Medical Editor: John P. Cunha, DO, FACOEP
Visudyne (verteporfin) for Injection is a light activated drug used in photodynamic therapy for the treatment of blood vessel disorders in the eye, macular degeneration, and other eye diseases. Common side effects of Visudyne include:
- slight changes in vision
- dry eyes
- irritation/redness/swelling/itching of eyelids
- seeing flashes of light
- weak or tired feeling
- mild skin rash or itching
- joint pain
- muscle weakness
- flu-like symptoms (fever, chills, body aches, sore throat), or
- injection site reactions (pain, swelling, bleeding, or itching).
Visudyne therapy is a two-step process where the medication is injected first and then activated by laser light treatment to the eye(s) 15 minutes later. Skin and eyes will be sensitive to light following treatment with Visudyne, so it is important to protect your eyes and skin from sunlight or bright indoor light for at least 5 days after treatment. Sunblock will not be sufficient to protect your skin against UV rays during this time, so clothing should be used to cover skin. Certain drugs such as diabetes medication, birth control pills, diuretics, antibiotics, as well as other drugs can interact with Visudyne. Tell your doctor of all medication you are taking. If you are pregnant you should only take Visudyne if the benefit outweighs the potential risk to the fetus. You should not take Visudyne if you are breastfeeding.
Our Visudyne (verteporfin) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; sweating; dizziness; swelling of your face, lips, tongue, or throat.
Tell your caregivers at once if you have a serious side effect such as:
- severe decrease in vision;
- sudden and severe pain;
- severe redness or other discoloration of your eyes;
- eye pain or seeing halos around lights;
- feeling like you might pass out;
- chest pain; or
- flushing (warmth, redness, or tingly feeling).
Less serious side effects may include:
- slight changes in your vision, seeing flashes of light;
- dry eyes;
- redness, swelling, or itching of your eyelids;
- feeling weak or tired;
- mild itching or skin rash;
- constipation, nausea;
- joint pain, muscle weakness;
- fever, chills, body aches, sore throat, flu symptoms; or
- pain, swelling, bleeding, or itching where the medicine was injected.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Visudyne (Verteporfin Injection)
The following serious adverse reactions are described elsewhere in the labeling:
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, vaso-vagal and hypersensitivity reactions have been reported. Vaso-vagal 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 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
|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|
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|
Read the entire FDA prescribing information for Visudyne (Verteporfin Injection)
© Visudyne Patient Information is supplied by Cerner Multum, Inc. and Visudyne Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.