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Visudyne verteporfin for injection 15 mg Injection, Powder, Lyophilized, For Solution, 1 injection — NDC 24208-0560-15 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Visudyne verteporfin for injection 15 mg Injection, Powder, Lyophilized, For Solution, 1 injection — NDC 24208-560-15 (Billing 24208-0560-15)

by Bausch & Lomb Incorporated · 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON

This is a package of 1 injection of Visudyne verteporfin for injection 15 mg Injection, Powder, Lyophilized, For Solution from Bausch & Lomb Incorporated, marketed since Apr 2000 and currently FDA-listed. It is this product's only package size.

NDC 24208-0560-15
🏷️ FDA NDC (as labeled) 24208-560-15 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 24208-560-15
Product NDC 24208-560
11-digit billing NDC 24208056015
NCPDP billing unit EA — each (per item)
RxCUI 313595, 351914
UNII 0X9PA28K43
Application # NDA021119
SPL Set ID 2f0a34ce-3c57-4ac8-b28e-512be807272f
Established class (EPC) Photoenhancer
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 2000-04-12
Route INTRAVENOUS
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance VERTEPORFIN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86700065002120
GCN Seq No 045121
GCN 92232
HICL code 021150
Ingredient (HICL) Verteporfin
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q2
Therapeutic class — intermediate (HIC2) Drugs Acting On The Eye
HIC3 code Q2A
Therapeutic class — specific (HIC3) Ocular Photoactivated Vessel-Occluding Agents
AHFS code 52:44.00.00
AHFS class Macular Degeneration Agents
FDB label name VISUDYNE 15 MG VIAL
FDB brand name Visudyne
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 045121
  • GCN: 92232
  • GPI-14 (Medi-Span): 86700065002120
  • HICL (First Databank): 021150
  • AHFS class code: 52:44.00.00
  • RxCUI (RxNorm): 313595
Why two NDCs? The FDA registers this code as 24208-560-15 — 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 → 24208-0560-15. 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 Photoenhancer class.

Pharmacologic class Photoenhancer
Drug family (ATC) Antineovascularisation agents
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.

Clinical

Label name VISUDYNE 15 MG VIAL Ingredient Verteporfin
📖 What it is MedlinePlus · NLM

Verteporfin injection is used in combination with photodynamic therapy (PDT; treatment with a laser light) to treat abnormal growth of leaky blood vessels in the eye caused by wet age-related macular degeneration (AMD; an ongoing disease of the eye that causes loss of the ability to see straight ahead and may make it more difficult to read, drive, or perform other daily activities), pathologic myopia (a serious form of nearsightedness that worsens with time), or histoplasmosis (a fungal infection) of the eye. Verteporfin is in a class of medications called photosensitizing agents. When vertepo...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats abnormal blood vessels growing under the center of your retina. This is called predominantly classic subfoveal CNV. It is used when the cause is age-related macular degen...
  • You get an infusion into a vein in your arm over 10 minutes. About 15 minutes after it starts, a doctor shines a special red laser into your eye. Your eye doctor will recheck you a...
  • Avoid direct sunlight and bright indoor light for 5 days. This protects your skin and eyes from sunburn-like reactions. Cover your skin and eyes when you go outside, and ask your c...
  • Injection site discomfort, blurred vision, flashes of light and back pain during the infusion are common. Call your doctor right away if your vision drops suddenly, or if the injec...
📖 Read our full Verteporfin Injection guide →

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.

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.
Medicare Part B allowsASP · J3396 $11.374 / J3396 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)24208-560-15
11-digit billing NDC24208-0560-15
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3396
DescriptorInjection, verteporfin, 0.1 mg
Billing units / pkg150 units
How the units are derivedThis package is 1; the HCPCS unit is 0.1 MG, so one package = 150 billing units.
Medicare Part B spend (2026 (Q1))$317,817 · 190 claims · $1,672.72 per claim (all NDCs under J3396)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
24208-0560-15 You're viewing this Main listing 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON 2023-02-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Visudyne 15 mg 00187-5600-15 Bausch 1 injection — — FDA listed —
Visudyne 15 mgthis 24208-0560-15 Bausch 1 injection — — 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

🏛️
2000
On the market since
Apr 2000
📍
2026
Currently FDA-listed
26 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.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII QN83US2B0N
    Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.

