Photofrin: Uses, Dosage & Side Effects
A photosensitizing agent used in photodynamic therapy (PDT) for esophageal cancer, endobronchial non-small cell lung cancer, and high-grade dysplasia in Barrett’s esophagus
Photofrin (porfimer sodium) is a photosensitizing medication used as the first step of photodynamic therapy (PDT), a two-stage treatment that combines a light-activated drug with targeted laser illumination to destroy abnormal cells. Porfimer sodium is preferentially retained in tumor tissue following intravenous injection; when the tumor is later exposed to red laser light of a specific wavelength (630 nm), the drug generates reactive oxygen species that kill cancer cells and damage their supplying blood vessels. Photofrin is approved for the treatment of obstructing or early-stage esophageal cancer, high-grade dysplasia in Barrett’s esophagus, and endobronchial non-small cell lung cancer. It is administered exclusively in specialized hospital or clinic settings and requires a prescription. Because porphyrins persist in skin for weeks after injection, patients must take strict light-avoidance precautions for at least 30 days.
Quick Facts: Photofrin
Key Takeaways
- Photofrin (porfimer sodium) is a photosensitizer used in photodynamic therapy (PDT), a two-step treatment: first a drug injection, then targeted illumination of the tumor with 630 nm red laser light delivered through an endoscope or bronchoscope.
- It is approved for palliative treatment of obstructing esophageal cancer, high-grade dysplasia in Barrett’s esophagus in patients who cannot have surgery, and for early and advanced endobronchial non-small cell lung cancer in patients unsuitable for surgery or radiotherapy.
- All patients become temporarily photosensitive. Direct sunlight and bright indoor light must be strictly avoided for at least 30 days after injection; full resolution may take up to 90 days or longer in some patients.
- Photofrin must not be used in patients with porphyria, esophageal or gastric varices, pre-existing tracheoesophageal or bronchoesophageal fistulas, or tumors invading major blood vessels, because of the risk of life-threatening bleeding or perforation.
- Photodynamic therapy is highly localized, sparing most healthy tissue, and can be repeated for up to three courses at prescribed intervals when the clinical response supports continued treatment.
What Is Photofrin and What Is It Used For?
Photofrin contains the active substance porfimer sodium, a complex mixture of porphyrin oligomers derived from hematoporphyrin. It is classified as a first-generation photosensitizer and is used in a specialized oncology technique known as photodynamic therapy (PDT). The fundamental principle of PDT is to combine a drug that is harmless in the dark with a specific wavelength of visible light that activates the drug only where it is needed, allowing selective destruction of diseased tissue while sparing the surrounding normal tissue. PDT therefore differs fundamentally from conventional chemotherapy, which circulates throughout the body and causes systemic effects.
After porfimer sodium is administered intravenously, the porphyrins circulate in the bloodstream and gradually accumulate in many tissues. Tumor cells, however, retain the photosensitizer for longer than most normal tissues, thanks to features such as abnormal blood supply, leaky vasculature, larger interstitial spaces, and altered lymphatic drainage. After a recommended drug-to-light interval of approximately 40 to 50 hours, the ratio of photosensitizer in tumor versus healthy tissue is maximized. At that point, a thin fiberoptic cable is advanced through an endoscope (to reach esophageal lesions) or a bronchoscope (to reach airway tumors), and 630 nm red laser light is delivered directly to the tumor for several minutes.
When porphyrin molecules in the tumor absorb photons of red light, they are promoted to an excited singlet state and then to a longer-lived triplet state. The energy is transferred to molecular oxygen present in the tissue, converting it to highly reactive singlet oxygen and other reactive oxygen species (ROS). These ROS are extremely cytotoxic: they oxidize cellular membranes, proteins, and organelles, triggering both apoptotic and necrotic cell death. They also damage the endothelium of the small blood vessels that nourish the tumor, producing vascular shutdown and ischemic injury of the tumor. A secondary inflammatory response further contributes to tumor clearance and may help activate local antitumor immunity.
