Version May 2024
Therapy is a two-step process; first the infusion of verteporfin, then the activation of verteporfin with a nonthermal diode laser (for light administration details, see Administration).
Subfoveal choroidal neovascularization: IV: 6 mg/m2 BSA; may repeat at 3-month intervals (if evidence of choroidal neovascular leakage).
Note: Treatment in more than one eye: Patients who have eligible lesions in both eyes should be evaluated and treatment should first be done to the more aggressive lesion. Following safe and acceptable treatment, the second eye can be treated one week later. Patients who have had previous verteporfin therapy, with an acceptable safety profile, may then have both eyes treated concurrently (~3 months after the initial treatment). Treat the more aggressive lesion followed immediately with the second eye. The light treatment to the second eye should begin no later than 20 minutes from the start of the infusion.
There are no dosage adjustments provided in manufacturer's labeling; however it is unlikely that patients with renal impairment will be affected since elimination is predominantly via the feces.
Mild impairment: There are no dosage adjustments provided in manufacturer's labeling; however, half-life is increased by 20% with mild hepatic impairment.
Moderate-to-severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing. Patients ≥75 years were less likely to benefit from therapy in clinical trials.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Local: Injection site reaction (including bleeding at injection site, inflammation at injection site, injection site necrosis, pain at injection site, rash at injection site, skin discoloration at injection site, swelling at injection site)
Ophthalmic: Visual disturbance (including blurred vision, decreased visual acuity, photopsia, scotoma, visual field defect)
1% to 10%:
Cardiovascular: Atrial fibrillation, hypertension, peripheral vascular disease, varicose veins
Dermatologic: Eczema, skin photosensitivity
Endocrine & metabolic: Albuminuria
Gastrointestinal: Constipation, nausea
Genitourinary: Prostatic disease
Hematologic & oncologic: Anemia, decreased white blood cell count, gastrointestinal carcinoma, leukocytosis
Hepatic: Increased liver enzymes
Nervous system: Hypoesthesia, myasthenia, sleep disturbance, vertigo
Neuromuscular & skeletal: Arthralgia, arthropathy, asthenia, back pain (primarily during infusion)
Ophthalmic: Abnormal lacrimation, blepharitis, cataract, conjunctival injection, conjunctivitis, diplopia, eye pruritus, severe vision loss (1% to 5%; at treatment site, with or without subretinal/retinal or vitreous hemorrhage; decrease in 4 lines or more within 7 days of treatment), xerophthalmia
Otic: Hearing loss
Renal: Increased serum creatinine
Respiratory: Cough, flu-like symptoms, pharyngitis, pneumonia
Miscellaneous: Fever
Frequency not defined:
Cardiovascular: Chest pain, vasodepressor syncope
Hypersensitivity: Anaphylaxis, hypersensitivity reaction
Neuromuscular & skeletal: Musculoskeletal pain (during infusion)
Ophthalmic: Retinal detachment (nonrhegmatogenous), retinal ischemia (retinal or choroidal vessel nonperfusion), retinal pigment epithelium tear
Hypersensitivity to verteporfin or any component of the formulation; porphyria
Canadian labeling: Additional contraindications (not in US labeling): Severe hepatic impairment
Concerns related to adverse effects:
• Extravasation: May cause severe pain, swelling, inflammation, or discoloration at the injection site, especially if the extravasated area is exposed to light; localized skin necrosis following extravasation has occurred. Standard precautions should be taken to avoid extravasation (eg, free-flowing IV line, use of largest arm vein [antecubital, if possible]; avoid using small veins on the back of the hand). If extravasation occurs, stop the infusion immediately and protect area from direct light until swelling and discoloration have faded; use cold compresses and oral pain medications, if necessary.
• Hypersensitivity: Anaphylaxis had been reported; immediately discontinue therapy and initiate appropriate therapy in patients experiencing anaphylactic or other severe allergic reaction.
• Ophthalmic effects: May cause visual disturbances such as abnormal vision, decreased vision, or visual field defects; these effects may interfere with the ability to drive or use machinery.
