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Photofrin Porfimer Sodium 75 mg/31.8mL Injection, Powder, For Solution, 1 vial — NDC 76128-0155-75 package photo

Photofrin Porfimer Sodium 75 mg/31.8mL Injection, Powder, For Solution, 1 vial

by Pinnacle Biologics, Inc. · 1 VIAL in 1 BOX, UNIT-DOSE (76128-155-75) / 31.8 mL in 1 VIAL
NDC 76128-0155-75
🏷️ FDA NDC (as labeled) 76128-155-75 billing pads the product segment with a zero
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 76128-155-75
Product NDC 76128-155
11-digit billing NDC 76128015575
NCPDP billing unit EA — each (per item)
RxCUI 242166, 687066
UNII Y3834SIK5F
UPC 0376128155756
Application # NDA020451
SPL Set ID 5c4841b4-fbc0-4163-8ee1-cb28629cbfbf
Established class (EPC) Photoactivated Radical Generator
Mechanism of action Photoabsorption
Physiologic effect Photosensitizing Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1995-12-27
Route INTRAVENOUS
Dosage form INJECTION, POWDER, FOR SOLUTION
Substance PORFIMER SODIUM
GPI-14 21707070102140
GPI class Photofrin
GCN Seq No 048666
GCN 14373
HICL code 011790
Ingredient (HICL) Porfimer Sodium
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1R
Therapeutic class — specific (HIC3) Photoactivated, Antineoplastic Agents (Systemic)
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name PHOTOFRIN 75 MG VIAL
FDB brand name Photofrin
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 76128-155-75 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 76128-0155-75. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Photoactivated Radical Generator class.

Pharmacologic class Photoactivated Radical Generator
Drug family (ATC) Sensitizers used in photodynamic/radiation therapy
How it works Photoabsorption
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerPinnacle Biologics, Inc.
Application holderPINNACLE BIOLOGICS INC
FDA applicationNDA020451 (NDA)
Labeler code76128
First marketedDec 1995
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PHOTOFRIN 75 MG VIAL Ingredient Porfimer Sodium
📖 What it is MedlinePlus · NLM

Porfimer is used in combination with photodynamic therapy (PDT; treatment with a laser light) to treat cancer or precancer of the esophagus and non-small cell lung cancer (NSCLC). Porfimer is in a class of medications called photoactivated radical generators. It works by killing porfimer-treated cancer cells when activated by PDT.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Photofrin 75 mg/31.8mLthis 76128-0155-75 Pinnacle 1 vial — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
1995
On the market since
Dec 1995
📍
2026
Currently FDA-listed
31 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
76128-0155-75 You're viewing this 1 VIAL in 1 BOX, UNIT-DOSE (76128-155-75) / 31.8 mL in 1 VIAL 1995-12-27 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 76128-155-75, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 76128-0155-75, written without dashes as 76128015575. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 76128-0155-75, the first segment (76128) is the labeler code FDA assigned to Pinnacle Biologics, Inc.; the middle segment (0155) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (75) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Pinnacle Biologics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pinnacle Biologics, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE PHOTOFRIN is a photoactivated radical generator indicated for: Esophageal Cancer ( 1.1 ) Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy Endobronchial Cancer ( 1.2 ) Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett’s Esophagus ( 1.3 ) Ablation of high-grade dysplasia (HGD) in Barrett’s esophagus (BE) patients who do not undergo esophagectomy

1.1Esophageal Cancer PHOTOFRIN ® is indicated for the palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their healthcare provider, cannot be satisfactorily treated with Nd:YAG laser therapy.

1.2Endobronchial Cancer PHOTOFRIN is indicated for the treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated. PHOTOFRIN is indicated for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC.