Because the clinical effect is confined to the area illuminated by the laser, PDT is a highly localized treatment. This is an important advantage in organs where surgical resection would cause unacceptable morbidity, such as the esophagus and the airway. The tissue depth of the effect with 630 nm light is approximately 5 to 10 mm, which is ideal for treating superficial or luminal tumors but limits use for deeply invasive disease.
Photofrin is approved by the U.S. Food and Drug Administration (FDA), Health Canada, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and regulatory authorities in several European markets for the following indications:
- Obstructing esophageal cancer: Photofrin PDT is used as palliative treatment of completely or partially obstructing esophageal cancer in patients who cannot be treated satisfactorily with laser therapy alone or with surgery. By necrosing exophytic tumor, PDT reopens the esophageal lumen and improves the ability to swallow.
- Early (T1) esophageal cancer and microinvasive disease: In patients who are not candidates for esophagectomy, PDT can be used to ablate superficial esophageal cancer with curative intent. Reported complete response rates exceed 75% in selected patients.
- High-grade dysplasia (HGD) in Barrett’s esophagus: Photofrin PDT is approved for ablation of HGD in patients with Barrett’s esophagus who are not candidates for, or have refused, esophagectomy. Long-term data from pivotal randomized trials show a significant reduction in the incidence of progression to invasive adenocarcinoma compared with omeprazole alone.
- Early-stage (microinvasive) endobronchial non-small cell lung cancer (NSCLC): Photofrin is approved for patients with early-stage endobronchial NSCLC for whom surgery and radiotherapy are not indicated. PDT can achieve complete local response rates exceeding 70% in this setting.
- Advanced obstructive endobronchial NSCLC: PDT is used to reduce endobronchial tumor burden and to palliate symptoms of airway obstruction (such as dyspnea, post-obstructive pneumonia, and hemoptysis) in patients with advanced disease. It can be used alone or in combination with other modalities.
Beyond its approved indications, porfimer sodium has been studied in a number of other tumor types, including cholangiocarcinoma, bladder cancer, head and neck cancer, and gynecological malignancies. Any use outside the approved indications should only occur within the framework of a clinical trial or based on documented best practices for the specific setting.
Unlike traditional intravenous chemotherapy or radiation therapy, photodynamic therapy is a local, repeatable treatment. The injected drug itself does not damage cells unless it is activated by the correct wavelength of light. This means the physician can aim the treatment precisely at visible tumor tissue while the rest of the body remains protected, as long as the patient avoids bright light during the photosensitive period.
What Should You Know Before Receiving Photofrin?
Contraindications
Photofrin has a number of absolute contraindications. Administration of the drug, or laser exposure of a patient who has received it, in any of these situations can cause serious harm.
- Porphyria: Photofrin must not be used in patients with any form of porphyria, because these individuals already overproduce photosensitive porphyrins and can experience severe photosensitivity reactions.
- Known hypersensitivity: Patients with a documented allergy to porfimer sodium, to porphyrin-based drugs, or to any of the excipients must not receive this medication.
- Esophageal or gastric varices: PDT in the presence of varices carries a high risk of life-threatening hemorrhage as the tumor necroses and tissue sloughs.
- Existing tracheoesophageal or bronchoesophageal fistula: Light-induced necrosis can enlarge the fistula and cause aspiration or mediastinitis.
- Tumors eroding into major blood vessels: PDT must not be used when the tumor invades the aorta, pulmonary artery, or other large vessels, because necrosis may precipitate massive bleeding.
- Esophageal ulcers greater than 1 cm deep into the submucosa: These pose a high risk of perforation after treatment.
- Emergency airway obstruction: PDT is not an emergency treatment; it requires 40 to 50 hours between injection and light exposure, which is too slow when immediate relief of obstruction is required.
Warnings and Precautions
All patients become temporarily photosensitive after Photofrin injection. Exposure of unprotected skin or eyes to sunlight or bright indoor light (operating theatre lamps, halogen lights, tanning beds, unshielded dental or examination lights) can cause sunburn-like reactions ranging from mild erythema to severe burns and blisters. Photosensitivity must be assumed to persist for at least 30 days and, in some individuals, up to 90 days or longer. Sunscreen alone is not sufficient – protection must be provided by protective clothing, hats, sunglasses, and by reducing exposure to all ambient light during the first days after injection.
