Porfimer

>10%

Anemia (32%)

Fever (31%)

Pleural effusion (28%)

Constipation (24%)

Chest pain (22%)

Abd pain (20%)

Dyspnea (18%)

Pneumonia (16%)

Insomnia (14%)

Back pain (11%)

1-10%

Atrial-fib (10%)

Dysphagia (10%)

Pharyngitis (10%)

Resp distress (9%)

Decr wt (9%)

Hematemesis (8%)

Dehydration (7%)

Hypotension (7%)

Peripheral edema (7%)

Cardiac failure (7%)

Tachycardia (6%)

Asthenia (6%)

Hypertension (6%)

Cough (6%)

Diarrhea (5%)

Generalized edema (5%)

Pregnancy Category: C

Lactation: not known if excreted in breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• fever, chills, pale skin, cough, stabbing chest pain, coughing up mucus or blood;

• wheezing, gasping for breath, anxiety, sweating, fast or uneven heart rate;

• pain in your chest or left side, pain behind your breastbone, pain when you breathe, feeling short of breath (even when lying down);

• dehydration--if you feel very thirsty or hot, are unable to urinate, and have heavy sweating or hot and dry skin; or

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects may include:

• increased sensitivity of your eyes to light;

• nausea, vomiting, stomach pain;

• constipation;

• back pain;

• sleep problems (insomnia); or

• sore throat, mild cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• If you have an allergy to porfimer or any other part of porfimer.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• 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 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 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.

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 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, change in eyesight.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• 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.
• 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.

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.

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

(POR fi mer)

Barrett esophagus dysplasia (photodynamic therapy): Ablation of high-grade dysplasia in Barrett esophagus (in patients who do not undergo esophagectomy)

Endobronchial cancer (photodynamic therapy): Treatment of microinvasive endobronchial non-small cell lung cancer (NSCLC) in patients for whom surgery and radiation therapy are not indicated; reduction of obstruction and symptom palliation in patients with obstructing (partial or complete) endobronchial NSCLC

Esophageal cancer (photodynamic therapy): Palliation of completely obstructing esophageal cancer, or partially obstructing esophageal cancer in patients who cannot be treated satisfactorily with Nd:YAG laser therapy.

Refer to adult dosing.

Store intact vials at 20°C to 25°C (68°F to 77°F). Reconstituted solutions should be protected from light and used immediately after preparation.

Data not available.

Data not available.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.