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How-to Guide
Cysview Media Turnkey Kit
5/2012 Page 1
How to Use the Cysview® (hexaminolevulinate HCl) Media Turnkey Kit
This document is designed to help you and your institution raise awareness of the
availability of Cysview® (hexaminolevulinate HCl) at your location. Cysview is an optical
imaging agent indicated for the detection of non-muscle invasive papillary cancer of
the bladder in patients with known or suspected bladder cancer.
The Cysview Media Turnkey Kit is a collection of customizable materials that you can
distribute to local media outlets and use internally as a means to position your
institution on the cutting edge of medical centers that use the latest cancer-detection
technology.
The customized version of these materials will need to be reviewed and approved in
advance of distribution by Photocure. After you customize these materials, please
submit them to Ambaw Bellete, Head, and US Cancer Commercial Operations of
Photocure at [email protected]
This Media Turnkey Kit consists of the following materials:
·
Letter to Referral Physicians
·
Template press release
Letter to PCPs
In addition to informing the media, your institution may also want to make local
primary care physicians (PCPs) aware of the availability of Cysview in the local area.
The letter also encourages PCPs to refer their patients to undergo Cysview cystoscopy
at your institution, and to visit your facility to see Cysview in action.
Template Press Release
A press release is a specific type of document sent to media to inform them of local,
regional or national news that may be of interest to their audience. It is used to
generate reporters' interest in your story and must follow a specific format.
The template press release included in the Cysview Media Turnkey Kit is intended to
give the media a brief explanation of Cysview and its functions. It is written to be
customized by you with specific information about your facility. It includes
placeholders for your organization's name, the dateline, and the contact information
for the person at your institution who will be responsible for coordinating media
interviews. It also includes examples of quotes for your organization's spokesperson,
as well as placeholders for that person’s name and title. After you develop your
template press release it will need to be reviewed and approved by Photocure before
distribution.
Ideally, the individual you select as your spokesperson should be a physician (urooncologist) with direct experience or familiarity with Cysview. Other spokespersons
may include your institution’s CEO, medical director, a department head, or an
administrator. You may choose to include quotes from more than one spokesperson,
as this will enhance the credibility of the press release. Review the quotes, or generate
them with each spokesperson, and edit them as necessary based on each
spokesperson’s input and feedback.
How-to Guide
Cysview Media Turnkey Kit
5/2012 Page 2
When the news release has been completed, reviewed and approved by the
appropriate people at your institution, the next step is to format it on your
institution’s letterhead using a similar double-spaced configuration. The final step is
to ensure that the news release has been reviewed and approved by Photocure.
Risk & Safety Information
The risk and safety information should be used to explain the risks associated with the
use of Cysview to patients. Patients should understand all product risk information
prior to receiving Cysview.
Important Risk and Safety Information about Cysview
Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of
bladder cancer and is not for repetitive use.
Anaphylaxis reactions including anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis,
and abnormal urinalysis have been reported after administration of Cysview. The most common adverse
reactions seen in clinical trials were bladder spasm, dysuria, hematuria, and bladder pain.
Cysview should not be used in patients with porphyria, gross hematuria, or with known hypersensitivity to
hexaminolevulinate, or in patients receiving intravesical chemotherapy or BCG treatment within 3 months
of Cysview photodynamic blue-light cystoscopy. There are no known drug interactions with
hexaminolevulinate; however, no specific drug interaction studies have been performed. Using Cysview,
fluorescence of non-malignant areas may occur, and Cysview may fail to detect some malignant lesions.
Safety and effectiveness have not been established in pediatric patients. Cysview should only be used
during pregnancy if the potential benefit justifies the potential risk to the fetus. It is not known whether
hexaminolevulinate is excreted in human milk. Because many drugs are excreted in human milk, exercise
caution when Cysview is administered to nursing mothers. No clinically important differences in safety or
efficacy have been observed between older and younger patients.
Cysview is approved for use with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system. For
system set up and general information for the safe use of the PDD system, please refer to the Karl Storz
instruction manuals for each of the components.
