Trelstar

TRELSTAR- triptorelin pamoate injection, powder, lyophilized, for suspension
TRELSTAR- triptorelin pamoate
Watson Pharma, Inc.

1 INDICATIONS AND USAGE

TRELSTAR is indicated for the palliative treatment of advanced prostate cancer [see Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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.

2.3 Reconstitution Instructions for TRELSTAR with MIXJECT SYSTEM

Please read the instructions completely before you begin.

TRELSTAR MIXJECT diagram.
(click image for full-size original)

TRELSTAR MIXJECT diagram.

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

TRELSTAR MIXJECT Activation instructions.
(click image for full-size original)

TRELSTAR MIXJECT Activation instructions.

3 DOSAGE FORMS AND STRENGTHS

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

4 CONTRAINDICATIONS

4.1 Hypersensitivity

TRELSTAR is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH [see Warnings and Precautions (5.1 )].

4.2 Pregnancy

TRELSTAR may cause fetal harm when administered to a pregnant woman. Expected hormonal changes that occur with TRELSTAR treatment increase the risk for pregnancy loss and fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1) ]. TRELSTAR is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Anaphylactic shock, hypersensitivity, and angioedema related to triptorelin administration have been reported. In the event of a hypersensitivity reaction, therapy with TRELSTAR should be discontinued immediately and the appropriate supportive and symptomatic care should be administered.

5.2 Transient Increase in Serum Testosterone

Initially, triptorelin, like other GnRH agonists, causes a transient increase in serum testosterone levels. As a result, isolated cases of worsening of signs and symptoms of prostate cancer during the first weeks of treatment have been reported with GnRH agonists. Patients may experience worsening of symptoms or onset of new symptoms, including bone pain, neuropathy, hematuria, or urethral or bladder outlet obstruction [see Clinical Pharmacology (12.2)].

5.3 Metastatic Vertebral Lesions and Urinary Tract Obstruction

Cases of spinal cord compression, which may contribute to weakness or paralysis with or without fatal complications, have been reported with GnRH agonists. If spinal cord compression or renal impairment develops, standard treatment of these complications should be instituted, and in extreme cases an immediate orchiectomy considered.

Patients with metastatic vertebral lesions and/or with upper or lower urinary tract obstruction should be closely observed during the first few weeks of therapy.

5.4 Effect on QT/QTc Interval

Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications.

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