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Trelstar Depot

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Trelstar Depot

TRELSTAR®
(triptorelin pamoate) for Injectable Suspension

Trelstar Depot

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) 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-co­glycolide 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.

What are the possible side effects of triptorelin (Trelstar Depot, Trelstar Depot Mixject, Trelstar LA, Trelstar LA Mixject)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect. Some of these side effects are symptoms of prostate cancer that may occur because the medicine raises your testosterone levels:

  • painful or difficult urination, burning when you urinate, blood in the urine;
  • bone pain;
  • numbness, tingling, or muscle weakness...

Read All Potential Side Effects and See Pictures of Trelstar Depot »

What are the precautions when taking triptorelin pamoate (Trelstar Depot)?

Before using triptorelin, tell your doctor or pharmacist if you are allergic to it; or to other LHRH-type drugs (such as leuprolide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, personal or family history of weak/broken bones (osteoporosis), diabetes, heart disease (such as heart attack), stroke, high cholesterol, family history of sudden cardiac death.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely....

Read All Potential Precautions of Trelstar Depot »

Last reviewed on RxList: 6/28/2011
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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