Reconstituting Hexvix®

Hexvix packshot
* Nordic example shown, package may vary by country and region

Hexvix® reconstitution - 7 easy steps

step 1

Fasten the plunger rod into the rubber stopper of the syringe by turning the plugger rod clockwise until it stops.

step 2

Remove the blue cap of the powder vial

Penetrate the stopper of the powder vial with the Mini-Spike transfer device

Remove the cap from the syringe and keep it for later use

Hold the syringe upright and carefully press the plunger rod upward to remove air

step 3

Connect the syringe to the Mini-Spike transfer device

Inject about 10 ml of the solvent into the powder vial

The vial should be about ¾ full

step 4

Without withdrawing the Mini-Spike from the vial, hold the powder vial and the syringe in a firm grip

Shake gently to ensure complete dissolution

step 5

Withdraw all of the dissolved solution from the powder vial into the syringe

step 6

Disconnect the empty vial and Mini-Spike transfer device from the syringe

Plug the syringe with the syringe cap

Gently mix the contents of the syringe

Hexvix is now reconstituted and ready for use

The appearance of the reconstituted solution is clear to slightly opalescent, and colorless to pale yellow

step 7

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-Lock

Gently instill 50ml of Hexvix into the bladder

Hexvix® reconstitution – additional notes11

note 1
note 2
note 3

Tips and tricks

OBSERVATION
CAUSE
SOLUTION
VISUAL

Weak fluorescence

  • Equipment failure or
  • Blood in the bladder or
  • Inadequate time or
  • Air bubbles or
  • Concealed tumours
  • Make sure equipment is working and connected properly
  • If blood is present, remove resectoscope and flush using a bladder syringe attached to the trocar
  • Ensure that Hexvix® was instilled 1 hour prior to cystoscopyr
  • Remove any air bubbles
  • Look behind any folds
tip 1

No fluorescence

 
  • The equipment has not been set up correctly or
  • Blue Light is not activated
  • No malignant activated lesions
  • Ensure you are using correct equipment; look for blue or violet marker
  • Make sure Hexvix® has been instilled, and check for fluorescence in bladder neck
  • Inspect light source; original light bulb?
tip 2

Green hue

 
  • Urine in the bladder
  • Always drain the bladder at start of the procedure
  • Remove resectoscope, set trocar valve to exit position, and allow urine to drain passively
tip 3

Entire bladder appears red under white and blue light

 
  • Recent Bacillus Calmette-Guerin treatment or inflammation
  • If clinically feasible, avoid BLC® with Hexvix®/Cysview® until 6 weeks after last BCG treatment and in patients with bladder infection
  • Either continue procedure without the benefit of Blue Light diagnosis or reschedule
tip 4

Photo bleaching

 
  • Prolonged use of blue light
  • Blue light too close to lesion during procedure
  • Alternate between white light and blue light. If the tumour is visible in white light, use BLC® with Hexvix®/Cysview® for control after resection
  • Do not use Blue Light close to the tumour for extended time periods. If photo bleaching appears, shut off the blue light and work elsewhere
  • Mark small lesions early during procedure
tip 5

Uncertainty around a large pink/red area

 
 

Direct scope 90° toward lesion. Fill bladder slightly. Stretch area with loop and see if it disappears

Questions:

Has a cytology been taken? Were bacterial cultures taken? Has patient used catheter for longer periods?

Is CIS suspected?Cold cup biopsy and no fulguration

Did the patient have a positive urine cytology? Treat as carcinoma in situ

tip 6

Trouble finding orifice or suspicion that orifice might have been resected

 
 
Switch to Blue Light and wait in suspected area; you might see a green cloud emerging because urine appears fluorescent green under blue light
tip 7

Resection management in White Light

resection management

Images courtesy of Professor Malmström, Uppsala University

resection management 2

To avoid false-negative diagnoses
Ensure adequate time after instillation of Hexvix®

