TRELSTAR^TM DEPOT 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.

TRELSTAR^TM DEPOT Must Be Administered Under the Supervision of a Physician.

The recommended dose of TRELSTAR^TM DEPOT is 3.75 mg incorporated in a depot formulation and is administered monthly as a single intramuscular injection. The lyophilized microgranules are to be reconstituted in sterile water. No other diluent should be used.

Reconstitute in accord with the following: For TRELSTAR^TM DEPOT :

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) Withdraw the entire content of the reconstituted suspension into the syringe and inject it immediately. 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.

For the TRELSTAR^TM DEPOT Debioclip^TM single-dose delivery system:

1. Remove the Tyvek® cover from the blister pack.

2. Remove the vial from its case. Remove the flip-off vial cover and place the vial in the vertical position.

3. Hold the lower part of the TRELSTAR^TM DEPOT Debioclip^TM and press it firmly onto the top of the vial (See Figure).

4. Hold firmly the syringe barrel. Push the finger grip in the direction of the vial as far as it will go (until you hear a click).

5. Take the plunger rod and screw it into the upper joint of the syringe.

6. Press the plunger rod to release the contents of the syringe into the vial.

7. Mix and withdraw the contents of the vial into the syringe.

8. Remove the syringe from the TRELSTAR^TM DEPOT Debioclip^TM.

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

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.

Dosage Adjustments: Patients with renal or hepatic impairment showed 2- to 4-fold higher exposure than young healthy males. The clinical consequences of this increase, as well as the potential need for dose adjustment, is unknown.

TRELSTAR^TM DEPOT (NDC 0009-7664-01) is supplied in a single-dose vial with a flip-off seal containing sterile lyophilized triptorelin pamoate microgranules equivalent to 3.75 mg triptorelin peptide base, incorporated in a biodegradable copolymer of lactic and glycolic acids. A single dose vial of TRELSTAR^TM DEPOT contains triptorelin pamoate (3.75 mg as peptide base units), poly-d,l-lactide-co-glycol-ide (170 mg), mannitol, USP (85 mg), carboxymethylcellulose sodium, USP (30 mg), and polysorbate 80, NF (2 mg).

TRELSTAR^TM DEPOT (NDC 0009-5219-01) is also supplied in the TRELSTAR^TM DEPOT Debioclip^TM single-dose delivery system consisting of a vial with a flip-off seal containing sterile lyophilized triptore-lin pamoate microgranules equivalent to 3.75 mg of triptorelin pep-tide base, incorporated in a biodegradable copolymer of lactic and glycolic acids, and a pre-filled syringe containing 2 mL sterile water for injection, USP.

When mixed with sterile water for injection, TRELSTAR^TM DEPOT is administered every 28 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]. U.S. Patent No.: 5,134,122; 5,225,205; 5,192,741. ^TMTrademark

Manufactured for: Pharmacia & Upjohn Company Kalamazoo, MI 49001, USA, Manufactured by: Debio RP, CH-1920 Martigny, Switzerland, 818 916 002 FDA Revision Date: 10/20/2005.

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