INDICATIONS AND USES Adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial or renal carcinoma.
CONTRAINDICATIONS Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease Known sensitivity to DEPO-PROVERA (medroxyprogesterone acetate or any of its other ingredients).
ADVERSE REACTIONS See PRECAUTIONS for possible adverse effects on the fetus Reproductive System and Breast Disorders –breakthrough bleeding –spotting –change in menstrual flow –amenorrhea –changes in cervical erosion and cervical secretions –breast tenderness and galactorrhea –erectile dysfunction Nervous System Disorders –headache –dizziness –somnolence –convulsions Psychiatric Disorders –nervousness –euphoria –mental depression –insomnia General Disorders and Administration Site Conditions –edema –pyrexia –fatigue –malaise Investigations –change in weight (increase or decrease) Hepatobiliary Disorders –cholestatic jaundice, including neonatal jaundice Skin and Subcutaneous Tissue Disorders –skin sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash –acne, alopecia and hirsutism –rash (allergic) with and without pruritis Immune System Disorders –anaphylactoid reactions and anaphylaxis –angioedema Gastrointestinal Disorders –nausea Endocrine Disorders –corticoid-like effects (e.g., Cushingoid syndrome) Metabolism and Nutrition Disorders –hypercalcemia In a few instances there have been undesirable sequelae at the site of injection, such as residual lump, change in color of skin, or sterile abscess. A statistically significant association has been demonstrated between use of estrogen-pro-gestin combination drugs and pulmonary embolism and cerebral thrombosis and embolism. For this reason patients on progestin therapy should be carefully observed. There is also evidence suggestive of an association with neuro-ocular lesions, e.g. retinal thrombosis and optic neuritis. The following adverse reactions have been observed in patients receiving estrogen-progestin combination drugs: –rise in blood pressure in susceptible individuals –premenstrual syndrome –changes in libido –changes in appetite –cystitis-like syndrome –headache –nervousness –fatigue –backache –hirsutism –loss of scalp hair –erythema multiforma –erythema nodosum –hemorrhagic eruption –itching –dizziness The following laboratory results may be altered by the use of estrogen-progestin combination drugs: –increased sulfobromophthalein retention and other hepatic function tests –coagulation tests: increase in prothrombin factors VII, VIII, IX, and X –metyrapone test –pregnanediol determinations –thyroid function: increase in PBI, and butanol extractable protein bound iodine and decrease in T3 uptake values
DRUG INTERACTIONS Aminoglutethimide administered concomitantly with DEPO-PROVERA Sterile Aqueous Suspension may significantly depress the serum concentrations of medroxyprogesterone acetate. DEPO-PROVERA users should be warned of the possibility of decreased efficacy with the use of this or any related drugs. In vitro Medroxyprogesterone acetate is metabolized primarily by hydroxylation via the CYP3A4. Though no formal drug interaction trials have been conducted, concomitant administration of strong CYP3A inhibitors is expected to increase concentrations of medroxyprogesterone acetate, whereas the concomitant administration of strong CYP3A inducers is expected to decrease medroxyprogesterone acetate concentrations. Therefore, coadministration with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's Wort) should be avoided.