HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
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DEPO-SUBQ PROVERA 104® (medroxyprogesterone acetate)
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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.
DEPO-SUBQ PROVERA 104® Quick Finder
Highlights
Boxed Warning
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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Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
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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Warnings and Precautions
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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Adverse Reactions
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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Drug Interactions
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on Depo-subQ provera 104
Moderate or Strong...
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Use in Specific Populations
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
[See Warnings and Precautions (5.3,...
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Clinical Studies
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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References
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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How Supplied/Storage and Handling
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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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
...
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Report Adverse Event
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.
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.
(800)-332-1088.