Prior to Cysview administration, read the Full Prescribing Information and follow the preparation and
reconstitution instructions.
Other Considerations for Using this Kit
Here are some additional tips for maximizing the impact and effectiveness of the
Cysview Media Turnkey Kit materials:
Distributing media materials: Once your press release, media advisory, or other
materials have been edited, approved, and printed on your letterhead, you are ready
to send them to your target media.
You should first call the media outlets you're targeting and ask for the editor or
reporter to whom medical or healthcare-related information should be directed. Be
sure to find out how your media contacts prefer to receive press materials, whether
by mail, e-mail, or fax. The larger the media outlet, the busier reporters and editors
tend to be, and the more particular they may be with regard to how they want to
receive news-related information. Ask if they would appreciate a “heads-up” when a
release is on its way, or a follow-up call to gauge the reporter’s interest.
How-to Guide
Cysview Media Turnkey Kit
5/2012 Page 3
Photograph: Sending a photograph with your press release will increase the chances
that a print publication will cover your story. Enclosed in the Kit is a photo of the
Cysview product to accompany your press release. If you decide to take your own
photo of a patient (or a model) being scanned, be sure to have the patient or model
How-to Guide
Cysview Media Turnkey Kit
5/2012 Page 4
sign a consent form, which grants permission to take and use the photo for
promotional purposes. You may wish to check with your institution’s legal staff to
ensure that the consent form is worded appropriately. The photograph also may be
accompanied by an image of how the bladder appears with and without the use of
Cysview.
Spokesperson preparation: If a media outlet is interested in your press release, it could be
used as a basis for an article or feature story. Be sure to have a spokesperson briefed
and ready to be interviewed. If possible, try to get a sense of the kinds of questions the
reporter may ask, and work with your spokesperson to prepare answers to those
questions.
Site visit invitation: Editors and reporters may want a first-hand look at how Cysview
works. Feel free to invite them to visit your facility for a tour, and have your
spokesperson available to meet with them.
Follow up: It is always gratifying when a local media outlet reports on your story. After
the story appears, send the editor a thank-you note. This will help you develop an
ongoing relationship with that reporter, which will be helpful for future news
announcements coming from your institution.
Letter to R e f e r r a l Physicians
Cysview Media Turnkey Kit
5/2012
Page 1
[RECIPIENT'S NAME]
[STREET ADDRESS]
[CITY, STATE, ZIP]
Dear [RECIPIENT’S NAME]:
We are pleased to inform you that Cysview® (hexaminolevulinate HCl), a newly approved
optical imaging agent for detection of bladder cancer, is now available at [INSTITUTION].
Cysview is indicated for use in the cystoscopic detection of cancer non-muscle invasive
papillary cancer of the Bladder among patients suspected or known to have lesion(s) on
the basis of a prior cystoscopy. It is used with the Karl Storz D-Light C Photodynamic
Diagnostic (PDD) system to perform cystoscopy with the blue light setting (Mode 2) as an
adjunct to the white light setting (Mode 1). Cysview is not for repetitive use and is not a
replacement for random bladder biopsies or other procedures used in the detection of
bladder cancer.
The availability of Cysview in the local area is expected to yield more accurate detection
and diagnosis of bladder cancer, a disease that has an annual incidence of 70,000, and a
mortality rate of 14,000.1 As you may be aware, diagnosis of bladder cancer can be
particularly challenging, even to the specialist. The most common initial sign of the disease
is red-colored urine, which calls for urine cytology and white light cystoscopy. Although
cytology provides specificity and sensitivity in detecting high-grade lesions, it provides no
information on the location and extent of disease.2
Consequently, many diagnoses are missed, possibly resulting in delayed or incomplete
treatment, which may lead to serious complications and a lower chance of survival for
patients with potentially aggressive tumors.