Manufacturer & labeler

LabelerBausch & Lomb Incorporated
Application holderBAUSCH AND LOMB IRELAND LTD
FDA applicationNDA021119 (NDA)
Labeler code24208
First marketedApr 2000
Product typeHuman Prescription Drug
Portfolio92 products on file
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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 85 words ▾

1 INDICATIONS AND USAGE VISUDYNE ® (verteporfin for injection) therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD), pathologic myopia or presumed ocular histoplasmosis. There is insufficient evidence to indicate VISUDYNE for the treatment of predominantly occult subfoveal CNV. VISUDYNE (verteporfin for injection) therapy is a photoenhancer indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Recommended Dose : 6 mg/m 2 body surface area. ( 2.2 ) • Reconstitution : Reconstitute each vial of VISUDYNE with 7 mL of Sterile Water for Injection to provide 7.5 mL containing 2 mg/mL of verteporfin. Reconstituted VISUDYNE must be protected from light and used within 4 hours.

( 2.3 ) • Dilution : Dilute desired dose of reconstituted VISUDYNE with 5% Dextrose for Injection to a total infusion volume of 30 mL. ( 2.3 ) • Infusion : Administer intravenously over 10 minutes at a rate of 3 mL/minute, using an appropriate syringe pump and in-line filter. ( 2.3 ) • Light Administration : The recommended light dose is 50 J/cm 2 of neovascular lesion administered at an intensity of 600 mW/cm 2 .

The wavelength of the laser light should be 689±3 nm. This light dose is administered over 83 seconds, starting 15 minutes after the start of the VISUDYNE infusion. ( 2.4 )

2.1Important Administration Instructions A course of VISUDYNE (verteporfin for injection) therapy is a two-step process requiring administration of both drug and light. • The first step is the administration of VISUDYNE. • The second step is the activation of VISUDYNE with light from a nonthermal diode laser. The physician should re-evaluate the patient 3 months after treatment and if choroidal neovascular leakage is detected on fluorescein angiography, therapy may be repeated. Lesion Size Determination The greatest linear dimension (GLD) of the lesion should be estimated by fluorescein angiography and color fundus photography.

All classic and occult CNV, blood and/or blocked fluorescence, and any serous detachments of the retinal pigment epithelium should be included for this measurement. Fundus cameras with magnification within the range of 2.4-2.6X are recommended. The GLD of the lesion on the fluorescein angiogram must be corrected for the magnification of the fundus camera to obtain the GLD of the lesion on the retina.

Spot Size Determination The treatment spot size should be 1,000 microns larger than the GLD of the lesion on the retina to allow a 500 micron border, ensuring full coverage of the lesion. The maximum spot size used in the clinical trials was 6,400 microns. The nasal edge of the treatment spot must be positioned at least 200 microns from the temporal edge of the optic disc, even if this will result in lack of photoactivation of CNV within 200 microns of the optic nerve.

2.2Recommended Dosage of VISUDYNE The recommended dose of VISUDYNE is 6 mg/m 2 body surface area.

2.3VISUDYNE Administration Avoid contact with the eyes and skin during preparation and administration of VISUDYNE. Because of the potential to induce photosensitivity reactions, any exposed person must be protected from bright light [see Warnings and Precautions ( 5.1 ) and How Supplied/Storage and Handling ( 16 )] . Reconstitution Reconstitute each vial of VISUDYNE with 7 mL of Sterile Water for Injection.

Each reconstituted vial provides 7.5 mL solution containing 2 mg/mL of verteporfin. Reconstituted VISUDYNE must be protected from light and used within 4 hours. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Reconstituted VISUDYNE is an opaque dark green solution. Dilution VISUDYNE may precipitate in saline solutions. Do not use normal saline or other parenteral solutions, except 5% Dextrose for Injection, for dilution of the reconstituted VISUDYNE.

Do not mix VISUDYNE in the same solution with other drugs. The volume of reconstituted VISUDYNE required to achieve the desired dose of 6 mg/m 2 body surface area is withdrawn from the vial and diluted with 5% Dextrose for Injection to a total infusion volume of 30 mL. After dilution, protect from light and use within 4 hours.

Intravenous Infusion The full infusion volume is administered intravenously over 10 minutes at a rate of 3 mL/minute, using an appropriate syringe pump and in-line filter. The c… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 80 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 15 mg of verteporfin as a dark green lyophilized cake in a single-dose vial for reconstitution. VISUDYNE is intended for intravenous injection only. Each reconstituted vial provides 7.5 mL solution containing 2 mg/mL of verteporfin. • For injection: 15 mg of verteporfin as a dark green lyophilized cake in a single-dose vial for reconstitution.

