|
abarelix Classification |
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| IM | 2 days | 3 days (blood level) | 1 mo* |
Observe patient for at least 30 min following injection for immediate-onset systemic allergic reactions (urticaria, pruritus, hypotension, syncope). Treat symptomatically; if hypotension or syncope occur measures such as leg elevation, oxygen, IV fluids, antihistamines, corticosteroids, and epinephrine should be used. Risk of reaction increases with duration of treatment.Lab Test Considerations:
Measure serum total testosterone concentrations just prior to administration on Day 29 and every 8 wk thereafter. Overall effectiveness may decrease with increased duration of therapy
May cause ↑ serum AST and ALT levels. Monitor serum transaminase levels prior to and periodically during therapy.Monitor serum PSA levels periodically during therapy.May cause slight ↓ in hemoglobin.May cause ↑ in serum triglycerides.May cause ↓ in bone mineral density.Abarelix should be prescribed only by physicians enrolled and qualified by the Plenaxis User Safety Program.IM: Prior to reconstitution, shake vial. Hold vial at 45° angle and tap lightly on table to break up any caking. Using enclosed 18 gauge needle and 3 cc syringe, withdraw 2.2 ml of 0.9% NaCl. Discard remaining diluent. With vial upright, insert needle all the way into vial and inject diluent quickly. Before withdrawing needle, remove 2.2 ml of air. Shake vial immediately for approximately 15 seconds. Allow vial to stand for approximately 2 min. Tap vial to reduce foaming and swirl vial occasionally. Do not reinject air into vial. Locate a second injection spot on stopper and insert the 18 gauge needle. Invert vial and draw up some of the suspension into syringe and reinject into remaining solids in vial without removing needle. Repeat until all solids are dispersed. Swirl vial before withdrawal and withdraw entire contents (at least 2 ml) by positioning needle in vial at a 45° angle. Pull the plunger back to recover residual suspension in needle, then exchange needle with the enclosed 22 gauge 1 1/2 inch injection needle. Administer the entire reconstituted suspension IM immediately. Must be administered within 1 hr of reconstitution.Inform patient of purpose and risks of abarelix.May cause dizziness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.Advise patient to notify physician immediately if symptoms of immediate-onset systemic allergic reaction occur.Decreased serum testosterone levels resulting in suppressed spread of metastatic prostate cancer, with decreased neurologic complications, bladder outlet obstruction and need for opioid analgesics.