1.3High-Grade Dysplasia in Barrett’s Esophagus PHOTOFRIN is indicated for the ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION PHOTOFRIN ( 2.1 ) PHOTOFRIN administration: 2 mg/kg intravenous Photoactivation ( 2.2 ) Esophageal Cancer Laser light dose of 300 J/cm of fiber optic diffuser length 40–50 hours following injection with PHOTOFRIN; repeated, if needed, 96-120 hours after initial injection Endobronchial Cancer Laser light dose of 200 J/cm of fiber optic diffuser length 40–50 hours following injection with PHOTOFRIN; repeated, if needed, after gentle debridement of residual tumor 96-120 hours after initial injection High-Grade Dysplasia in Barrett’s Esophagus Laser light dose of 130 J/cm of fiber optic diffuser length 40–50 hours following injection with PHOTOFRIN; repeated, if needed, with a light dose of 50 J/cm of fiber optic diffuser length 96-120 hours after initial injection

2.1Important Administration Instructions Photodynamic therapy (PDT) with PHOTOFRIN is a two-stage process requiring administration of both drug and light. The first stage of PDT is the intravenous injection of PHOTOFRIN at 2 mg/kg. Illumination with laser light 40–50 hours following injection with PHOTOFRIN constitutes the second stage of therapy.

A second laser light application may be given 96-120 hours after injection [ see Dosage and Administration ( 2.2 )] . In clinical studies on endobronchial cancer, debridement via endoscopy was required 2-3 days after the initial light application. Standard endoscopic techniques are used for light administration and debridement.

Healthcare providers should be fully familiar with the patient’s condition and trained in the safe and efficacious treatment of esophageal or endobronchial cancer, or high-grade dysplasia (HGD) in Barrett’s esophagus (BE) using PDT with PHOTOFRIN and associated light delivery devices. PDT with PHOTOFRIN should be applied only in those facilities properly equipped for the procedure. The laser system must be approved for delivery of a stable power output at a wavelength of 630 ± 3 nm.

Light is delivered to the tumor by cylindrical OPTIGUIDE™ fiber optic diffusers passed through the operating channel of an endoscope/bronchoscope. Instructions for use of the fiber optic and the selected laser system should be read carefully before use. OPTIGUIDE™ cylindrical diffusers are available in several lengths.

The choice of diffuser tip length depends on the length of the tumor or Barrett’s mucosa to be treated. Diffuser length should be sized to avoid exposure of nonmalignant tissue to light and to prevent overlapping of previously treated malignant tissue. Refer to the OPTIGUIDE™ instructions for use for complete instructions concerning the fiber optic diffuser.

2.2PHOTOFRIN Recommended Dosage The recommended dosage of PHOTOFRIN is 2 mg/kg of body weight administered as a single slow intravenous injection over 3 to 5 minutes. Preparation and Administration Reconstitute each vial of PHOTOFRIN with 31.8 mL of either 5% Dextrose Injection (USP) or 0.9% Sodium Chloride Injection (USP), resulting in a final concentration of 2.5 mg/mL. Shake well until dissolved.

Do not mix PHOTOFRIN with other drugs in the same solution. Discard unused portion. PHOTOFRIN reconstituted with 5% Dextrose Injection (USP) or with 0.9% Sodium Chloride Injection (USP), has a pH in the range of 7 to 8.

PHOTOFRIN has been formulated with an overage to deliver the 75 mg labeled quantity. The reconstituted product should be protected from bright light and used immediately. Reconstituted PHOTOFRIN is an opaque solution, in which detection of particulate matter by visual inspection is extremely difficult.

Reconstituted PHOTOFRIN however, like all parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Management of Extravasation Precautions should be taken to present extravasation at the injection site. If extravasation occurs, care must be taken to protect the area from light.

There is no known benefit from injectin…

💊 Dosage Forms and Strengths 40 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 75 mg of porfimer sodium as a lyophilized powder in a single-dose vial for reconstitution. For injection: 75 mg porfimer sodium as a lyophilized powder in single-dose vial for reconstitution ( 3 )

⛔ Contraindications 164 words ▾

4 CONTRAINDICATIONS PHOTOFRIN is contraindicated in patients with porphyria. Photodynamic therapy (PDT) is contraindicated in patients with an existing tracheoesophageal or bronchoesophageal fistula. PDT is contraindicated in patients with tumors eroding into a major blood vessel.