( 3 ) • Each reconstituted vial provides 7.5 mL solution containing 2 mg/mL of verteporfin. ( 3 )

⛔ Contraindications 52 words ▾

4 CONTRAINDICATIONS VISUDYNE (verteporfin for injection) is contraindicated for patients with porphyria or a known hypersensitivity to any component of this preparation [see Adverse Reactions ( 6 )] . VISUDYNE (verteporfin for injection) is contraindicated for patients with porphyria or a known hypersensitivity to any component of this preparation. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Extravasation : If extravasation occurs, the infusion should be stopped immediately. The extravasation area must be thoroughly protected from direct light until swelling and discoloration have faded in order to prevent the occurrence of local burn. ( 5.1 ) • Exposure to Sun or Direct Light : Following injection with VISUDYNE (verteporfin for injection), care should be taken to avoid exposure of skin or eyes to direct sunlight or bright indoor light for 5 days.

( 5.2 ) • Anaphylactic Reactions : Immediately discontinue administration of VISUDYNE and initiate appropriate therapy if an anaphylactic or other serious allergic reaction occurs during or following infusion. ( 5.4 )

5.1Local Adverse Reactions - Extravasation Standard precautions should be taken during infusion of VISUDYNE (verteporfin for injection) to avoid extravasation. Examples of standard precautions include, but are not limited to: • A free-flowing intravenous (IV) line should be established before starting VISUDYNE infusion and the line should be carefully monitored. • Due to the possible fragility of vein walls of some elderly patients, it is strongly recommended that the largest arm vein possible, preferably antecubital, be used for injection. • Small veins in the back of the hand should be avoided.

Extravasation of VISUDYNE, especially if the affected area is exposed to light, can cause severe pain, inflammation, swelling or discoloration at the injection site. Localized (skin) necrosis at the injection site following extravasation has also been reported. If extravasation does occur, the infusion should be stopped immediately.

The extravasation area must be thoroughly protected from direct light until swelling and discoloration have faded in order to prevent the occurrence of local burn, which could be severe. Cold compresses should be applied to the injection site. Oral medications for pain relief may be administered.

5.2Exposure to Sun or Direct Light Following injection with VISUDYNE (verteporfin for injection), care should be taken to avoid exposure of skin or eyes to direct sunlight or bright indoor light for 5 days. In the event of extravasation during infusion, the extravasation area must be thoroughly protected from direct light until the swelling and discoloration have faded in order to prevent the occurrence of a local burn which could be severe. If emergency surgery is necessary within 48 hours after treatment, as much of the internal tissue as possible should be protected from intense light.

5.3Decreased Vision After Treatment Patients who experience severe decrease of vision of 4 lines or more within 1 week after treatment should not be retreated, at least until their vision completely recovers to pretreatment levels and the potential benefits and risks of subsequent treatment are carefully considered by the treating physician.

5.4Anaphylactic Reactions Cases of anaphylactic reactions have been reported in patients receiving VISUDYNE. Medical supervision is recommended during infusion. If an anaphylactic or other serious allergic reaction occurs during or following infusion, administration of VISUDYNE should be discontinued immediately and appropriate therapy should be initiated.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Local Adverse Reactions – Extravasation [see Warnings and Precautions ( 5.1 )] • Exposure to Sun or Direct Light [see Warnings and Precautions ( 5.2 )] • Decreased Vision after Treatment [see Warnings and Precautions ( 5.3 )] • Porphyria and Hypersensitivity [see Contraindications ( 4 )] Most common adverse reactions (incidence ˃10%) are injection site reactions and visual disturbances. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 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. Severe chest pain, vasovagal and hypersensitivity reactions have been reported. Vasovagal and hypersensitivity reactions on rare occasions can be severe.

These reactions may include syncope, sweating, dizziness, rash, dyspnea, flushing and changes in blood pressure and heart rate. General symptoms can include headache, malaise, urticaria, and pruritus. The most frequently reported adverse reactions to VISUDYNE (verteporfin for injection) are injection site reactions (including pain, edema, inflammation, extravasation, rashes, hemorrhage and discoloration) and visual disturbances (including blurred vision, flashes of light, decreased visual acuity and visual field defects, including scotoma).

