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

Contraindications, Pregnancy (4)

Removed 04/2024

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 x 1 1/2 inch Terumo® SurGuard™ Needles. (3)

CONTRAINDICATIONS

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%): 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

Pregnancy: Discontinue if pregnancy occurs. (8.1)
Lactation: Detectable amounts of drug have been identified in the milk of mothers receiving Depo-Provera CI. (8.2)
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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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.

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

Contraindications, Pregnancy (4)

Removed 04/2024

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 x 1 1/2 inch Terumo® SurGuard™ Needles. (3)

CONTRAINDICATIONS

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%): 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

Pregnancy: Discontinue if pregnancy occurs. (8.1)
Lactation: Detectable amounts of drug have been identified in the milk of mothers receiving Depo-Provera CI. (8.2)
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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