Verteporfin For Injection (Visudyne)

Trade Name : Visudyne

Valeant Pharmaceuticals North America LLC

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 15 mg/1

VERTEPORFIN Photoabsorption [MoA],Photoenhancer [EPC],Photosensitizing Activity [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Verteporfin For Injection (Visudyne) which is also known as Visudyne and Manufactured by Valeant Pharmaceuticals North America LLC. It is available in strength of 15 mg/1 per ml. Read more

Verteporfin For Injection (Visudyne) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

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 therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis. ()

A course of VISUDYNE therapy is a two-step process requiring administration of both drug and light.
The first step is the intravenous infusion 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.

VISUDYNE is a reconstituted sterile solution intended for intravenous injection only. Each reconstituted vial provides 7.5 mL solution containing 2 mg/mL of verteporfin.

VISUDYNE is contraindicated for patients with porphyria or a known hypersensitivity to any component of this preparation [].
VISUDYNE is contraindicated for patients with porphyria or a known hypersensitivity to any component of this preparation. ()

No data

The following serious adverse reactions are described elsewhere in the labeling:
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 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 infection, 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
Most common adverse reactions (incidence u02c310%) are:
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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, u03b2-carotene, ethanol, formate and mannitol, would be expected to decrease VISUDYNE activity. Drugs that decrease clotting, vasoconstriction or platelet aggregation, e.g., thromboxane A2 inhibitors, could also decrease the efficacy of VISUDYNE therapy.

No data

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.

VISUDYNE is a light activated drug used in photodynamic therapy. 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-(u00b1)-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 C41H42N4O8 with a molecular weight of approximately 718.8. Each mL of reconstituted VISUDYNE contains:
ACTIVE: Verteporfin, 2 mg
INACTIVES: Ascorbyl palmitate, butylated hydroxytoluene, dimyristoyl phosphatidylcholine, egg phosphatidylglycerol and lactose

No data

No data

No data

VISUDYNE (verteporfin for injection) is supplied in a single-use glass vial with a gray bromobutyl stopper and aluminum flip-off cap. It contains a lyophilized dark green cake with 15 mg verteporfin.
NDC 0187-5600-15
Store VISUDYNE between 20u00b0-25u00b0C (68u00b0-77u00b0F).

Advise patients who receive VISUDYNE that they will become temporarily photosensitive after the infusion. Patients should be advised to wear a wrist band 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.
Manufactured for:
Manufactured by:
Visudyne is a registered trademark of Novartis AG used under license. All other product/brand names are trademarks of their respective owners.
u00a9Bausch & Lomb Incorporated
9589700
Rev. 02/2017

Rx only
NDC
Visudyneu00ae
(verteporfin for injection)n n
15 mg
1 Single-Use Vial

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Verteporfin For Injection (Visudyne)

Trade Name : Visudyne

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Verteporfin For Injection (Visudyne)

Trade Name : Visudyne

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

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QUICK LINKS

CONTACT US

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