HIGHLIGHTS OF PRESCRIBING INFORMATION
These 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 DENSITY
See full prescribing information for complete boxed warning.
INDICATIONS AND USAGE
Depo-subQ provera 104 is a progestin that is indicated in females of reproductive age for:
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
DOSAGE FORMS AND STRENGTHS
Injectable suspension: 104 mg/0.65 mL (3)
WARNINGS AND PRECAUTIONS
Most 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.
Strong CYP3A inhibitors and inducers: Avoid concomitant use. (7)
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.