Photofrin Generic Name & Formulations
Legal Class
Rx
General Description
Porfimer (as sodium) 75mg/vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Pharmacological Class
Photosensitizing agent.
How Supplied
Single-use vial—1
Manufacturer
Photofrin Indications
Indications
Palliation of patients with completely obstructing esophageal cancer or partially obstructing esophageal cancer who cannot be satisfactorily treated with Nd:YAG laser therapy. Ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy.
Photofrin Dosage and Administration
Adult
See full labeling. Give by slow IV inj over 3–5mins. 2mg/kg then illumination with laser light 40–50hrs following injection. Esophageal cancer: 2nd course may be given at a minimum of 30 days after initial therapy; max 3 courses (separated by ≥30 days). High-grade dysplasia in Barrett's esophagus: 2nd course may be given at a minimum of 90 days after initial therapy; max 3 courses (separated by ≥90 days).
Children
Not established.
Photofrin Contraindications
Contraindications
Porphyria. Existing tracheoesophageal or bronchoesophageal fistula. Tumors eroding into a major blood vessel. Emergency treatment of patients with severe acute respiratory distress caused by an obstructing endobronchial lesion. Esophageal or gastric varices. Esophageal ulcers >1cm in diameter.
Photofrin Boxed Warnings
Not Applicable
Photofrin Warnings/Precautions
Warnings/Precautions
Avoid direct sunlight or bright indoor light; wear dark sunglasses when outdoors. Increased risk of fatal massive hemoptysis with large, centrally located tumors, cavitating tumors, extensive tumor extrinsic to the bronchus. Caution with endobronchial tumors in locations where treatment-induced inflammation could obstruct airway; monitor for respiratory distress. Severe renal or hepatic impairment: may prolong photosensitivity period. Avoid extravasation. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 5 months after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for 5 months after last dose).
Photofrin Pharmacokinetics
See Literature
Photofrin Interactions
Interactions
Increased risk of photosensitivity reactions with other photosensitizing agents (eg, tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, fluoroquinolones); avoid. Separate radiotherapy by 2–4 weeks.
Photofrin Adverse Reactions
Adverse Reactions
Photosensitivity reactions (eg, erythema, swelling, itching, burning sensation, feeling hot, blisters), constipation, pain, GI upset, pyrexia, dyspnea, pneumonia; chest pain, ocular sensitivity, hemoptysis (may be fatal), esophageal strictures, thromboembolism.
Photofrin Clinical Trials
See Literature
Photofrin Note
Not Applicable
Photofrin Patient Counseling
See Literature
Photofrin Generic Name & Formulations
Legal Class
Rx
General Description
Porfimer (as sodium) 75mg/vial; lyophilized pwd for IV inj after reconstitution; preservative-free.
Pharmacological Class
Photosensitizing agent.
How Supplied
Single-use vial—1
Manufacturer
Photofrin Indications
Indications
Reduction of obstruction and palliation in patients with completely or partially obstructing endobronchial non-small-cell lung cancer (NSCLC). Treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy is not indicated.
Photofrin Dosage and Administration
Adult
See full labeling. Give by slow IV inj over 3–5mins. 2mg/kg then illumination with laser light 40–50hrs following injection. 2nd course may be given at a minimum of 30 days after initial therapy; max 3 courses (separated by ≥30 days).
Children
Not established.
Photofrin Contraindications
Contraindications
Porphyria. Existing tracheoesophageal or bronchoesophageal fistula. Tumors eroding into a major blood vessel. Emergency treatment of patients with severe acute respiratory distress caused by an obstructing endobronchial lesion. Esophageal or gastric varices. Esophageal ulcers >1cm in diameter.
Photofrin Boxed Warnings
Not Applicable
Photofrin Warnings/Precautions
Warnings/Precautions
Avoid direct sunlight or bright indoor light; wear dark sunglasses when outdoors. Increased risk of fatal massive hemoptysis with large, centrally located tumors, cavitating tumors, extensive tumor extrinsic to the bronchus. Caution with endobronchial tumors in locations where treatment-induced inflammation could obstruct airway; monitor for respiratory distress. Severe renal or hepatic impairment: may prolong photosensitivity period. Avoid extravasation. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 5 months after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for 5 months after last dose).
Photofrin Pharmacokinetics
See Literature
Photofrin Interactions
Interactions
Increased risk of photosensitivity reactions with other photosensitizing agents (eg, tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, fluoroquinolones); avoid. Separate radiotherapy by 2–4 weeks.
Photofrin Adverse Reactions
Adverse Reactions
Photosensitivity reactions (eg, erythema, swelling, itching, burning sensation, feeling hot, blisters), constipation, pain, GI upset, pyrexia, dyspnea, pneumonia; chest pain, ocular sensitivity, hemoptysis (may be fatal), esophageal strictures, thromboembolism.
Photofrin Clinical Trials
See Literature
Photofrin Note
Not Applicable
Photofrin Patient Counseling
See Literature