"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"...
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In rats subcutaneous administration of 250 to 500 times the recommended human dose, expressed on a per body weight basis, resulted in dyspnea, decreased activity, and local irritation at the injection site. There is no evidence at present that there is a clinical counterpart of this phenomenon. In early clinical trials with leuprolide acetate doses as high as 20 mg/day for up to two years caused no adverse effects differing from those observed with the 1 mg/day dose.
- LUPRON (leuprolide acetate injection) INJECTION is contraindicated in patients known to be hypersensitive to GnRH, GnRH agonist analogs or any of the excipients in LUPRON (leuprolide acetate injection) INJECTION: Reports of anaphylactic reactions to GnRH agonist analogs have been reported in the medical literature.
- LUPRON (leuprolide acetate injection) is contraindicated in women who are or may become pregnant while receiving the drug. LUPRON (leuprolide acetate injection) may cause fetal harm when administered to a pregnant woman. Therefore, the possibility exists that spontaneous abortion may occur if the drug is administered during pregnancy. If this drug is administered during pregnancy or if the patient becomes pregnant while taking any formulation of LUPRON (leuprolide acetate injection) , the patient should be apprised of the potential hazard to the fetus.
Last reviewed on RxList: 3/3/2011
This monograph has been modified to include the generic and brand name in many instances.
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