Trelstar LA

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 l.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 precautions when taking triptorelin pamoate (Trelstar LA)?

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, 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. Limit alcoholic...

Read All Potential Precautions of Trelstar LA »


Trelstar LA Consumer (continued)

SIDE EFFECTS: See also the How to Use section.

Hot flashes (flushing), decreased sexual interest/ability, shrinking of the testicles, and breast tenderness/swelling may occur as a result of lowered testosterone levels. Dizziness and headache may also occur with this drug. If any of these effects bother you, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: bone/joint/unusual pain, easily broken bones, swelling of the ankles/feet, unusual weakness, inability to move (paralysis), increased thirst, unusual change in the amount of urine.

Get medical help right away if any of these rare but serious side effects occur: chest discomfort/pain, irregular heartbeat, weakness on one side of the body, slurred speech.

Rarely, a serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first dose of this medication. Get medical help right away if any of these serious side effects occur: sudden severe headache, mental/mood changes (such as confusion), vision changes, vomiting, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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, 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. Limit alcoholic beverages.

Females: Triptorelin is not usually used by women. It must not be used by pregnant women because it may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. Breast-feeding is also not recommended during triptorelin treatment. Consult your doctor for more details and before breast-feeding, and to discuss reliable forms of birth control.



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