Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 29 August 2018
PRECAUTIONS General Standard precautions should be taken during infusion of Visudyne® (verteporfin for injection) to
Examples of standard precautions include, but are not
Due to the possible fragility of vein walls of some elderly patients,
Extravasation of Visudyne, especially if
If extravasation does occur, the infusion should be stopped immediately.
Oral medications for pain
At a >10-fold higher dose given by bolus injection to sedated or anesthetized pigs, verteporfin caused
VISUDYNE resulted in
At 10 µg/mL (approximately 5 times the expected plasma concentration in human patients), there was
100 µg/mL, there was
Patients should be supervised during Visudyne infusion.
Information for Patients Patients who receive Visudyne will become temporarily photosensitive after the infusion.
Patients should wear a wristband to remind them to
During that period,
Sources of bright light include, but are not
Prolonged exposure to
If treated patients must go outdoors in daylight during the first
Patients should not stay in the
Following Visudyne treatment,
Patients should not drive or use machines as long as these symptoms persist.
Drug Interactions Drug interaction studies in humans have not been conducted with Visudyne.
Verteporfin is rapidly eliminated by the liver, mainly as unchanged drug.
Microsomal cytochrome P450 does not appear to play a role in verteporfin metabolism.
Based on the mechanism of action of verteporfin, many drugs used concomitantly could influence the effect of Visudyne therapy.
Possible examples include the following: Calcium channel blockers,
Other photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin) could increase the
Compounds that quench
Photodynamic therapy (PDT) as a class has been reported to result in
In addition, other photodynamic therapeutic agents have been shown to increase the incidence of SCE in Chinese hamster ovary (CHO) cells irradiated with visible light and in Chinese hamster lung fibroblasts irradiated with near UV light,
Verteporfin was not evaluated in these latter systems.
It is not known how the
Pregnancy Teratogenic Effects: Pregnancy Category C Rat fetuses of dams administered verteporfin for injection intravenously at?10 mg/kg/day during organogenesis (approximately 40-fold human exposure at 6 mg/m2 based on AUCinf in female
Rat fetuses of dams administered 25 mg/kg/day (approximately 125 fold the human exposure at 6 mg/m2 based on AUCinf in female
In pregnant rabbits, a
Visudyne should be used during pregnancy only if the
Nursing Mothers Verteporfin and its diacid metabolite have been found in the breast milk of one woman after a 6 mg/m2 infusion.
The verteporfin breast milk levels were up to 66 % of the corresponding plasma levels and
The diacid metabolite had lower peak concentrations but persisted up to at least 48 hours.
Because of the
Geriatric Use Approximately 90 % of the patients treated with Visudyne in the clinical efficacy trials were over the age of 65.
Vasovagal and hypersensitivity reactions on
These reactions may include syncope, sweating, dizziness, rash, dyspnea, flushing and changes in
General symptoms can include
The most frequently reported
These events occurred in approximately 10 % - 30 % of patients.
The following events, listed by Body System, were reported more frequently with Visudyne therapy than with placebo therapy and occurred in 1 % - 10 % of patients: Ocular Treatment Site:
Blepharitis, cataracts, conjunctivitis/conjunctival injection, dry eyes,
vertigo Respiratory: Cough, pharyngitis, pneumonia
4 lines, within 7 days after treatment has been reported in 1 % - 5 % of patients.
Partial recovery of vision was observed in some patients.
Photosensitivity reactions usually occurred in the form of skin sunburn following exposure to sunlight.
The higher incidence of back pain in the Visudyne group occurred primarily during infusion.
They have been chosen for inclusion based on factors such as
DOSAGE AND ADMINISTRATION A course of Visudyne® (verteporfin for injection) therapy is a two-step process requiring administration of both drug and light.
The first step is the intravenous infusion of Visudyne.
The second step is the activation of Visudyne with light from a nonthermal diode laser.
The physician should reevaluate the patient every 3 months and if choroidal neovascular
Lesion Size Determination The
Fundus cameras with magnification within the range of 2.4-2.6X are
Spot Size Determination The treatment spot size should be 1000 microns larger than the GLD of the lesion on the retina to allow a 500 micron border, ensuring full coverage of the lesion.
The maximum spot size used in the clinical trials was 6400 microns.
The nasal edge of the treatment spot must be positioned at least 200 microns from the temporal edge of the optic disc, even if this will result in
Visudyne® Administration Reconstitute each vial of Visudyne with 7 mL of
Visudyne may precipitate in saline solutions.
Do not mix Visudyne in the same solution with other drugs.
The full infusion volume is administered intravenously over 10
The clinical studies were conducted using a standard infusion line filter of 1.2 microns.
Precautions should be taken to prevent extravasation at the injection site.
If extravasation occurs,
Visudyne is controlled by
In the treatment of choroidal neovascularization,
This dose is administered over 83 seconds.
Follow the laser system manuals for procedure set up and operation.
The laser system must deliver a
Light is delivered to the retina as a single
The following laser systems have been tested for compatibility with Visudyne and are
Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA 95051 - 0901, Zeiss VISULAS 690s laser and VISULINK® PDT adapter manufactured by Carl Zeiss Meditec Inc., 5160 Hacienda Drive, Dublin, CA 94568, Ceralas™ I laser system and Ceralink™ Slit Lamp Adapter manufactured by Biolitec Inc., 515 Shaker Road, East Longmeadow, MA 01028, Quantel Activis laser console and the ZSL30 ACT™, ZSL120 ACT™ and HSBMBQ ACT™ slit lamp adapters distributed by Quantel Medical, 601 Haggerty Lane, Bozeman, MT 59715.
Concurrent Bilateral Treatment The
In patients who present with eligible lesions in both eyes, physicians should evaluate the potential
If the patient has already received
Immediately at the end of
In patients who present for the first time with eligible lesions in both eyes
One week after the first course, if
Approximately 3 months later, both eyes can be evaluated and concurrent treatment following a new Visudyne infusion can be started if both lesions still show evidence of
|Agency product number||0X9PA28K43|
|Date Last Revised||07-04-2010|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||QLT Ophthalmics, Inc.|