Before and during treatment with Photofrin, inform your healthcare team about any condition or circumstance that may affect your safety:
- Ocular sensitivity: For approximately 30 days after injection, wear sunglasses with an average white-light transmittance of less than 4% (dark enough that you cannot easily see the outline of your hand at 30 cm) when outside during daylight hours or in brightly lit indoor environments.
- Respiratory complications: After endobronchial PDT, airway edema, inflammation, and tissue sloughing can temporarily worsen airway obstruction. Life-threatening or fatal dyspnea, tracheoesophageal fistula, and massive hemoptysis have been reported. Patients with tumors close to major blood vessels require particularly careful assessment.
- Esophageal complications: Esophageal perforation, strictures, and fistula formation can occur. Severe chest pain, odynophagia (pain on swallowing), fever, leukocytosis, or hematemesis should prompt immediate re-evaluation and endoscopy.
- Risk of fatal bleeding: Sloughing of tumor can expose large blood vessels, particularly in long-standing or deeply invasive disease. A few cases of massive, fatal hemorrhage have been reported.
- Hepatic impairment: Porfimer sodium is eliminated primarily via the liver. Patients with hepatic impairment may have prolonged photosensitivity and may require longer light-avoidance periods. Use with caution.
- Renal impairment: Limited data are available in patients with severe renal impairment. Caution and close monitoring are advised.
- Cardiovascular disease: Chest pain after esophageal PDT can be difficult to distinguish from cardiac chest pain; patients with underlying coronary disease require careful monitoring.
- Geriatric patients: Elderly patients may have reduced functional reserve and may be more vulnerable to complications of tissue necrosis and to drug-induced photosensitivity.
- Concomitant radiation: Radiation treatment should ideally not be given within 2 to 4 weeks before PDT because of the additive risk of tissue toxicity. If radiation is planned after PDT, the interval should allow sufficient healing.
- Other photosensitizing drugs: Any concomitant medication that can itself increase light sensitivity (see interactions below) will amplify the risk of skin reactions.
Your treating physician will review your medical history, current medications, laboratory tests, and imaging before confirming that you are a suitable candidate for PDT.
Mandatory Light-Avoidance Precautions
Photosensitivity begins within minutes after injection and must be managed carefully throughout the post-treatment period. The following precautions apply to every patient receiving Photofrin:
- From injection to day 30 at minimum: Avoid exposure of skin and eyes to direct sunlight and bright indoor light. Cover yourself with dark, tightly woven clothing, a wide-brimmed hat, gloves, and socks whenever you are in a brightly lit environment, and wear dark sunglasses outdoors.
- Indoor lighting is allowed: You should not stay in a completely dark room. Exposure to normal ambient indoor lighting helps inactivate skin photosensitizer through photobleaching and accelerates recovery.
- Sunscreen is not sufficient: Photofrin photosensitivity is caused by visible light, which sunscreens do not block. Protection must rely on clothing and physical barriers.
- Before resuming outdoor activity: After day 30, test a small area of skin (such as the back of the hand) by exposing it to direct sunlight for 10 minutes. If no redness, swelling, or blistering develops within 24 hours, you may gradually resume normal outdoor activity. Start with brief exposures and increase gradually.
- Hospital and dental visits: Inform healthcare providers that you have received Photofrin. Bright examination lamps, operating-room lights, and high-intensity dental lights can cause burns.
- Air travel: During flight, lower the window shade on your seat to avoid direct sunlight.
Pregnancy, Breastfeeding, and Fertility
Photofrin should not be used during pregnancy unless the clinical benefit clearly outweighs the potential risk to the fetus. Animal reproductive studies have shown embryotoxicity and fetotoxicity at doses below those used clinically. There are no adequate and well-controlled studies in pregnant women. Women of childbearing potential must use effective contraception during treatment and for at least 3 months after the last dose. Patients who become pregnant during treatment should inform their physician immediately.
It is not known whether porfimer sodium is excreted in human breast milk. Because many drugs are excreted in milk and because of the potential for serious adverse reactions in the nursing infant, a decision should be made to discontinue breastfeeding or to avoid this medication while breastfeeding, taking into account the importance of the drug to the mother.
