Visudyne™ (Verteporfin)

Therapy

Visudyne Therapy:A Two-Step Process

Step 1

Step 2

IV administration of a non-toxic, light activated drug

Subsequent activation by a specific wavelength of light using non-thermal diode laser device

Visudyne is a light-activated drug:

Visudyne Formulation

Supplied in single-use 15 mg vials

Sterile, lipid-based, freeze-dried, dark-green powder

Stored at room temperature (20–25ºC or 68–77ºF)

A free-flowing IV line is established, preferably in the antecubital vein

Establishing the IV Line

Determining GLD and Treatment Spot Size Determine GLD of entire

lesion on photographic image Calculate actual GLD on

retina Add 1000 µm to allow a

500 µm border around lesion (Ensure full coverage of lesion and allow for small eye movements)

Treatment spot should be no closer than 200 µm to edge of optic disc

Treatment spot size

GLD

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Setting the Laser

Enter contact lens magnification

Enter the spot size (GLD + 1000 µm)

Start the timer at the beginning of infusion

Zeiss Visulas690s Laser and

VisulinkPDT adapter

Coherent OpalPhotoactivator Laser

and LaserLinkadapter

Visudyne Infusion Kit

Tubing Filters Needles Catheter Syringes

Calculating BSA

Height

Weight

BSA(e.g.: 1.88 m2)

Visudyne is reconstituted with sterile water for injection

Visudyne Reconstitution

7 mL of water is added to the vial to give a volume of 7.5 mL

The vial is gently agitated to ensure complete dissolution

Solution must be protected from light and used within 4 hours

Reconstituted drug has a concentration of 2 mg/mL

Calculating the Visudyne Dose

Drugdose

6 mg/m2

BSA

e.g. 1.88 m2

Totaldrugdose

e.g. 11.28 mg

Reconstituteddrug

concentration

2 mg/mL

Volumereconstituted

drug

e.g. 5.64 mL

=

Preparing the Infusion

The appropriate volume of Visudyne solution is withdrawn from the vial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 tubing

Filter NeedleVenous access

A 1.2 µm filter is fitted to the syringe

The syringe is connectedto the IV line

Syringe in pump

Infusion Connections

Infusing the Visudyne Solution

An infusion or syringe pump delivers the 30 mL of drug over 10 minutes

The timer on the laser system is started at the same time as the infusion

Physician or nurse must monitor patient throughout 10-minute infusion

Precautions to Avoid Extravasation

Extravasation may cause severe pain, inflammation, swelling, and discoloration of the injection site

The IV line should be carefully monitored during treatment and infusion stopped if extravasation is suspected or recognized

Even with good technique, extravasation may occur

Procedure in the Event of Extravasation

If more than half the dose delivered Proceed with light application, as scheduled (15 minute after start of infusion,

even if duration of infusion was less than 10 minutes)

If less than half the dose delivered 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

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

Patient is positioned at slit lamp immediately after end of infusion

Light source: Non thermal diode laser

Light is applied 15 minutes after start of infusion

Light at 689 nm is delivered via a fiber optic and slit lamp using a contact lens

Light dose– 600 mW/cm2

– 83 seconds50 J/cm2

Positioning Patient and Applying Laser

Visudyne: Light application

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

The first eye (with aggressive lesion) is treated 15 minutes after the start of infusion

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

The second eye is treated no later than 20 minutes after the start of infusion

If the patient has received previous Visudyne treatment with an acceptable safety profile:

Follow-up and Retreatment

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 first2 years

Early phase of angiogram showing recurrent leakage within a hypofluorescent

region 3 months after Visudyne therapy

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Physician needs to manage patient expectations

Patient Education

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

Patients should be provided with information to take home

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

Normal indoor / home light – tube light, bulb light, television light - acceptable

Patient Education

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

CNV rarely causes total blindness Low vision aids may help many patients to

perform daily activities

Management of Clinically Relevant Adverse Events

Extravasation Avoidable with proper precautions

Infusion-related back pain No adverse sequelae known at this time Resolves within a short time

Photosensitivity reactions Avoidable with proper precautions Treat as sunburn (sunscreen is ineffective)

Acute severe vision decrease within 7 days Observation, no retreatment recommended