DEPO-PROVERA® CI Contraindications (medroxyprogesterone acetate injectable suspension, for intramuscular use) | Pfizer Medical Information - US

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4 CONTRAINDICATIONS

The use of Depo-Provera CI is contraindicated in the following conditions:

Known or suspected pregnancy or as a diagnostic test for pregnancy.
Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease [see Warnings and Precautions (5.2)].
Known or suspected malignancy of breast [see Warnings and Precautions (5.3)].
Known hypersensitivity to Depo-Provera CI (medroxyprogesterone acetate) or any of its other ingredients [see Warnings and Precautions (5.5)].
Significant liver disease [see Warnings and Precautions (5.7)].
Undiagnosed vaginal bleeding [see Warnings and Precautions (5.10)].

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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.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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WARNING: LOSS OF BONE MINERAL DENSITY

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...

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1 INDICATIONS AND USAGE

Depo-Provera CI is indicated for use by females of reproductive potential to prevent pregnancy.

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2 DOSAGE AND ADMINISTRATION

2.1 Prevention of Pregnancy

Both the 1 mL vial and the 1 mL prefilled syringe of Depo-Provera CI should be vigorously shaken just before...

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3 DOSAGE FORMS AND STRENGTHS

Sterile Aqueous suspension: 150mg/ml

Prefilled syringes are available packaged with 22-gauge × 1 1/2 inch Terumo® SurGuard™ Needles.

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4 CONTRAINDICATIONS

The use of Depo-Provera CI is contraindicated in the following conditions:

Known or suspected pregnancy or as a diagnostic test for pregnancy.
Active thrombophlebitis, or current or...

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5 WARNINGS AND PRECAUTIONS

5.1 Loss of Bone Mineral Density

Use of Depo-Provera CI reduces serum estrogen levels and is associated with significant loss of bone...

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6 ADVERSE REACTIONS

The following important adverse reactions observed with the use of Depo-Provera CI are discussed in greater detail in the Warnings and Precautions section (...

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7 DRUG INTERACTIONS

7.1 Changes in Contraceptive Effectiveness Associated With Co-Administration of Other Products

If a woman on hormonal contraceptives takes a...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Depo-Provera CI should not be administered during pregnancy. [See Contraindications...

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11 DESCRIPTION

Depo-Provera CI contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Depo-Provera CI (medroxyprogesterone acetate [MPA]) inhibits the secretion of gonadotropins which primarily...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

[See Warnings and Precautions, (5.3,...

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14 CLINICAL STUDIES

14.1 Contraception

In five clinical studies using Depo-Provera CI, the 12-month failure rate for the group of women treated with Depo-Provera CI...

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15 REFERENCES

Li CI, Beaber EF, Tang, MCT et al. Effect of Depo-Medroxyprogesterone Acetate on Breast Cancer Risk among Women 20 to 44 years of Age. Cancer Research 2012;72:2028–2035.
Paul C, Skegg DCG, Spears...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Depo-Provera CI is supplied in the following strengths and package configurations:

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17 PATIENT COUNSELING INFORMATION

"See FDA-approved patient labeling (Patient Information)."

Advise patients at the beginning of treatment that their menstrual cycle...

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Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), 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 either 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/medwatchor by calling
(800)-332-1088.