The effect of Photofrin on male fertility is unknown. Men should discuss contraception and family planning with their physician before treatment.
Driving and Operating Machinery
Photofrin itself has not been shown to impair cognitive function, but patients may feel tired, nauseated, or short of breath in the days after treatment. Furthermore, the need to wear very dark sunglasses for approximately 30 days may reduce vision enough to make driving unsafe during the day. Patients should not drive if they feel unwell, if visibility is impaired by required sunglasses, or if they are taking any other medication that affects alertness.
Important Information About Ingredients
Each vial of Photofrin contains 75 mg of porfimer sodium as a lyophilized powder. The product is reconstituted with 5% dextrose for injection or sodium chloride 0.9% solution before administration, providing a final concentration of 2.5 mg/mL. Patients on sodium-restricted or dextrose-restricted diets should inform their healthcare team in advance. Porfimer sodium products are typically free of preservatives; each vial is intended for single use only.
How Does Photofrin Interact with Other Drugs?
Photofrin itself has no known interactions with cytochrome P450 enzymes, but many interactions are pharmacodynamic rather than pharmacokinetic. Drugs that are themselves photosensitizing add to the skin and ocular risks of PDT, while drugs that interfere with the generation or action of reactive oxygen species (ROS) may reduce tumor response. Other interactions may compromise wound healing, affect tissue oxygenation, or increase the risk of bleeding.
Major Interactions
| Interacting Drug or Class | Effect | Clinical Significance |
|---|---|---|
| Tetracyclines (doxycycline, tetracycline) | Additive photosensitivity, greater risk of severe sunburn-like reactions | Avoid during the photosensitive period; choose a non-photosensitizing alternative antibiotic if needed |
| Sulfonamides (co-trimoxazole, sulfasalazine) | Increased photosensitivity | Avoid or use with heightened light-protection measures |
| Phenothiazines (chlorpromazine, promazine) | Additive photosensitivity | Avoid if possible during the 30-day photosensitive period |
| Thiazide diuretics (hydrochlorothiazide, chlortalidone) | Increased risk of drug-induced photosensitivity | Use with caution; increase light-avoidance measures |
| Sulfonylurea hypoglycemics (glibenclamide, gliclazide) | Additive photosensitivity | Continue as clinically required with strict light precautions |
| Griseofulvin and other antifungals | Increased photosensitivity | Consider alternative antifungal therapy where possible |
| Dimethyl sulfoxide (DMSO) and mannitol | Quench reactive oxygen species generated by PDT | May reduce tumor response; avoid prior to illumination |
| High-dose beta-carotene and other antioxidants | Scavenge reactive oxygen species, potentially reducing efficacy | Avoid high-dose antioxidant supplements during PDT period |
Minor and Theoretical Interactions
| Interacting Drug or Class | Effect | Clinical Significance |
|---|---|---|
| Corticosteroids (prednisone, methylprednisolone) | May reduce the inflammatory response that contributes to PDT efficacy | Used cautiously; low-dose courses for symptom control are generally acceptable |
| Calcium channel blockers and vasodilators | Improve tissue perfusion and may enhance PDT efficacy | No dose change required; existing cardiovascular therapy is usually continued |
| Anticoagulants (warfarin, DOACs) and antiplatelets (aspirin, clopidogrel) | Increased risk of bleeding at treatment site following tumor necrosis | Timing may need to be adjusted around endoscopy; discuss with your team |
| Allopurinol | Scavenges hydroxyl radicals, theoretical reduction in PDT efficacy | No strict prohibition; awareness is sufficient |
| Radiotherapy, recent | Compromised tissue healing, potential for increased necrosis | PDT should generally be separated from radiotherapy by several weeks |
Because photodynamic therapy is typically performed in patients with serious cancers who take multiple supportive medications, a complete medication review is always performed before treatment. Over-the-counter products, herbal remedies, and dietary supplements (especially St. John’s wort, which is itself photosensitizing) should be disclosed. If an interacting drug cannot be stopped, light-avoidance measures are intensified and the clinical team weighs the benefit of PDT against the potential increased risk of adverse effects.
