Trelstar
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
TRELSTAR is indicated for the palliative treatment of advanced prostate cancer [see Clinical Studies (14)].
History
There is currently no drug history available for this drug.
Other Information
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:
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.
| Ingredients |
TRELSTAR |
TRELSTAR |
TRELSTAR |
| triptorelin pamoate |
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.
Sources
Trelstar Manufacturers
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Actavis Pharma, Inc.
![Trelstar (Triptorelin Pamoate) Injection, Powder, Lyophilized, For Suspension Trelstar (Triptorelin Pamoate) Kit [Actavis Pharma, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Trelstar | Actavis Pharma, Inc.
2.1 Dosing InformationTRELSTAR must be administered under the supervision of a physician.
TRELSTAR is administered by a single intramuscular injection in either buttock. Dosing schedule depends on the product strength selected (Table 1). The lyophilized microgranules are to be reconstituted in sterile water. No other diluent should be used.
Table 1. TRELSTAR Recommended Dosing Dosage 3.75 mg 11.25 mg 22.5 mg Recommended dose 1 injection every
4 weeks 1 injection every
12 weeks 1 injection every
24 weeksDue to different release characteristics, the dosage strengths are not additive and must be selected based upon the desired dosing schedule.
The suspension should be administered immediately after reconstitution.
As with other drugs administered by intramuscular injection, the injection site should be alternated periodically.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
2.2 Reconstitution Instructions for TRELSTARPlease read the instructions completely before you begin.
Wash your hands with soap and hot water and put on gloves immediately prior to preparing the injection. Place the vial in a standing upright position on a clean, flat surface that is covered with a sterile pad or cloth. Remove the Flip-Off® button from the top of the vial, revealing the rubber stopper. Disinfect the rubber stopper with an alcohol wipe. Discard the alcohol wipe and allow the stopper to dry. Using a syringe fitted with a sterile 21-gauge needle, withdraw 2 mL sterile water for injection, and inject into the vial. Shake well to thoroughly disperse particles to obtain a uniform suspension. The suspension will appear milky. Slowly withdraw the entire contents of the reconstituted suspension into the syringe. The suspension should be administered immediately after reconstitution. Inject the patient in either buttock with the contents of the syringe. 2.3 Reconstitution Instructions for TRELSTAR with MIXJECT SYSTEMPlease read the instructions completely before you begin.
MIXJECT Preparation
Wash your hands with soap and hot water and put on gloves immediately prior to preparing the injection. Place the sealed tray on a clean, flat surface that is covered with a sterile pad or cloth. Peel the cover away from the tray and remove the MIXJECT components and the TRELSTAR vial. Remove the Flip-Off button from the top of the vial, revealing the rubber stopper. Place the vial in a standing upright position on the prepared surface. Disinfect the rubber stopper with the alcohol wipe. Discard the alcohol wipe and allow the stopper to dry. Proceed to MIXJECT Activation.
MIXJECT Activation
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