Trelstar Indications, Dosage, Storage, Stability - Triptorelin pamoate

Trelstar Indications, Dosage, Storage, Stability - Triptorelin pamoate

INDICATIONS

TRELSTAR^TM 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.

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

The recommended dose of TRELSTAR^TM 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^TM 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. The suspension should be discarded if not used immediately after reconstitution.

For the TRELSTAR^TM LA 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 LAÞ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 LA 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.

TRELSTAR^TM LA (NDC 0009-5215-01) 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^TM 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^TM LA (NDC 0009-5216-01) is also supplied in the TRELSTAR^TM LA Debioclip^TM 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 2 mL sterile water for injection, USP. When mixed with sterile water for injection, TRELSTAR^TM 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.

U.S. Patent No.: 5,134,122; 5,225,205; 5,192,741. ^TM Trademark, Manufactured for: Pharmacia & Upjohn Company Kalamazoo, MI 49001, USA, Manufactured by: Debio RP CH-1920 Martigny, Switzerland, August 2001

Rx only