triptorelin pamoate - Generic Medications

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 C 64 H 82 N 18 O 13 · C 23 H 16 O 6 and the molecular weight is 1699.9. The structural formula is: Structural formula for TRELSTAR (triptorelin pamoate). 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. Table 5. TRELSTAR Composition Ingredients TRELSTAR 3.75 mg TRELSTAR 11.25 mg TRELSTAR 22.5 mg triptorelin pamoate (base units) 3.75 mg 11.25 mg 22.5 mg poly- d,l -lactide-co-glycolide 138 mg 120 mg 183 mg mannitol, USP 71 mg 74 mg 74 mg carboxymethylcellulose sodium, USP 25 mg 26 mg 26 mg polysorbate 80, NF 1.7 mg 1.7 mg 1.7 mg 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 vial adapter, and a separate pre-filled syringe that contains sterile water for injection, USP, 2 mL.