Product Information

Description

TRELSTAR is indicated for the treatment of advanced prostate cancer [see Clinical Studies (14)].

TRELSTAR is a white to slightly yellow lyophilized cake.  When reconstituted, TRELSTAR has a milky appearance.  It contains a pamoate salt of triptorelin, a synthetic decapeptide agonist analog of gonadotropin releasing hormone (GnRH). The chemical name of triptorelin pamoate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-tryptophyl-L-leucyl-L-arginyl-L-prolylglycine amide (pamoate salt).  The empirical formula is C64H82N18O13 · C23H16O6 and the molecular weight is 1699.9. The structural formula is. The TRELSTAR products are sterile, lyophilized biodegradable microgranule formulations supplied as single dose vials.  Refer to Table 5 for the composition of each TRELSTAR product. When 2 mL sterile water is added to the vial containing TRELSTAR and mixed, a suspension is formed which is intended as an intramuscular injection.  TRELSTAR is available in a  vial plus a MIXJECT vial adapter, and a separate pre-filled syringe that contains sterile water for injection, USP, 2 mL.