DEPO-SUBQ PROVERA 104® Highlights

(medroxyprogesterone acetate)

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)

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, 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 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: 7/2024

Find DEPO-SUBQ PROVERA 104® medical information:

Find DEPO-SUBQ PROVERA 104® medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

DEPO-SUBQ PROVERA 104® Quick Finder

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)

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, 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 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: 7/2024
Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

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

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

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

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

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 call (800) 822-7967.