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DEPO-PROVERA® CI Highlights (medroxyprogesterone acetate injectable suspension, for intramuscular use)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DEPO-PROVERA CI safely and effectively. See full prescribing information for DEPO-PROVERA CI.

DEPO-PROVERA CI (medroxyprogesterone acetate) injectable suspension, for intramuscular use

Initial U.S. Approval: 1959

WARNING: LOSS OF BONE MINERAL DENSITY

See full prescribing information for complete boxed warning.

  • Women who use Depo-Provera Contraceptive Injection (Depo-Provera CI) 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-Provera CI 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-Provera CI is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. (1, 5.1)

RECENT MAJOR CHANGES

Indications and Usage (1)12/2020

INDICATIONS AND USAGE

  • Depo-Provera CI is a progestin indicated for use by females of reproductive potential to prevent pregnancy. (1)

Limitations of Use:

The use of Depo-Provera CI is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. (1, 5.1)

DOSAGE AND ADMINISTRATION

  • The recommended dose is 150 mg of Depo-Provera CI every 3 months (13 weeks) administered by deep, intramuscular (IM) injection in the gluteal or deltoid muscle. (2.1)

DOSAGE FORMS AND STRENGTHS

  • Vials containing sterile aqueous suspension: 150 mg per mL (3)
  • Prefilled syringes: prefilled syringes are available packaged with 22-gauge × 1 1/2 inch Terumo® SurGuard™ Needles. (3)

CONTRAINDICATIONS

  • Known or suspected pregnancy or as a diagnostic test for pregnancy. (4)
  • Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease. (4)
  • Known or suspected malignancy of breast. (4)
  • Known hypersensitivity to Depo-Provera CI (medroxyprogesterone acetate or any of its other ingredients). (4)
  • Significant liver disease. (4)
  • Undiagnosed vaginal bleeding. (4)

WARNINGS AND PRECAUTIONS

  • Thromboembolic Disorders: Discontinue Depo-Provera CI in patients who develop thrombosis. (5.2)
  • Cancer Risks: Monitor women with a strong family history of breast cancer carefully. (5.3)
  • Ectopic Pregnancy: Consider ectopic pregnancy if a woman using Depo-Provera CI becomes pregnant or complains of severe abdominal pain. (5.4)
  • Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment. (5.5)
  • Liver Function: Discontinue Depo-Provera CI if jaundice or disturbances of liver function develop. (5.7)
  • Carbohydrate Metabolism: Monitor diabetic patients carefully. (5.12)

ADVERSE REACTIONS

Most common adverse reactions (incidence >5%) are: menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain >10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%. (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

Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of contraceptive drug products. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with Depo-Provera CI. (7.1)

USE IN SPECIFIC POPULATIONS

  • Nursing Mothers: Detectable amounts of drug have been identified in the milk of mothers receiving Depo-Provera CI. (8.3)
  • Pediatric Patients: Depo-Provera CI is not indicated before menarche. (8.4)

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

Revised: 12/2020

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