PDT is not suitable for emergency treatment of patients with severe acute respiratory distress caused by an obstructing endobronchial lesion because 40 to 50 hours are required between injection with PHOTOFRIN and laser light treatment. PDT is not suitable for patients with esophageal or gastric varices, or patients with esophageal ulcers >1 cm in diameter. Porphyria ( 4 ) Existing tracheoesophageal or bronchoesophageal fistula ( 4 , 5.1 ) Tumors eroding into a major blood vessel ( 4 , 5.2 ) Emergency treatment of patients with severe acute respiratory distress caused by an obstructing endobronchial lesion because 40 to 50 hours are required between injection of PHOTOFRIN and laser light treatment ( 4 ) Esophageal or gastric varices or esophageal ulcers >1 cm in diameter ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Gastroesophageal Fistula and Perforation : Do not initiate PHOTOFRIN with photodynamic therapy (PDT) in patients with esophageal tumors eroding into the trachea or bronchial tree or bronchial wall. ( 5.1 ) Pulmonary and Gastroesophageal Hemorrhage : Assess patients for tumors eroding into a pulmonary blood vessel and esophageal varices. Do not administer light directly to an area with esophageal varices.

( 5.2 ) High-Grade Dysplasia (HGD) in Barrett’s Esophagus (BE) : After treatment of HGD in BE, conduct endoscopic biopsy surveillance every 3 months, until 4 consecutive negative evaluations for HGD have been recorded. ( 5.3 ) Photosensitivity and Ocular Photosensitivity : Observe precautions to avoid exposure of skin and eyes to direct sunlight or bright indoor light for at least 30 days. Instruct patients when outdoors to wear dark sunglasses which have an average light transmittance of <4% for at least 30 days and until ocular sensitivity resolves.

( 5.4 , 5.5 ) Use Before or After Radiotherapy : Allow 2-4 weeks between PDT and subsequent radiotherapy. ( 5.6 ) Chest Pain : Substernal chest pain can occur ( 5.7 ) Airway Obstruction and Respiratory Distress : Administer with caution to patients with tumors in locations where treatment- induced inflammation can obstruct the main airway. Monitor patients closely between the laser light therapy and the mandatory debridement bronchoscopy for any evidence of respiratory distress.

( 5.8 ) Esophageal Strictures : Esophageal strictures can occur ( 5.9 ) Hepatic and Renal Impairment : Patients with hepatic or renal impairment may need longer precautionary measures for photosensitivity. ( 5.10 ) Thromboembolism : Thromboembolic events can occur. ( 5.11 ) Embryo-Fetal Toxicity : May cause embryo-fetal toxicity.

Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.12 , 8.1 )

5.1Gastroesophageal Fistula and Perforation Serious and sometimes fatal gastrointestinal and esophageal necrosis and perforation can occur following treatment with PHOTOFRIN with PDT. Do not initiate PHOTOFRIN with PDT in patients with esophageal tumors eroding into the trachea or bronchial tree or bronchial wall because of the high likelihood of tracheoesophageal or bronchoesophageal fistula.

5.2Pulmonary and Gastroesophageal Hemorrhage Patients with large, centrally located tumors, cavitating tumors, or extensive tumors extrinsic to the bronchus are at high risk for fatal massive hemoptysis. Assess patients for tumors eroding into a pulmonary blood vessel [ see Contraindications ( 4 )] and esophageal varices. Do not administer light directly to an area with esophageal varices because of the high risk of hemorrhage.

