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

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

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.

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 medroxyprogesterone (Depo-Provera) and risk of breast cancer. Br Med J 1989; 299:759-62.

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

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.

DEPO-SUBQ PROVERA 104® Quick Finder

Pfizer samples (for eligible HCPs)

Requests for samples of prescription medications can be made by contacting Pfizer for Professionals at 1-800-505-4426 or by visiting the PfizerPro website www.pfizerpro.com.
Report an adverse event or concern about the quality of a Pfizer product

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.
If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly by visiting www.fda.gov/medwatch or by calling (800)-332-1088.
Assistance programs (for eligible patients)

Pfizer RxPathways connects eligible patients to a range of assistance programs that offer insurance support, co-pay help, and medicines for free or at a savings. Patients and physicians can contact RxPathways at (866) 706-2400 or visit the website for more information on these programs www.pfizerrxpathways.com.
Resources

Show All Hide All

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

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.

...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

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.

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on Depo-subQ provera 104

Moderate or Strong...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

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

Read more

Did you find an answer to your question? Yes No

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

[See Warnings and Precautions (5.3,...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

17 PATIENT COUNSELING INFORMATION

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

...

Read more

Did you find an answer to your question? Yes No

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

...

Read more

Did you find an answer to your question? Yes No

Did you find an answer to your question? Yes No

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985^*

*Contact Medical Information.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

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.