medroxyprogesterone (Rx)

Brand and Other Names:DepoProvera, Depo-SubQ Provera 104, more...MPA, Provera
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Dosing & Uses


Dosage Forms & Strengths


  • 2.5mg
  • 5mg
  • 10mg

injectable suspension

  • 150mg/mL
  • 400mg/mL

prefilled syringe suspension

  • 104mg/0.65mL

Amenorrhea, Uterine Bleeding

Uterine bleeding: 5-10 mg/day PO for 5-10 days; beginning day 16 or 21 of the menstrual cycle; withdrawal bleeding may be expected within 3 to 7 days after discontinuing medroxyprogesterone

Amenorrhea, secondary: 5-10 mg/day PO for 5-10 days; may be started at any time; withdrawal bleeding may be expected within 3-7 days after discontinuing medroxyprogesterone


150 mg deep IM or 104 mg SC every 3 months

Endometrial Carcinoma, Recurrent or Metastatic (adjunctive/palliative therapy)

400-1000 mg IM qweek

Endometrial Hyperplasia Reduction

5-10 mg PO qDay for 12-14 consecutive days each month beginning on day 1 or day 16 of the cycle; administer therapy for shortest duration possible at lowest effective dose consistent with treatment goals in postmenopausal women

Reevaluate patients as clinically appropriate to determine if treatment is still necessary; in postmenopausal women with a utero, consider an estrogen with a progestin; patients who have had a hysterectomy, generally do not need a progestin; adjust dose based on patient response; attempt to taper or discontinue at 3-6 month intervals


Prefilled syringe suspension: 104 mg SC every 3 months for no longer than 2 years

Dosing considerations

  • Give initial injection during first 5 days of menstrual cycle to avoid inadvertent administration to pregnant woman
  • If patient is nursing, give initial injection no earlier than 6 weeks post partum

Paraphilia (Off-label)

100-600 mg IM weekly; alternatively, 100-500 mg PO qDay; maintenance: 100 mg IM every 1-4 weeks

Immune Thrombocytopenic Purpura (Orphan)

Orphan indication sponsor

  • ZaBeCor Pharmaceutical Company, LLC; 821 Westview Street; Philadelphia, PA 19119

Safety and efficacy not established



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            Adverse Effects



            Breakthrough bleeding

            Change in menstrual flow





            Pain at injection site

            Frequency Not Defined


            Change in weight






            Breast tenderness


            Abdominal pain

            Nausea and vomiting

            Cholestatic jaundice

            Deep vein thrombosis (DVT)


            Postmarketing reports

            Rash (allergic) with and without pruritus, change in weight (increase or decrease), pyrexia, edema/fluid retention, fatigue, decreased glucose tolerance

            Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides

            Injection site reaction, injection site pain/tenderness, injection site persistent atrophy/indentation/dimpling, lipodystrophy acquired, injection site nodule/lump



            Black Box Warnings

            Bone mineral density loss (injection)

            • Medroxyprogesterone contraceptive injection may cause significant loss of bone mineral density
            • Bone loss is greater with increasing duration of use and may not be completely reversible
            • Unknown whether use during critical period of bone accretion (adolescence or early adulthood) will reduce peak bone mass and increase osteoporotic fracture risk in later life
            • Use for long-term (>2 years) birth control only if other contraceptive methods are inadequate or poorly tolerated

            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

            Long-term use of contraceptive

            • The contraceptive dosage form should not be used as a long-germ birth control method (>2 years) unless other birth control methods are not cindered adequate

            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
            • Unknown whether this finding applies to younger postmenopausal women

            Dose & duration (oral)

            • In the absence of comparable data, cardiovascular and dementia risks should be assumed to be similar for other doses of CE and MPA and for other combinations and dosage forms of estrogens and progestins
            • Accordingly, estrogens, with or without progestins, should be prescribed at lowest effective dosage and for shortest duration consistent with treatment goals and individual risks

            Patient information

            • Patients should be informed that medroxyprogesterone contraceptive does not protect against HIV infection and other sexually transmitted diseases


            Known or suspected pregnancy or as a diagnostic test for pregnancy

            Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease

            History or suspected malignancy of breast

            Undiagnosed vaginal bleeding

            Known anaphylactic reaction or angioedema

            Significant known liver impairment or disease

            Documented hypersensitivity


            Use caution in patients with asthma, diabetes mellitus, history of depression, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas

