DEPO PROVERA (MEDROXYPROGESTERONE ACETATE)

Depo-Provera (Medroxyprogesterone acetate)

Depo-Provera CI is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation

Prevention Of Pregnancy

Both the 1 mL vial and the 1 mL prefilled syringe of Depo-Provera CI should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension. The recommended dose is 150 mg of Depo-Provera CI every 3 months (13 weeks) administered by deep IM injection in the gluteal or deltoid muscle. Depo-Provera CI should not be used as a long-term birth control method (i.e. longer than 2 years) unless other birth control methods are considered inadequate. Dosage does not need to be adjusted for body weight [see Clinical Studies].

To ensure the patient is not pregnant at the time of the first injection, the first injection should be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breast-feeding; and if exclusively breast-feeding, ONLY at the sixth postpartum week. If the time interval between injections is greater than 13 weeks, the physician should determine that the patient is not pregnant before administering the drug. The efficacy of Depo-Provera CI depends on adherence to the dosage schedule of administration.

Side Effects

The following important adverse reactions observed with the use of Depo-Provera CI are discussed in greater detail in the Warnings and Precautions section (5):

• Loss of Bone Mineral Density [see WARNINGS AND PRECAUTIONS]
• Thromboembolic disease [see WARNINGS AND PRECAUTIONS]
• Breast Cancer [see WARNINGS AND PRECAUTIONS]
• Anaphylaxis and Anaphylactoid Reactions [see WARNINGS AND PRECAUTIONS]
• Bleeding Irregularities[see WARNINGS AND PRECAUTIONS]
• Weight Gain [see WARNINGS AND PRECAUTIONS]

CLINICAL TRIALS EXPERIENCE

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the two clinical trials with Depo-Provera CI, over 3,900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of Depo-Provera CI. The population studied ranges in age from 15 to 51 years, of which 46% were White, 50% Non-White, and 4.9% Unknown race. The patients received 150 mg Depo-Provera CI every 3-months (90 days). The median study duration was 13 months with a range of 1-84 months. Fifty-eight percent of patients remained in the study after 13 months and 34% after 24 months.

WARNING: This medication may cause serious bone loss. The risk of bone loss increases with the longer use of this medication. This bone loss may be permanent even after you stop using medroxyprogesterone injections. This medication should not be used for longer than 2 years unless other birth control methods will not work for you. The years of adolescence and early adulthood are important for your body to build healthy bones. Use of this medication may increase the risk of broken bones when you are older. Discuss with your doctor the risks and benefits of this medication and other birth control choices.

Keep all your medical/lab appointments. Your doctor may test your bone density while you are using this medication. Be sure to get enough vitamin D and calcium in your diet. Consult your doctor or pharmacist to determine whether you need calcium/vitamin D supplements to help keep your bones healthy.

Use of this medication does not protect you against sexually transmitted diseases (e.g., HIV, hepatitis B, gonorrhea). Consult your doctor or pharmacist if you have any questions.