Photofrin Side Effects

Generic name: porfimer

Note: This document contains side effect information about porfimer. Some of the dosage forms listed on this page may not apply to the brand name Photofrin.

Some side effects of Photofrin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to porfimer: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking porfimer (the active ingredient contained in Photofrin) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• cough with yellow or green mucus, stabbing chest pain, feeling short of breath, coughing up mucus or blood;

• tight feeling in your throat, trouble swallowing;

• fever, chills;

• sudden numbness or weakness, problems with vision, speech, or balance;

• pain, swelling, warmth, or redness in one or both legs;

• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or

• anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, fast or uneven heart rate.

Less serious side effects of porfimer 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.

For Healthcare Professionals

Applies to porfimer: intravenous powder for injection

General

General side effects have included fever (31%), pain (up to 22%), chest pain (up to 22%), back pain (up to 11%), weight decrease (9%), peripheral edema (up to 7%), dehydration (7%), asthenia (6%), generalized edema (5%), and surgical complication (5%). Patients with at least one adverse event have been as high as 95%.

Respiratory

Respiratory side effects including pleural effusion (32%), dyspnea (up to 30%), pneumonia (up to 18%), hemoptysis (16%), coughing (up to 15%), pharyngitis (11%), bronchitis (10%), respiratory insufficiency (up to 10%), increased sputum (8%), and tracheoesophageal fistula (6%) have been reported.

Cardiovascular

Cardiovascular side effects have included edema (18%), atrial fibrillation (10%), cardiac failure (7%), hypotension (7%), tachycardia (6%), and hypertension (6%).

Nervous system

Nervous system side effects have included dysphonia (5%).

Gastrointestinal

Gastrointestinal side effects have included constipation (up to 24%), nausea (24%), abdominal pain (20%), vomiting (17%), dysphagia (10%), esophageal edema (8%), esophageal tumor bleeding (8%), hematemesis (8%), dyspepsia (6%), esophageal stricture (6%), diarrhea (5%), eructation (5%), esophagitis (5%), and melena (5%).

Psychiatric

Psychiatric side effects have included insomnia (up to 14%), anorexia (8%), confusion (8%), and anxiety (up to 7%).

Hematologic

Hematologic side effects have included anemia (32%).

Immunologic

Immunologic side effects have included moniliasis (9%).

Dermatologic

Dermatologic side effects have included photosensitivity reaction (up to 22%).

Genitourinary

Genitourinary side effects have included urinary tract infection (7%).

Local

Local side effects have included exudate (22%), obstruction (19%), stricture (11%), and ulceration (9%).

Ocular

Ocular side effects have included ocular discomfort (commonly described as sensitivity to sun, bright lights, or car headlights).

A case of cataracts has been reported in a fifty-one year old obese man treated with porfimer (the active ingredient contained in Photofrin) The patient suffered from a photodynamic therapy (PDT) response. Within two months post PDT, the patient noted difficulty with his distant vision. A thorough eye examination revealed a change in the refractive error that later progressed to cataracts in both eyes.

Both of the parents of the patient with cataracts in both eyes had a history of cataracts in their seventies. Whether porfimer directly caused or accelerated a familial underlying condition is unknown.

Other

Other side effects including a few cases of fluid imbalance have been reported following the use of photodynamic therapy (PDT) with porfimer (the active ingredient contained in Photofrin) in patients with overtly disseminated intraperitoneal malignancies.

Fluid imbalance is an expected PDT treatment-related event.

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