These events occurred in approximately 10%-30% of patients. The following events, listed by Body System, were reported more frequently with VISUDYNE therapy than with placebo therapy and occurred in 1%-10% of patients: Ocular Treatment Site: Blepharitis, cataracts, conjunctivitis/conjunctival injection, dry eyes, ocular itching, severe vision decrease with or without subretinal/retinal or vitreous hemorrhage Body as a Whole: Asthenia, fever, flu syndrome, infusion related pain primarily presenting as back pain, photosensitivity reactions Cardiovascular: Atrial fibrillation, hypertension, peripheral vascular disorder, varicose veins Dermatologic: Eczema Digestive: Constipation, gastrointestinal cancers, nausea Hemic and Lymphatic: Anemia, white blood cell count decreased, white blood cell count increased Hepatic: Elevated liver function tests Metabolic/Nutritional: Albuminuria, creatinine increased Musculoskeletal: Arthralgia, arthrosis, myasthenia Nervous System: Hypesthesia, sleep disorder, vertigo Respiratory: Cough, pharyngitis, pneumonia Special Senses: Cataracts, decreased hearing, diplopia, lacrimation disorder Urogenital: Prostatic disorder Severe vision decrease, equivalent of >4 lines, within 7 days after treatment has been reported in 1%-5% of patients.

Partial recovery of vision was observed in some patients. Photosensitivity reactions usually occurred in the form of skin sunburn following exposure to sunlight. The higher incidence of back pain in the VISUDYNE group occurred primarily during infusion.

The following adverse events have occurred either at low incidence (<1%) during clinical trials or have been reported during the use of VISUDYNE in clinical practice where these reactions were reported voluntarily from a population of unknown size and frequency of occurrence cannot be determined precisely. They have been chosen for inclusion based on factors such as seriousness, frequency of reporting, possible causal connection to VISUDYNE, or a combination of these factors: Ocular Treatment Site: Retinal detachment (nonrhegmatogenous), retinal or choroidal vessel nonperfusion, retinal pigment epithelial tear.

Non-ocular Events: Chest pain and other musculoskeletal pain during infusion, anaphylactic reaction during or following infusion, injection site necrosis.

🔄 Drug Interactions 159 words ▾

7 DRUG INTERACTIONS Drug interaction studies in humans have not been conducted with VISUDYNE. Verteporfin is rapidly eliminated by the liver, mainly as unchanged drug. Metabolism is limited and occurs by liver and plasma esterases.

Microsomal cytochrome P450 does not appear to play a role in verteporfin metabolism. Based on the mechanism of action of verteporfin, many drugs used concomitantly could influence the effect of VISUDYNE therapy. Possible examples include the following: Calcium channel blockers, polymyxin B or radiation therapy could enhance the rate of VISUDYNE uptake by the vascular endothelium.

Other photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics and griseofulvin) could increase the potential for skin photosensitivity reactions. Compounds that quench active oxygen species or scavenge radicals, such as dimethyl sulfoxide, β-carotene, ethanol, formate and mannitol, would be expected to decrease VISUDYNE activity. Drugs that decrease clotting, vasoconstriction or platelet aggregation, e.g., thromboxane A 2 inhibitors, could also decrease the efficacy of VISUDYNE therapy.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no data with the use of VISUDYNE in pregnant women to inform a drug-associated risk. Intravenous administration of verteporfin to pregnant rats during the period of organogenesis produced an increase in the incidence of anophthalmia/microphthalmia and wavy ribs at exposures approximately 40-fold the human exposure at the recommended clinical dose. Verteporfin did not produce adverse fetal effect in rats or rabbits at exposures 6- to 20-fold the human exposure at the recommended clinical dose.

There are no adequate and well-controlled studies in pregnant women. VISUDYNE should be used during pregnancy only if the benefit justifies the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.

Data Animal Data Rat fetuses of dams administered verteporfin for injection intravenously during organogenesis exhibited an increase in the incidence of anophthalmia/microphthalmia and wavy ribs at doses ≥10 mg/kg/day (approximately 40-fold the human exposure at the recommended dose of 6 mg/m 2 , based on AUC in female rats). No teratogenic effects were observed in rat fetuses at a dose of 2 mg/kg/day (approximately 6-fold the human exposure at the recommended dose of 6 mg/m 2 , based on AUC in female rats). In pregnant rabbits, a decrease in maternal body weight gain and food consumption was observed in animals that received verteporfin for injection intravenously at doses up to 10 mg/kg/day during organogenesis.

