"The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for"...
In clinical trials using daily subcutaneous leuprolide acetate in patients with prostate cancer, doses as high as 20 mg/day for up to 2 years caused no adverse effects differing from those observed with the 1 mg/day dose. The adverse event profiles were similar in patients receiving one or two Viadur® (leuprolide acetate implant) implants.
- Viadur® (leuprolide acetate implant) is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components in Viadur® (leuprolide acetate implant) . Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature.2
- Viadur® (leuprolide acetate implant) is contraindicated in women and in pediatric patients and was not studied in women or children. Moreover, leuprolide acetate can cause fetal harm when administered to a pregnant woman. Major fetal abnormalities were observed in rabbits but not in rats after administration of leuprolide acetate throughout gestation. There were increased fetal mortality and decreased fetal weights in rats and rabbits. The effects on fetal mortality are expected consequences of the alterations in hormonal levels brought about by this drug. The possibility exists that spontaneous abortion may occur.
2. MacLeod TL et al. Anaphylactic reaction to synthetic luteinizing hormone-releasing hormone. Fertil Steril 1987; 48(3): 500-502.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/8/2011
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