Pronunciation:

me-drox-ee-proe-JES-ter-one AS-e-tate

Brand Names:

• Depo-Provera
• Depo-Provera Contraceptive
• Depo-SubQ Provera 104

Dosage Forms:

• Suspension

Warnings:

Women who use Depo-Provera CI(R) injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. Depo-Provera CI(R) should not be used longer than 2 years unless other birth control methods are considered inadequate .

Women who use medroxyPROGESTERone acetate injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of medroxyPROGESTERone acetate during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. MedroxyPROGESTERone acetate should not be used as a long-term birth control method (ie, longer than 2 years) unless other birth control methods are considered inadequate .

Classifications:

Therapeutic—

Contraceptive, Progestin

Pharmacologic—

Medroxyprogesterone

Uses of This Medicine:

Medroxyprogesterone injection is used to prevent pregnancy. It is a birth control method that works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

This medicine does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

Medroxyprogesterone injection is also used with other medicines to help relieve symptoms of inoperable, recurrent, and metastatic (cancer that has already spread) endometrial or kidney cancer.

This medicine is to be given only by or under the immediate supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies on the relationship of age to the effects of Depo-Provera CI® (contraceptive injection) or Depo-Subq Provera 104® have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medicine in teenagers are not expected. This medicine may be used for birth control in teenage females, but should not be used before the start of menstruation.

Appropriate studies have not been performed on the relationship of age to the effects of Depo-Provera® in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of Depo-Provera CI® (contraceptive injection) or Depo-Subq Provera 104® have not been performed in the geriatric population. This medicine should not be used in elderly women.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Depo-Provera® in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Tranexamic Acid

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Belzutifan
• Bexarotene
• Bosentan
• Carbamazepine
• Cenobamate
• Clobazam
• Dabrafenib
• Darunavir
• Dexamethasone
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Fosaprepitant
• Fosphenytoin
• Griseofulvin
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolic Acid
• Nafcillin
• Nevirapine
• Oxcarbazepine
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pitolisant
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rufinamide
• Secobarbital
• St John's Wort
• Sugammadex
• Tazemetostat
• Telaprevir
• Theophylline
• Topiramate
• Ulipristal

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding—Depo-Provera CI® (contraceptive injection) or Depo-Subq Provera 104® should not be used in patients with this condition.

• Asthma or
• Breast cancer, family history of or
• Depression, history of or
• Diabetes or
• Eye disease or
• Fluid retention (edema or body swelling) or
• Heart disease or
• Hypertension (high blood pressure) or
• Kidney disease or
• Migraine headaches (severe headache) or
• Osteoporosis, current or risk factors for—Use with caution. May make these conditions worse.

• Blood clots, or history of or
• Breast cancer, known or suspected or
• Liver disease, significant or
• Problems with circulation or blood clots, now or in the past or
• Stroke, now or in the past—Should not be used in patients with these conditions.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or clinic. This medicine is given as a shot into one of your muscles (usually in the buttocks or upper arm).

If you are using Depo-Provera®: This medicine is initially given on a weekly basis, but the frequency may be less often over time.

If you are using Depo-Provera CI®(contraceptive injection) or Depo-Subq Provera 104®:

• To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.
• This medicine comes with patient information insert. Read them carefully and make sure you understand them before receiving this medicine. If you have any questions, ask your doctor.
• Your doctor must make sure you are not pregnant before you start treatment with this medicine. For most women, this means you must receive your first shot during the first 5 days of a normal menstrual period. You will need to receive this medicine every 3 months (12 to 14 weeks). Be sure to keep all appointments with your doctor to receive your injections.
• If you plan to start this medicine after having a baby, you should receive your first shot within 5 days after your baby is born. If you plan to breastfeed your new baby, talk to your doctor about when to get your first shot. Some doctors may suggest waiting 6 weeks before getting your first shot, but others may suggest getting the shot sooner after the baby is born. If you wait 6 weeks, talk to your doctor about using an alternative form of birth control.
• If you are switching from another method of birth control, carefully follow your doctor’s instructions about when to have your first injection of this medicine.
• You need to have enough calcium and vitamin D in your diet. Your doctor might suggest that you take supplements.

Missed dose—

Call your doctor or pharmacist for instructions.

You must have your shot of Depo-Provera CI® contraceptive injection) or Depo-Subq Provera 104® every 12 to 14 weeks to prevent pregnancy. If you do not get another shot after 14 weeks, talk with your doctor. You may need to use another form of birth control and wait until your next menstrual period before starting the shots again.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits when you are using Depo-Provera CI® (contraceptive injection) or Depo-Subq Provera 104® to make sure this medicine is working properly. These visits will usually be every 3 months, but some doctors require them more often. Your doctor will check your blood pressure once a year. Blood tests may be needed to check for unwanted effects.

