HOW TO USE HEXVIX. A practical guide for preparation of Hexvix

Transcription

1 HOW TO USE HEXVIX A practical guide for preparation of Hexvix

2 IMPACT OF BLADDER CANCER Bladder cancer (BC) is the 4th most frequent cancer in men and 9th most in women in developed countries 1 The incidence of BC varies /100,000 (men) and 3.9/100,000 (women) in Western Europe 1. Ferlay J et al., GLOBOCAN 2008 v1.2, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 [Internet]. Lyon, France: International Agency for Research on Cancer; National Cancer Institute, SEER Cancer Stat Fact Sheets: Cancer of Urinary Bladder. seer.cancer.gov/statfacts/html/urinb.html, 10/25/2012

3 IMPACT OF BLADDER CANCER BC is classified in 1 : non-muscle-invasive BC (NMIBC, app. 70%) of which Ta are 70% T1 are 20% CIS are 10% muscle-invasive BC (MIBC, app. 30%) 1. Witjes JA et al. Eur Urol 2010; 57:

4 IMPACT OF BLADDER CANCER NMIBC is characterized by its biological behaviour of frequent recurrence and progression This results in1,2,3,4 repeated cystoscopies and TURBTs for the patient BC is one of the most expensive cancers to manage BC has the highest lifetime treatment costs per patient of all cancers 1. Avritscher EB et al., Clinical model of lifetime cost of treating bladder cancer and associated complications. Urology 2006; 68: Botteman et al.,the health economics of bladder cancer: a comprehensive review of the published literature.pharmacoeconomics 2003; 21: Sangar VK et al., The economic consequences of prostate and bladder cancer in the UK. BJU International 2005; 95: Sievert KD et al., Economic aspects of bladder cancer: what are the benefits and costs? World Journal of Urology 2009; 27:

5 PATIENT PATHWAY WITH HEXVIX BLUE- LIGHT TURBT Hexvix blue-light cystoscopy results in 1,2,3,4 improved detection of NMIBC improved removal of tumours during resection better staging better surgical outcome 1. Witjes JA et al. Eur Urol 2010; 57: Stenzl A et al. J Urol 2010: 184: Hermann GG et al. BJU Int 2011; 108: E Geavlete B et al BJU Int;

6 EQUIPMENT REQUIRED FOR PREPARATION AND ADMINISTRATION The Hexvix pack contains: 85mg hexaminolevulinate (as hexaminolevulinate hydrochloride), powder in a sterile colourless glass vial 50ml polypropylene vial containing solvent Other equipment you will need: 50ml Luer-Lok syringe Large gauge needle (16 to 19G or 1.2 mm) Luer-Lok adapter Disposable catheter Catheter pack Gloves Anaesthetic antiseptic lubricant

7 HOW TO PREPARE HEXVIX Withdraw 50ml of the solvent for Hexvix into a sterile 50ml syringe. The solvent is a clear, colourless solution. To facilitate the uptake, it is recommended to use a 16- or 19-gauge needle (or 1.2mm). All steps should be performed with sterile equipment and under aseptic conditions

8 HOW TO PREPARE HEXVIX Inject about 10ml of this solvent into the vial of Hexvix powder. Without withdrawing the needle from the vial, hold the powder vial and the syringe in a firm grip and shake gently to ensure complete dissolution. All steps should be performed with sterile equipment and under aseptic conditions

9 HOW TO PREPARE HEXVIX Withdraw all of the dissolved solution from the powder vial into the syringe. Gently mix the contents of the syringe. All steps should be performed with sterile equipment and under aseptic conditions

10 HOW TO PREPARE HEXVIX Hexvix is now reconstituted and ready for use. The appearance of the reconstituted solution is clear to slightly opalescent, and colourless to pale yellow 4

11 HEXVIX INSTILLATION Ensure that the bladder is completely empty prior to Hexvix instillation. Patients should be catheterised. Connect the syringe containing Hexvix to the catheter using Luer-Lok and gently instill 50ml of Hexvix into the bladder. 5

12 CONTACT TIME Patients should retain the fluid for approximately 1h. Do not start the examination earlier than 1h after instillation of Hexvix. If the patient did not retain Hexvix in the bladder for 1h, allow 1h to pass from the instillation of Hexvix into the bladder to the start of the cystoscopic examination. The examination can be performed up to 3h after instillation which allows flexibility Cysview TM prescibing information 2011

13 WHEN TO PREPARE HEXVIX? This medicinal product does not require any special storage conditions. After dilution with the solvent: From a microbiological point of view, the product should be used immediately. Chemical and physical stability of the solution has been demonstrated for 2h at 2 to 8 C. In-use storage times and conditions prior to use are the responsibility of the user. For single use only. Any unused product should be discarded.