Pink fluorescence on bladder neck should always be seen if the instillation was administered properly

resection management 3

Images courtesy of Dr. Sia Daneshmand, Keck Hospital, USC

Bladder neck
Fluorescence is considered normal and not necessarily tumour

resection management 4

Health Economics

Hexvix® is cost effective in the treatment and management of NMIBC8,22

  • Hexvix® and single shot mitomycin (MMC) led to a reduction in the number of TURBTs and patients requiring in-hospital admission compared to WLC27
  • Reduction in the cost burden of NMIBC in terms of further management (follow-up repeated TURBTs) and treatment (chemotherapy instillation, BCG instillation, cystectomy)8
  • Bladder cancer has the highest lifetime treatment cost per patient of all cancers24,25,26
  • Use local Budget Impact Models, Value Dossiers and other Health Economics tools as appropriate references when creating your health economics messaging for your market
  • The key is to highlight the core items in the diagram opposite “Hexvix® reduces the cost burden of bladder cancer treatment versus WLC alone8

The use of Hexvix® to assist primary TURBT is more expensive than WLC alone

  • Hexvix® combined with single shot mitomycin (MMC) led to a reduction in the number of TURBTs and patients requiring in-hospital admission compared to WLC27
  • Reduction in the cost burden of NMIBC in terms of further management (follow-up repeated TURBTs) and treatment (chemotherapy instillation, BCG instillation, cystectomy)8
  • Bladder cancer has the highest lifetime treatment cost per patient of all cancers26

Hexvix® use led to reduced healthcare costs8

health economics

Guidelines

When should I use Hexvix®

All major international NMIBC guidelines contain guidance on Hexvix® use and should be consulted16-28

Hexvix® use is covered in AUA, EAU, NCCN, NICE, AFU, and amongst other major international and national NMIBC guidelines

Hexvix® should be used for the first TURBT and for all intermediate and high-risk patients, during surgical treatment and surveillance/follow-up2,8,9

EORTC risk categories - basis for stratification of treatment and follow-up14

eortc risk categories

 

Bladder cancer

Bladder Cancer Background

Bladder Cancer is the fourth most prevalent cancer for both sexes in Europe and North America.29

  • There are about 940,000 prevalent cases for both sexes of bladder cancer in Europe and North America29
  • In males Bladder Cancer is the third most prevalent cancer30
  • GLOBOCAN estimates an incidence 288,794 (new cases)31 in Europe and North America

bladder cancer both sexes

bladder cancer world view

Bladder cancer males

Incidence and mortality of bladder cancer is particularly high in Europe and North America32

Incidence and mortality

33. Datamonitor Report “Bladder Cancer: Disease Coverage” Downloaded on January 2019.

incidence and mortality 2

Risk factors

risk factor 1
The major risk factor for bladder cancer is smoking, which is estimated to account for 50–65% of cases in males and 20–35% of cases in females33
risk factor 2
Additionally several environmental carcinogens are thought to influence bladder cancer susceptibility16

Bladder cancer tumor classification

  • Non-muscular invasive bladder cancer (NMIBC) includes the subtypes:
    34. Anastasiadis et al. Ther Adv Urol 2012; 4(1):13-32. tumor classification
  • Approximately 75% of patients with BC present with a disease confined to the mucosa (stage Ta, CIS) or submucosa (stage T1)16
  • T1 and CIS, as compared to Ta, have high malignant potential16
  • CIS is the hardest of all tumors to detect

tumor classification 2

CIS – Carcinoma in Situ

CIS simply isn’t visible in half of cases observed13

The mere presence of CIS more than doubles the risk of progression14

CIS is a high grade carcinoma with potential for invasion and metastases13

carcinoma in situ

 

High-recurrence rates

Bladder cancer is associated with high-risk of recurrence14

high recurrence rates

High economic cost of treatment


Bladder cancer is expensive to manage14,35,36

Bladder cancer has the highest lifetime treatment cost per patient of all cancers14,35,36

High rate of incomplete TURBTs

High rate of residual tumor after Transurethral Resection of Bladder Tumor (TURBT), 34% - 76% of patients have evidence of
tumor on repeat TURBT at 2-6 weeks35,36,37

High unmet need

Comparatively little evolution in the 5-year relative survival rate for Bladder cancer versus other cancers since 197538

High recurrence rate and risk of progression requires frequent and
lifetime follow-up with:

  • Multiple cystoscopies
  • TURBTs
  • Instillation therapy
  • For more information please refer to the Patient Burden Section

high unmet need