What Is the Correct Dosage of Photofrin?
Photofrin is always prepared, administered, and activated in a specialized hospital or endoscopy unit. The dose is calculated on the patient’s actual body weight and is standardized across the approved indications. Treatment consists of two distinct steps – the drug phase (porfimer sodium injection) and the light phase (laser illumination) – separated by a fixed interval that allows preferential tumor uptake.
Drug Dose: Porfimer Sodium Injection
Step 1 – Intravenous Injection
Standard dose: 2 mg/kg body weight
Route: Slow intravenous injection over 3 to 5 minutes
Preparation: Reconstitute each 75 mg vial with 31.8 mL of 5% dextrose for injection or 0.9% sodium chloride for injection, giving a final concentration of 2.5 mg/mL
Protect the reconstituted solution from bright light and use immediately. Do not mix Photofrin with other drugs in the same solution. A separate IV line should be used if other medications are being infused simultaneously.
Light Dose: 630 nm Laser Illumination
Step 2 – First Light Exposure
Timing: 40 to 50 hours after injection
Wavelength: 630 nm red laser light
Delivery: Through a cylindrical or microlens optical fiber advanced via endoscope (esophageal disease) or bronchoscope (endobronchial disease)
Light dose (standard): 300 J/cm of diffuser tip length for esophageal tumors; 200 J/cm for endobronchial tumors; 130 J/cm of diffuser length for high-grade dysplasia in Barrett’s esophagus.
Step 2 (optional) – Second Light Exposure
Timing: 96 to 120 hours after the single injection
Purpose: Debridement of treatment site is performed first (vigorous endoscopic washing and removal of necrotic tumor) to expose any residual viable tumor, which is then illuminated at the same light dose as the first exposure.
The second light exposure uses the same single injection of Photofrin – no additional drug is given.
Indication-Specific Light Dosing
| Indication | Light Dose | Minimum Retreatment Interval | Maximum Courses |
|---|---|---|---|
| Obstructing esophageal cancer (palliative) | 300 J/cm of diffuser length | 30 days | 3 courses per lifetime |
| Early/microinvasive esophageal cancer | 300 J/cm of diffuser length | 30 days | 3 courses per lifetime |
| High-grade dysplasia in Barrett’s esophagus | 130 J/cm of diffuser length | 90 days | 3 courses per lifetime |
| Early endobronchial NSCLC | 200 J/cm of diffuser length | 30 days | 3 courses per lifetime |
| Advanced obstructive endobronchial NSCLC | 200 J/cm of diffuser length | 30 days | 3 courses per lifetime |
Special Populations
Elderly patients: No dose adjustment of porfimer sodium is required based on age alone. However, older adults may have reduced cardiopulmonary reserve and may tolerate the inflammatory response to tumor necrosis less well; they are monitored particularly carefully.
Hepatic impairment: Patients with moderate to severe hepatic impairment may have prolonged elimination of porfimer sodium, which can extend the photosensitive period. Use with caution; consider extended light-avoidance precautions.
Renal impairment: Limited data exist. Clinical judgment and close monitoring are required; no specific dose adjustment is routinely made.
Children: Safety and efficacy of Photofrin in children and adolescents have not been established. Its use is limited to adult oncology.
Obesity: The dose is based on actual body weight. There is no upper-weight cap specified in the label, but practitioners may use clinical judgment in extremely obese patients to avoid disproportionate light doses.
Missed Treatment
Because Photofrin is administered during a scheduled hospital visit, there is no risk of a patient “forgetting” a dose as there would be with an oral medicine. If an illumination procedure has to be postponed for clinical reasons (for example, an infection), your physician will decide whether the light exposure can still fall within the approved drug-to-light window or whether the injection needs to be repeated at a later date.
Overdose
Information on drug-alone overdose of porfimer sodium is very limited. No specific antidote is available. If a dose substantially above 2 mg/kg has been administered, the patient should not be exposed to the planned light treatment. Extended and stricter light-avoidance measures are applied and general supportive care is given. Overdose of light (inadvertent high-fluence illumination of non-target tissue) can cause severe local injury and is managed with supportive wound care and specialist input.