Optimal treatment of bladder cancer depends on the availability of highly sensitive and
specific diagnostic techniques that are capable of comprehensively detecting as many
tumors as possible. Improved detection and diagnosis may extend time to recurrence and
limit disease progression. Indeed, the high bladder cancer recurrence rate is thought to be
due, in part, to poor detection of lesions at investigation, underscoring the need for
reliable diagnostic techniques and tools.3
In a pivotal clinical trial, Cysview cystoscopy significantly improved the detection of nonmuscle- invasive papillary bladder cancer, compared to standard white light
cystoscopy.4 With the Cysview procedure, additional Ta or T1 tumors were found in 16.9%
o f t h e patients compared to white light alone.5
Cysview is the latest example of our institution’s commitment to improving patient care.
We encourage you to refer your patients with known or suspected bladder cancer to
undergo Cysview cystoscopy at [INSTITUTION], and to visit our facility to see how this
innovative imaging agent is used. Please contact me if you would like to make an
appointment.
Sincerely,
XXXXX
Letter to R e f e r r a l Physicians
Cysview Media Turnkey Kit
5/2012
Page 2
Important Risk and Safety Information about Cysview
Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder
cancer and is not for repetitive use.
Anaphylaxis reactions including anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis, and
abnormal urinalysis have been reported after administration of Cysview. The most common adverse reactions
seen in clinical trials were bladder spasm, dysuria, hematuria, and bladder pain.
Cysview should not be used in patients with porphyria, gross hematuria, or with known hypersensitivity to
hexaminolevulinate, or in patients receiving intravesical chemotherapy or BCG treatment within 3 months of
Cysview photodynamic blue-light cystoscopy. There are no known drug interactions with hexaminolevulinate;
however, no specific drug interaction studies have been performed. Using Cysview, fluorescence of nonmalignant areas may occur, and Cysview may fail to detect some malignant lesions.
Safety and effectiveness have not been established in pediatric patients. Cysview should only be used during
pregnancy if the potential benefit justifies the potential risk to the fetus. It is not known whether
hexaminolevulinate is excreted in human milk. Because many drugs are excreted in human milk, exercise
caution when Cysview is administered to nursing mothers. No clinically important differences in safety or
efficacy have been observed between older and younger patients.
Cysview is approved for use with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system. For
system set up and general information for the safe use of the PDD system, please refer to the Karl Storz
instruction manuals for each of the components.
Prior to Cysview administration, read the Full Prescribing Information and follow the preparation and
reconstitution instructions.
Bladder cancer. National Cancer Institute Web site.
http://www.cancer.gov/cancertopics/types/bladder. Accessed April 29, 2010.
2 Frampton JE, Plosker GL. Hexyl aminolevulinate in the detection of bladder cancer. Drugs.
2006; 66:571-578.
3 Clinical Aspects of Bladder Cancer. Hexvix Web site.
http://www.hexvix.com/journalists/clinical_aspects_of_bladder_cancer.asp. Accessed May 11,
2010.
4 Grossman HB, Gomella L, Fradet Y, et al. A phase III, multicenter comparison of
hexaminolevulinate fluorescence cystoscopy and white light cystoscopy for the detection of
superficial papillary lesions in patients with bladder cancer. J Urol.
5 Mynderse L, Stenzl A, Denziger S, et al. Hexaminolevulinate fluorescence cystoscopy improves
detection and resection of papillary bladder cancer lesions and reduces early recurrences. J. Urol.
1
Risk & Safety Information
Cysview Media Turnkey Kit
5/2012
Page 1
Cysview™ (hexaminolevulinate HCl) Product
Information and Important Risk and Safety Information
Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of
bladder cancer and is not for repetitive use.
Anaphylaxis reactions including anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis,
and abnormal urinalysis have been reported after administration of Cysview. The most common adverse
reactions seen in clinical trials were bladder spasm, dysuria, hematuria, and bladder pain.
