porfimer (Rx)

>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%)

Contraindications

Hypersensitivity to porphyrins

Porphyria

Emergency treatment of severe acute respiratory distress when caused by endobronchial lesion

Esophageal or gastric varices

Esophageal ulcers

Tracheoesophageal or bronchoesophageal fistula; tumor erosion into major blood vessel

Cautions

Separate from radiotherapy by 2-4 wk

Avoid sunlight following injection

Esophageal stricture reported within 6 months of initiating treatment (usually within 6 months of treatment)

Inflammation resulting from treatment may obstruct airway (not for use in patients with esophageal tumors eroding into the trachea or bronchial tree

Potentially fatal gastrointestinal and esophageal necrosis and perforation may occur following treatment

May experience substernal chest pain from inflammatory responses within the treatment area

Risk of hemorrhage increased in patients esophageal varices or tumors eroding into pulmonary blood vessels

Ocular discomfort reported

Photosensitivity reactions reported in patients exposed to direct sunlight or bright indoor light

Thromboembolism reported, particularly in patients with other risk factors (eg, advanced cancer, postsurgery, prolonged immobilization, CV disease)

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.

Mechanism of Action

Cytotoxic activity dependent on light and oxygen; activated by laser light to produce oxygen free radicals and vascular necrosis via thromboxane A2 release

Pharmacokinetics

Half-Life: 17 days (first dose); 30 days (second dose); retained longest in tumors, skin, and reticuloendothelial organs

Peak Plasma Concentration: 15 mcg/mL

Protein Bound: 90%

Vd: 0.49 L/kg

Clearance: 0.051 mL/min/kg

IV Incompatibilities

Do not mix with other drugs in the same solution

IV Preparation

Reconstitute with 31.8 mL of either D5W or NS resulting in a final concentration of 2.5 mcg/mL & pH of 7-8

Shake well until dissolved

Protect the reconstituted product from bright light & use immediately

Reconstituted porfimer is an opaque solution in which detection of particulate matter by visual inspection is extremely difficult

IV Administration

Administer slow IVP over 3-5 min

Use of gloves & eye protection is recommended

Storage

Store intact vials at controlled room temp 20-25°C (68-77°F)