Visudyne (Page 2 of 4)

5.2 Exposure to Sun or Direct Light

Following injection with VISUDYNE (verteporfin for injection), care should be taken to avoid exposure of skin or eyes to direct sunlight or bright indoor light for 5 days. In the event of extravasation during infusion, 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. If emergency surgery is necessary within 48 hours after treatment, as much of the internal tissue as possible should be protected from intense light.

5.3 Decreased Vision After Treatment

Patients who experience severe decrease of vision of 4 lines or more within 1 week after treatment should not be retreated, at least until their vision completely recovers to pretreatment levels and the potential benefits and risks of subsequent treatment are carefully considered by the treating physician.

5.4 Anaphylactic Reactions

Cases of anaphylactic reactions have been reported in patients receiving VISUDYNE. Medical supervision is recommended during infusion. If an anaphylactic or other serious allergic reaction occurs during or following infusion, administration of VISUDYNE should be discontinued immediately and appropriate therapy should be initiated.


The following serious adverse reactions are described elsewhere in the labeling:

Local Adverse Reactions – Extravasation [see Warnings and Precautions (5.1)]
Exposure to Sun or Direct Light [see Warnings and Precautions (5.2)]
Decreased Vision after Treatment [see Warnings and Precautions (5.3)]
Porphyria and Hypersensitivity [see Contraindications (4)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Severe chest pain, vasovagal and hypersensitivity reactions have been reported. Vasovagal and hypersensitivity reactions on rare occasions can be severe. These reactions may include syncope, sweating, dizziness, rash, dyspnea, flushing and changes in blood pressure and heart rate. General symptoms can include headache, malaise, urticaria, and pruritus.

The most frequently reported adverse reactions to VISUDYNE (verteporfin for injection) are injection site reactions (including pain, edema, inflammation, extravasation, rashes, hemorrhage and discoloration) and visual disturbances (including blurred vision, flashes of light, decreased visual acuity and visual field defects, including scotoma). 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, ocular
itching, severe vision decrease with or without subretinal/retinal or vitreous

Body as a Whole: Asthenia, fever, flu syndrome, infusion related pain primarily presenting as
back pain, photosensitivity reactions

Cardiovascular: Atrial fibrillation, hypertension, peripheral vascular disorder, varicose veins

Dermatologic: Eczema

Digestive: Constipation, gastrointestinal cancers, nausea

Hemic and Lymphatic: Anemia, white blood cell count decreased, white blood cell count increased

Hepatic: Elevated liver function tests

Metabolic/Nutritional: Albuminuria, creatinine increased

Musculoskeletal: Arthralgia, arthrosis, myasthenia

Nervous System: Hypesthesia, sleep disorder, vertigo

Respiratory: Cough, pharyngitis, pneumonia

Special Senses: Cataracts, decreased hearing, diplopia, lacrimation disorder

Urogenital: Prostatic disorder

Severe vision decrease, equivalent of >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.

The following adverse events have occurred either at low incidence (<1%) during clinical trials or have been reported during the use of VISUDYNE in clinical practice where these reactions were reported voluntarily from a population of unknown size and frequency of occurrence cannot be determined precisely. They have been chosen for inclusion based on factors such as seriousness, frequency of reporting, possible causal connection to VISUDYNE, or a combination of these factors:

Ocular Treatment Site: Retinal detachment (nonrhegmatogenous), retinal or choroidal vessel
nonperfusion, retinal pigment epithelial tear.

Non-ocular Events: Chest pain and other musculoskeletal pain during infusion, anaphylactic reaction during or following infusion, injection site necrosis.


Drug interaction studies in humans have not been conducted with VISUDYNE.

Verteporfin is rapidly eliminated by the liver, mainly as unchanged drug. Metabolism is limited and occurs by liver and plasma esterases. 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, polymyxin B or radiation therapy could enhance the rate of VISUDYNE uptake by the vascular endothelium. Other photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin) could increase the potential for skin photosensitivity reactions. Compounds that quench active oxygen species or scavenge radicals, such as dimethyl sulfoxide, β-carotene, ethanol, formate and mannitol, would be expected to decrease VISUDYNE activity. Drugs that decrease clotting, vasoconstriction or platelet aggregation, e.g., thromboxane A2 inhibitors, could also decrease the efficacy of VISUDYNE therapy.


8.1 Pregnancy

Risk Summary

There are no data with the use of VISUDYNE in pregnant women to inform a drug-associated risk. Intravenous administration of verteporfin to pregnant rats during the period of organogenesis produced an increase in the incidence of anophthalmia/microphthalmia and wavy ribs at exposures approximately 40-fold the human exposure at the recommended clinical dose.

Verteporfin did not produce adverse fetal effect in rats or rabbits at exposures 6- to 20-fold the human exposure at the recommended clinical dose.

There are no adequate and well-controlled studies in pregnant women. VISUDYNE should be used during pregnancy only if the benefit justifies the potential risk to the fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.


Animal Data

Rat fetuses of dams administered verteporfin for injection intravenously during organogenesis exhibited an increase in the incidence of anophthalmia/microphthalmia and wavy ribs at doses ≥10 mg/kg/day (approximately 40-fold the human exposure at the recommended dose of 6 mg/m2 , based on AUC in female rats). No teratogenic effects were observed in rat fetuses at a dose of 2 mg/kg/day (approximately 6-fold the human exposure at the recommended dose of 6 mg/m2 , based on AUC in female rats).

In pregnant rabbits, a decrease in maternal body weight gain and food consumption was observed in animals that received verteporfin for injection intravenously at doses up to 10 mg/kg/day during organogenesis. The no observed adverse effect level (NOAEL) for maternal toxicity was 3 mg/kg/day (approximately 6-fold the recommended human dose of 6 mg/m2 , based on body surface area). No teratogenic effects were observed in rabbit fetuses at doses up to 10 mg/kg/day (approximately 20-fold the recommended human dose of 6 mg/m2 , based on body surface area).

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