medroxyprogesterone (Rx)

Brand and Other Names:DepoProvera, Depo-SubQ Provera 104, more...MPA, Provera
  • Print

Dosing & Uses

AdultPediatric

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
Next:

Interactions

Interaction Checker

and medroxyprogesterone

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            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
            Previous
            Next:

            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

            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
            Previous
            Next:

            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.

            Previous
            Next:

            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)
            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.