Eligard

ELIGARD^® is indicated for the palliative treatment of advanced prostate cancer.

ELIGARD^® is administered

As with other drugs administered by subcutaneous injection, the injection site should vary periodically.  The specific injection location should be an area with sufficient soft or loose subcutaneous tissue.  In clinical trials, the injections were administered in the upper- or mid-abdominal area.  Avoid areas with brawny or fibrous subcutaneous tissue or locations that could be rubbed or compressed (i.e., with a belt or clothing waistband).

ELIGARD^® is an injectable suspension of leuprolide acetate available in a single-dose kit. The kit consists of a two-syringe mixing system, a sterile safety needle (Table 3), a desiccant, and a package insert for reconstitution and administration procedures. The syringes are packaged separately: Syringe A contains the ATRIGEL^® Delivery System and the Syringe B contains leuprolide acetate powder.  When reconstituted, ELIGARD^® is administered as a single dose.

No pharmacokinetic drug-drug interaction studies were conducted with ELIGARD^®.

ELIGARD^® is a sterile polymeric matrix formulation of leuprolide acetate, a GnRH agonist, for subcutaneous injection.  It is designed to deliver leuprolide acetate at a controlled rate over a one-, three-, four- or six-month therapeutic period.

Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular and ovarian steroidogenesis.  The analog possesses greater potency than the natural hormone.  The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:

ELIGARD^® is prefilled and supplied in two separate, sterile syringes whose contents are mixed immediately prior to administration.  The two syringes are joined and the single dose product is mixed until it is homogenous.  ELIGARD^® is administered subcutaneously, where it forms a solid drug delivery depot.

One syringe contains the ATRIGEL^® Delivery System and the other contains leuprolide acetate.  ATRIGEL^® is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable poly (DL-lactide-co-glycolide) (PLGH or PLG) polymer formulation dissolved in a biocompatible solvent, N-methyl-2-pyrrolidone (NMP).

Refer to Table 6 for the delivery system composition and reconstituted product formulation for each ELIGARD^® product.