Porfimer Injection

WHY is this medicine prescribed?

Porfimer is used in combination with photodynamic therapy (PDT; treatment with a laser light) to treat cancer or precancer of the esophagus and non-small cell lung cancer (NSCLC). Porfimer is in a class of medications called photoactivated radical generators. It works by killing porfimer-treated cancer cells when activated by PDT.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Porfimer comes as a powder to be made into a solution to be injected intravenously (into a vein) by a healthcare provider. It is usually given over 3 to 5 minutes. Then your doctor will administer the special laser light in the area to be treated at a certain time after porfimer was given. In some cases, your doctor may give you additional laser light treatments, but no additional doses of porfimer are necessary.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking porfimer,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• some medications should not be taken with porfimer. Make sure you have discussed any medications you are currently taking or plan to take before receiving porfimer and PDT treatment with your doctor and pharmacist. Before starting, stopping, or changing any medications when receiving porfimer and PDT treatment, please get the advice of your doctor or pharmacist.

• tell your doctor if you have porphyria (an inherited condition that may cause skin and nervous system problems), certain types of fistulas (abnormal connection to other organs) in the esophagus (tube that connects the throat to the stomach), tumors that are very near major blood vessels, a rapid need treat a lesion in your esophagus that is causing serious breathing problems, certain types and sizes of lesions or enlarged veins in the esophagus or stomach areas. Your doctor will probably tell you not to receive porfimer.

• tell your doctor if you have recently had surgery or have a condition with limited mobility and if you have or have ever had cancer, heart and blood vessel, liver, or kidney disease.

• tell your doctor if you are pregnant or plan to become pregnant. Porfimer may harm the fetus. You may be required to have a negative pregnancy test before you start treatment with porfimer. You or your partner should use birth control during treatment with porfirmer and for 5 months after the final dose. Talk to your doctor about what birth control is right for you or your partner.

• you should not breast feed during treatment with porfimer and for 5 months after the final dose.

• you know that porfimer treatment will make your skin and eyes very sensitive to sunlight and other types of light. Plan to avoid exposure of your skin and eyes to sunlight or bright indoor light from examination lamps, including dental lamps, operating room lamps, and unshaded lightbulbs at close proximity for at least 30 days after receiving porfimer.In some people with liver or kidney disease, it may be necessary to avoid sunlight or bright indoor light for 90 days or more. Do not avoid light entirely during this time; you should expose your skin to soft indoor light. You must wear protective clothing and dark sunglasses (that allows <4% light to reach the skin or eyes) when outdoors. Sunscreen will not protect you from sunlight during this time. Your doctor will help you to test when it is safe to resume outdoor activities without these precautions.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Porfimer may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea, vomiting, constipation
• abdominal or back pain
• sore throat
• trouble sleeping
• redness of the skin

Some side effects can be serious. If you experience any of these symptoms, tell your doctor immediately or get emergency medical treatment:

• trouble breathing or swallowing
• swelling, tenderness, or pain in a leg
• shortness of breath, chest pain
• fever, cough, shortness of breath
• swelling, itching, burning, or blisters on the skin
• pain or redness near the site of injection
• coughing up blood or bloody mucous

Porfimer may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.