Cysview should not be used in patients with porphyria, gross hematuria, or with known hypersensitivity to
hexaminolevulinate, or in patients receiving intravesical chemotherapy or BCG treatment within 3 months
of Cysview photodynamic blue-light cystoscopy. There are no known drug interactions with
hexaminolevulinate; however, no specific drug interaction studies have been performed. Using Cysview,
fluorescence of non-malignant areas may occur, and Cysview may fail to detect some malignant lesions.
Safety and effectiveness have not been established in pediatric patients. Cysview should only be used
during pregnancy if the potential benefit justifies the potential risk to the fetus. It is not known whether
hexaminolevulinate is excreted in human milk. Because many drugs are excreted in human milk, exercise
caution when Cysview is administered to nursing mothers. No clinically important differences in safety or
efficacy have been observed between older and younger patients.
Cysview is approved for use with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system. For
system set up and general information for the safe use of the PDD system, please refer to the Karl Storz
instruction manuals for each of the components.
Prior to Cysview administration, read the Full Prescribing Information and follow the preparation and
reconstitution instructions.
]
Template Press Release
Cysview Media Turnkey Kit 5/2012 Page 4
[INSTITUTION] ADOPTS INNOVATIVE IMAGING AGENT TO IMPROVE DETECTION OF
CERTAIN BLADDER CANCER
New Procedure Helps Physicians at [INSTITUTION] More Ac c u r a t e l y Detect Certain
Bladder Tumors than Use of Standard Diagnostic Technology
[LOCATION, DATE] – [INSTITUTION] is one of a select number of medical centers nationwide
offering Cysview® (hexaminolevulinate HCl), a newly approved optical imaging agent for
the detection of papillary cancer of the bladder in patients with known or suspected
bladder cancer. The availability of Cysview signals the arrival of an innovative diagnostic
technology for [LOCATION]-area residents who have or may have bladder cancer, and
underscores [INSTITUTION]’s reputation as a leading comprehensive medical facility
in [REGION].
Cysview is used to detect bladder cancer in individuals suspected or known to have
lesion(s) in the bladder, based on a prior cystoscopy (examination of the bladder and
urethra using a cystoscope, a thin, tube-like instrument with a light and a lens for
viewing). It is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system,
which includes a white light setting (Mode 1) to illuminate the bladder during a routine
cystoscopy, and a blue light setting (Mode 2) to induce and view fluorescence, (i.e.,
Cysview) thereby enabling physicians to detect lesions in the bladder.
More than 70,000 people in the US were diagnosed with cancer of the bladder in 2009,
and an estimated 14,000 Americans died from the disease last year, according to the
National Cancer Institute.1 Bladder cancer is the fourth most common type of cancer in
men, and the eighth most common in women. Smoking is the most likely cause of
bladder cancer.2 The most common initial sign of the disease is red-colored urine, which
calls for urine cytology (tests performed on cells in urine to detect disease) and
cystoscopy.3
[SAMPLE QUOTE:]
“Bladder cancer is difficult to detect. A missed diagnosis can result in delayed or
incomplete treatment, which may lead to serious complications and a lower chance of
survival for patients with potentially aggressive tumors,” noted [INSTITUTION
SPOKESPERSON, TITLE]. “Cysview represents an important advance in diagnostic
technology, enabling more accurate diagnosis of bladder tumors compared to the
standard technique. Patients with known or suspected bladder cancer can now come to
[INSTITUTION] to undergo diagnostic procedures administered by physicians who have
been specially trained in the use of this innovative technology.”
The standard diagnostic procedure for bladder cancer combines urine cytology and
white light cystoscopy.4 Although cytology provides specificity and sensitivity in detecting
high-grade (highly abnormal) lesions, it provides no information on the location and
extent of the disease. If the cells test positive for cancer, the next step is direct visual
inspection of the urothelium and mucosa (the inside of the bladder) with white light
cystoscopy to localize the tumors. The physician perform Transurethral resection (TUR), a
form of cystoscopy-guided biopsy, of suspicious areas of the bladder, and then test the
tissue samples to determine if they are malignant.5,6
Template Press Release
Cysview Media Turnkey Kit 5/2012 Page 5
[SAMPLE QUOTE:]
“The availability of Cysview is in keeping with [CENTER]’s commitment to advancing
patient care,” commented [CENTER SPOKESPERSON]. “We are dedicated to finding new
ways to improve the lives of patients living with serious diseases such as cancer, and
Cysview is the latest example. By facilitating early diagnosis of bladder cancer, this
innovative imaging agent can enable appropriate, timely treatment that may improve
patients’ chances of survival.”
