TRELSTAR is indicated for the palliative treatment of advanced prostate cancer [see Clinical Studies].

Dosing Information

TRELSTAR must be administered under the supervision of a physician.

TRELSTAR is administered by a single intramuscular injection in either buttock. Dosing schedule depends on the product strength selected (Table 1). The lyophilized microgranules are to be reconstituted in sterile water. No other diluent should be used.

Table 1. TRELSTAR Recommended Dosinq

Due to different release characteristics, the dosage strengths are not additive and must be selected based upon the desired dosing schedule.

The suspension should be administered immediately after reconstitution.

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

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Reconstitution Instructions for TRELSTAR

Please read the instructions completely before you begin.

• Wash your hands with soap and hot water and put on gloves immediately prior to preparing the injection.
• Place the vial in a standing upright position on a clean, flat surface that is covered with a sterile pad or cloth.
• Remove the Flip-Off® button from the top of the vial, revealing the rubber stopper.
• Disinfect the rubber stopper with an alcohol wipe. Discard the alcohol wipe and allow the stopper to dry.
• Using a syringe fitted with a sterile 21-gauge needle, withdraw 2 mL sterile water for injection, and inject into the vial.
• Shake well to thoroughly disperse particles to obtain a uniform suspension. The suspension will appear milky.
• Slowly withdraw the entire contents of the reconstituted suspension into the syringe.
• The suspension should be administered immediately after reconstitution.
• Inject the patient in either buttock with the contents of the syringe.

Reconstitution Instructions for TRELSTAR with MIXJECT SYSTEM

Please read the instructions completely before you begin.

MIXJECT Preparation

Wash your hands with soap and hot water and put on gloves immediately prior to preparing the injection. Place the sealed tray on a clean, flat surface that is covered with a sterile pad or cloth. Peel the cover away from the tray and remove the MIXJECT components and the TRELSTAR vial. Remove the Flip-Off button from the top of the vial, revealing the rubber stopper. Place the vial in a standing upright position on the prepared surface. Disinfect the rubber stopper with the alcohol wipe. Discard the alcohol wipe and allow the stopper to dry. Proceed to MIXJECT Activation.

MIXJECT Activation

Peel the cover away from the blister pack containing the vial adapter. Do not remove the vial adapter from the blister pack. Place the blister pack containing the vial adapter firmly on the vial top, piercing the vial. Push down gently until you feel it snap in place. Remove the blister pack from the vial adapter.

(a) Screw the plunger rod into the barrel end of the syringe. Remove the cap from the syringe barrel.

(b) Connect the syringe to the vial adapter by screwing it clockwise into the opening on the side of the vial adapter. Be sure to gently twist the syringe until it stops turning to ensure a tight connection.

While holding the vial, place your thumb on the plunger rod and push the plunger rod in all the way to transfer the diluent from the pre-filied syringe into the vial. Do not release the plunger rod.

Keeping the plunger rod depressed, gently swirl the vial so that the diluent rinses the sides of the vial. This will ensure complete mixing of TRELSTAR (triptorelin pamoate for injectable suspension) and the sterile water diluent. The suspension will now have a milky appearance. In order to avoid separation of the suspension, proceed to the next steps without delay.

(a) Invert the MIXJECT system so that the vial is at the top. Grasp the MIXJECT system firmly by the syringe and pull back the plunger rod slowly to draw the reconstituted TRELSTAR (triptorelin pamoate for injectable suspension) into the syringe.

(b) Return the vial to its upright position, and disconnect the vial adapter and vial from the MIXJECT syringe assembly by turning the plastic cap of the vial adapter clockwise. Grasp only the plastic cap when removing.

Lift up the safety cover and remove the clear plastic needle shield by pulling it from the assembly. The safety cover should be perpendicular to the needle, with the needle facing away from you. The syringe containing the TRELSTAR (triptorelin pamoate for injectable suspension) suspension is now ready for administration. The suspension should be administered immediately after reconstitution. The suspension should be administered immediately after constitution.

After administering the injection, immediately activate the safety mechanism by centering your thumb or forefinger on the textured finger pad area of the safety cover and pushing it forward over the needle until you hear or feel it lock. Use the one-handed technique and activate the mechanism away from yourself and others. Activation of the safety cover causes virtually no splatter. Immediately discard the syringe assembly after a single use into a suitable sharps container.

Dosage Forms and Strengths

Injectable suspension: 3.75 mg, 11.25 mg, 22.5 mg.

TRELSTAR is supplied in a single dose vial with a Flip-Off seal containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids.

TRELSTAR is also supplied in the TRELSTAR MIXJECT single-dose delivery system consisting of a vial with a Flip-Off seal containing sterile lyophilized triptorelin pamoate microgranules incorporated in a biodegradable copolymer of lactic and glycolic acids, a MIXJECT vial adapter, and a pre-filled syringe containing sterile water for injection, USP, 2 mL, pH 6 to 8.5.

TRELSTAR 3.75 mg- NDC 52544-153-02 (single dose vial) and NDC 52544-189-76 (TRELSTAR 3.75 mg with MIXJECT single-dose delivery system)

TRELSTAR 11.25 mg- NDC 52544-154-02 (single dose vial) and NDC 52544-188-76 (TRELSTAR 11.25 mg with MIXJECT single-dose delivery system)

TRELSTAR 22.5 mg- NDC 52544-156-02 (single dose vial) and NDC 52544-092-76 (TRELSTAR 22.5 mg with MIXJECT single-dose delivery system)

Storage

Store at 20 - 25°C (68 - 77°F); [See USP Controlled Room Temperature.] Do not freeze TRELSTAR with MIXJECT.

Address medical inquiries to: WATSON Medical Communications P.O. Box 1953 Morristown, NJ 07962-1953 800-272-5525 Watson® Distributed By: Watson Pharma, Inc. Morristown, NJ 07962 USA Manufactured By: Debio RP CH-1920 Martigny, Switzerland MIXJECT is manufactured by and is a registered trademark of: Medimop Medical Projects Ltd. Ra'anana, Israel The pre-filled syringe containing sterile water for injection is manufactured by: Abbott Biologicals BV Olst, The Netherlands

Last reviewed on RxList: 6/30/2011
This monograph has been modified to include the generic and brand name in many instances.