VISUDYNE SIDE EFFECTS

SIDE EFFECTS

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

• Local Adverse Reactions – Extravasation
• Exposure to Sun or Direct Light
• Decreased Vision After Treatment
• Porphyria and Hypersensitivity

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 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 infection, dry eyes, ocular itching, severe vision decrease with or without subretinal/retinal or vitreous hemorrhage

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

SRC: NLM .