Visudyne (verteporfin)

The usual dose of verteporfin in the treatment of subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis is 6 mg/m2. The recommended light dose is 50 J/cm2 of neovascular lesion administered at an intensity of 600 mW/cm2 over 83 seconds. Light dose, light intensity, ophthalmic lens magnification factor, and zoom lens setting are important parameters for the appropriate delivery of light to the predetermined treatment spot. The greatest linear dimension (GLD) of the lesion, including all classic and occult choroidal neovascularization, blood and/or blocked fluorescence, and any serous detachments of the retinal pigment epithelium, is estimated by fluorescein angiograph and color fundus photography and is corrected for the magnification of the fundus camera to obtain the GLD of the lesion on the retina. The treatment spot size should be 1000 mcm larger than the GLD of the lesion on the retina to allow a 500-mcm border and ensure full coverage of the lesion. In clinical studies the maximum spot size used was 6400 mcm. The nasal edge of the treatment spot must be positioned as least 200 mcm from the temporal edge of the optic disc, even if this will result in lack of exposure of choroidal neovascularization within 200 mcm of the optic nerve.

Photodynamic therapy with verteporfin may be repeated every 3 months in patients with choroidal neovascular leakage detected on fluorescein angiography. Results of clinical studies in patients with subfoveal choroidal neovascularization due to age-related macular degeneration showed that the average number of treatments decreased from 3.4 during the first year to 2.1 during the second year (total of 5.4 treatments over the 24-month period). Safety and efficacy of photodynamic therapy with verteporfin for longer than 2 years have not been established to date.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Porphyria.

Known hypersensitivity to verteporfin or any ingredient in the formulation.

• Lactation
• Porphyria

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Injection site reactions and visual disturbances were the most frequently reported adverse effects among those reported in 1% or more of patients receiving verteporfin. In clinical studies in patients with subfoveal choroidal neovascularization due to age-related macular degeneration, injection site reactions (e.g., extravasation, rash) were reported in 15.9 or 5.8% of patients receiving verteporfin or placebo, respectively; cataracts were reported in up to 14.9% of verteporfin-treated patients and 15% of placebo-treated patients. Blepharitis; conjunctivitis/conjunctival injection; dry eyes; ocular itching; severe vision loss with or without subretinal or vitreous hemorrhage; back pain during infusion; asthenia; fever; flu-like syndrome; atrial fibrillation; hypertension; peripheral vascular disorder; varicose veins; eczema; constipation; GI cancers; nausea; anemia; leukocyte count increase/decrease; increased liver function test results; albuminuria; serum creatinine increase; arthralgia; arthrosis; myasthenia; hypesthesia; sleep disorder; vertigo; cough; pharyngitis; pneumonia; hearing decrease; diplopia; lacrimation disorder; and prostatic disorder occurred in 1-10% of verteporfin-treated patients.

Retinal detachment (nonrhegmatogenous), retinal or choroidal vessel nonperfusion, chest pain and other musculoskeletal pain during infusion, syncope, and vasovagal reactions have occurred in patients receiving verteporfin.

More Frequent

• Blurred vision
• Photophobia
• Reduced visual acuity
• Visual changes
• Visual field defect

Less Frequent

• Abnormal hepatic function tests
• Anemia
• Atrial fibrillation
• Blepharitis
• Cataracts
• Conjunctivitis
• Hypertension
• Ocular hemorrhage
• Pneumonia
• Vision impairment

Rare or Very Rare

• Anaphylaxis
• Chest pain
• Extravasation injury
• Hypersensitivity drug reaction
• Leukopenia
• Retinal detachment
• Tear of retinal pigment epithelium

More Frequent

• Headache disorder
• Injection site sequelae

Less Frequent

• Arthralgia
• Back pain
• Benign prostatic hyperplasia
• Constipation
• Cough
• Diplopia
• Dry eye
• Eczema
• Fever
• Flu-like symptoms
• General weakness
• Hypoesthesia
• Muscle weakness
• Nausea
• Pharyngitis
• Proteinuria
• Skin photosensitivity
• Sleep disorder
• Varicose veins
• Vertigo

Rare or Very Rare

• Hearing loss
• Musculoskeletal pain

No enhanced messaging available.

Safety and efficacy not established in children.

Category C. (See Users' Guide.)

It is not known if verteporfin is distributed in milk; caution if used in nursing women.

Approximately 90% of patients in clinical studies were 65 years of age or older. Efficacy of verteporfin therapy is reduced with increasing age (e.g., 75 years of age or older).