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Trelstar

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Trelstar

TRELSTAR®
(triptorelin pamoate) for Injectable Suspension

DRUG DESCRIPTION

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:

TRELSTAR® (triptorelin pamoate) Structural Formula Illustration

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 136 mg 118 mg 182 mg
mannitol, USP 69 mg 76 mg 68 mg
carboxymethylcellulose sodium, USP 24 mg 27 mg 24 mg
polysorbate 80, NF 1.6 mg 1.8 mg 1.6 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 two packaging configurations: (a) TRELSTAR vial alone or (b) TRELSTAR vial plus a MIXJECT vial adapter, and a separate pre-filled syringe that contains sterile water for injection, USP, 2 mL, pH 6 to 8.5.

Last reviewed on RxList: 3/27/2013
This monograph has been modified to include the generic and brand name in many instances.

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