"The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
DOSAGE AND ADMINISTRATION
The suspension is intended for intramuscular administration only.
Endometrial Or Renal Carcinoma
Doses of 400 mg to 1000 mg of DEPO-PROVERA Sterile Aqueous Suspension per week are recommended initially. If improvement is noted within a few weeks or months and the disease appears stabilized, it may be possible to maintain improvement with as little as 400 mg per month. Medroxyprogesterone acetate is not recommended as primary therapy, but as adjunctive and palliative treatment in advanced inoperable cases including those with recurrent or metastatic disease.
Of the 349 subjects in a clinical study of Depo Provera in renal carcinoma, 30 percent were 65 and over, while 5 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
This product has been used primarily in post-menopausal women for the treatment of endometrial carcinoma. Clinical experience has not identified differences in safety or effectiveness between elderly and younger patients.
The effect of renal impairment on DEPO-PROVERA pharmacokinetics has not been studied.
DEPO-PROVERA Sterile Aqueous Suspension is available as 400 mg/mL in 2.5 mL vials.
NDC 0009-0626-01 2.5ml vial
Distributed by: Pharmacia & Upjohn Co., Division of Pfizer Inc., NY, NY 10017. Revised June 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/28/2016
Additional Depo-Provera Information
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