Depo Provera
Description
Clinical
Indications
Side Effects
Warnings
OverDosage
Patient Info


INDICATIONS

AND USES

DEPO-PROVERA Contraceptive Injection is indicated ONLY for the prevention of pregnancy. To ensure that DEPO-PROVERA Contraceptive Injection is not administered inadvertently to a pregnant woman, 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. The efficacy of DEPO-PROVERA Contraceptive Injection depends on adherence to the recommended dosage schedule (see

DOSAGE AND ADMINISTRATION
). 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 Contraceptive Injection, the 12-month failure rate for the group of women treated with DEPO-PROVERA Contraceptive Injection 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 Contraceptive Injection, the efficacy of these contraceptive measures depends in part on the reliability of use. The effectiveness of DEPO-PROVERA Contraceptive Injection 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
Method
Lowest
Expected 		Typical
Injectable progestogen
  DEPO-PROVERA
0.3 0.3
Implants
  Norplant (6 capsules)
0.2 ** 0.2 **
Female sterilization
0.2 0.4
Male sterilization
0.1 0.15
Pill
  3
  Combined
0.1  
  Progestogen ONLY
0.5  
IUD
  3
  Progestasert
2  
  Copper T 380A
0.8  
Condom
2 12
Diaphragm
6 18
Cap
6 18
Spermicides
3 21
Sponge
   
  Parous women
9 28
  Nulliparous women
6 18
Periodic abstinence
  1-9 20
Withdrawal
4 18
No method
85 85
Source: Trussell et al 1
* Lowest expected - when used exactly as directed.
Typical - includes those not following directions exactly.
** from Norplant® package insert.

DOSAGE AND ADMINISTRATION

Both the 1 mL vial and the 1 mL prefilled syringe of DEPO-PROVERA Contraceptive Injection 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 Contraceptive Injection 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 Contraceptive Injection depends on adherence to the dosage schedule of administration.

HOW SUPPLIED

DEPO-PROVERA Contraceptive Injection (medroxyprogesterone acetate injectable suspension 150 mg/mL) is available as:

NDC 0009-0746-30     1 mL vial

NDC 0009-0746-34     5 × 1 mL vials

NDC 0009-0746-35     25 × 1 mL vials

NDC 0009-7376-01     1 mL prefilled syringe

NDC 0009-7376-02     6 × 1 mL prefilled syringes

NDC 0009-7376-03     24 × 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.
  2. Schwallie PC, Assenzo JR. Contraceptive use-efficacy study utilizing medroxyprogesterone acetate administered as an intramuscular injection once every 90 days. Fertil Steril. 1973; 24 :331-339.
  3. WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Breast cancer and depot-medroxyprogesterone acetate: a multi-national study. Lancet . 1991; 338 :833-838.
  4. WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Depot-medroxyprogesterone acetate (DMPA) and risk of epithelial ovarian cancer. Int J Cancer. 1991; 49 :191-195.
  5. WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Depot-medroxyprogesterone acetate (DMPA) and risk of liver cancer. Int J Cancer . 1991; 49 :182-185.
  6. WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Depot-medroxyprogesterone acetate (DMPA) and risk of invasive squamous-cell cervical cancer. Contraception. 1992; 45 :299-312.
  7. WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Depot-medroxyprogesterone acetate (DMPA) and risk of endometrial cancer. Int J Cancer. 1991; 49 :186-190.
  8. Surveillance, Epidemiology, and End Results: Incidence and Mortality Data, 1973-1977. National Cancer Institute Monograph, 57: June 1981. (NIH publication No. 81-2330).
  9. Gray RH, Pardthaisong T. In Utero exposure to steroid contraceptives and survival during infancy. Am J Epidemiol. 1991; 134 :804-811.
  10. Pardthaisong T, Gray RH. In Utero exposure to steroid contraceptives and outcome of pregnancy. Am J Epidemiol. 1991; 134 :795-803.
  11. Pardthaisong T, Gray RH, McDaniel EB, Chandacham A. Steroid contraceptive use and pregnancy outcome. Teratology. 1988; 38 :51-58.
  12. Van Deijk WA, Biljham GH, Mellink WAM, Meulenberg PMM. Influence of aminoglutethimide on plasma levels of medroxyprogesterone acetate: its correlation with serum cortisol. Cancer Treatment Reports . 1985; 69 :1, 85-90.
  13. Paul C, Skegg DCG, Spears GFS. Depot medroxyprogesterone (Depo-Provera) and risk of breast cancer. Br Med J . 1989; 299 :759-762.
  14. Skegg DCG, Noonan EA, Paul C, Spears GFS, Meirik O, Thomas DB. Depot Medroxyprogesterone Acetate and Breast Cancer: A Pooled Analysis from the World Health Organization and New Zealand Studies. JAMA . 1995; 273(10) :799-804.
Rx only  

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, Kalamazoo, MI 49001, USA
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