Dosing & Uses
Dosage Forms & Strengths
tablet
- 2.5mg
- 5mg
- 10mg
injectable IM suspension
- 150mg/mL
- 400mg/mL
prefilled syringe suspension
- 104mg/0.65mL
Metastatic Endometrial Carcinoma
Depo-Provera only
Indicated for adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial carcinoma
400-1000 mg IM qWeek initially
Metastatic Renal Carcinoma
Depo-Provera only
Indicated for adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic renal carcinoma
400-1000 mg IM qWeek initially
Secondary Amenorrhea
Provera only
Indicated for secondary amenorrhea due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer
5 or 10 mg PO qDay for 5-10 days; therapy may start at any time
Progestin withdrawal bleeding usually occurs within 3-7 days after discontinuing medroxyprogesterone
Abnormal Uterine Bleeding
Provera only
Indicated for abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer
5 or 10 mg PO qDay for 5-10 days; begin day 16 or 21 of the menstrual cycle
Progestin withdrawal bleeding usually occurs within 3-7 days after discontinuing medroxyprogesterone
Endometrial Hyperplasia Reduction
Provera only
Indicated for prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625-mg tablets
5 or 10 mg PO qDay for 12-14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day or 16th day of the cycle; start at the lowest dose
Lowest effective dose has not been determined
Contraception
Depo-Provera SubQ 104 only
Indicated for prevention of pregnancy in females of reproductive potential
104 mg SC every 12-14 weeks
Sexually active women who have regular menses: Administer first injection only during the first 5 days of a normal menstrual period
Breastfeeding women: Administer first injection during or after the sixth postpartum week
Use for >2 years is not recommended (unless other birth control methods or medical therapies for endometriosis-associated pain are considered inadequate) due to the impact on bone mineral density (BMD) with long-term use
Endometriosis-Associated Pain
Depo-Provera SubQ 104 only
Indicated for prevention of pregnancy in females of reproductive potential
104 mg SC every 12-14 weeks
Sexually active women who have regular menses: Administer first injection only during the first 5 days of a normal menstrual period
Breastfeeding women: Administer first injection during or after the sixth postpartum week
Use for >2 years is not recommended (unless other birth control methods or medical therapies for endometriosis-associated pain are considered inadequate) due to the impact on bone mineral density (BMD) with long-term use
Immune Thrombocytopenic Purpura (Orphan)
Orphan indication sponsor
- ZaBeCor Pharmaceutical Company, LLC; 821 Westview Street; Philadelphia, PA 19119
Dosage Modifications
Renal impairment
- IM or PO: Not studied
Hepatic impairment
-
IM
- Do not use by women with significant liver disease; discontinue if jaundice or disturbances of liver function occur
-
PO
- Majority of medroxyprogesterone (MPA) is eliminated via hepatic metabolism
- In patients with advanced liver disease, MPA disposition was significantly altered (reduced elimination)
In patients with fatty liver, the mean percent dose excreted in the 24-hr urine as intact MPA after a 10 mg or 100 mg dose was 7.3% and 6.4%, respectively
Dosing Considerations
Switching from another method of contraception to Depo-SubQ Provera 104
- Combined hormonal contraceptives: Administer first SC injection within 7 days after the last day of using the combined hormonal contraceptive method (ie, within 7 days after taking the last active pill)
- Implant: Administer the first SC injection on the day of implant removal
- Contraceptive vaginal ring or transdermal system: Administer the first SC injection on the day the next ring or transdermal system should be inserted or applied
- Depot medroxyprogesterone acetate injectable suspension for IM use (DMPA-IM): Administer SC injection 12-14 weeks after the last dose of DMPA-IM
-
Intrauterine device (IUD) or intrauterine System (IUS)
- Administer first SC injection on the day of IUD/IUS removal
- If IUD/IUS is not removed on the first day of the menstrual cycle, use a nonhormonal backup method of birth control for the first 7 days after SC administration
Limitations of use
Depo-SubQ Provera
- Not recommended as a long-term (ie, >2 years) birth control method or therapy for endometriosis-associated pain unless other options are considered inadequate
Contraception
Depo-Provera SubQ 104 only
Indicated for prevention of pregnancy in females of reproductive potential
104 mg SC every 12-14 weeks
Sexually active women who have regular menses: Administer first injection only during the first 5 days of a normal menstrual period
