Administering Trelstar® with MIXJECT®
Instructions for Use
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 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.
|1 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.||2 Disinfect the rubber stopper with the alcohol wipe. Discard the alcohol wipe and allow the stopper to dry.
Proceed to MIXJECT® Activation.
|1 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.||
2 A) Screw the plunger rod into the barrel end of the syringe. Remove the cap from the syringe barrel.
2 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.
|3 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-filled syringe into the vial. Do not release the plunger rod.||4 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 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.|
5 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 into the syringe.
5 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.
|6 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 suspension is now ready for administration. The suspension should be administered immediately after reconstitution.|
|7 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.|
- Trelstar® full Prescribing Information, Watson Pharma, Inc.
- Data on file, Watson Pharma, Inc. DEB-TRI6M-301 Clinical Study Report, May 2008.
- Lundström EA, Rencken RK, van Wyk JH, et al. Triptorelin 6-month formulation in the management of patients with locally advanced and metastatic prostate cancer: an open-label, non-comparative, multicentre, phase III study. Clin Drug Investig. 2009;29:757-765.
- Data on file. Watson Pharma, Inc. DEB-96-TRI-01 (first phase) Clinical Study Report; July 1999.
- Data on file. Watson Pharma, Inc. DEB-96-TRI-01 (second phase) Clinical Study Report; June 1999.
- Oefelein MG, Feng A, Scolieri MJ, Ricchiutti D, Resnick MI. Reassessment of the definition of castrate levels of testosterone: implications for clinical decision making. Urology. 2000;56:1021-1024.
- Morote J, Orsola A, Planas J, et al. Redefining clinically significant castration levels in patients with prostate cancer receiving continuous androgen deprivation therapy. J Urol. 2007;178:1290-1295.
- Heyns CF, Simonin M-P, Grosgurin P, Schall R, Porchet HC. Comparative efficacy of triptorelin pamoate and leuprolide acetate in men with advanced prostate cancer. BJU International. 2003;92:226-231.
Trelstar® is indicated for the palliative treatment of advanced prostate cancer.
Important Safety Information
The most commonly reported adverse events associated with the use of Trelstar® 22.5 mg included hot flushes (71.7%), erectile dysfunction (10.0%), and testicular atrophy (7.5%) • The most commonly reported adverse events associated with the use of Trelstar® 3.75 mg/Trelstar® 11.25 mg included hot flushes (58.6%/73.0%), skeletal pain (12.1%/13.2%), impotence (7.1%/2.3%), headache (5.0%/6.9%), leg pain (2.1%/5.2%), and edema in legs (0.0%/6.3%) • Trelstar® is contraindicated in women who are or may become pregnant as well as patients who are hypersensitive to triptorelin, other GnRH agonists, or GnRH • Anaphylactic shock, hypersensitivity, and angioedema related to triptorelin administration have been reported • Trelstar® causes an initial transient increase in testosterone levels. Patients may experience the onset or exacerbation of symptoms during this period, including bone pain, neuropathy, hematuria, urethral or bladder outlet obstruction, or spinal cord compression that may contribute to weakness or paralysis with or without fatal complications. Patients with metastatic vertebral lesions and/or urinary tract obstruction should be closely observed. Hyperglycemia and an increased risk of developing diabetes, as well as increased risk of myocardial infarction, sudden cardiac death, and stroke have been reported in men receiving GnRH analogs. Patients should be monitored for blood glucose level and cardiovascular disease, and managed according to current clinical practice
MIXJECT® is a registered trademark of Medimop Medical Projects Ltd.
Flip-Off® is a registered trademark of West Pharmaceutical Services, Inc.