            Not recommended as primary therapy for renal or endometrial cancer

            If used with conjugated estrogens, may increase risk of MI, stroke, pulmonary emboli, DVT, breast cancer; discontinue therapy in patients who develop thrombosis

            Depo-Provera: Prolonged use may result in significant loss of bone density

            Depo-subQ medroxyprogesterone 104 long-term not recommended (ie, >2 years) as birth control method or medical therapy for endometriosis-associated pain unless other options considered inadequate; bone mineral density (BMD) should be evaluated when a woman needs to continue on therapy; in adolescents, interpretation of BMD results should take into account patient age and skeletal maturity

            In women with osteoprosys risk factors, other birth control methods or therapies for endometriosis-associated pain should be considered risk/benefit analysis for use of depo-subQ medroxyprogesterone 104; depo-subQ medroxyprogesterone 104 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)

            Monitor women with a strong family history of breast cancer

            Consider ectopic pregnancy if a woman receiving therapy becomes pregnant or complains of severe abdominal pain

            Provide emergency medical treatment if anaphylaxis occurs

            Discontinue if jaundice or disturbances of liver function develop

            Use may mask onset of menopause in women treated for endometrial cancer

            Not for use in children prior to menarche

            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

            Discontinue if the following develop: hepatic impairment/ cholestatic jaundice, visual problems, 4-6 wk before major surgery, any symptoms of VTE, massive BP increase, unusually severe migraines or first-time migraines

            Depression (3% of depo-subQ medroxyprogesterone 104-treated patients) and other mood disorders have been reported; discontinue if it occurs

            Studies of addition of progestin for 10 or more 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

            Most women using depo-subQ medroxyprogesterone 104 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

            Blood pressure should be monitored 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

            Medroxyprogesterone acetate reduces serum estrogen levels when given as 150 mg IM every 3 months and is associated with loss of bone mineral density (BMD); this loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion; unknown if use by younger women will reduce peak bone mass and increase risk for osteoporotic fracture in later life; an evaluation of BMD may be appropriate in some patients who use higher doses of medroxyprogesterone acetate for long-term treatment of endometrial or renal carcinoma

            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 multi-dose 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 subcutaneous administration or release of drug into subcutaneous 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 depo-subQ medroxyprogesterone 104, as demonstrated in a study of 15 women who received multiple doses of depo-subQ medroxyprogesterone 104
              • Median time to ovulation was 10 months after last injection
              • Earliest return to ovulation was 6 months after last injection
              • 12 women (80%) ovulated within 1 year of last injection
            • However, ovulation has occurred as early as 14 weeks after single dose of depo-subQ medroxyprogesterone 104; therefore, administer next depo-subQ medroxyprogesterone 104 12 to 14 weeks after last injection
            • Return to fertility is likely to be delayed after stopping therapy; among 28 women using depo-subQ medroxyprogesterone 104 for contraception who stopped treatment to become pregnant, 7 women were lost to follow-up; one woman became pregnant within one year of her last injection and another woman became pregnant 443 days after her last injection; the remaining 19 women had not become pregnant; it is not known if these 19 women were still attempting to become pregnant or if they had started a new contraceptive method

            Pregnancy & Lactation


            Although therapy should not be used during pregnancy, there appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to medroxyprogesterone acetate injections in early pregnancy; neonates exposed to medroxyprogesterone acetate in-utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual or social development


            Although the drug is detectable in the milk of mothers receiving therapy, milk composition, quality, and amount are not adversely affected; neonates and infants exposed to medroxyprogesterone acetate from breast milk have been studied for developmental and behavioral effects through puberty, and no adverse effects have been noted

            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.



            Mechanism of Action

            Progestin; inhibits secretion of gonadotropins from pituitary gland, prevents follicular maturation and ovulation, and stimulates growth of mammary tissues


            Bioavailability: PO, 0.6-10%

            Duration: IM, 3 months

            Peak plasma time: IM, 3 wk; PO, 2-4 hr


            Protein bound: 90%


            Metabolized by liver

            Metabolites: At least 16 have been identified


            Half-life: IM, 50 days

            Excretion: Urine





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