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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
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Porfimer: Drug information

Porfimer: Drug information
(For additional information see "Porfimer: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Photofrin
Pharmacologic Category
  • Antineoplastic Agent, Miscellaneous
Dosing: Adult
Barrett esophagus dysplasia

Barrett esophagus dysplasia (photodynamic therapy): IV: 2 mg/kg, followed by endoscopic exposure to the appropriate laser light; repeat courses must be separated by at least 90 days (delay subsequent treatment for insufficient healing) for a maximum of 3 courses.

Cholangiocarcinoma, unresectable

Cholangiocarcinoma, unresectable (photodynamic therapy) (off-label use): IV: 2 mg/kg, followed 48 hours later by light activation (Ref).

Endobronchial non-small cell lung cancer

Endobronchial non-small cell lung cancer (photodynamic therapy): IV: 2 mg/kg, followed by endoscopic exposure to the appropriate laser light and debridement; repeat courses must be separated by at least 30 days (delay subsequent treatment for insufficient healing) for a maximum of 3 courses.

Esophageal cancer

Esophageal cancer (photodynamic therapy): IV: 2 mg/kg, followed by endoscopic exposure to the appropriate laser light and debridement; repeat courses must be separated by at least 30 days (delay subsequent treatment for insufficient healing) for a maximum of 3 courses.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use caution as porfimer elimination (and photosensitivity) may be prolonged.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use caution as porfimer elimination (and photosensitivity) may be prolonged.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Cardiovascular: Chest pain (8% to 22%), edema (5% to 18%)

Dermatologic: Skin photosensitivity (19% to 69%)

Gastrointestinal: Esophageal stenosis (6% to 38%), nausea (24%), constipation (5% to 24%), abdominal pain (20%), vomiting (17%), dysphagia (10%)

Hematologic & oncologic: Anemia (esophageal cancer: 32%)

Nervous system: Pain (5% to 22%), insomnia (5% to 14%)

Neuromuscular & skeletal: Back pain (3% to 11%)

Respiratory: Pleural effusion (5% to 32%), dyspnea (7% to 30%), bronchial obstruction (≤21%), bronchial plugs (≤21%), pneumonia (12% to 18%), hemoptysis (16%), cough (7% to 15%), bronchoconstriction (bronchostenosis: 11%), pharyngitis (11%)

Miscellaneous: Fever (16% to 31%), serous drainage (22%)

1% to 10%:

Cardiovascular: Atrial fibrillation (10%), hypotension (7%), peripheral edema (5% to 7%), cardiac failure (≤7%), hypertension (6%), tachycardia (6%), substernal pain (5%), acute myocardial infarction (<5%), angina pectoris (<5%), bradycardia (<5%), pulmonary embolism (<5%), sick sinus syndrome (<5%), supraventricular tachycardia (<5%)

Endocrine & metabolic: Weight loss (9%), dehydration (7%)

Gastrointestinal: Anorexia (8%), disease of esophagus (esophageal edema: 8%), hematemesis (8%), tracheoesophageal fistula (6%), dyspepsia (2% to 6%), diarrhea (5%), eructation (5%), esophagitis (5%), melena (5%), esophageal perforation (<5%), gastric ulcer (<5%), intestinal obstruction (<5%), peritonitis (<5%)

Genitourinary: Urinary tract infection (7%)

Hematologic & oncologic: Tumor hemorrhage (8%), pulmonary hemorrhage (<5%)

Hepatic: Jaundice (<5%)

Infection: Candidiasis (9%), abscess (lung: <5%)

Nervous system: Confusion (8%), anxiety (6% to 7%), voice disorder (5%)

Neuromuscular & skeletal: Asthenia (6%)

Ophthalmic: Diplopia (<5%), eye pain (<5%), photophobia (<5%), visual disturbance (<5%)

Respiratory: Bronchitis (≤10%), respiratory insufficiency (6% to 10%), bronchospasm (<5%), laryngeal edema (<5%), pneumonitis (<5%), productive cough (8%), pulmonary edema (<5%), respiratory failure (<5%), stridor (<5%)

Miscellaneous: Ulcer (bronchial: 9%), postoperative complication (5%)

<1%, postmarketing, and/or case reports: Cataract, cerebrovascular accident, cutaneous nodule, fluid volume disorder, fragile skin, gastrointestinal necrosis, gastrointestinal perforation, hemorrhage, hypertrichosis, infusion related reaction (including dizziness and urticaria), local tissue necrosis (esophageal), pseudoporphyria, sepsis, skin discoloration, thromboembolism, wrinkling of skin

Contraindications

Porphyria; photodynamic therapy (PDT) is contraindicated in patients with existing tracheoesophageal or bronchoesophageal fistula, tumors eroding into a major blood vessel, emergency treatment of severe acute respiratory distress when caused by an obstructing endobronchial lesion, esophageal or gastric varices, esophageal ulcers >1 cm in diameter.

Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to porphyrins; PDT is contraindicated in patients with papillary bladder cancer who have received prior total bladder radiation or whose functional bladder capacity is <200 mL and in patients with coexisting bladder tumors of stage greater than stage 1 (T1) who have invasive cancer.

Warnings/Precautions

Concerns related to adverse effects:

• Airway obstruction: Treatment-induced inflammation may obstruct airway. Use with caution in patients with endobronchial tumors, especially if in areas where main airway may be obstructed (long or surrounding tumors). Necrotic debris or mucositis may also cause airway obstruction. Monitor closely between laser therapy and debridement for respiratory distress; may require urgent bronchoscopy to remove secretions or debris.

• Chest pain: Inflammatory responses within the treatment area may result in substernal chest pain.

• Esophageal strictures: Esophageal strictures may occur, usually within 6 months of treatment. May require multiple dilations to resolve. The risk is increased with nodule pretreatment or with re-treatment of the same area.

• Extravasation: Avoid extravasation. If extravasation occurs, protect affected area from light; use of antidotes is of unknown benefit.

• Gastroesophageal fistula/perforation: Serious and potentially fatal gastrointestinal and esophageal necrosis and perforation may occur following treatment. Due to the high risk for fistula, do not use in patients with esophageal tumors eroding into the trachea or bronchial tree/wall. Use is contraindicated in patients with existing tracheoesophageal or bronchoesophageal fistula.

• Hemorrhage: Patients with esophageal varices or tumors eroding into pulmonary blood vessels are at increased risk for hemorrhage, including fatal massive pulmonary hemoptysis (FMH). Do not administer light directly to an area with esophageal varices due to the potential for hemorrhage. Other risk factors for FMH include large, centrally located tumors, cavitating tumors, or extensive tumor extrinsic to the bronchus.

• Ocular photosensitivity: Ocular discomfort has been reported with sun or bright light exposure (or car headlights). For at least 30 days (and until ocular sensitivity resolves), when outdoors, patients should wear dark sunglasses that have an average white light transmittance of <4%.

• Photosensitivity: Photosensitivity reactions are common in patients who are exposed to direct sunlight or bright indoor light (eg fluorescent lights, unshaded light bulbs, examination/operating lights). Conventional UV sunscreens are not protective against photosensitivity reactions caused by visible light. Photosensitivity may last 30 to 90 days or more. Encourage exposure to ambient indoor light (aids in gradually inactivating residual porfimer). Patients should be educated to test for residual photosensitivity before resuming exposure to sunlight. Re-exposure to general sunlight should be gradual (expose small area of skin [not the face] for 10 minutes), if no photosensitivity (eg, edema, erythema, blistering) occurs after 24 hours, may gradually resume normal outdoor activities; if photosensitivity occurs then wait 2 weeks and retest.

• Thromboembolism: Thromboembolic events may occur, generally in patients with additional risk factors for thromboembolism (eg, advanced cancer, prolonged immobilization, cardiovascular disease, following major surgery).

Disease-related concerns:

• Barrett esophagus: In patients with Barrett esophagus, conduct rigorous surveillance (endoscopic biopsy every 3 months until 4 consecutive negative results for high-grade dysplasia followed by further follow-up per physician judgment). The long-term effects of photodynamic therapy in patients with Barrett esophagus are not known. Esophageal strictures are common adverse events associated with photodynamic therapy of Barrett esophagus; esophageal dilation may be required.

• Esophageal/gastric varices: Not suited for treatment of patients with esophageal or gastric varices (due to the high risk for hemorrhage).

• Hepatic impairment: Elimination may be prolonged in hepatic impairment; toxicities may be increased. Photosensitivity may persist beyond 90 days in patients with mild to severe hepatic impairment.

• Renal impairment: Elimination may be prolonged in renal impairment; toxicities may be increased. Photosensitivity may persist beyond 90 days in patients with severe renal impairment.

Concurrent drug therapy issues:

• Photosensitizing drugs: Concurrent use with other photosensitizing agents may increase the risk for photosensitivity reactions.

