal bleeding
- Have or have ever had breast cancer or think you have 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 professional may do a physical examination and check your blood and urine.
Tell your healthcare professional about all your medical conditions.
Most importantly, tell your healthcare professional 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 or have ever had breast cancer, or think you have breast cancer
- 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 blood clots
- Bone disease
- Anorexia nervosa (an eating disorder)
- A strong family history of osteoporosis
- Use of a drug 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 professional regularly if you have any of these conditions.
Some medicines may make depo-subQ provera 104 less effective at preventing pregnancy, including those listed below:
- Bosentan (used to treat pulmonary arterial hypertension)
- Efavirenz, etravirine (HIV medicines)
- Modafinil (used to improve wakefulness)
- Mitotane (used to treat adrenal cortical carcinoma)
- Phenytoin, carbamazepine, phenobarbital (used to treat seizures)
- Rifampin (an antibiotic)
- St. John's Wort (herbal medicinal product)
Tell your healthcare professional about all the medicines you take. This includes prescription and over-the-counter medicines, vitamins, and herbal products.
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 professional.
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 professional 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 fallopian tubes (Ectopic Pregnancy). If you have severe pain low in your belly, tell your healthcare professional 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 professional you are taking depo-subQ provera 104 if you are going to have blood or urine tests.
Liver problems. Your healthcare professional 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 professional if you have these symptoms.
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 2 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
- Using a drug 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 2 years, your healthcare professional 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.
Abnormal or very heavy bleeding. If you start having very heavy or very long periods, tell your healthcare professional.
Allergic reaction. Allergic reactions to depo-subQ provera 104 have been reported. 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 professional or go to the Emergency Room right away.
Serious blood clots. Call your healthcare professional 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
Depression. If you suffer from depression or have a history of depression, inform your healthcare provider if you notice any worsening of your depression while taking 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 1 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 uncommon, but may happen. If there is swelling or your skin gets hot, has pus or looks bruised 1 or more days after your shot, call your healthcare professional.
Women using depo-subQ provera 104 for birth control or endometriosis had these less common side effects: Vaginal inflammation, vaginal thrush, abdominal pain, urinary tract infections, acne, depression, less sex drive, nausea, back pain, breast pain/tenderness, fatigue, anxiety, being irritable, dizziness, hot flushes and fluid retention.
If you feel you are having other side effects, talk with your healthcare professional.
There have been several studies of women who use birth control like depo-subQ provera 104.
- Women who use depo-subQ provera 104 may have a slightly increased risk of breast cancer compared to non-users.
- The risk of cancer of the ovary, liver, or cervix did not change.
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 professional for a pre-pregnancy check-up. Your healthcare professional 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 professional 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.
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 labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
Revised December 2020