"The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for"...
(triptorelin pamoate) for Injectable Suspension
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.
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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