How the Injection and Light Are Given
On Day 1 you will arrive at the hospital or oncology day unit. After confirmation of your identity and weight, the nurse or physician will prepare the Photofrin injection. The drug is given slowly over 3 to 5 minutes through a secure intravenous line, usually into a large antecubital vein. You may be offered sedation or analgesia depending on the planned procedure. Immediately after injection, the team will remind you about light-protection measures before you leave.
On Day 3 (40 to 50 hours later) you return for the light exposure. For esophageal disease, this is performed during upper gastrointestinal endoscopy under sedation; the endoscopist passes a balloon catheter or cylindrical diffuser into the esophagus so that the laser light can treat the full circumference or a selected segment of the esophageal wall. For endobronchial disease, flexible bronchoscopy is used, and a cylindrical diffuser is advanced into the target airway. Laser illumination typically lasts 8 to 12 minutes, depending on the diffuser length and prescribed energy. On Day 5 to 7, a second endoscopic or bronchoscopic visit may be scheduled for debridement and, if residual tumor is seen, a second light exposure.
Photofrin is prepared, injected, and activated exclusively by trained healthcare professionals in a hospital or specialized clinic. You will not handle the drug yourself. Follow-up endoscopy or bronchoscopy visits are essential to remove necrotic tissue, detect complications early, and assess response.
What Are the Side Effects of Photofrin?
Photodynamic therapy produces two broad categories of side effect: systemic photosensitivity, which reflects the presence of porphyrins throughout the body and in the skin, and local treatment-site toxicity, which reflects the intentional destruction of tumor and the inflammatory response it provokes. Some additional non-specific effects (fatigue, nausea, infection) also occur. Your medical team will monitor you for all categories and manage symptoms as they arise.
Cutaneous Photosensitivity Reactions
Some degree of photosensitivity is expected in every patient. Typical reactions are sunburn-like: erythema, swelling, itching, burning, and in more severe cases blistering and desquamation. Severity correlates with the intensity and duration of light exposure rather than with the time since injection, so even a brief, bright exposure many weeks later can produce a significant reaction. Careful protection, rather than treatment after the fact, is therefore the cornerstone of management. Ocular discomfort, sensitivity to light, and temporary visual changes can also occur.
Side Effects by Frequency (Esophageal PDT)
Very Common
May affect more than 1 in 10 people
- Cutaneous photosensitivity reactions (sunburn-like)
- Chest pain (retrosternal or epigastric)
- Nausea, vomiting
- Dysphagia (difficulty swallowing)
- Odynophagia (painful swallowing)
- Esophageal stricture (narrowing)
- Fever
- Constipation
- Anemia
- Fatigue and general weakness
- Dehydration
- Abdominal pain
Common
May affect up to 1 in 10 people
- Pleural effusion (fluid around the lung)
- Atrial fibrillation or other arrhythmias
- Insomnia and anxiety
- Weight loss
- Edema of the face or extremities
- Pharyngitis
- Moniliasis (oral or esophageal candidiasis)
- Urinary tract infection
- Hiccups
- Melena (dark stools) or hematemesis (vomiting blood) from treatment site
Uncommon
May affect up to 1 in 100 people
- Esophageal perforation
- Tracheoesophageal fistula
- Mediastinitis
- Pneumonia (including aspiration pneumonia)
- Severe cutaneous photosensitivity reactions with blistering
- Serious esophageal bleeding
- Sepsis
- Pulmonary embolism
- Cardiac ischemia
Rare
May affect up to 1 in 1,000 people
- Fatal hemorrhage from erosion into major vessel
- Severe anaphylactoid or hypersensitivity reaction to the injection
- Tumor lysis syndrome
- Acute respiratory distress
Not Known
Frequency cannot be estimated from available data
- Long-term ocular photosensitivity persisting beyond 90 days in some patients
- Secondary skin pigmentary changes at sites of repeated light exposure
Side Effects by Frequency (Endobronchial PDT)
The side effect profile after endobronchial PDT shares the systemic photosensitivity pattern above but has a different spectrum of local effects because the treated anatomy is the airway.