5.3High-Grade Dysplasia (HGD) in Barrett’s Esophagus (BE) The long-term effect of PDT on HGD in BE is unknown. There is always a risk of cancer or abnormal epithelium that is invisible to the endoscopist beneath the new squamous cell epithelium; these facts emphasize the risk of overlooking cancer in such patients and the need for rigorous continuing surveillance despite the endoscopic appearance of complete squamous cell reepithelialization. Conduct endoscopic biopsy surveillance every 3 months, until 4 consecutive negative evaluations for HGD have been recorded; further follow-up may be scheduled every 6 to 12 months, as per judgment of healthcare providers.

The follow-up period of the randomized study at the time of analysis was a minimum of 2 years (range 2 to 5.6 years).

5.4Photosensitivity All patients who receive PHOTOFRIN will be photosensitive and must observe precautions to avoid exposure of skin and eyes to direct sunlight or bright indoor light (from examination lamps, including dental lamps, operating room lamps, unshaded light bulbs at close proximity, etc.) for at least 30 days. Some patients may remain photosensitive for up to 90 days or more. The photosensitivity is due to residual drug, which wil…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Gastroesophageal Fistula and Perforation [see Warnings and Precautions ( 5.1 )] Pulmonary and Gastroesophageal Hemorrhage [see Warnings and Precautions ( 5.2 )] High-Grade Dysplasia (HGD) in Barrett’s Esophagus (BE) [see Warnings and Precautions ( 5.3 )] Photosensitivity [see Warnings and Precautions ( 5.4 )] Ocular Sensitivity [see Warnings and Precautions ( 5.5 )] Use Before or After Radiotherapy [see Warnings and Precautions ( 5.6 )] Chest Pain [see Warnings and Precautions ( 5.7 )] Airway Obstruction and Respiratory Distress [see Warnings and Precautions ( 5.8 )] Esophageal Strictures [see Warnings and Precautions ( 5.9 )] Thromboembolism [see Warnings and Precautions ( 5.11 )] Most common adverse reactions (>10%) are Esophageal Cancer : Anemia, pleural effusion, pyrexia, constipation, nausea, chest pain, pain, abdominal pain, dyspnea, photosensitivity reaction, pneumonia, vomiting, insomnia, back pain, pharyngitis ( 6.1 ) Obstructing Endobronchial Cancer : Dyspnea, photosensitivity reaction, hemoptysis, pyrexia, cough, pneumonia ( 6.1 ) Superficial Endobronchial Tumors : Exudate, photosensitivity reaction, bronchial obstruction, edema, bronchostenosis ( 6.1 ) High-Grade Dysplasia in Barrett’s Esophagus : Photosensitivity reaction, esophageal stenosis, vomiting, chest pain, nausea, pyrexia, constipation, dysphagia, abdominal pain, pleural effusion, dehydration ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pinnacle Biologics, Inc. at 1-866-248-2039 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overall Adverse Reaction Profile Systemically induced effects of photodynamic therapy (PDT) with PHOTOFRIN consist of photosensitivity and mild constipation. All patients who receive PHOTOFRIN will be photosensitive and must observe precautions to avoid sunlight and bright indoor light [see Warnings and Precautions ( 5.4 ) ].

Photosensitivity reactions occurred in approximately 20% of cancer patients and in 69% of high-grade dysplasia (HGD) in Barretts esophagus (BE) patients treated with PHOTOFRIN. Typically, these reactions were mostly mild to moderate erythema, but they also included swelling, pruritus, burning sensation, feeling hot, or blisters. In a single study of 24 healthy subjects, some evidence of photosensitivity reactions occurred in all subjects.Other less common skin manifestations were also reported in areas where photosensitivity reactions had occurred, such as increased hair growth, skin discoloration, skin nodule, skin wrinkling and increased skin fragility.

These manifestations may be attributable to a pseudoporphyria state (temporary drug-induced cutaneous porphyria). Most toxicities of this therapy are local effects seen in the region of illumination and occasionally in surrounding tissues. The local adverse reactions are characteristic of an inflammatory response induced by the photodynamic effect.

