Porfimer

What is porfimer?

Porfimer is a prescription medicine that is used to treat cancer. It is used to treat changes in the swallowing tube called Barrett’s esophagus.

Description

Porfimer sodium is a photoactivated radical generator. Porfimer sodium is a mixture of oligomers formed by ether and ester linkages of up to eight porphyrin units. The structural formula below is representative of the components of porfimer sodium.

PHOTOFRIN (porfimer sodium) for injection, for intravenous use, is supplied in a single-dose vial as dark red to reddish brown lyophilized powder, which has a cake-like appearance. Each vial contains 75 mg of porfimer sodium. Hydrochloric acid and/ or sodium hydroxide may be added to adjust the pH to within 7.2-7.9. There are no preservatives or other additives.

Mechanism of Action

The cytotoxic and antitumor actions of PHOTOFRIN are light and oxygen dependent. Photodynamic therapy (PDT) with PHOTOFRIN is a two-stage process. The first stage is the intravenous administration of PHOTOFRIN. Clearance from a variety of tissues occurs over 40-72 hours, but tumors, skin, and organs of the reticuloendothelial system (including liver and spleen) retain PHOTOFRIN for a longer period. The second stage is the illumination with 630 nm wavelength laser light. Tumor selectivity in treatment occurs through a combination of selective retention of PHOTOFRIN and selective delivery of light.

Cellular damage caused by PDT with PHOTOFRIN is a consequence of the propagation of radical reactions. Radical initiation may occur after porfimer sodium absorbs light to form a porphyrin excited state. Spin transfer from porfimer sodium to molecular oxygen may then generate singlet oxygen. Subsequent radical reactions can form superoxide and hydroxyl radicals. Tumor death also occurs through ischemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release. As opposed to a thermal effect, the laser treatment with porfimer sodium induces a photochemical effect. The necrotic reaction and associated inflammatory responses may evolve over several days.

Before taking porfimer, tell your doctor:

• If you are allergic to porfimer; 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 any of these health problems: Fistula of swallowing tube (esophagus), porphyria, a tumor in a blood vessel, ulcer in swallowing tube, or swollen veins in the stomach or swallowing tube.
• If you are getting radiation.

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

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 porfimer 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 porfimer?

• Tell all of your health care providers that you take porfimer. This includes your doctors, nurses, pharmacists, and dentists.
• If you have upset stomach, throwing up, diarrhea, or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may get sunburned more easily. Avoid sun, sunlamps, bright indoor lights, and tanning beds for as long as you were told by your doctor. Wear clothing and eyewear that protects you from the sun. Sunscreens will not protect you.
• It is important for your skin to be in normal indoor light after getting porfimer instead of a dark room. You will need to test your skin before being in bright indoor light or sunlight. This lasts for at least 30 days after treatment. Some people may burn easily for up to 90 days. Follow what your doctor has told you to do in regard to indoor and outdoor light.
• Bright lights may bother you for some time after using porfimer. Wear sunglasses for as long as you were told by your doctor.
• People using porfimer may get skin reactions where porfimer is used. These reactions may include blisters, burning, itching, redness, swelling, or a warm feeling. Call your doctor if you have skin reactions that are very bad, bother you, or do not go away.
• Blood clots have happened with porfimer. Tell your doctor if you have ever had a blood clot. Talk with your doctor.
• Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is porfimer best taken?

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

• It is given into a vein for a period of time.
• This medicine is used with light therapy.
• Follow up with the doctor as you have been told.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of porfimer 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.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Signs of dehydration like dry skin, mouth, or eyes; thirst; fast heartbeat; dizziness; fast breathing; or confusion.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Mouth irritation or mouth sores.
• Throat irritation.
• Fast or abnormal heartbeat.
• Trouble swallowing.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Cough that does not go away.
• Feeling very tired or weak.
• Vaginal itching or discharge.
• Feeling confused.
• Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.
• Very bad and sometimes deadly stomach or bowel problems have happened with porfimer. This includes stomach or bowel bleeding, holes or tears, and tissue death. Call your doctor right away if you have fever or chills; black, tarry, or bloody stools; stomach pain; stomach swelling/throwing up blood or throw up that looks like coffee grounds.

What are some other side effects of porfimer?

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:

• Hair growth.
• Change in color of skin.
• Bumps, thick, dry, or wrinkled skin.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• Feeling tired or weak.
• Weight loss.
• Cough.
• Trouble sleeping.
• Back pain.
• Anxiety.

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 porfimer?

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

Label

VIAL LABEL PANEL

CARTON LABEL PANEL