Very Common
May affect more than 1 in 10 people
- Cutaneous photosensitivity reactions
- Cough and sputum production (including blood-tinged)
- Dyspnea (shortness of breath), especially transient worsening in the first days
- Hemoptysis (coughing up blood) – usually minor
- Fever
- Chest pain
- Airway obstruction by edema, mucus, or debris requiring clearance
Common
May affect up to 1 in 10 people
- Pneumonia (including post-obstructive)
- Bronchitis or bronchospasm
- Pneumothorax
- Respiratory insufficiency
- Anemia and leukocytosis
- Headache
- Hypotension during or after procedure
Uncommon
May affect up to 1 in 100 people
- Tracheoesophageal or bronchoesophageal fistula (serious)
- Major pulmonary hemorrhage
- Tracheal edema with stridor
- Respiratory failure
- Cardiac arrhythmia
- Pulmonary embolism
Rare
May affect up to 1 in 1,000 people
- Fatal massive hemoptysis
- Acute respiratory distress syndrome (ARDS)
- Life-threatening anaphylactoid reaction
Contact your medical team or attend the emergency department without delay if you experience any of the following after PDT: severe or progressive chest pain, fever above 38.5°C, shortness of breath at rest, blood in vomit, black or bloody stools, coughing up large amounts of blood, new confusion, or severe sunburn-like reactions despite light precautions. These may represent complications that require urgent assessment.
Most local reactions, such as chest pain and swallowing difficulty after esophageal PDT, peak in the first 5 to 14 days and gradually settle as the necrotic tissue is cleared and healing begins. Your team may prescribe liquid or soft diets, analgesia, antacids or proton pump inhibitors, antiemetics, and antibiotics as required. Endoscopic dilation may be needed if a persistent esophageal stricture develops.
If you experience any side effects not listed here, tell your doctor or nurse. You can also report suspected side effects to your national pharmacovigilance authority (e.g., the FDA MedWatch program in the United States, Health Canada’s MedEffect, or the MHRA Yellow Card Scheme in the United Kingdom) to help monitor the ongoing benefit-risk profile of Photofrin.
How Should Photofrin Be Stored?
Keep this medicine out of the sight and reach of children. Do not use after the expiry date stated on the vial label and outer carton after EXP. The expiry date refers to the last day of that month.
- Unopened vials: Store at 15°C to 25°C (59°F to 77°F). Do not freeze. Keep the vial in the outer carton to protect from light.
- Reconstituted solution: Use immediately after reconstitution. Discard any unused portion. If the solution is briefly retained before use, it must be protected from light and discarded if not administered without delay.
- Inspection: Do not use the product if the powder or solution appears discolored or if particulate matter is present.
- Spill handling: Any spill is managed with absorbent materials; gloves are worn and the area is wiped with 70% ethanol and then with soap and water to prevent ambient-light sensitization.
As Photofrin is supplied to specialized oncology and endoscopy units, storage and disposal are handled by the hospital pharmacy. Do not dispose of any medicines via wastewater or household waste. The doctor or nurse will ensure proper disposal of unused medicine to protect the environment.
What Does Photofrin Contain?
Active Substance
The active substance is porfimer sodium, a complex mixture of porphyrin oligomers obtained by treating hematoporphyrin with acid and alkali, followed by ether-linkage and ester-linkage formation of multiple porphyrin units. Each single-use vial contains 75 mg of porfimer sodium as a lyophilized (freeze-dried) cake.
Inactive Ingredients (Excipients)
- Hydrochloric acid and/or sodium hydroxide (for pH adjustment)
- No preservatives are added
The product is reconstituted immediately before use with one of the following diluents:
- 5% dextrose for injection
- 0.9% sodium chloride for injection
Appearance
Photofrin is a dark reddish-brown to dark reddish-purple cake or powder in a clear glass vial. After reconstitution, the solution is an opaque dark red liquid. Each package typically contains one single-use vial.
Manufacturer and Marketing Authorization
Photofrin is marketed under the Photofrin trade name by Pinnacle Biologics (North America) and through regional marketing authorization holders in other jurisdictions. The manufacturing and labeling details printed on the carton should always be considered authoritative for any specific product lot.