A few cases of fluid imbalance have been reported in patients treated with PHOTOFRIN PDT for overtly disseminated intraperitoneal malignancies. Fluid imbalance is an expected PDT-related event. A case of cataracts has been reported in a 51-year-old obese man treated with PHOTOFRIN PDT for HGD in BE.

The patient suffered from a PDT response with development of a deep esophageal ulcer. Within two months post PDT, the patient noted difficulty with his distant vision. A thorough eye examination revealed a change in the refractive error that later progressed to cataracts in both eyes.

Both of his parents had a history of cataracts in their 70s. Whether PHOTOFRIN directly caused or accelerated a familial unde…

🔄 Drug Interactions 69 words ▾

7 DRUG INTERACTIONS Other Photosensitizing Agents : May increase the risk of photosensitivity reaction ( 7.1 )

7.1Use with Other Photosensitizing Agents PHOTOFRIN can cause photosensitivity. The concomitant use of PHOTOFRIN with other photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones) may increase the risk of a photosensitivity reaction. Avoid the concomitant use of PHOTOFRIN with other products known to cause photosensitivity.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advice not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on animal studies, PHOTOFRIN may cause embryo-fetal toxicity when administered to a pregnant woman. There are no available data on PHOTOFRIN use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Intraveneous administration of porfimer sodium to pregnant rats and rabbits during the period of organogenesis at dose levels approximately 0.64 times the recommended human dose of PHOTOFRIN based on body surface area (BSA) resulted in increased fetal resorptions, decreased litter size, and reduced fetal weight, but did not cause fetal malformations.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. Data Animal Data Intravenous administration of porfimer sodium to pregnant rats for 10 days during the period of organogenesis at dose levels 0.64 times the recommended human dose of PHOTOFRIN based on BSA resulted in maternal and embryo-fetal toxicity resulting in increased resorptions, decreased litter size, delayed ossification, and reduced fetal weight but did not cause major fetal malformations.

Intravenous administration of porfimer sodium to pregnant rabbits for 13 days during the period of organogenesis at dose levels 0.65 times the recommended human dose of PHOTOFRIN based on BSA caused maternal toxicity resulting in increased resorptions, decreased litter size, and reduced fetal body weight but did not cause major fetal malformations. Intravenous administration of porfimer sodium to rats for at least 42 days during late pregnancy (post- organogenesis, GD17-PND21) through lactation at dose levels 0.32 times the recommended human dose of PHOTOFRIN based on BSA caused a reversible decrease in growth of offspring.

Parturition was unaffected.

8.2Lactation Risk Summary There are no data on the presence of porfimer sodium in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed infant, advise patients that breastfeeding is not recommended during treatment with PHOTOFRIN and for 5 months after the last dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to the initiation of PHOTOFRIN therapy [see Use in Specific Populations ( 8.1 )] . Contraception PHOTOFRIN may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 )] . Females Advise females of reproductive potential to use effective contraception during treatment with PHOTOFRIN and for 5 months after the final dose.

Males Advise male patients with female partners of reproductive potential to use condoms during treatment with PHOTOFRIN and for 5 months following the final dose .

8.4Pediatric Use Safety and effectiveness in pediatrics have not been established.

8.5Geriatric Use Approximately 70% of the patients treated with PDT using PHOTOFRIN in clinical trials were over 60 years of age. No overall differences in safety or effectiveness were observed between these patients compared to younger patients.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on animal studies, PHOTOFRIN may cause embryo-fetal toxicity when administered to a pregnant woman. There are no available data on PHOTOFRIN use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Intraveneous administration of porfimer sodium to pregnant rats and rabbits during the period of organogenesis at dose levels approximately 0.64 times the recommended human dose of PHOTOFRIN based on body surface area (BSA) resulted in increased fetal resorptions, decreased litter size, and reduced fetal weight, but did not cause fetal malformations.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. Data Animal Data Intravenous administration of porfimer sodium to pregnant rats for 10 days during the period of organogenesis at dose levels 0.64 times the recommended human dose of PHOTOFRIN based on BSA resulted in maternal and embryo-fetal toxicity resulting in increased resorptions, decreased litter size, delayed ossification, and reduced fetal weight but did not cause major fetal malformations.

