Verteporfin

Frequency Not Determined

Visual disturbances

Injection site reactions  including extravasation and rashes

Edema

Hemorrhage

Inflammation

Flashes of light

Severe vision loss (1-4%)

Photosensitivity

Headache

Conjunctivitis

Dry eyes

Ocular itching

Subconjunctival

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

WBC incr/decr

Elev LFTs

Albuminuria

Leukocyte count increase/decrease

Increased liver function test results

Albuminuria

Increased serum creatinine

Arthralgia

Arthrosis

Myasthenia

Hypesthesia

Sleep disorder

Vertigo

Pharyngitis

Pneumonia

Hearing decrease

Lacrimation disorder

Prostatic disorder

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of verteporfin, there are no specific foods that you must exclude from your diet when receiving this medication.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication
• your height

Verteporfin therapy consists of two steps: administration of verteporfin and activation of verteporfin with light from a nonthermal diode laser. The dose of verteporfin is based on body surface area and the light administration is based on the lesion size being treated. Therapy may be repeated after 3 months, if needed.

You should not receive this medicine if you have porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

You should not receive verteporfin if you are allergic to it, or if you have porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

To make sure verteporfin is safe for you, tell your doctor if you have:

• liver disease;

• gallbladder disease; or

• if you are receiving radiation treatment.

FDA pregnancy category C. It is not known whether verteporfin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Verteporfin can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using verteporfin.

Verteporfin is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Verteporfin must be given slowly, and the IV infusion can take at least 10 minutes to complete.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when verteporfin is injected.

You will receive laser light treatment to your eye(s) within 15 minutes after the start of your verteporfin infusion.

After receiving verteporfin, you must protect your eyes from natural sunlight and bright indoor light for at least 5 days.. For best protection, wear dark sunglasses whenever you are outdoors or while indoors under bright lighting.

You should not stay in the dark while you are indoors, as this can actually cause the drug to stay active in your body longer. It is best to spend your time in ambient indoor light such as indirect sunlight through a window, or low-wattage incandescent lighting. Avoid areas where you will be exposed to halogen or fluorescent light.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Photosensitizing agent activated by low-intensity laser light; synthetic benzoporphyrin derivative.1 2 3 4 5 6 7

Not metabolized by CYP-450 isoenzymes.1

No formal drug interactions studies in humans to date.1

Compounds That Quench Active Oxygen Species or Scavenge Radicals

Possible decreased verteporfin activity with concomitant use of these agents (e.g., alcohol, beta carotene, dimethylsulfoxide, formate, mannitol).1

Drugs That Decrease Clotting, Vasoconstriction, or Platelet Aggregation

Possible decreased efficacy of verteporfin therapy.1

Specific Drugs

• Tell all of your health care providers that you take this medicine. 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 verteporfin. 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 this medicine. 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 verteporfin while you are pregnant.

Subfoveal choroidal neovascularization: 6 mg/m2 body surface area intravenously over 10 minutes, once. The drug is photoactivated by 83 seconds of laser light administration (689 nm) commencing 15 minutes after start of the infusion.

Bilateral lesions in patients who have never undergone verteporfin therapy: 6 mg/m2 body surface area intravenously over 10 minutes, once. The drug is photoactivated by 83 seconds of laser light administration (689 nm) commencing 15 minutes after start of the infusion. The most aggressive lesion should be treated first. If, after the first treatment, an acceptable safety profile is identified, treatment of the second eye can commence no sooner than one week following the first course.

Bilateral lesions in patients who have undergone previous verteporfin therapy: 6 mg/m2 body surface area intravenously over 10 minutes, once. The drug is photoactivated by 83 seconds of laser light administration (689 nm) commencing 15 minutes after start of the infusion. If the patient showed an acceptable safety profile following the first course of verteporfin therapy then both eyes may be treated concurrently after a single administration of verteporfin. The more aggressive lesion should be treated first 15 minutes after the start of the verteporfin infusion. The treatment of the second eye should be initiated immediately at the end of the light treatment of the first eye using the same light dose and intensity as for the first eye. The treatment of the second eye should start no later than 20 minutes after the start of the verteporfin infusion.

Patients may be retreated in 3 months, if necessary.