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 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.