Visudyne®
GoodRxVerteporfin · intravenous infusion
Injections & Implants
IndicationVISUDYNE ® (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.
Contraindications
- Porphyria
- Known hypersensitivity to any component of this preparation
Available Forms15 mg single-dose vial, 7.5 mL at 2 mg/mL after reconstitution
Mechanism of ActionVISUDYNE (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.
Dosage6 mg/m² body surface area. Reconstitute each vial with 7 mL of Sterile Water for Injection to provide 7.5 mL containing 2 mg/mL; protect from light and use within 4 hours. Dilute the desired dose with 5% Dextrose for Injection to a total infusion volume of 30 mL; protect from light and use within 4 hours. Do not use normal saline or other parenteral solutions, except 5% Dextrose for Injection, for dilution (it may precipitate in saline), and do not mix it with other drugs. Infuse intravenously over 10 minutes at 3 mL/minute, using an appropriate syringe pump and in-line filter. Starting 15 minutes after the infusion starts, deliver a light dose of 50 J/cm² of neovascular lesion at an intensity of 600 mW/cm² and a wavelength of 689±3 nm over 83 seconds. Re-evaluate 3 months after treatment; if choroidal neovascular leakage is detected on fluorescein angiography, therapy may be repeated.
Warnings & Precautions
- Extravasation: Standard precautions to avoid extravasation include a free-flowing, carefully monitored IV line and the largest arm vein possible, preferably antecubital; small veins in the back of the hand should be avoided. Extravasation, especially if the affected area is exposed to light, can cause severe pain, inflammation, swelling or discoloration at the injection site, and localized (skin) necrosis has also been reported.
- Local burn: If extravasation occurs, stop the infusion immediately and protect the area from direct light until swelling and discoloration have faded, to prevent a local burn, which could be severe. Apply cold compresses; oral medications for pain relief may be administered.
- Photosensitivity: Following injection, care should be taken to avoid exposure of skin or eyes to direct sunlight or bright indoor light for 5 days. If emergency surgery is necessary within 48 hours after treatment, as much of the internal tissue as possible should be protected from intense light.
- Decreased 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.
- Anaphylactic 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.
Common Side Effects
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).
Pregnancy & LactationPregnancy: 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.
Lactation: 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.
Pediatric UseSafety and effectiveness in pediatric patients have not been established.