Porfimer Sodium Solution for injection

What is this medicine?

PORFIMER is a light sensitizing drug that is used in photodynamic therapy (PDT). This medicine stays in tumor cells longer than it does in most healthy cells. This targets the tumor cells for laser light therapy. It is used to treat Barrett's esophagus, esophageal cancer, and lung cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• esophageal fistulas, varices, or ulcers

• porphyria

• recent or ongoing radiation therapy

• tumors that are growing into major blood vessels

• an unusual or allergic reaction to porfimer, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This drug is given as an injection into a vein. It is administered in a hospital or clinic by a specially trained health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• alcohol

• allopurinol

• aspirin

• beta-carotene

• bexarotene

• dimethyl sulfoxide

• isotretinoin

• formate

• mannitol

• medicines for blood pressure like amlodipine, felodipine, nifedipine

• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin

• other medicines that may make you sensitive to the sun like phenothiazines, some medicines for diabetes, thiazide diuretics, griseofulvin, tetracyclines, sulfonamide, and fluoroquinolone antibiotics

• steroid medicines like prednisone or cortisone

• vitamins A and E

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This therapy will cause swelling and pain at the site of the tumor with more secretions and mucus in the lungs or throat. Contact your doctor right away if you have trouble breathing or swallowing. Tell your doctor if your symptoms do not go away or if they get worse.

This medicine will make you more sensitive to light. Sunscreens will NOT protect from this new sensitivity. You must avoid exposing skin and eyes to sunlight and bright indoor lights (unshaded light bulbs at close range) for at least 30 days. This medicine stays in the cells of your skin and eyes for 1 to 3 months. You should continue to expose your body to regular light bulb light. Regular exposure to normal indoor lighting will help to breakdown the medicine in your body. The level of light sensitivity will be different for different areas of the body. After 30 days test your skin sensitivity by getting direct sunlight or bright indoor light on a small area of skin for 10 minutes. If there is no skin reaction, no redness, no swelling, no blisters, within 24 hours, you may begin to spend more time in bright light. If a reaction occurs, wait another 2 weeks before trying again.

Your eyes will be more sensitive to light after taking this medicine. Light from the sun, bright lights, or car headlights may bother your eyes. Wear dark sunglasses for at least 30 days after taking this medicine.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• blisters, redness, swelling of skin (similar to a severe sunburn)

• breathing problems

• changes in vision

• chest or throat pain

• coughing up or vomiting blood

• dark or bloody stools

• fast, irregular heartbeat

• fever

• problems swallowing

• swelling of the ankles, feet, hands

• unusually high or low blood pressure

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor if they continue or are bothersome):

• constipation

• loss of appetite

• nausea, vomiting

• sensitive to the sun and bright lights

• stomach gas, upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.