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VISUDYNE is a brand name for Verteporfin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ................................................................................... 3 CONTRAINDICATIONS ......................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
VISUDYNE is a drug to be used in VISUDYNE Therapy. VISUDYNE Therapy is a two-stage process requiring administration of both VISUDYNE and nonthermal red light.
CAUTION:
VISUDYNE Therapy should only be used by physicians trained in the treatment of predominantly classic subfoveal choroidal neovascularization using photodynamic therapy with verteporfin for injection and specified lasers. Following VISUDYNE injection, residual photosensitivity for 48 hours or more may result in erythema and blistering of the skin when exposed to sunlight or brightly focused indoor light.
Use of incompatible lasers that do not provide the required characteristics of light for the photoactivation of VISUDYNE could result in incomplete treatment due to partial photoactivation of VISUDYNE, overtreatment due to overactivation of VISUDYNE, or damage to surrounding normal tissue.
Appropriate facilities and personnel must be available to treat any complications of the procedure, as well as for the emergency treatment of allergic reactions to the agent itself (see 'Cardiovascular' and 'Immune'). General Following injection with VISUDYNE, care should be taken to avoid exposure of skin or eyes to direct sunlight or bright indoor light for 2 days.
If emergency surgery is necessary within 48 hours after treatment, as much of the internal tissue as possible should be protected from intense light (see 'Skin'). Extravasation of VISUDYNE, especially if the affected area is exposed to light, can cause severe pain, inflammation, swelling or discoloration at the injection site.
Localized (skin) necrosis at the injection site following extravasation has also been reported. If extravasation does occur, the infusion should be stopped immediately. The extravasation area must be thoroughly protected from direct light until the swelling and discoloration have faded in order to prevent the occurrence of a local burn which could be severe.
Cold compresses should be applied to the injection site. The relief of pain may require analgesic treatment. Standard precautions should be taken during infusion of VISUDYNE to avoid extravasation. Examples of standard precautions include, but are not limited to the following: a free-flowing intravenous (IV) line should be established before starting VISUDYNE infusion and the line should be carefully monitored, due to the possible fragility of vein walls of some elderly patients, it is strongly recommended that the largest arm vein possible, preferably antecubital, be used for injection, small veins in the back of the hand should be avoided.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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VISUDYNE® Product Monograph Page 5 of 36 Cases of anaphylactic reactions have been observed in patients receiving VISUDYNE. If an anaphylactic or other serious allergic reaction occurs during or following infusion, administration of VISUDYNE should be discontinued immediately and appropriate therapy be initiated (see ‘Immune’).
Carcinogenesis and Mutagenesis No studies have been conducted to evaluate the carcinogenic potential of verteporfin. Verteporfin was not mutagenic, in the absence or presence of light, when studied in microbial mutagenicity, unscheduled DNA synthesis, mammalian point mutation, chromosome aberration, and mouse micronucleus assays.
Photodynamic therapy (PDT) as a class has been reported to result in DNA damage including DNA strand breaks, alkali-labile sites, DNA degradation, and DNA-protein cross links which may result in chromosomal aberrations, sister chromatid exchanges (SCE), and mutations.
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, increase mutations and DNA-protein cross-linking in mouse L5178 cells, and increase DNA-strand breaks in malignant human cervical carcinoma cells, but not in normal cells.
Verteporfin was not evaluated in these latter systems. It is not known how the potential for DNA damage with PDT agents translates into human risk. No effect on male or female reproduction has been observed in rats following intravenous administration of verteporfin for injection up to 10 mg/kg/day (approximately 60- and 40-fold human exposure at 6 mg/m2 based on AUCinf in male and female rats, respectively).
Males were dosed 28 days prior to and during mating until necropsy (approximately 60 days). Females were dosed for 14 days prior to and during mating until Gestation Day 7. Cardiovascular Chest pain, vaso-vagal reactions and hypersensitivity reactions related to VISUDYNE infusion, have been reported.
Both vaso-vagal and hypersensitivity reactions are associated with general symptoms such as syncope, sweating, dizziness, rash, dyspnoea, flushing, and changes in blood pressure and heart rate. On rare occasions these reactions may be severe, and potentially include seizure.
This may be related to complement activation (see 'Immune'). Hepatic / Biliary / Pancreatic VISUDYNE Therapy should be considered carefully in patients with moderate hepatic impairment or biliary obstruction since there is no clinical experience with verteporfin in such patients.
Since verteporfin is excreted primarily via the biliary (hepatic) route, increased verteporfin exposure is possible (see 'ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions'). VISUDYNE® Product Monograph Page 6 of 36 Immune VISUDYNE at >5 times the expected maximum plasma concentration in treated patients caused a low level of complement activation in human blood in vitro.
VISUDYNE resulted in a concentration-dependent increase in complement activation in human blood in vitro. At 10 mcg/mL (approximately 5 times the expected plasma concentration in human patients), there was mild to moderate complement activation.
At ≥100 mcg/mL, there was significant complement activation. , chest pain, syncope, dyspnea, and flushing) (see […]