Visudyne

Generic name: verteporfin
Drug class: Miscellaneous antineoplastics

Medically reviewed by  A Ras MD.

What is Visudyne?

Visudyne is a prescription medicine that is used to treat macular degeneration.

Description

VISUDYNE (verteporfin for injection) is a light activated drug used in photodynamic therapy. The finished drug product is a lyophilized dark green cake. Verteporfin is a 1:1 mixture of two regioisomers (I and II), represented by the following structures:

The chemical names for the verteporfin regioisomers are:

9-methyl (I) and 13-methyl (II) trans-(±)-18-ethenyl-4,4a,-dihydro-3,4-bis(methoxycarbonyl)-4a,8,14,19-tetramethyl-23H, 25H-benzo[b]porphine-9,13-dipropanoate

The molecular formula is C41H42N4O8 with a molecular weight of approximately 718.8. Each mL of reconstituted VISUDYNE contains:

ACTIVE: verteporfin, 2 mg

INACTIVES: ascorbyl palmitate, butylated hydroxytoluene, dimyristoyl phosphatidylcholine, egg phosphatidylglycerol and lactose

Mechanism of Action

VISUDYNE (verteporfin for injection) therapy is a two-stage process requiring administration of both verteporfin for injection and nonthermal red light.

Verteporfin is transported in the plasma primarily by lipoproteins. Once verteporfin is activated by light in the presence of oxygen, highly reactive, short-lived singlet oxygen and reactive oxygen radicals are generated. Light activation of verteporfin results in local damage to neovascular endothelium, resulting in vessel occlusion. Damaged endothelium is known to release procoagulant and vasoactive factors through the lipoxygenase (leukotriene) and cyclooxygenase (eicosanoids such as thromboxane) pathways, resulting in platelet aggregation, fibrin clot formation and vasoconstriction. Verteporfin appears to somewhat preferentially accumulate in neovasculature, including choroidal neovasculature. However, animal models indicate that the drug is also present in the retina. Therefore, there may be collateral damage to retinal structures following photoactivation including the retinal pigmented epithelium and outer nuclear layer of the retina. The temporary occlusion of the CNV following VISUDYNE therapy has been confirmed in humans by fluorescein angiography.

Before taking Visudyne, tell your doctor:

• If you are allergic to Visudyne; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have porphyria.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Visudyne with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Visudyne?

• Tell all of your health care providers that you take Visudyne. This includes your doctors, nurses, pharmacists, and dentists.
• Have an eye exam as you have been told by your doctor.
• Use care when driving or doing other tasks that call for clear eyesight.
• Your skin may be more sensitive to light. Avoid sources of bright light for 5 days after you get Visudyne. This includes sun, sunlamps, tanning beds, and bright indoor light. Wear clothing and eyewear that protects you from the sun. Sunscreens will not help. You may also need to avoid using certain medical devices after getting Visudyne. Talk with your doctor.
• Do not stay in the dark. It is best to get normal amounts of indoor light. Talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Visudyne while you are pregnant.

How is Visudyne best taken?

Use Visudyne as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.
• A laser is needed to make Visudyne work.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Visudyne that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Dizziness or passing out.
• Flushing.
• Very bad headache.
• Chest pain or pressure.
• Change in eyesight, eye pain, or very bad eye irritation.
• Feeling very tired or weak.
• Sweating a lot.
• Shortness of breath.
• Fast or slow heartbeat.
• Bleeding where the shot is given.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.

What are some other side effects of Visudyne?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.
• Blurred eyesight.
• Dry eyes.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Visudyne?

• If you need to store Visudyne at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL