Verteporfin Side Effects

Brand Names: Visudyne

Please note - some side effects for Verteporfin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Verteporfin - for the Consumer

Verteporfin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Verteporfin:

Blurred vision or other vision changes; headache; mild discomfort or redness at the injection site.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); pain or swelling at the injection site; sensitivity to bright light lasting more than 5 days after your dose; severe vision changes or vision loss; skin rash or severe sunburn.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Ocular

Severe vision decrease has been reported in 1% to 5% of patients within 7 days of treatment. Partial recovery occurred in many patients (percentage not given).

An 82-year-old woman experienced a sudden decrease in vision acuity, measured as Snellen visual acuity of 20/200 in both eyes, within approximately 4 hours following ocular photodynamic therapy with verteporfin. Further examination revealed a gross central serous retinal detachment and outlined the CNV within the choroid, and a focal area of hyperpermeability on the supertemporal margin of the CNV. Within approximately 4 days visual acuity returned to 20/40 in both eyes, and examination reveled complete closure of the occult CNV, cessation of hyperpermeability and leakage, and resolution of the retinal detachment. Visual acuity continued to improve and remained stable at 20/30 up to the last examination performed at 9 months after treatment.

Ocular side effects have included blurred vision, decreased visual acuity, visual field defects, blepharitis, cataracts, conjunctivitis, conjunctival injection, dry eyes, ocular itching, severe vision loss, lacrimation disorder, diplopia, mild stromal haze, and subconjunctival, subretinal, or vitreous hemorrhage. Significant exudation associated with vision loss has also been reported. Retinal detachment (nonhegmatogenous), retinal or choroidal vessel nonperfusion have been reported rarely.

General

The most frequent adverse effects associated with verteporfin have included headaches, injection site reactions, and visual disturbances in 10% to 30% of patients.

Cardiovascular

Cardiovascular side effects have included atrial fibrillation, hypertension, peripheral vascular disorder, varicose veins. Paroxysmal atrial fibrillation and acute myocardial infarction have occurred rarely (single case report).

A case of paroxysmal atrial fibrillation and acute myocardial infarction occurred in a patient with no prior cardiac symptoms 3 hours after verteporfin administration.

Dermatologic

Dermatologic side effects have included photosensitivity (sunburn after exposure to sunlight) and eczema.

Gastrointestinal

Gastrointestinal side effects have included constipation, nausea, and gastrointestinal cancers.

Hematologic

Hematologic side effects have included anemia, increased or decreased WBC count, and transient neutropenia.

Verteporfin infusion-associated pain may be related to transient neutropenia. A small study described four patients who experienced infusion-related pain and whose average absolute neutrophil counts decreased from 4589/mm3 preinfusion to 1688/mm3 postinfusion. Five control patients with no significant change in neutrophil counts experienced no pain during infusion.

Hepatic

Hepatic side effects have included elevated liver function tests.

Renal

Renal side effects have included albuminuria, increased creatinine, and nephrotic syndrome.

A 66-year-old female developed minimal change nephrotic syndrome (MCNS) characterized by general weakness, edema, proteinuria, hypoproteinemia, hypoalbuminemia, and increased serum cholesterol after 4 cycles of verteporfin/photodynamic therapy. A renal biopsy revealed effacement of visceral epithelial cell foot processes, which is consistent with MCNS.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthrosis, and myasthenia. Musculoskeletal pain during infusion has been reported rarely.

Nervous system

Nervous system side effects have included hypesthesia, sleep disorder, and vertigo.

Respiratory

Respiratory side effects have included cough, pharyngitis, and pneumonia.

Genitourinary

Genitourinary side effects have included prostatic disorder.

Other

Side effects of the body as a whole have included asthenia, back pain, fever, and flu syndrome. Noncardiac chest and neck pain, syncope, and shortness of breath during verteporfin infusion have been reported rarely.

Back pain associated with verteporfin infusion, usually in the lower back, has been reported in 2.2% of patients. The pain may be severe and resolves 5 to 10 minutes after discontinuation of the infusion. An anecdotal report of 3 patients describes beneficial effects of intravenous diphenhydramine in reducing back pain.

Other

Other side effects have included decreased hearing.

Hypersensitivity

Hypersensitivity side effects have included severe hypersensitivity reactions, severe allergic reactions with dyspnea and flushing, and vaso-vagal reactions. These effects have occurred primarily during infusion.

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