(medroxyprogesterone acetate)

Prescribing Information
Download Prescribing Information

Health Professional Information

Highlights

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.

•
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)

RECENT MAJOR CHANGES

Warnings and Precautions, Injection Site Reactions (5.10)

12/2024

INDICATIONS AND USAGE

Depo-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 STRENGTHS

Injectable 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, lump/nodule and discoloration) 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 REACTIONS

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.

DRUG INTERACTIONS

Strong CYP3A inhibitors and inducers: Avoid concomitant use. (7)

USE IN SPECIFIC POPULATIONS

•
Pregnancy: Discontinue if pregnancy occurs. (8.1)
•
Lactation: Detectable amounts of drug have been identified in the milk of mothers receiving depot-medroxyprogesterone acetate. (8.2)
•
Pediatric patients (after menarche): Bone loss is a particular concern. (8.4)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 12/2024

Medication Guide
Download Consumer Medicine Information

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Additional Resources

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.

Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.

Available 9AM-5PM ET Monday to Friday; excluding holidays.

 

Submit a medical question for a Pfizer medicine or a vaccine. 

The submission will be reviewed during our standard business hours.

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information: 
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.