Frequently Asked Questions About Photofrin
Photofrin (porfimer sodium) is a photosensitizer used in photodynamic therapy (PDT) for several approved indications: palliative treatment of obstructing esophageal cancer, curative-intent treatment of early or microinvasive esophageal cancer in patients unfit for surgery, ablation of high-grade dysplasia in Barrett’s esophagus when esophagectomy is declined or not feasible, curative treatment of microinvasive endobronchial non-small cell lung cancer, and palliation of obstructive endobronchial NSCLC. It has also been studied off-label in other tumors.
Photofrin PDT is performed in two stages. On Day 1, porfimer sodium is injected intravenously at a dose of 2 mg/kg over 3 to 5 minutes. On Day 3 (40 to 50 hours later), the tumor is illuminated with 630 nm red laser light delivered through a fiberoptic probe passed via endoscopy (for esophageal disease) or bronchoscopy (for airway disease). A second illumination may be performed on Day 5 to 7 after debridement of necrotic tumor. The entire course is one drug injection with one or two light exposures; no additional injection is required for the second light.
Photosensitivity begins within minutes of the injection. Patients must avoid direct sunlight and bright indoor light for a minimum of 30 days. In many patients, photosensitivity has declined sufficiently by 30 days; in others it can persist for up to 90 days and occasionally longer. Before resuming normal outdoor activity, test a small patch of skin (for example, the back of the hand) by exposing it to direct sunlight for 10 minutes; if no redness, swelling, or blistering appears within 24 hours, you may gradually resume outdoor activity. Increase exposure gradually over several more days.
In patients with early, superficial (T1) esophageal cancer who are not candidates for surgery, Photofrin PDT can achieve complete response rates of around 75–85% and is used with curative intent. In advanced, obstructing disease, PDT is used palliatively to relieve obstruction and improve swallowing rather than to cure the cancer. For high-grade dysplasia in Barrett’s esophagus, PDT has been shown in randomized trials to significantly reduce progression to invasive adenocarcinoma. The treatment goal depends on the stage of disease and should be discussed carefully with your oncologist and gastroenterologist.
Yes. A full course of Photofrin PDT can be repeated up to three times in a patient’s lifetime, with minimum intervals of 30 days for esophageal and endobronchial cancer and 90 days for high-grade dysplasia in Barrett’s esophagus. Each course is one porfimer sodium injection followed by one (and sometimes two) light exposures. Whether retreatment is advisable depends on the tumor response to the first course, tolerability, residual or recurrent disease, and overall clinical condition.
Photofrin is contraindicated in patients with porphyria, porphyrin allergy, esophageal or gastric varices, existing tracheoesophageal or bronchoesophageal fistulas, tumors invading major blood vessels, deep esophageal ulcers, or situations requiring emergency airway decompression. It is also not recommended in pregnancy unless clearly necessary, in children (where safety has not been established), and requires particular caution in severe hepatic or renal impairment. Your physician will review your history and test results carefully before deciding that PDT is appropriate for you.
No. Sunscreens are designed to block ultraviolet (UV) light, not the visible wavelengths that activate porfimer sodium in the skin. Protection after Photofrin treatment depends on physical barriers: dark, tightly woven clothing covering as much skin as possible, a wide-brimmed hat, gloves, socks, and dark sunglasses with a visible-light transmittance below 4%. You should avoid direct sunlight and brightly lit environments, not simply apply sunscreen before going outside.
References
- U.S. Food and Drug Administration (FDA). Photofrin (porfimer sodium) for Injection – Prescribing Information. Revised 2024. Available from: FDA Drug Label.
- 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):460–468. doi:10.1016/j.gie.2006.12.037.
- Moghissi K, Dixon K, Thorpe JA, Stringer M, Oxtoby C. Photodynamic therapy (PDT) in early central lung cancer: a treatment option for patients ineligible for surgical resection. Thorax. 2007;62(5):391–395. doi:10.1136/thx.2006.061143.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Esophageal and Esophagogastric Junction Cancers. Version 2.2025.
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