About [INSTITUTION]
[insert institutional boilerplate here]
For more information about Cysview at [CENTER], contact [CONTACT NAME] at
[TELEPHONE NUMBER], or visit our Web site at [www.XXX.net].
Cysview® (hexaminolevulinate hydrochloride) for Intravesical Solution
Product Indication:
Cysview is indicated for use in the cystoscopic detection of non-muscle invasive papillary
cancer of the bladder among patients suspected or known to have lesion(s) on the basis of
a prior cystoscopy. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic
(PDD) system to perform cystoscopy with the blue light setting (Mode 2) as an adjunct to
the white light setting (Mode 1).
Cysview is not for repetitive use and is not a replacement for random bladder biopsies or
other procedures used in the detection of bladder cancer.
Important Risk and Safety Information about Cysview
Product Risk Information:
Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder
cancer and is not for repetitive use.
Anaphylaxis reactions including anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis, and
abnormal urinalysis have been reported after administration of Cysview. The most common adverse reactions
seen in clinical trials were bladder spasm, dysuria, hematuria, and bladder pain.
Cysview should not be used in patients with porphyria, gross hematuria, or with known hypersensitivity to
hexaminolevulinate, or in patients receiving intravesical chemotherapy or BCG treatment within 3 months of
Cysview photodynamic blue-light cystoscopy. There are no known drug interactions with hexaminolevulinate;
however, no specific drug interaction studies have been performed. Using Cysview, fluorescence of nonmalignant areas may occur, and Cysview may fail to detect some malignant lesions.
Safety and effectiveness have not been established in pediatric patients. Cysview should only be used during
pregnancy if the potential benefit justifies the potential risk to the fetus. It is not known whether
hexaminolevulinate is excreted in human milk. Because many drugs are excreted in human milk, exercise caution
when Cysview is administered to nursing mothers. No clinically important differences in safety or efficacy have
been observed between older and younger patients.
Cysview is approved for use with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system. For system
set up and general information for the safe use of the PDD system, please refer to the Karl Storz instruction
manuals for each of the components.
Prior to Cysview administration, read the Full Prescribing Information and follow the preparation and
reconstitution instructions.
Template Press Release
Cysview Media Turnkey Kit 5/2012 Page 6
CONTACT:
[NAME OF INSTITUTION MEDIA REPRESENTATIVE] [TELEPHONE NUMBER]
[E-MAIL ADDRESS]
###
Bladder cancer. National Cancer Institute Web site.
http://www.cancer.gov/cancertopics/types/bladder. Accessed April 29, 2010.
1
What you need to know about bladder cancer. National Cancer Institute Web site.
httpt://www.cancer.gov/cancertopics/wyntk/bladder. Updated September 16, 2002. Accessed
April 30, 2010.
2
Bladder cancer treatment (PDQ®). National Cancer Institute Web site.
http://www.cancer.gov/cancertopics/pdq/treatment/bladder/Patient. Modified July 9, 2010.
Accessed July 20,
2010.
3
Goh AC, Lerner SP. Application of new technology in bladder cancer diagnosis and treatment.
World J Urol.
4
Klem B, Lappin G, Nicholson S, et al. Determination of the bioavailability of [14C]hexaminolevulinate using accelerator mass spectrometry after intravesical administration to
human volunteers. J Clin Pharmacol.
5
Frampton JE, Plosker GL. Hexyl aminolevulinate in the detection of bladder cancer. Drugs.
2006;66:571-578.
6