Breastfeeding women: Administer first injection during or after the sixth postpartum week
Use for >2 years is not recommended (unless other birth control methods or medical therapies for endometriosis-associated pain are considered inadequate) due to the impact on bone mineral density (BMD) with long-term use
Endometriosis-Associated Pain
Depo-Provera SubQ 104 only
Indicated for prevention of pregnancy in females of reproductive potential
104 mg SC every 12-14 weeks
Sexually active women who have regular menses: Administer first injection only during the first 5 days of a normal menstrual period
Breastfeeding women: Administer first injection during or after the sixth postpartum week
Use for >2 years is not recommended (unless other birth control methods or medical therapies for endometriosis-associated pain are considered inadequate) due to the impact on bone mineral density (BMD) with long-term use
Dosage Modifications
Renal impairment
IM or PO: Not studied
Hepatic impairment
-
IM
- Do not use by women with significant liver disease; discontinue if jaundice or disturbances of liver function occur
-
PO
- Majority of medroxyprogesterone (MPA) is eliminated via hepatic metabolism
- In patients with advanced liver disease, MPA disposition was significantly altered (reduced elimination)
- In patients with fatty liver, the mean percent dose excreted in the 24-hr urine as intact MPA after a 10 mg or 100 mg dose was 7.3% and 6.4%, respectively
Dosing Considerations
Switching from another method of contraception to Depo-SubQ Provera 104
- Combined hormonal contraceptives: Administer first SC injection within 7 days after the last day of using the combined hormonal contraceptive method (ie, within 7 days after taking the last active pill)
- Implant: Administer the first SC injection on the day of implant removal
- Contraceptive vaginal ring or transdermal system: Administer the first SC injection on the day the next ring or transdermal system should be inserted or applied
- Depot medroxyprogesterone acetate injectable suspension for IM use (DMPA-IM): Administer SC injection 12-14 weeks after the last dose of DMPA-IM
- Intrauterine device (IUD) or intrauterine System (IUS) H5
- Administer first SC injection on the day of IUD/IUS removal
- If IUD/IUS is not removed on the first day of the menstrual cycle, use a nonhormonal backup method of birth control for the first 7 days after SC administration
Limitations of use
-
Depo-SubQ Provera
- Not recommended as a long-term (ie, >2 years) birth control method or therapy for endometriosis-associated pain unless other options are considered inadequate
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
SC
- Dysfunctional uterine bleeding (irregular, increase, decrease, spotting) (18%)
1-10%
SC
- Headache (9%)
- Increased weight (7%)
- Amenorrhea (6%)
- Injection site reactions (6%)
- Vaginitis, including candidiasis and bacterial (5%)
- Abdominal pain (4%)
- Urinary tract infections (4%)
- Acne (4%)
- Depression (3%)
- Decreased libido (3%)
- Nausea (3%)
- Back pain (3%)
- Breast pain/tenderness (2%)
- Fatigue (2%)
- Anxiety (1%)
- Irritability (1%)
- Dizziness (1%)
<1%
SC
- Breast lump
- Anemia
- Drug hypersensitivity
- Weight decreased
- Fluid retention
- Facial palsy
- Syncope
- Paresthesia
- Somnolence
- Tachycardia
- Hot flushes
- Asthma
- Dyspnea
- Diarrhea
- Abdominal distension
- Urticaria
- Pruritus
- Dry skin
- Dysmenorrhea
- Galactorrhea
- Dyspareunia
- Chest pain
Frequency Not Defined
IM
- Breakthrough bleeding
- Spotting
- Change in menstrual flow
- Amenorrhea
- Changes in cervical erosion and cervical secretions
- Breast tenderness and galactorrhea
- Erectile dysfunction
- Headache
- Dizziness
- Somnolence
- Convulsions
- Nervousness
- Euphoria
- Mental depression
- Insomnia
- Edema
- Pyrexia
- Fatigue
- Malaise
- Injection site reaction (eg, pain/tenderness, persistent atrophy/indentation/dimpling)
- Change in weight
- Cholestatic jaundice
- Skin sensitivity reactions
- Acne
- Alopecia
- Hirsutism
- Rash (allergic) with and without pruritus
- Anaphylactoid reactions
- Angioedema
- Nausea
- Corticoid-like effects (eg, Cushingoid syndrome)
- Hypercalcemia
PO
- Genitourinary system: Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions
- Breast: Breast tenderness, mastodynia, galactorrhea
- Cardiovascular: Thromboembolic disorders (eg, thrombophlebitis, pulmonary embolism)
- Gastrointestinal: Nausea, cholestatic jaundice
- Skin: Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.
- Eyes: Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis.
