HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use DEPO-SUBQ PROVERA 104 safely and effectively. See full prescribing information for DEPO-SUBQ PROVERA 104.
DEPO-SUBQ PROVERA 104 (medroxyprogesterone acetate) injectable suspension, for subcutaneous use Initial U.S. Approval: 1959 WARNING: LOSS OF BONE MINERAL DENSITYSee full prescribing information for complete boxed warning.- Women who use depo-subQ provera 104 may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. (5.1)
- It is unknown if use of depo-subQ provera 104 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. (5.1)
- Depo-subQ provera 104 is not recommended as a long-term (i.e., longer than 2 years) birth control method or medical therapy for endometriosis-associated pain unless other options are considered inadequate. (1, 5.1)
INDICATIONS AND USAGEDepo-subQ provera 104 is a progestin that is indicated in females of reproductive age for: - Prevention of pregnancy. (1)
- Management of endometriosis-associated pain. (1)
Limitations of Use: Use of depo-subQ provera 104 is not recommended as a long-term (i.e., longer than 2 years) birth control method or medical therapy for endometriosis-associated pain unless other options are considered inadequate. (1, 5.1) DOSAGE AND ADMINISTRATION- Only for healthcare professional administration. (2.1)
- Prior to first injection confirm the patient is not pregnant. (2.1)
- Administer 104 mg of depo-subQ provera 104 by subcutaneous injection into the anterior thigh or abdomen, once every 12 to 14 weeks. (2.1)
- See Full Prescribing Information for recommendations on switching from another contraceptive method to depo-subQ provera 104. (2.2)
- See Full Prescribing Information for important preparation and administration instructions. (2.3)
DOSAGE FORMS AND STRENGTHSInjectable suspension: 104 mg/0.65 mL (3) CONTRAINDICATIONS- Active thrombophlebitis, or current or history of thromboembolic disorders, or cerebral vascular disease. (4)
- Known, suspected, or past malignancy of the breast. (4)
- Significant liver disease. (4)
- Known hypersensitivity to medroxyprogesterone acetate or any of the ingredients of depo-subQ provera 104. (4)
- Undiagnosed vaginal bleeding. (4)
WARNINGS AND PRECAUTIONS- Thromboembolic disorders: Discontinue depo-subQ provera 104 in patients who develop arterial or venous thrombosis. (5.2)
- Breast cancer risks: Monitor women with a family history of breast cancer or a significant risk of breast cancer carefully. (5.3)
- Ectopic pregnancy: Consider ectopic pregnancy if a woman becomes pregnant or complains of severe abdominal pain. (5.4)
- Anaphylaxis: Provide emergency medical treatment. (5.5)
- Injection site reactions (e.g., persistent atrophy, dimpling/indentation, and lump/nodule) have been reported. (5.10)
- Diabetics may be at greater risk of hyperglycemia. (5.12)
- Jaundice and elevated transaminase: Discontinue depo-subQ provera 104 if jaundice or elevated transaminase levels develop. (5.13)
ADVERSE REACTIONSMost common adverse reactions (incidence >5%) are dysfunctional uterine bleeding, headache, increased weight, amenorrhea, and injection site reactions. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSStrong CYP3A inhibitors and inducers: Avoid concomitant use. (7) USE IN SPECIFIC POPULATIONS- Nursing mothers: Detectable amounts of drug have been identified in the milk of mothers receiving depot-medroxyprogesterone acetate. (8.3)
- Pediatric patients (after menarche): Bone loss is a particular concern. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 12/2020 |