Applies to porfimer: intravenous powder for solution.

Serious side effects of Porfimer

Along with its needed effects, porfimer may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking porfimer:

More common

• Bladder pain
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chest pain or discomfort
• confusion
• congestion
• cough
• coughing or spitting up blood
• difficult or troubled breathing
• difficult, burning, or painful urination
• difficulty with swallowing
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dryness or soreness of the throat
• extreme fatigue
• fast, pounding, or irregular heartbeat or pulse
• fever or chills
• frequent urge to urinate
• headache
• hoarseness
• increased sensitivity of the skin to sunlight
• irregular, fast or slow, or shallow breathing
• itching or skin rash
• lower back or side pain
• nervousness
• pale or blue lips, fingernails, or skin
• pale skin
• pounding in the ears
• redness or other discoloration of the skin
• runny nose
• severe pain in the chest
• severe sunburn
• slow or fast heartbeat
• sneezing
• sore throat
• sudden onset of severe breathing difficulty
• sweating
• swelling of the face, fingers, feet, or lower legs
• tender, swollen glands in the neck
• tightness in the chest
• unusual bleeding or bruising
• unusual tiredness or weakness
• voice changes
• vomiting of blood or material that looks like coffee grounds
• weight gain
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash

Less common

• Bloody, black, or tarry stools
• decrease in the amount of urine
• decreased urination
• dry mouth
• fainting
• heartburn
• increase in heart rate
• noisy, rattling breathing
• pain or burning in the throat
• rapid breathing
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• sunken eyes
• thirst
• troubled breathing at rest
• vomiting
• wrinkled skin

Other side effects of Porfimer

Some side effects of porfimer may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• back pain
• belching
• constipation
• diarrhea
• fear or nervousness
• indigestion
• lack or loss of strength
• loss of appetite
• nausea
• pain
• stomach discomfort, upset, or pain
• trouble sleeping
• weight loss

Less common

• Bloated or full feeling
• change in the color of treated skin
• excess air or gas in the stomach
• increased hair growth
• small lumps under the skin

For Healthcare Professionals

Applies to porfimer: intravenous powder for injection.

Dermatologic

Very common (10% or more): Photosensitivity reaction (37%)

Postmarketing reports: Angioedema, blister, dry skin, erythema, face edema, photodermatosis, pigmentation disorder, pruritus, pseudoporphyria, rash, skin burning sensation, sunburn, urticaria^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (37%), esophageal stricture (36%), vomiting (31%), esophageal narrowing (30%), constipation (24%), dysphagia (24%)

abdominal pain (20%)

Common (1% to 10%): Esophageal bleeding, esophageal edema, hematemesis, dyspepsia, esophageal stenosis, diarrhea, esophagitis, eructation, melena, esophageal pain, hiccups, odynophagia

Frequency not reported: Esophageal perforation, gastric ulcer, ileus, peritonitis, regurgitation, heartburn

Postmarketing reports: Gastrointestinal necrosis, dry lips, mouth edema, esophageal fistula, esophageal ulcer, oral pain, esophageal injury^[Ref]

Hematologic

Very common (10% or more): Anemia (32%)

Postmarketing reports: Leukocytosis, prolonged activated partial thromboplastin time, increased C-reactive protein, erythropenia, decreased hemoglobin, prolonged prothrombin time, increased blood urea^[Ref]

Respiratory

Very common (10% or more): Pleural effusion (32%), dyspnea (30%), exudate (22%), bronchial mucus plug or bronchial obstruction (21%), pneumonia (18%), cough (15%), hemoptysis (16%), pharyngitis (11%), bronchiostenosis (11%), bronchitis (10%), respiratory insufficiency (10%), respiratory distress

Common (1% to 10%): Tracheoesophageal fistula, bronchial ulceration

Frequency not reported: Bronchospasm, laryngotracheal edema, pneumonitis, pulmonary hemorrhage, pulmonary edema, respiratory failure, stridor, mediastinal inflammation, pulmonary thrombosis, pulmonary embolism, lung abscess, increased sputum

Postmarketing reports: Bronchial injury, bronchial fistula, bronchial hemorrhage, hiccups^[Ref]

Other

Very common (10% or more): Pyrexia (31%), chest pain (31%), pain (22%), generalized edema (18%), chest discomfort (10%)

Common (1% to 10%): Peripheral edema, asthenia/fatigue/malaise, substernal chest pain, candidiasis, post-procedural complication, post-procedural pain, sepsis

Postmarketing reports: Chills, swelling, decreased total protein^[Ref]

Psychiatric

Very common (10% or more): Insomnia (14%)

Common (1% to 10%): Confusional state, anxiety^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (11%)^[Ref]

Cardiovascular

Very common (10% or more): Atrial fibrillation (10%)

Common (1% to 10%): Cardiac failure, tachycardia, hypotension, hypertension

Frequency not reported: Angina pectoris, bradycardia, myocardial infarction, sick sinus syndrome, supraventricular tachycardia

Postmarketing reports: First degree atrioventricular block, deep vein thrombosis, embolism, phlebitis^[Ref]

Metabolic

Very common (10% or more): Dehydration (10%)

Common (1% to 10%): Decreased weight, anorexia

Frequency not reported: Fluid imbalance

Postmarketing reports: Fluid overload, hypocalcemia^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection

Postmarketing reports: Bladder spasm, dysuria, hydronephrosis, micturition urgency, nocturia, urinary retention^[Ref]

Nervous system

Common (1% to 10%): Dysphonia

Frequency not reported: Cerebrovascular accident

Postmarketing reports: Dizziness, hypoesthesia, vasovagal syncope^[Ref]

Oncologic

Common (1% to 10%): Tumor hemorrhage^[Ref]

Hepatic

Frequency not reported: Jaundice

Postmarketing reports: Pancreatitis, portal vein thrombosis^[Ref]

Ocular

Frequency not reported: Cataracts, ocular sensitivity, abnormal vision, diplopia, eye pain, photophobia

Postmarketing reports: Asthenopia, ocular hyperemia, abnormal visual acuity test^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity^[Ref]

Local

Postmarketing reports: Infusion reactions, application site edema^[Ref]