Intravenous administration of porfimer sodium to pregnant rabbits for 13 days during the period of organogenesis at dose levels 0.65 times the recommended human dose of PHOTOFRIN based on BSA caused maternal toxicity resulting in increased resorptions, decreased litter size, and reduced fetal body weight but did not cause major fetal malformations. Intravenous administration of porfimer sodium to rats for at least 42 days during late pregnancy (post- organogenesis, GD17-PND21) through lactation at dose levels 0.32 times the recommended human dose of PHOTOFRIN based on BSA caused a reversible decrease in growth of offspring.

Parturition was unaffected.

🆘 Overdosage 138 words ▾

10 OVERDOSAGE PHOTOFRIN Overdose There is limited information on overdosages involving PHOTOFRIN. Laser treatment should not be given if an overdose of PHOTOFRIN is administered. In the event of an overdose, instruct patients to protect their eyes and skin from direct sunlight or bright indoor lights for at least 30 days and then test for residual photosensitivity [ see Warnings and Precautions ( 5.4 )] .

PHOTOFRIN is not dialyzable. Overdose of Laser Light Following PHOTOFRIN Life-threatening dyspnea has been reported in a patient with a superficial endobronchial tumor who was administered a light dose higher than the recommended dose. Increased symptoms and damage to normal tissue might be expected following an overdose of light.

There is no information on overdose of laser light following PHOTOFRIN in patients with esophageal cancer or with high-grade dysplasia in Barrett’s esophagus.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The cytotoxic and antitumor actions of PHOTOFRIN are light and oxygen dependent. Photodynamic therapy (PDT) with PHOTOFRIN is a two-stage process. The first stage is the intravenous administration of PHOTOFRIN.

Clearance from a variety of tissues occurs over 40-72 hours, but tumors, skin, and organs of the reticuloendothelial system (including liver and spleen) retain PHOTOFRIN for a longer period. The second stage is the illumination with 630 nm wavelength laser light. Tumor selectivity in treatment occurs through a combination of selective retention of PHOTOFRIN and selective delivery of light.

Cellular damage caused by PDT with PHOTOFRIN is a consequence of the propagation of radical reactions. Radical initiation may occur after porfimer sodium absorbs light to form a porphyrin excited state. Spin transfer from porfimer sodium to molecular oxygen may then generate singlet oxygen.

Subsequent radical reactions can form superoxide and hydroxyl radicals. Tumor death also occurs through ischemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release. As opposed to a thermal effect, the laser treatment with porfimer sodium induces a photochemical effect.

The necrotic reaction and associated inflammatory responses may evolve over several days.

12.2Pharmacodynamics The duration of the PDT effect of PHOTOFRIN is dependent on retention and clearance of porfimer sodium from the tumor tissue and delivery of light. Drug Interaction Studies Findings in animals and cell culture suggest that many drugs could influence the effect of PDT, including compounds that quench active oxygen species or scavenge free radicals; decrease clotting, vasoconstriction or platelet aggregation: glucocorticosteroids; allopurinol; calcium channel blockers; and some prostaglandin inhibitors.

12.3Pharmacokinetics The pharmacokinetics of porfimer sodium were studied in 18 patients with cancer who received PHOTOFRIN 2 mg/kg/dose administered as a slow intravenous infusion over 3 to 5 minutes followed by a second dose administered 30 to 45 days later. The mean C max were comparable after the first and second dose (43.1±10.5 mcg/mL and 41.3±8.7 mcg/mL, respectively). The mean AUC 0-INF was about 34% higher after the second dose compared to that after the first dose (3937±1034 mcg.h/mL and 2937±627 mcg. hour/mL, respectively), indicating some accumulation upon repeated administration.

