Medroxyprogesterone

DEA Class; Rx, OTC

Common Brand Names; DepoProvera, Depo-SubQ Provera 104, MPA, Provera

Indicated for adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial carcinoma

Indicated for adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic renal carcinoma

Indicated for secondary amenorrhea due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer

Indicated for abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer

Indicated for prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625-mg tablets

Indicated for prevention of pregnancy in females of reproductive potential

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

Indicated for prevention of pregnancy in females of reproductive potential

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

SC

• Dysfunctional uterine bleeding (irregular, increase, decrease, spotting) (18%)
• 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%)
• 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

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

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

There is no use for medroxyprogesterone in pregnancy and therefore should be discontinued during pregnant

Published studies report the presence of medroxyprogesterone acetate in human milk

Exercise caution when medroxyprogesterone acetate is administered to a nursing woman