The no observed adverse effect level (NOAEL) for maternal toxicity was 3 mg/kg/day (approximately 6-fold the recommended human dose of 6 mg/m 2 , based on body surface area). No teratogenic effects were observed in rabbit fetuses at doses up to 10 mg/kg/day (approximately 20-fold the recommended human dose of 6 mg/m 2 , based on body surface area).

8.2Lactation Risk Summary Verteporfin and its diacid metabolite have been found in human breast milk following an intravenous infusion at the recommended human dose of 6 mg/m 2 . Verteporfin was present in breast milk at levels up to 66% of the corresponding plasma levels and declined below the limit of quantification (2 ng/mL) within 24 hours. The diacid metabolite had lower peak concentrations but persisted up to at least 48 hours.

Because of the potential for serious adverse reactions in nursing infants from VISUDYNE, a decision should be made whether to discontinue nursing or postpone treatment, taking into account the importance of the drug to the mother.

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

8.5Geriatric Use Approximately 90% of the patients treated with VISUDYNE in the clinical efficacy trials were over the age of 65. A reduced treatment effect was seen with increasing age.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no data with the use of VISUDYNE in pregnant women to inform a drug-associated risk. Intravenous administration of verteporfin to pregnant rats during the period of organogenesis produced an increase in the incidence of anophthalmia/microphthalmia and wavy ribs at exposures approximately 40-fold the human exposure at the recommended clinical dose. Verteporfin did not produce adverse fetal effect in rats or rabbits at exposures 6- to 20-fold the human exposure at the recommended clinical dose.

There are no adequate and well-controlled studies in pregnant women. VISUDYNE should be used during pregnancy only if the benefit justifies the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.

Data Animal Data Rat fetuses of dams administered verteporfin for injection intravenously during organogenesis exhibited an increase in the incidence of anophthalmia/microphthalmia and wavy ribs at doses ≥10 mg/kg/day (approximately 40-fold the human exposure at the recommended dose of 6 mg/m 2 , based on AUC in female rats). No teratogenic effects were observed in rat fetuses at a dose of 2 mg/kg/day (approximately 6-fold the human exposure at the recommended dose of 6 mg/m 2 , based on AUC in female rats). In pregnant rabbits, a decrease in maternal body weight gain and food consumption was observed in animals that received verteporfin for injection intravenously at doses up to 10 mg/kg/day during organogenesis.

The no observed adverse effect level (NOAEL) for maternal toxicity was 3 mg/kg/day (approximately 6-fold the recommended human dose of 6 mg/m 2 , based on body surface area). No teratogenic effects were observed in rabbit fetuses at doses up to 10 mg/kg/day (approximately 20-fold the recommended human dose of 6 mg/m 2 , based on body surface area).

🧒 Pediatric Use 13 words ▾

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

🧓 Geriatric Use 31 words ▾

8.5Geriatric Use Approximately 90% of the patients treated with VISUDYNE in the clinical efficacy trials were over the age of 65. A reduced treatment effect was seen with increasing age.

🆘 Overdosage 71 words ▾

10 OVERDOSAGE Overdose of drug and/or light in the treated eye may result in non-perfusion of normal retinal vessels with the possibility of severe decrease in vision that could be permanent. An overdose of drug will also result in the prolongation of the period during which the patient remains photosensitive to bright light. In such cases, it is recommended to extend the photosensitivity precautions for a time proportional to the overdose.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action VISUDYNE (verteporfin for injection) therapy is a two-stage process requiring administration of both verteporfin for injection and nonthermal red light. Verteporfin is transported in the plasma primarily by lipoproteins. Once verteporfin is activated by light in the presence of oxygen, highly reactive, short-lived singlet oxygen and reactive oxygen radicals are generated.

Light activation of verteporfin results in local damage to neovascular endothelium, resulting in vessel occlusion. Damaged endothelium is known to release procoagulant and vasoactive factors through the lipoxygenase (leukotriene) and cyclooxygenase (eicosanoids such as thromboxane) pathways, resulting in platelet aggregation, fibrin clot formation and vasoconstriction. Verteporfin appears to somewhat preferentially accumulate in neovasculature, including choroidal neovasculature.