• Photosensitivity: Avoid exposing skin or eyes to direct sunlight or bright indoor light for 5 days following treatment (ambient indoor light is acceptable and encouraged); in case of emergency surgery within 48 hours of treatment, protect as much of the internal tissue as possible from intense light. Prolonged exposure to light from light-emitting medical devices (eg, pulse oximeter) should be avoided for 5 days after administration.
Special populations:
• Older adult: Patients ≥75 years are less likely to benefit from therapy.
Other warnings/precautions:
• Appropriate use: Do not re-treat patients who experience a decrease of vision ≥4 lines within 1 week of treatment unless vision recovers and the potential benefits and risks are carefully considered. Patients with dark irides, occult lesions, or <50% classic choroidal neovascularization are less likely to benefit from therapy.
• Concurrent administration in both eyes: Use in more than one eye has not been studied; however, it is recommended that in patients requiring treatment in both eyes, initial treatment should be applied to the more aggressive lesion first, and after safe and effective treatment to the initial eye, the second eye may be treated 1 week later. After ~3 months and an acceptable safety profile with initial treatment, both eyes may be treated concurrently. Treat the more aggressive lesion first, followed immediately with the second eye. The light treatment to the second eye should begin no later than 20 minutes from the start of the infusion.
• Long-term use: Safety and efficacy have not been established of use for longer than 2 years.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Visudyne: 15 mg (1 ea) [contains egg phosphatidylglycerol, lactose]
No
Solution (reconstituted) (Visudyne Intravenous)
15 mg (per each): $2,051.65
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Visudyne: 15 mg (15 mL) [contains egg phosphatidylglycerol, lactose]
IV: Infuse at 3 mL/minute (over 10 minutes) using a syringe pump and an in-line filter (a standard 1.2 micron filter was used in studies). A free-flowing IV line should be established prior to starting infusion. Use of the largest arm vein, especially in elderly patients, is suggested; avoid small veins in the back of the hand.
Avoid contact with skin and eyes during preparation and administration; if contact occurs, protect contact area from bright light. Any spill should be wiped with a damp cloth (the use of rubber gloves is recommended); dispose of all materials properly.
May be an irritant with vesicant-like properties; avoid extravasation.
Extravasation management: Stop infusion immediately. Thoroughly protect the area of extravasation from direct light until swelling and discoloration have faded. Apply cold compresses to the injection site.
Light administration: Following intravenous infusion, verteporfin must be light activated using a nonthermal diode laser. The system must provide a stable power output at a wavelength of 689 ± 3 nm. Approved laser systems are listed in manufacturer's package insert. Light delivery should begin 15 minutes following the start of the 10-minute infusion. The light dose is 50 J/cm2 of neovascular lesion administered over 83 seconds at an intensity of 600 mW/cm2. Detailed instructions for determining lesion size, treatment spot size, and light administration may be found in the manufacturer's labeling.
Subfoveal choroidal neovascularization: Treatment of predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis.
Limitations of use: There is insufficient evidence to indicate verteporfin for the treatment of predominantly occult subfoveal choroidal neovascularization.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Photosensitizing Agents: May enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Ethanol may decrease efficacy of verteporfin. Management: Avoid ethanol during therapy.
Adverse events have been observed in some animal reproduction studies.
Verteporfin and its metabolite are excreted in breast milk. Milk concentrations were up to 66% of plasma levels in 1 woman following infusion; the metabolite was still detected 48 hours later. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends that nursing be discontinued or treatment be postponed, taking into account the importance of treatment to the mother.
Fluorescein angiography every 3 months to monitor choroidal neovascular leakage (if detected, repeat therapy). Monitor infusion site during infusion to avoid extravasation.
Following intravenous administration, verteporfin is transported by lipoproteins to the neovascular endothelium in the affected eye(s), including choroidal neovasculature and the retina. Verteporfin then needs to be activated by nonthermal red light, which results in local damage to the endothelium, leading to temporary choroidal vessel occlusion.
Metabolism: Hepatic and by plasma esterases to diacid metabolite
Half-life elimination: Terminal: 5 to 6 hours, biexponential
Excretion: Feces (predominantly); urine (<0.01%)
Hepatic function impairment: Half-life increased by ~20% in patients with mild hepatic impairment.
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