Distribution Clearance from a variety of tissues occurs over 40 to 72 hours, but tumors, skin, and organs of the reticuloendothelial system (including liver and spleen) retain porfimer sodium for a longer period. Porfimer sodium was approximately 90% protein bound in human serum in vitro. The binding was independent of concentration over the concentration range of 20 to 100 mcg/mL.

Elimination The elimination half- life is 410 hours after the first dose and increases to 725 hours after the second dose. Specific Populations No clinically significant differences in the pharmacokinetics of porfimer sodium were observed based on sex. The effect of renal and hepatic impairment has not been studied.

📦 How Supplied / Storage and Handling 174 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING PHOTOFRIN (porfimer sodium) for Injection is supplied as a lyophilized powder as follows: NDC 76128-155-75, 75 mg single-dose vial. Storage Store at Controlled Room Temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [ see USP Controlled Temperature ]. Spills and Disposal Spills of PHOTOFRIN should be wiped up with a damp cloth.

Skin and eye contact should be avoided due to the potential for photosensitivity reactions upon exposure to light; use of rubber gloves and eye protection is recommended. All contaminated materials should be disposed of in a polyethylene bag in a manner consistent with local regulations. Accidental Exposure PHOTOFRIN is neither a primary ocular irritant nor a primary dermal irritant.

However, because of its potential to induce photosensitivity, PHOTOFRIN might be an eye and/or skin irritant in the presence of bright light. It is important to avoid contact with the eyes and skin during preparation and/or administration. As with therapeutic overdosage, any overexposed person must be protected from bright light.

📋 Description 102 words ▾

11 DESCRIPTION Porfimer sodium is a photoactivated radical generator. Porfimer sodium is a mixture of oligomers formed by ether and ester linkages of up to eight porphyrin units. The structural formula below is representative of the components of porfimer sodium.

PHOTOFRIN (porfimer sodium) for injection, for intravenous use, is supplied in a single-dose vial as dark red to reddish brown lyophilized powder, which has a cake-like appearance. Each vial contains 75 mg of porfimer sodium. Hydrochloric acid and/ or sodium hydroxide may be added to adjust the pH to within 7.2-7.9.

There are no preservatives or other additives. Porfimer sodium Chemical Formula

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Photosensitivity Advise patients to avoid exposure of skin and eyes to direct sunlight or bright indoor light for at least 30 days following PHOTOFRIN [see Warnings and Precautions ( 5.4 , 5.5 )] . Inform patients that photosensitivity might last for more than 90 days if patients suffer from renal or hepatic impairment. Instruct patients to wear protective clothing and dark sunglasses when outdoors, which have an average white light transmittance of < 4%.

Encourage patients to expose their skin to ambient indoor light to facilitate elimination of PHOTOFRIN from their skin. Common Adverse Reactions Inform patients that treatment with PHOTOFRIN and photodynamic therapy might lead to adverse reactions which include chest pain, respiratory distress or esophageal strictures [see Warnings and Precautions ( 5.7 , 5.8 , 5.9 ) ]. Advise patients to contact their healthcare providers for new or worsening adverse reactions ) .

Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.12 ), Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential to use effective contraception during treatment with PHOTOFRIN and for 5 months after the final dose [see Use in Specific Populations ( 8.3 )] .

Advise male patients with female partners of reproductive potential to use condoms during treatment with PHOTOFRIN and for 5 months following the final dose [see Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 )] . Lactation Advise women not to breastfeed during treatment with PHOTOFRIN and for 5 months after the last dose [see Use in Specific Populations ( 8.2 )]. Distributed by: Pinnacle Biologics, Inc., 2801 Lakeside Drive, Suite 210 Bannockburn, IL 60015 PINN-204 v2

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.