However, animal models indicate that the drug is also present in the retina. Therefore, there may be collateral damage to retinal structures following photoactivation including the retinal pigmented epithelium and outer nuclear layer of the retina. The temporary occlusion of the CNV following VISUDYNE therapy has been confirmed in humans by fluorescein angiography.

12.3Pharmacokinetics Following intravenous infusion, verteporfin exhibits a bi-exponential elimination with a terminal elimination half-life of approximately 5-6 hours. The extent of exposure and the maximal plasma concentration are proportional to the dose between 6 and 20 mg/m 2 . At the intended dose, pharmacokinetic parameters are not significantly affected by gender.

Verteporfin is metabolized to a small extent to its diacid metabolite by liver and plasma esterases. NADPH-dependent liver enzyme systems (including the cytochrome P450 isozymes) do not appear to play a role in the metabolism of verteporfin. Elimination is by the fecal route, with less than 0.01% of the dose recovered in urine.

In a study of patients with mild hepatic insufficiency (defined as having two abnormal hepatic function tests at enrollment), AUC and C max were not significantly different from the control group; half-life, however, was significantly increased by approximately 20%.

🧬 Mechanism of Action 164 words ▾

12.1Mechanism of Action VISUDYNE (verteporfin for injection) therapy is a two-stage process requiring administration of both verteporfin for injection and nonthermal red light. Verteporfin is transported in the plasma primarily by lipoproteins. Once verteporfin is activated by light in the presence of oxygen, highly reactive, short-lived singlet oxygen and reactive oxygen radicals are generated.

Light activation of verteporfin results in local damage to neovascular endothelium, resulting in vessel occlusion. Damaged endothelium is known to release procoagulant and vasoactive factors through the lipoxygenase (leukotriene) and cyclooxygenase (eicosanoids such as thromboxane) pathways, resulting in platelet aggregation, fibrin clot formation and vasoconstriction. Verteporfin appears to somewhat preferentially accumulate in neovasculature, including choroidal neovasculature.

However, animal models indicate that the drug is also present in the retina. Therefore, there may be collateral damage to retinal structures following photoactivation including the retinal pigmented epithelium and outer nuclear layer of the retina. The temporary occlusion of the CNV following VISUDYNE therapy has been confirmed in humans by fluorescein angiography.

📦 How Supplied / Storage and Handling 149 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING VISUDYNE ® (verteporfin for injection) is supplied in a single-dose glass vial with a gray bromobutyl stopper and aluminum flip-off cap. It contains a lyophilized dark green cake with 15 mg verteporfin. NDC 24208-560-15 Store VISUDYNE at controlled room temperature between 20°C to 25°C (68°F to 77°F). Protect from light.

16.1Spills and Disposal Spills of VISUDYNE 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 materials should be disposed of properly.

16.2Accidental Exposure Because of the potential to induce photosensitivity reactions, it is important to avoid contact with the eyes and skin during preparation and administration of VISUDYNE. Any exposed person must be protected from bright light [see Warnings and Precautions ( 5.1 )] .

📋 Description 116 words ▾

11 DESCRIPTION VISUDYNE ® (verteporfin for injection) is a sterile, photoenhancer which is light activated drug when used in photodynamic therapy for intravenous administration. The finished drug product is a lyophilized dark green cake. Verteporfin is a 1:1 mixture of two regioisomers (I and II), represented by the following structures: The chemical names for the verteporfin regioisomers are: 9-methyl (I) and 13-methyl (II) trans-(±)-18-ethenyl-4,4a,-dihydro-3,4-bis(methoxycarbonyl)-4a,8,14,19-tetramethyl-23H, 25H-benzo[b]porphine-9,13-dipropanoate The molecular formula is C 41 H 42 N 4 O 8 with a molecular weight of approximately 718.8.

Each mL of reconstituted VISUDYNE contains: ACTIVE: verteporfin, 2 mg INACTIVES: ascorbyl palmitate (0.02 mg), butylated hydroxytoluene (0.002 mg), dimyristoyl phosphatidylcholine (9.4 mg), egg phosphatidylglycerol (6.5 mg), and lactose (92.0 mg). chem

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise patients who receive VISUDYNE that they will become temporarily photosensitive after the infusion. Patients should be advised to wear a wristband to remind them to avoid direct sunlight for 5 days. During that period, patients should be advised to avoid exposure of unprotected skin, eyes or other body organs to direct sunlight or bright indoor light.

