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Trelstar

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Trelstar

Indications
Dosage
How Supplied

INDICATIONS

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

DOSAGE AND ADMINISTRATION

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 Dosing

Dosage 3.75 mg 11.25 mg 22.5 mg
Recommended dose 1 injection every 4 weeks 1 injection every 12 weeks 1 injection every 24 weeks

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.

TRELSTAR With MIXJECT SYSTEM - Illustration

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

MIXJECT Activation - Illustration

HOW SUPPLIED

Dosage Forms And Strengths

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

Storage And Handling

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.

Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054 USA. Manufactured By: Debio RP, CH-1920 Martigny, Switzerland. MIXJECT is manufactured by: 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. For all medical inquiries contact: ACTAVIS Medical Communications, Parsippany, NJ 07054 USA. 800-272-5525. Revised: July 2014.

Last reviewed on RxList: 11/24/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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