- Central nervous system: Mental depression, insomnia, somnolence, dizziness, headache, nervousness.
- Miscellaneous: Hypersensitivity reactions (for example, anaphylaxis and anaphylactoid reactions, angioedema), rash (allergic) with and without pruritus, change in weight (increase or decrease), pyrexia, edema/fluid retention, fatigue, decreased glucose tolerance.
Estrogen plus progestin therapy
- Genitourinary system: Abnormal uterine bleeding/spotting, or flow; breakthrough bleeding; spotting; dysmenorrheal/pelvic pain; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.
- Breasts: Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
- Cardiovascular: Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
- Gastrointestinal: Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas.
- Skin: Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
- Eyes: Retinal vascular thrombosis, intolerance to contact lenses.
- Central nervous system: Headache, migraine, dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
- Miscellaneous: Increase or decrease in weight, reduced carbohydrate tolerance, aggravation of porphyria, edema, arthralgias, leg cramps, changes in libido, urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides
Warnings
Black Box Warnings
Bone mineral density loss (injection)
- Women who IM or SC medroxyprogesterone 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 SC or IM use 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
- IM or SC use is not recommended as a long-term (ie, longer than 2 years) birth control method or medical therapy for endometriosis-associated pain unless other options are considered inadequate
Cardiovascular risks (oral)
- Estrogens with progestins should not be used to prevent cardiovascular disease
- Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary embolism, and DVT in postmenopausal women aged 50-79 years undergoing 5.6 years of treatment with oral conjugated estrogens (CE) 0.625 mg/day plus medroxyprogesterone acetate (MPA) 2.5 mg/day versus placebo
Breast cancer
- Estrogen plus progestin substudy has demonstrated increased risk of invasive breast cancer
Dementia risks (oral)
- Estrogens with progestins should not be used to prevent dementia
- Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of probable dementia in postmenopausal women aged 65 years or older undergoing 4 years of treatment with CE 0.625 mg/day plus MPA 2.5 mg/day versus placebo
- In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins
- Therefore, prescribe estrogens with or without progestins at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman
Contraindications
Undiagnosed abnormal genital bleeding
Known, suspected, or history of breast cancer
Known or suspected estrogen- or progesterone-dependent neoplasia
Active DVT, PE, or a history of these conditions
Active arterial thromboembolic disease (eg, stroke, MI), or a history of these conditions
Known anaphylactic reaction or angioedema
Known liver impairment or disease
Known or suspected pregnancy
Cautions
Use caution in patients with asthma, diabetes mellitus, history of depression, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas
Therapy reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD); BMD should be evaluated when a woman needs to continue to receive therapy long-term; in adolescents, interpretation of BMD results should take into account patient age and skeletal maturity
Prolonged use of SC or IM use may result in significant loss of bone density; long-term use is not recommended (ie, >2 years) as birth control method or medical therapy for endometriosis-associated pain unless other options considered inadequate
In women with osteoporosis risk factors, other birth control methods or therapies for endometriosis-associated pain should be considered risk/benefit analysis for SC use; SC can pose an additional risk in patients with risk factors for osteoporosis (eg, metabolic bone disease, chronic alcohol and/or tobacco use, anorexia nervosa, strong family history of osteoporosis, or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids)
Consider ectopic pregnancy if a woman receiving therapy becomes pregnant or complains of severe abdominal pain
Provide emergency medical treatment if anaphylaxis occurs
Not for use in children prior to menarche
Inform medroxyprogesterone contraceptive does not protect against HIV infection and other sexually transmitted diseases
Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer
In some epidemiologic studies, use of estrogen plus progestin and estrogen-only products, in particular for 5 or more years, has been associated with increased risk of ovarian cancer; however, duration of exposure associated with increased risk is not consistent across all epidemiologic studies and some report no association
Depression and other mood disorders have been reported; discontinue if it occurs
Most women experienced changes in menstrual bleeding patterns, such as amenorrhea, irregular unpredictable spotting or bleeding, prolonged spotting or bleeding, or heavy bleeding; in cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated
Monitor blood pressure at regular intervals with estrogen plus progestin therapy