Special populations:

• Radiation therapy recipients: Allow 2 to 4 weeks to elapse after phototherapy prior to initiating radiation therapy; 4 weeks should elapse after radiation therapy prior to initiating phototherapy.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous, as sodium [preservative free]:

Photofrin: 75 mg (1 ea)

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Photofrin Intravenous)

75 mg (per each): $27,166.80

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: Administer slow IV injection over 3 to 5 minutes. Avoid extravasation (if extravasation occurs, protect area from light and sunlight).

Due to the potential for photosensitivity reactions, wear rubber gloves and eye protection and avoid skin and eye contact during administration; if overexposure occurs, protect from bright light. Spills should be wiped with a damp cloth and contaminated material should be disposed of properly.

Use: Labeled Indications

Barrett esophagus dysplasia (photodynamic therapy): Ablation of high-grade dysplasia in Barrett esophagus (in patients who do not undergo esophagectomy)

Endobronchial cancer (photodynamic therapy): Treatment of microinvasive endobronchial non-small cell lung cancer (NSCLC) in patients for whom surgery and radiation therapy are not indicated; reduction of obstruction and symptom palliation in patients with obstructing (partial or complete) endobronchial NSCLC

Esophageal cancer (photodynamic therapy): Palliation of completely obstructing esophageal cancer, or partially obstructing esophageal cancer in patients who cannot be treated satisfactorily with Nd:YAG laser therapy.

Use: Off-Label: Adult

Cholangiocarcinoma (unresectable)

Medication Safety Issues
High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes that have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy

Photosensitizing Agents: May enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Reproductive Considerations

Evaluate pregnancy status prior to use in females of reproductive potential. Females of reproductive potential should use effective contraception during treatment and for 5 months after the last porfimer dose. Males with female partners of reproductive potential should use condoms during treatment and for 5 months after the last porfimer dose.

Pregnancy Considerations

Based on the mechanism of action and data from animal reproduction studies, in utero exposure to porfimer may cause fetal harm.

Breastfeeding Considerations

It is not known if porfimer is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during treatment and for 5 months after the last porfimer dose.

Monitoring Parameters

Evaluate pregnancy status prior to use in females of reproductive potential. Monitor injection site during infusion (for extravasation); monitor in between laser and debridement for evidence of respiratory distress in patients with endobronchial tumors; monitor for signs/symptoms of photosensitivity, hemorrhage, thromboembolic events, gastroesophageal fistulas/perforation, esophageal strictures.

Mechanism of Action

Porfimer's cytotoxic activity is dependent on light and oxygen. Following administration, the drug is selectively retained in neoplastic tissues. Exposure of the drug to laser light at wavelengths >630 nm results in the production of oxygen free-radicals. Release of thromboxane A2, leading to vascular occlusion and ischemic necrosis, may also occur.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vdss: 0.49 ± 0.28 L/kg (Pereira 2010).

Protein binding, plasma: ~90%.

Half-life elimination: First dose: ~17 days; Second dose: ~30 days.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Photofrin;
  • (BG) Bulgaria: Photofrin;
  • (DE) Germany: Photofrin;
  • (FR) France: Photobarr | Photofrin;
  • (GB) United Kingdom: Photofrin;
  • (HU) Hungary: Photofrin;
  • (JP) Japan: Photofrin;
  • (KR) Korea, Republic of: Photofrin;
  • (LT) Lithuania: Photofrin;
  • (PT) Portugal: Photofrin
  1. Ortner ME, Caca K, Berr F, et al. Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study. Gastroenterology. 2003;125(5):1355-1363. doi:10.1016/j.gastro.2003.07.015 [PubMed 14598251]
  2. Overholt BF, Wang KK, Burdick JS, et al, “Five-Year Efficacy and Safety of Photodynamic Therapy With Photofrin in Barrett's High-Grade Dysplasia,” Gastrointest Endosc, 2007, 66(3):460-8. [PubMed 17643436]
  3. Pereira SP, Ayaru L, Ackroyd R, et al, “The Pharmacokinetics and Safety of Porfimer After Repeated Administration 30-45 Days Apart to Patients Undergoing Photodynamic Therapy,” Aliment Pharmacol Ther, 2010, 32(6):821-7. [PubMed 20629974]
  4. Photofrin (porfimer) [prescribing information]. Bannockburn, IL: Pinnacle Biologics Inc; November 2021.
  5. Photofrin (porfimer) [Canadian product monograph]. St. Michael, Barbados: Concordia Laboratories Inc; October 2014.
Topic 9791 Version 143.0

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