Source: FDA, National Drug Code (US) Revision Year: 2023
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 | 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 MIXJECT vial adapter, and a separate pre-filled syringe that contains sterile water for injection, USP, 2 mL.
| Dosage Forms and Strengths |
|---|
|
Injectable suspension: 3.75 mg, 11.25 mg, 22.5 mg. |
| How Supplied |
|---|
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TRELSTAR is supplied in the TRELSTAR MIXJECT single-dose delivery system consisting of a vial with a Flip-Off seal containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids, a MIXJECT vial adapter, and a pre-filled syringe containing sterile water for injection, USP, 2 mL. TRELSTAR 3.75 mg – NDC 74676-5902-1 (TRELSTAR 3.75 mg with MIXJECT single-dose delivery system) TRELSTAR 11.25 mg – NDC 74676-5904-1 (TRELSTAR 11.25 mg with MIXJECT single-dose delivery system) TRELSTAR 22.5 mg – NDC 74676-5906-1 (TRELSTAR 22.5 mg with MIXJECT single-dose delivery system) For all medical inquiries contact: Verity Pharma, Medical Affairs, 1-844-VERITY-1 (1-844-837-4891) Distributed By: Verity Pharmaceuticals, Inc., Ewing, NJ 08628 Manufactured By: Debiopharm Research & Manufacturing SA, CH-1920 Martigny, Switzerland MIXJECT is manufactured by: West Pharma. Services IL, Ltd., Ra’anana, Israel TRELSTAR and its design are registered trademarks of Verity Pharmaceuticals, Inc. |
| Drug | Countries | |
|---|---|---|
| TRELSTAR | Canada, United States |
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