Uses
Prostate Cancer
Palliative treatment of advanced symptomatic prostate cancer. Considered alternative therapy when GnRH agonist therapy is not appropriate, orchiectomy is unacceptable to the patient, and ≥1 of the following are present: risk of neurologic compromise secondary to metastases, ureteral or bladder outlet obstruction secondary to local encroachment or metastatic disease, or severe bone pain from skeletal metastases that persists despite opiate analgesia.
Appears to be as effective as leuprolide (with or without bicalutamide) in achieving and maintaining medical castration, but associated with a more rapid achievement of medical castration and a lower incidence of testosterone surge.
Dosage and Administration
General
- Consult specialized references for procedures for proper handling and disposal of antineoplastics.
- Restricted distribution program (Plenaxis® PLUS) in effect due to risk of immediate-onset allergic reactions. (See Preparations.)
Administration
IM Administration
Administer by IM injection into the buttock.
Use aspiration to avoid inadvertent injection into a blood vessel.
Observe patient for at least 30 minutes after each dose for possible immediate-onset allergic reactions. (See Boxed Warning and also Hypersensitivity Reactions under Cautions.)
Reconstitution
Reconstitute powder just prior to administration.
Prior to reconstitution, shake vial gently (e.g., hold at 45° angle and tap lightly on table) to break up any caking.
To reconstitute, withdraw 2.2 mL of sodium chloride 0.9% (using 18-gauge 1½-inch needle) into 3-mL syringe (both provided by manufacturer). Quickly inject diluent into vial containing 113 mg of abarelix powder (while vial is upright) to yield a concentration of 50 mg/mL; before withdrawing needle, remove 2.2 mL of air. Immediately shake vial for approximately 15 seconds, then let stand for approximately 2 minutes. Tap vial to reduce foaming and occasionally swirl; repeat once.
To further disperse solid particles, locate second injection spot on vial stopper and insert 18-gauge 1½-inch needle without reinjecting air into vial. Invert vial and withdraw small amount of suspension into syringe; without removing needle, reinject suspension at any remaining solid particles. Repeat until all solid particles are dispersed.
Swirl vial (without removing needle) and withdraw entire contents (at least 2 mL); recover residual suspension in needle, then replace with 22-gauge 1½-inch Safety Glide® needle (provided by manufacturer) for administration.
Powder for injectable suspension does not contain preservative; administer immediately or within 1 hour following reconstitution.
Dosage
Adults
Prostate Cancer
IM
100 mg on days 1, 15, and 29 (week 4), and then every 4 weeks thereafter.
In clinical studies, most patients received therapy for at least 24 weeks. Efficacy beyond 12 months not established.
Special Populations
No special population dosage recommendations at this time.
Print
Email
Save
FDA Alerts
Drug Info Tools
Medicare's drug plans are subsidized by the US federal government and offered through insurers.
