(medroxyprogesterone acetate injectable suspension, for intramuscular use)

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Highlights

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.

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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)
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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)
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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

Contraindications, Pregnancy (4)

Removed 04/2024

INDICATIONS AND USAGE

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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

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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

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

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

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

ADVERSE REACTIONS

Most common adverse reactions (incidence >5%): menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain >10 lb 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

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Pregnancy: Discontinue if pregnancy occurs. (8.1)
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Lactation: Detectable amounts of drug have been identified in the milk of mothers receiving Depo-Provera CI. (8.2)
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Pediatric Patients: Depo-Provera CI is not indicated before menarche. (8.4)

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

Revised: 7/2024

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