Dosing and uses of Photofrin (porfimer)
Adult dosage forms and strengths
powder for injection
- 75mg/vial
Esophageal Cancer, Endobronchial NSCLC
2 mg/kg IV over 3-5 minutes
Follow by corresponding spectrum of laser light 40-50 hours after injection, then again 96-120 hours after injection
Ablation of High-grade Dysplasia in Barrett's Esophagus
2 mg/kg IV over 3-5 minutes
Follow by corresponding spectrum of laser light 40-50 hours after injection, then again 96-120 hours after injection Barrett's esophagus patients who do not undergo esophagectomy
Bladder Carcinoma (Orphan)
Photodynamic therapy of transitional cell carcinoma in situ of the urinary bladder
Orphan sponsor
- QLT Phototherapeutics, Inc, Lederle Laboratories; 401 North Middletown Road; Pearl River, NY 10965
Cholangiocarcinoma (Orphan)
Orphan sponsor
- Pinnacle Biologics, Inc; 2801 lakeside Drive, Suite 209; Bannockburn, IL 60015
Mesothelioma (Orphan)
Orphan designation for malignant pleural mesothelioma
Orphan sponsor
- Pinnacle Biologics, Inc; 2801 lakeside Drive, Suite 209; Bannockburn, IL 60015
Other Indications & Uses
Ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy
Pediatric dosage forms and strengths
Safety and efficacy not established
Photofrin (porfimer) adverse (side) effects
>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%)
Warnings
Contraindications
Hypersensitivity to porphyrins
Tracheoesophageal or bronchoesophageal fistula; tumor erosion into major blood vesseL
Cautions
Separate from radiotherapy by 2-4 wk
Avoid sunlight following injection
Thromboembolism reported, particularly in patients with other risk factors (eg, advanced cancer, postsurgery, prolonged immobilization, CV disease)
Pregnancy and lactation
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.
Pharmacology of Photofrin (porfimer)
Mechanism of action
Activated by laser light to produce oxygen free radicals and vascular necrosis via thromboxane A2 release
Pharmacokinetics
Half-Life: 250 hr (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
Metabolism: N/A
Excretion: N/A
Dialyzable: No
Administration
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)
