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DEPO-SUBQ PROVERA 104®Index Section (medroxyprogesterone acetate)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: LOSS OF BONE MINERAL DENSITY

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

2.2 Switching from Another Method of Contraception

2.3 Preparation and Administration Instructions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Loss of Bone Mineral Density

5.2 Arterial and Venous Thromboembolic Disorders

5.3 Cancer Risks

5.4 Ectopic Pregnancy

5.5 Anaphylaxis

5.6 Fluid Retention

5.7 Weight Gain

5.8 Delayed Return of Ovulation or Fertility

5.9 Depression

5.10 Injection Site Reactions

5.11 Bleeding Irregularities

5.12 Risk of Hyperglycemia in Patients with Diabetes

5.13 Jaundice and Elevated Transaminase

5.14 Protection Against Sexually Transmitted Infections

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on Depo-subQ provera 104

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Contraception Studies

14.2 Endometriosis Studies

14.3 Bone Mineral Density in Women Treated with Depo-medroxyprogesterone acetate for Contraception

14.4 Bone Mineral Density Changes in Adolescent Females (12 to 18 years of age) Treated with DMPA-IM

14.5 Bone Fracture Incidence in Women Treated with Depo-medroxyprogesterone acetate for Contraception

14.6 Bone Mineral Density in Women Treated with Depo-subQ provera 104 for Endometriosis

15. REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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