DEPO-SUBQ PROVERA 104® Contraindications (medroxyprogesterone acetate) | Pfizer Medical Information - US

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4 CONTRAINDICATIONS

The use of depo-subQ provera 104 is contraindicated in the following conditions:

Active thrombophlebitis, or current or history of thromboembolic disorders, or cerebral vascular disease [see Warnings and Precautions (5.2)].
Known, suspected, or past malignancy of the breast [see Warnings and Precautions (5.3)].
Significant liver disease [see Warnings and Precautions (5.13)].
Known hypersensitivity to medroxyprogesterone acetate or any of the ingredients in depo-subQ provera 104 [see Warnings and Precautions (5.5)].
Undiagnosed vaginal bleeding [see Warnings and Precautions (5.11)].

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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-subQ provera 104 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-subQ provera 104 is indicated in females of reproductive age for:

Prevention of pregnancy and
Management of endometriosis-associated pain.

...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Depo-subQ provera 104 is only for subcutaneous administration and is only to be...

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3 DOSAGE FORMS AND STRENGTHS

Injectable suspension (104 mg/0.65 mL) in a single-dose pre-filled syringe, packaged with a 26-gauge × 3/8-inch Terumo SurGuard® needle.

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4 CONTRAINDICATIONS

The use of depo-subQ provera 104 is contraindicated in the following conditions:

Active thrombophlebitis, or current or history of thromboembolic disorders, or cerebral vascular...

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5 WARNINGS AND PRECAUTIONS

5.1 Loss of Bone Mineral Density

Use of depo-subQ provera 104 reduces serum estrogen levels and is associated with significant loss of bone...

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6 ADVERSE REACTIONS

The following important adverse reactions are described in more detail in other sections of the prescribing information:

Loss of bone mineral density [see...

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7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on Depo-subQ provera 104

Moderate or Strong...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

There is no use for depo-subQ provera 104 in pregnancy and therefore depo-subQ provera 104 should be discontinued during...

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11 DESCRIPTION

Depo-subQ provera 104 contains medroxyprogesterone acetate (MPA), a derivative of progesterone, as its active ingredient. MPA is a white to off-white, odorless crystalline powder that is stable in air and that...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Depo-subQ provera 104 inhibits the secretion of gonadotropins, which primarily prevents follicular maturation and...

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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 Studies

In three open label clinical studies, depo-SubQ provera 104 (104 mg given every three months subcutaneously), was...

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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 GFS. Depot...

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16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Depo-subQ provera 104 medroxyprogesterone acetate injectable suspension (104 mg/0.65 mL) is available in a...

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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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Pfizer Safety

To report an adverse event related to a Pfizer product 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 to report an adverse event related to a Pfizer product, please call Pfizer Medical Information 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.