Visudyne® for Injection 15mg/Vial
INFORMATION FOR THE PATIENT
INDICATIONS AND CLINICAL USE
VISUDYNE® (verteporfin for injection) as part of photodynamic therapy (i.e., VISUDYNE® Therapy) is indicated for the treatment of predominantly classic subfoveal choroidal neovascularization in patients with:
• age-related macular degeneration (AMD),
• pathologic myopia,
• presumed ocular histoplasmosis.
VISUDYNE® is not recommended for use in children or adolescents. The efficacy and safety of VISUDYNE® has not been established in the pediatric population.
Approximately 90% of the patients treated with VISUDYNE® in the clinical efficacy trials were over the age of 65. A reduced treatment effect was seen with increasing age.
ABOUT THE DISEASE
Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is an eye disease that may get worse over time. It’s the leading cause of severe, permanent vision loss in people over age 60. Wet macular degeneration is a chronic eye disorder that causes blurred vision or a blind spot in the visual field. It’s generally caused by abnormal blood vessels that leak fluid or blood into the macula (MAK-u-luh). The macula is in the part of the retina responsible for central vision. Wet macular degeneration is one of two types of age-related macular degeneration. The other type — dry macular degeneration — is more common and less severe. The wet type always begins as the dry type. Early detection and treatment of wet macular degeneration may help reduce vision loss and, in some instances, recover vision
Pathological myopia is an extremely high amount of nearsightedness that causes a major alteration of the shape or globe of the eye, which may lead to profound vision loss.
Presumed Ocular Histoplasmosis
Presumed Ocular Histoplasmosis Syndrome (POHS) causes atrophy around the optic nerve and multiple scars, called histo spots, in the choroid. These symptoms are accompanied by new blood vessel growth (neovascularization) that starts adjacent to a histo spot.POHS affects young and middle-aged adults and is a major cause of choroidal neovascularization in patients younger than age 50.
FREQUENTLY ASKED QUESTIONS
Verteporfin belongs to the class of medications called photosensitizing agents. It is used to treat “wet” age-related macular degeneration (AMD), pathologic myopia (a severe form of nearsightedness), and presumed ocular histoplasmosis (a fungal infection of the eye).
In these conditions, vision loss occurs when damage in the macula (centre of the retina) is caused by choroidal neovascularization (CNV), which is an ingrowth of abnormal blood vessels. These blood vessels leak blood and fluids to cause scarring. Verteporfin is used to treat the predominantly classic form of CNV, where the leakage occurs rapidly. When activated by light, verteporfin works to destroy the abnormal blood vessels growing in the macula.
The recommended dose is based on body surface area and will be determined by the doctor.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.
Verteporfin is injected by intravenous (into a vein) infusion, usually in the arm, where the medication is given over a 10-minute period. This medication is given by a health care professional. After a few minutes, the doctor shines a light (laser) on the eye, where the medication has traveled to the abnormal blood vessels in the eye. This light activates verteporfin to start working.
It is important that this medication be given exactly as recommended by your doctor. If you miss an appointment to receive verteporfin, contact your doctor as soon as possible to reschedule your appointment.
This medication is stored at room temperature and protected from light.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Do not use this medication if you:
- are allergic to verteporfin or any ingredients of this medication
- have porphyria
- have severe liver dysfunction
The side effects listed below are not experienced by everyone who uses this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people using this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- back pain (temporary)
- chest pain (temporary)
- decrease in pain or touch sensitivity
- dry, itchy, or painful eyes
- injection site reactions such as pain, redness, swelling, bleeding, discoloration, or rash
- increased blood pressure
- light sensitivity
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- appearance of light flashes or floaters
- blurred vision
- changes in heart rate
- decrease in sharpness of vision
- dry, itchy eyes
- flu-like symptoms (sudden lack of energy, fever, cough, sore throat)
- gaps in vision
- increased blood pressure
- shortness of breath
- signs of anemia (low red blood cell counts; e.g., pale skin, unusual tiredness or weakness)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- severe decrease in vision (often sudden)
- signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
- signs of an allergic reaction (e.g., difficulty breathing; hives; swelling of face, lips, tongue, or throat)
- signs of stroke (e.g., sudden vision change, dizziness, difficulty speaking, difficulty moving one side of the body)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are using this medication.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Liver function: Verteporfin may not clear from the body at the expected rate in cases where the liver is not working properly. This increases the risk of experiencing side effects. If you have moderate liver dysfunction, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Photosensitivity: Verteporfin can make you more sensitive to light. Avoid exposure of skin or eyes to direct sunlight or bright indoor light for 2 days after receiving verteporfin. This includes tanning salons, bright halogen lighting, high power lighting (such as those used in dental offices), and light-emitting medical devices.
Exposure to light can cause pain, inflammation, swelling, or discoloration at the injection site. Some people may also develop a rash. If you are going outside, wear protective clothing and dark sunglasses. Sunscreens with ultraviolet protection will not protect against this type of light sensitivity. You may be given a wristband to remind yourself and others that you are light sensitive.
You should not stay in the dark; in fact, you should expose your skin to ambient indoor lighting, since this will help inactivate the medication in the skin through a process called photo bleaching.
Surgery: Bright lights such as those used in operating rooms and dentist’s offices can activate verteporfin. If you are scheduled for surgery or have a dental appointment soon after a treatment with verteporfin, let your doctor or dentist know that you have received this medication.
Vision: You may experience temporary changes in vision that may affect your ability to drive or use machines. Do not perform these tasks until you determine you can do them safely without any impaired vision. Verteporfin can also make eyes more sensitive to light (see “Photosensitivity” above).
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking verteporfin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding. You should stop breast-feeding for 96 hours (4 days) after receiving verteporfin.
Children: The safety and effectiveness of using this medication have not been established for children.
There may be an interaction between verteporfin and any of the following:
- anticlotting medications (e.g., ASA, clopidogrel)
- beta carotene
- calcium channel blockers (e.g., amlodipine, nifedipine)
- nonsteroidal anti-inflammatory medications (NSAIDs; e.g., celecoxib, ibuprofen, naproxen)
- phenothiazines (e.g., chlorpromazine, perphenazine)
- quinolone antibiotics (e.g., ciprofloxacin, levofloxacin, norfloxacin)
- radiation therapy
- St. John’s wort
- sulfonamides (e.g., celecoxib, sulfamethoxazole)
- sulfonylureas (e.g., gliclazide, glyburide)
- thiazide diuretics (e.g., hydrochlorothiazide)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.