WARNING

Immediate-onset systemic allergic reactions, some resulting in hypotension and syncope, have occurred after administration of Plenaxis™. These immediate-onset reactions have been reported to occur following any administration of Plenaxis™, including after the initial dose. The cumulative risk of such a reaction increases with the duration of treatment (see WARNINGS). Following each injection of Plenaxis™, patients should be observed for at least 30 minutes in the office and in the event of an allergic reaction, managed appropriately.

Only physicians who have enrolled in the Plenaxis™ PLUS Program (Plenaxis™ User Safety Program), based on their attestation of qualifications and acceptance of prescribing responsibilities, may prescribe Plenaxis™ (See DOSAGE AND ADMINISTRATION and HOW SUPPLIED).

Plenaxis™ is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia.

The effectiveness of Plenaxis™ in suppressing serum testosterone to castrate levels decreases with continued dosing in some patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics). Effectiveness beyond 12 months has not been established. Treatment failure can be detected by measuring serum total testosterone concentrations just prior to administration on Day 29 and every 8 weeks thereafter (see WARNINGS).