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, in the risk/benefit assessment for women who use Depo-Provera CI long-term (see WARNINGS.) It is a long-term injectable contraceptive in women when administered at 3-month (13-week) intervals. Dosage does not need to be adjusted for body weight.

In five clinical studies using DEPO-PROVERA CI, the 12-month failure rate for the group of women treated with DEPO-PROVERA CI was zero (no pregnancies reported) to 0.7 by Life-Table method. Pregnancy rates with contraceptive measures are typically reported for only the first year of use as shown in Table 1. Except for intrauterine devices (IUD), implants, sterilization, and DEPO-PROVERA CI, the efficacy of these contraceptive measures depends in part on the reliability of use. The effectiveness of DEPO-PROVERA CI is dependent on the patient returning every 3 months (13 weeks) for reinjection.

Table 1
Lowest Expected and Typical Failure Rates*
Expressed as Percent of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use

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. To ensure the patient is not pregnant at the time of the first injection, the first injection MUST 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.

DEPO-PROVERA CI (medroxyprogesterone acetate sterile aqueous suspension

150 mg/mL) is available as:

NDC 0009-0746-30                         1 mL vial
NDC 0009-0746-35                         25 x 1 mL vials
NDC 0009-7376-01                         1 mL prefilled syringe
NDC 0009-7376-02                         6 x 1 mL prefilled syringes
NDC 0009-7376-03                         24 x 1 mL prefilled syringes

DEPO-PROVERA CI prefilled syringes are available packaged with 22-gauge x 1 ½ inch BD SafetyGlideTM Needles in the following presentations:

NDC 0009-7376-04                         1 mL prefilled syringe
NDC 0009-7376-05                         6 x 1 mL prefilled syringes
NDC 0009-7376-06                         24 x 1 mL prefilled syringes

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

REFERENCES

1. Trussell J, Hatcher RA, Cates W Jr, Stewart FH, Kost K. A guide to interpreting contraceptive efficacy studies. Obstet Gynecol. 1990; 76:558-567.

DEPO-PROVERA Contraceptive Injection 1 mL vials are manufactured by: Pharmacia & Upjohn Company Kalamazoo, MI 49001, USA
DEPO-PROVERA Contraceptive Injection 1 mL prefilled syringes are manufactured by: Pharmacia & Upjohn, N.V./S.A. Puurs, Belgium for: Pharmacia & Upjohn Company A subsidiary of Pharmacia Corporation Kalamazoo, MI 49001, USA Revised November 2004
FDA rev date: 10/28/2005

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