Although you are using Depo-Provera CI® (contraceptive injection) or Depo-Subq Provera 104® to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause your bones to lose calcium, which can lead to osteoporosis (thin or weak bones). This calcium loss could continue the whole time you are receiving this medicine. Your bones should start to rebuild calcium after you stop using this medicine. This is more of a concern if you are a teenager, smoke or drink alcohol regularly, have other bone problems, anorexia nervosa (an eating disorder), a family history of osteoporosis, or use other medicines that also affect your bones (such as steroids or medicine to treat seizures).

You will need to talk with your doctor if you want to use this medicine for more than 2 years. You might need to be tested to make sure your bones are not losing too much calcium.

Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty or trouble breathing, a sudden, severe headache, slurred speech, a sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor immediately if you have blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

There is a very slight chance that this medicine could increase risk of breast cancer in some women. Talk to your doctor about this risk. Make sure your doctor knows if anyone in your family has had breast cancer.

Call your doctor right away if you have severe lower abdominal or stomach pain 3 to 5 weeks after receiving Depo-Provera CI® (contraceptive injection) or Depo-Subq Provera 104®. You may have a pregnancy outside of the uterus (womb), which is called an ectopic pregnancy. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

Most women have changes in their menstrual periods while using Depo-Provera CI® (contraceptive injection) or Depo-Subq Provera 104®. You might have irregular bleeding, spotting, or heavier or lighter periods. Many women stop having periods. Call your doctor if you have very heavy or nonstop bleeding.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may cause injection site reactions. Tell your doctor right away if you have bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause fluid retention (edema) and weight gain in some patients. Tell your doctor right away if you have bloating or swelling of face, arms, hands, lower legs, or feet, tingling of hands or feet, or unusual weight gain or loss.

Using these medicine may cause adrenal problems. Tell your doctor right away if you have darkening of the skin, diarrhea, nausea, or weight gain around your neck, upper back, breast, face, or waist.

If you plan to have children after you stop using Depo-Provera CI® (contraceptive injection), it may take up to year or longer before you can become pregnant. However, do not depend on this medicine to prevent pregnancy for more than 13 weeks.

Depo-Provera CI® (contraceptive injection) or Depo-Subq Provera 104® will not protect you from getting HIV/AIDS or other sexually transmitted infections. If this is a concern for you, talk with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Absent, missed, or irregular menstrual periods

menstrual changes

stopping of menstrual bleeding

Less common

Breast pain

cramps

heavy bleeding

increased clear or white vaginal discharge

itching of the vagina or genital area

pain during sexual intercourse

swelling

thick, white vaginal discharge with no odor or with a mild odor

Incidence not known

Anxiety

black, tarry stools

blood in the stools

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in skin color

chest pain or tightness

chills

clay-colored stools

clear or bloody discharge from the nipple

cough

dark urine

decrease in height

difficult or labored breathing

difficulty with swallowing

dimpling of the breast skin

dizziness or lightheadedness

dull ache or feeling of pressure or heaviness in the legs

fainting

fast, pounding, or irregular heartbeat or pulse

fever

general feeling of discomfort or illness

headache

hives, itching, or rash

increased thirst

inverted nipple

itching skin near damaged veins

loss of appetite

lump in the breast or under the arm

nausea

no sensation in the legs

noisy breathing

pain in the back, ribs, arms, or legs

pain, redness, tenderness, or swelling of the arm, foot, or leg

pale skin

persistent crusting or scaling of the nipple

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness or swelling of the breast

seizures

sore on the skin of the breast that does not heal

stomach pain

swelling

swollen feet and ankles

trouble breathing

unable to move the legs

unpleasant breath odor

unusual bruising or bleeding

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Decreased interest in sexual intercourse

inability to have or keep an erection

increased weight

loss in sexual ability, desire, drive, or performance

nervousness

stomach discomfort

Less common

Backache

blemishes on the skin

bloating

depression

difficulty with moving

feeling of warmth

hair loss or thinning of the hair

lack or loss of strength

leg cramps

muscle pain or stiffness

pain in the joints

pimples

redness of the face, neck, arms, and occasionally, upper chest

sudden sweating

trouble sleeping

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

brown, blotchy spots on the exposed skin

changes in appetite

diarrhea

drowsiness

dry skin

hoarseness

increased hair growth, especially on the face

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

increased sweating and body odor

indigestion

loss of appetite

passing of gas

patchy brown or dark brown discoloration of the skin

stomach pain, fullness, or discomfort

swelling of the armpits

unexpected or excess milk flow from breasts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.