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

  • 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

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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

  • 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

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