Trelstar LA (Triptorelin Pamoate) - Indications and Dosage

INDICATIONS AND USAGE

TRELSTAR LA is indicated in the palliative treatment of advanced prostate cancer. It offers an alternative treatment for prostate cancer when orchiectomy or estrogen administration are either not indicated or unacceptable to the patient.

DOSAGE AND ADMINISTRATION

TRELSTAR LA Must Be Administered Under the Supervision of a Physician.

The recommended dose of TRELSTAR LA is 11.25 mg incorporated in a long acting formulation administered every 84 days as a single intramuscular injection administered in either buttock. The lyophilized microgranules are to be reconstituted in sterile water. No other diluent should be used. Reconstitute in accord with the following:

For TRELSTAR LA:

1. Using a syringe fitted with a sterile 20-gauge needle, withdraw 2 mL sterile water for injection, USP, and after removing the flip-off seal from the vial, inject into the vial.

2. Shake well to thoroughly disperse particles to obtain a uniform suspension. The suspension will appear milky.

3. Slowly withdraw the entire contents of the reconstituted suspension into the syringe.

4. Inject the patient in either buttock with the contents of the syringe.

For the TRELSTAR LA Clip'n'Ject^® single-dose delivery system, see adjacent INSTRUCTIONS FOR CLIP'N'JECT® USE section.

The suspension should be discarded if not used immediately after reconstitution.

As with other drugs administered by intramuscular injection, the injection site should be altered periodically.

HOW SUPPLIED

TRELSTAR LA (NDC 52544-154-02) is supplied in a single-dose vial with a flip-off seal containing sterile lyophilized triptorelin pamoate microgranules equivalent to 11.25 mg triptorelin peptide base, incorporated in a biodegradable copolymer of lactic and glycolic acids. A single dose vial of TRELSTAR LA contains triptorelin pamoate (11.25 mg as peptide base units), poly- d,l -lactide-co-glycolide (145 mg), mannitol, USP (85 mg), carboxymethylcellulose sodium, USP (30 mg), and polysorbate 80, NF (2 mg).

TRELSTAR LA (NDC 52544-154-76) is also supplied in the TRELSTAR LA Clip'n'Ject^® single-dose delivery system consisting of a vial with a flip-off seal containing sterile lyophilized triptorelin pamoate microgranules equivalent to 11.25 mg of triptorelin peptide base, incorporated in a biodegradable copolymer of lactic and glycolic acids, and a pre-filled syringe containing sterile water for injection, USP, 2 mL, pH 6 to 8.5.

When mixed with sterile water for injection, TRELSTAR LA is administered every 84 days as a single intramuscular injection.

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not freeze.

Rx only

Product No. 1120-02
Revised: August 2006

S0806

U.S. Patent Nos.: 5,134,122; 5,225,205; 5,192,741.

Clip'n'Ject and Flip-Off button are manufactured by and are registered trademarks of West Pharmaceutical Services, Inc.  Lionville, PA 19341 USA

Tyvek^® is a registered trademark of E.I. du Pont de Nemours and Company

Manufactured for:
Watson Pharma, Inc.
A subsidiary of Watson Pharmaceuticals, Inc.
Corona, CA 92880  USA
by: Debio RP
CH-1920 Martigny, Switzerland