Abarelix (Discontinued manufacturer 5/2005)
- Hypersensitivity reactions: Immediate-onset systemic allergic reactions, some resulting in hypotension and syncope, have occurred after the administration of abarelix. These reactions have been reported to occur following any administration of the drug, including after the initial dose. The cumulative risk of such a reaction increases with the duration of treatment.
- Patients should be observed for AT LEAST 30 minutes following each injection 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.
- This drug is indicated for the pallative 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 metastatses persisting on narcotic analgesia.
- The effectiveness of Plenaxis in suppressing serum testosterone to castrate levels decreases with continued dosing in some patients. 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.
Note: This drug was voluntarily discontinued by the manufacturer 5/2005.
Updated January 2018