Sources of bright light include, but are not limited to, tanning salons, bright halogen lighting and high power lighting used in surgical operating rooms or dental offices. Prolonged exposure to light from light-emitting medical devices such as pulse oximeters should also be avoided for 5 days following VISUDYNE administration. If treated patients must go outdoors in daylight during the first 5 days after treatment, they should be advised to protect all parts of their skin and their eyes by wearing protective clothing and dark sunglasses.

UV sunscreens are not effective in protecting against photosensitivity reactions because photoactivation of the residual drug in the skin can be caused by visible light. Patients should be advised to not stay in the dark and should be encouraged to expose their skin to ambient indoor light, as it will help inactivate the drug in the skin through a process called photobleaching. Following VISUDYNE treatment, patients should be advised that they may develop visual disturbances such as abnormal vision, vision decrease, or visual field defects that may interfere with their ability to drive or use machines.

Patients should be advised to not drive or use machines as long as these symptoms persist. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Alcami Carolinas Corporation Charleston, SC 29405 USA VISUDYNE is a registered trademark of CHEPLAPHARM ARZNEIMITTEL GMBH used under license.

Other product/brand names are trademarks of the respective owners. © 2023 Bausch & Lomb Incorporated or its affiliates 9589703

🧬 Pharmacokinetics 144 words ▾

12.3Pharmacokinetics Following intravenous infusion, verteporfin exhibits a bi-exponential elimination with a terminal elimination half-life of approximately 5-6 hours. The extent of exposure and the maximal plasma concentration are proportional to the dose between 6 and 20 mg/m 2 . At the intended dose, pharmacokinetic parameters are not significantly affected by gender.

Verteporfin is metabolized to a small extent to its diacid metabolite by liver and plasma esterases. NADPH-dependent liver enzyme systems (including the cytochrome P450 isozymes) do not appear to play a role in the metabolism of verteporfin. Elimination is by the fecal route, with less than 0.01% of the dose recovered in urine.

In a study of patients with mild hepatic insufficiency (defined as having two abnormal hepatic function tests at enrollment), AUC and C max were not significantly different from the control group; half-life, however, was significantly increased by approximately 20%.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Age-Related Macular Degeneration Two adequate and well-controlled, double-masked, placebo-controlled, randomized studies were conducted in patients with classic-containing subfoveal CNV secondary to AMD. A total of 609 patients (VISUDYNE 402, placebo 207) were enrolled in these two studies. During these studies, retreatment was allowed every 3 months if fluorescein angiograms showed any recurrence or persistence of leakage.

The placebo control (sham treatment) consisted of intravenous administration of Dextrose 5% in Water, followed by light application identical to that used for VISUDYNE therapy. The difference between treatment groups statistically favored VISUDYNE at the 1-year and 2-year analyses for visual acuity endpoints. The subgroup of patients with predominately classic CNV lesions was more likely to exhibit a treatment benefit (N=242; VISUDYNE 159, placebo 83).

Predominantly classic CNV lesions were defined as those in which the classic component comprised 50% or more of the area of the entire lesion. For the primary efficacy endpoint (percentage of patients who lost less than 3 lines of visual acuity), these patients showed a difference of approximately 28% between treatment groups at both Months 12 and 24 (67% for VISUDYNE patients compared to 40% for placebo patients, at Month 12; and 59% for VISUDYNE patients compared to 31% for placebo patients, at Month 24). Severe vision loss (≥6 lines of visual acuity from baseline) was experienced by 12% of VISUDYNE-treated patients compared to 34% of placebo-treated patients at Month 12, and by 15% of VISUDYNE-treated patients compared to 36% of placebo-treated patients at Month 24.

Patients with predominantly classic CNV lesions that did not contain occult CNV exhibited the greatest benefit (N=134; VISUDYNE 90, placebo 44). At 1 year, these patients demonstrated a 49% difference between treatment groups when assessed by the <3 lines-lost definition (77% vs. 27%).

Older patients (≥75 years), patients with dark irides, patients with occult lesions or patients with less than 50% classic CNV were less likely to benefit from VISUDYNE therapy. The safety and efficacy of VISUDYNE beyond 2 years have not been demonstrated. Based on the Treatment of Age Related Macular Degeneration with Photodynamic Therapy Study (TAP) extension study, the average number of treatments per year was 3.5 in the first year after diagnosis, 2.4 in the second, 1.3 in the third, 0.4 in the fourth and 0.1 in the fifth year.