In women with preexisting hypertriglyceridemia, estrogen therapy may be associated with elevations of plasma triglycerides leading to pancreatitis; consider discontinuation of treatment if pancreatitis occurs
Progestins may cause some degree of fluid retention; women with condition influenced by fluid retention including epilepsy, migraine, asthma, cardiac or renal dysfunction, require careful observation
Estrogen therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur
Therapy should be discontinued pending examination if there is a sudden partial or complete loss of vision, or if there is a sudden onset of proptosis; diplopia or migraine; if examination reveals papilledema or retinal vascular lesions, medication should be withdrawn
Patients may exhibit suppressed adrenal function; medroxyprogesterone acetate may have cortisol-like glucocorticoid activity and provide negative feedback to hypothalamus or pituitary; this may result in decreased plasma cortisol levels, decreased cortisol secretion, and low plasma ACTH levels; use of sterile aqueous suspension may, due to its cortisol-like glucocorticoid activity, also produce Cushingoid symptoms such as weight gain, edema/fluid retention, and facial swelling
Monitor patients for hepatic dysfunction periodically and temporarily interrupt therapy if patient develops hepatic dysfunction; do not resume use until markers of liver function return to normal
Any multidose use of vials may lead to contamination unless strict aseptic technique is observed
Treatment with progestin may mask the onset of the climacteric
Persistent injection site reactions may occur after administration due to inadvertent SC administration or release of drug into SC space while removing the needle
Some patients receiving progestins may exhibit a decrease in glucose tolerance; therefore, patients with diabetes may be at greater risk of hyperglycemia
Delayed return of ovulation or fertility
- Return to ovulation is likely to be delayed after stopping SC injection
- Median time to ovulation was 10 months after last injection
- Earliest return to ovulation was 6 months after last injection
Cardiovascular disorders
- An increased risk of PE, DVT, stroke, and MI has been reported with estrogen plus progestin therapy
- Discontinue estrogen plus progestin therapy immediately if any of these events occur or be suspected,
- Risk factors for arterial vascular disease (eg, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) should be managed appropriately
Malignant neoplasms
- Studies of addition of progestin for ≥10 days of cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone; possible risks associated with the use of progestins with estrogens compared to estrogen-alone regimens include an increased risk of breast cancer
- Monitor women with a strong family history of breast cancer
- Use may mask onset of menopause in women treated for endometrial cancer
Pregnancy & Lactation
Pregnancy
There is no use for medroxyprogesterone in pregnancy and therefore should be discontinued during pregnant
Women who may have been exposed to medroxyprogesterone injections had little or no increased risk of birth defects in early pregnancy
It is unknown whether medroxyprogesterone acetate can cause fetal harm when administered to a pregnant woman
Fertility
- Medroxyprogesterone acetate at high doses is an antifertility drug and high doses would be expected to impair fertility until discontinuing treatment
Lactation
Published studies report the presence of medroxyprogesterone acetate in human milk
Exercise caution when medroxyprogesterone acetate is administered to a nursing woman
Although medroxyprogesterone acetate is detectable in the milk of mothers receiving DMPA-IM, milk composition, quality, and amount do not appear to be adversely affected
Effects on milk production and lactation initiation/duration remain unclear when administered before 6 weeks after delivery
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Progestin inhibits the secretion of gonadotropins, which primarily prevents follicular maturation and ovulation and causes thickening cervical mucus; these actions contribute to its contraceptive effects
Suppression of serum estradiol concentrations is likely to be responsible for the therapeutic effect on endometriosis-associated pain
Absorption
Peak plasma concentration
- Oral (single dose): 1.01 ng/mL (2 x 10-mg doses); 0.805 ng/mL (8 x 2.5-mg doses)
- Oral (multiple doses): 0.71 ng/mL (10-mg dose)
Peak plasma time
- Oral (single dose): 2.65 ng/mL (2 x 10-mg doses); 2.22 ng/mL (8 x 2.5-mg doses)
- Oral (multiple doses): 2.83 ng/mL (10-mg dose)
AUC
- Oral (single dose): 6.95 ng/mL (2 x 10-mg doses); 5.62 ng/mL (8 x 2.5-mg doses)
- Oral (multiple doses): 6.01 ng/mL (10-mg dose)
Distribution
Protein bound: ~90%
Vd
- Oral (single dose): 78,024 L (2 x 10-mg doses); 62,748 L (8 x 2.5-mg doses)
- Oral (multiple doses): 40,654 ng/mL (10-mg dose)
Metabolism
- Following oral dosing, MPA is extensively metabolized in the liver via hydroxylation, with subsequent conjugation and elimination in the urine
Elimination
Half-life
- Oral (single dose): 12.1 hr (2 x 10-mg doses); 11.6 hr (8 x 2.5-mg doses)
- Oral (multiple doses): 16.6 ng/mL (10-mg dose)
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Patient Handout
Formulary
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