Transcript Visudyne™ (Verteporfin) Therapy

Visudyne™
(Verteporfin)
Therapy
Visudyne Therapy:
A Two-Step Process
Step 1
IV administration of a non-toxic, light activated drug
Step 2
Subsequent activation by a specific wavelength of light using nonthermal diode laser device
Visudyne Formulation
Visudyne is a lightactivated drug:
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Supplied in single-use
15 mg vials
Sterile, lipid-based,
freeze-dried,
dark-green powder
Stored at room
temperature (20–25ºC
or 68–77ºF)
Establishing the IV Line
A free-flowing IV line
is established,
preferably in the
antecubital vein
Determining GLD and
Treatment
Spot Size
 Determine GLD of entire
Treatment spot size
GLD
lesion on photographic image
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Calculate actual GLD on
retina
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Add 1000 µm to allow a
500 µm border around lesion
(Ensure full coverage of lesion and
allow for small eye movements)
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Treatment spot should
be no closer than 200 µm to
edge of optic disc
Setting the Laser
Zeiss Visulas
690s Laser and
Visulink
PDT adapter
Coherent Opal
Photoactivator Laser
and LaserLink
adapter
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Enter contact lens
magnification
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Enter the spot size
(GLD + 1000 µm)
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Start the timer at the
beginning of infusion
Visudyne Infusion Kit
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Tubing
Filters
Needles
Catheter
Syringes
Calculating BSA
Height
Weight
BSA
(e.g.: 1.88 m2)
Visudyne Reconstitution
Visudyne is reconstituted with
sterile water for injection
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7 mL of water is added to the vial
to give a volume of 7.5 mL
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The vial is gently agitated to
ensure complete dissolution
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Solution must be protected from
light and used within 4 hours
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Reconstituted drug has a
concentration of 2 mg/mL
Calculating the Visudyne Dose
Drug
dose
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6 mg/m2
Total
drug
dose
e.g. 11.28 mg
BSA
e.g. 1.88 m2
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Reconstituted
drug
concentration
2 mg/mL
=
Volume
reconstituted
drug
e.g. 5.64 mL
Preparing the Infusion
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The appropriate volume of
Visudyne solution is
withdrawn from the vial
The Visudyne solution is
transferred to the 30 mL
syringe
D5W is added to give the
final 30 mL volume for
infusion
Infusion Connections
Syringe
in pump
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A 1.2 µm filter is fitted to
the syringe
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The syringe is connected
to the IV line
Infusion
tubing
Filter
Needle
Venous
access
Infusing the Visudyne Solution
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An infusion or syringe
pump delivers the 30 mL
of drug over 10 minutes
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The timer on the laser
system is started at the
same time as the infusion
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Physician or nurse must
monitor patient
throughout 10-minute
infusion
Precautions to Avoid
Extravasation
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Extravasation may cause
severe pain, inflammation,
swelling, and discoloration
of the injection site
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The IV line should be
carefully monitored during
treatment and infusion
stopped if extravasation is
suspected or recognized
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Even with good technique,
extravasation may occur
Procedure in the Event of
Extravasation
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If more than half the dose delivered
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Proceed with light application, as scheduled (15 minute after start of
infusion, even if duration of infusion was less than 10 minutes)
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If less than half the dose delivered
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Obtain better venous access
Begin light application 15 minutes after restarting infusion
Apply cold compress or ice immediately
Elevate patient’s arm for 1 day, when possible
Protect from light for at least 5 days or as long as skin is
swollen or discolored
Consult burns specialist or dermatologist if needed
If venous access was not obtained after several attempts,
treatment can be attempted again after 24 hours
Ending the Infusion
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The pump is turned off
The IV line is flushed with 5 mL D5W until all
remaining Visudyne is cleared from the line
The laser timer will indicate when to begin light
application
Positioning Patient and
Applying Laser
 Patient is positioned at slit
lamp immediately after end of
infusion
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Light source: Non thermal
diode laser
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Light is applied 15 minutes
after start of infusion
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Light at 689 nm is delivered via
a fiber optic and slit lamp
using a contact lens
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Light dose
– 600 mW/cm2
– 83 seconds
50 J/cm2
Visudyne: Light application
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Why 689 nm (red light) ???
Light at this wavelength is not absorbed
strongly by naturally present substances
The strongest absorption peak is at 400 nm
(blue light)
Not clinically useful, as this is the same as
the absorption peak of oxyhaemoglobin
Concurrent Bilateral Treatment
If the patient has received previous Visudyne
treatment with an acceptable safety profile:
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The first eye (with aggressive lesion) is
treated 15 minutes after the start of infusion
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Immediately after treatment of the first eye,
the laser is reset to the parameters of the
second eye, with the same light dose,
intensity and duration
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The second eye is treated no later than 20
minutes after the start of infusion
Follow-up and Retreatment
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Early phase of angiogram
showing recurrent leakage
within a hypofluorescent
region 3 months after
Visudyne therapy
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Follow-up visits after a
treatment should be
scheduled at least as often
as every 10–14 weeks
Fluorescein angiography is
required to determine
whether leakage has
recurred
Retreatment is often
necessary during the first
2 years
Patient Education
Physician needs to manage
patient expectations
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In patients for whom treatment is
indicated, Visudyne therapy:
– Reduces risk of moderate or
severe vision loss in AMD
– Increases likelihood of stable
or improved vision in
pathologic myopia
Retreatment often required at
3-month intervals in first 2 years
Patient Education
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Patients should be provided with
information to take home
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Patients should avoid exposure
to direct sunlight or strong
artificial light (halogen) according
to physician’s instructions (Up to
48 hours after t/t) e.g. dental
procedure, surgical operating
rooms
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Normal indoor / home light – tube
light, bulb light, television light -
Patient Education
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Patients should wear dark
sunglasses, long sleeves and
trousers, if they need to go
outdoors during the first 48 hours
(sunscreens do not protect from
photosensitivity reactions)
Patients should call with
questions, concerns or problems
(e.g. sudden decrease in vision,
pain at injection site)
Low Vision Aids
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CNV rarely causes total blindness
Low vision aids may help many patients to
perform daily activities
Management of Clinically
Relevant Adverse Events
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Extravasation
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Infusion-related back pain
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No adverse sequelae known at this time
Resolves within a short time
Photosensitivity reactions
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Avoidable with proper precautions
Avoidable with proper precautions
Treat as sunburn (sunscreen is ineffective)
Acute severe vision decrease within 7 days
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Observation, no retreatment recommended