14.2Pathologic Myopia One adequate and well-controlled, double-masked, placebo-controlled, randomized study was conducted in patients with subfoveal CNV secondary to pathologic myopia. A total of 120 patients (VISUDYNE 81, placebo 39) were enrolled in the study. The treatment dosing and retreatments were the same as in the AMD studies.

The difference between treatment groups statistically favored VISUDYNE at the 1-year analysis but not at the 2-year analysis for visual acuity endpoints. For the primary efficacy endpoint (percentage of patients who lost less than 3 lines of visual acuity), patients at the 1-year timepoint showed a difference of approximately 19% between treatment groups (86% for VISUDYNE patients compared to 67% for placebo patients). However, by the 2-year timepoint, the effect was no longer statistically significant (79% for VISUDYNE patients compared to 72% for placebo patients).

Based on the Verteporfin in Photodynamic Therapy in Pathologic Myopia (VIP-PM) extension study in pathologic myopia, the average number of treatments per year was 3.5 in the first year after diagnosis, 1.8 in the second, 0.4 in the third, 0.2 in the fourth and 0.1 in the fifth.

14.3Presumed Ocular Histoplasmosis One open-label study was conducted in patients with subfoveal CNV secondary to presumed ocular histoplasmosis. A total of 26 patients were treated with VISUDYNE in the study. The treatment dosing and retreatments for VISUDYNE were the same as the AMD studie… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No studies have been conducted to determine the carcinogenic potential of verteporfin. Mutagenesis Photodynamic therapy (PDT) as a class has been reported to result in DNA damage including DNA strand breaks, alkali-labile sites, DNA degradation, and DNA-protein cross-links which may result in chromosomal aberrations, sister chromatid exchanges (SCE), and mutations. In addition, other photodynamic therapeutic agents have been shown to increase the incidence of SCE in Chinese hamster ovary (CHO) cells irradiated with visible light and in Chinese hamster lung fibroblasts irradiated with near UV light, increase mutations and DNA-protein cross-linking in mouse L5178 cells, and increase DNA-strand breaks in malignant human cervical carcinoma cells, but not in normal cells.

Verteporfin was not evaluated in these latter systems. It is not known how the potential for DNA damage with PDT agents translates into human risk. Impairment of Fertility No effect on male or female fertility has been observed in rats following intravenous administration of verteporfin for injection up to 10 mg/kg/day (approximately 60- and 40-fold human exposure at 6 mg/m 2 based on AUC in male and female rats, respectively).

13.2Animal Toxicology and/or Pharmacology At a >10-fold higher dose given by bolus injection to sedated or anesthetized pigs, verteporfin caused severe hemodynamic effects, including death, probably as a result of complement activation. These effects were diminished or abolished by pretreatment with antihistamine and they were not seen in conscious nonsedated pigs.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 187 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No studies have been conducted to determine the carcinogenic potential of verteporfin. Mutagenesis Photodynamic therapy (PDT) as a class has been reported to result in DNA damage including DNA strand breaks, alkali-labile sites, DNA degradation, and DNA-protein cross-links which may result in chromosomal aberrations, sister chromatid exchanges (SCE), and mutations. In addition, other photodynamic therapeutic agents have been shown to increase the incidence of SCE in Chinese hamster ovary (CHO) cells irradiated with visible light and in Chinese hamster lung fibroblasts irradiated with near UV light, increase mutations and DNA-protein cross-linking in mouse L5178 cells, and increase DNA-strand breaks in malignant human cervical carcinoma cells, but not in normal cells.

Verteporfin was not evaluated in these latter systems. It is not known how the potential for DNA damage with PDT agents translates into human risk. Impairment of Fertility No effect on male or female fertility has been observed in rats following intravenous administration of verteporfin for injection up to 10 mg/kg/day (approximately 60- and 40-fold human exposure at 6 mg/m 2 based on AUC in male and female rats, respectively).

📄 Package Label / Principal Display Panel 34 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-560-15 Rx only Visudyne ® (verteporfin for injection) 15 mg/vial Must be reconstituted and further diluted. FOR INTRAVENOUS INFUSION 1 Single-Use Dose Vial Discard Unused Portion Sterile 9589603 carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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← 24208-0555-55 · Bausch 24208-0580-60 · Bausch →
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