VISUDYNE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VISUDYNE (VISUDYNE).
Verteporfin, a benzoporphyrin derivative, is a photosensitizer activated by nonthermal red light (689 nm). Upon activation, in the presence of oxygen, it generates reactive oxygen species (e.g., singlet oxygen) causing local damage to endothelial cells, leading to occlusion of abnormal choroidal neovasculature.
| Metabolism | Metabolized via liver by non-specific esterases to active metabolite benzoporphyrin derivative diacid (BPD-DA); further metabolism minimal; eliminated primarily in feces via biliary excretion. |
| Excretion | Biliary/fecal: >90% unchanged; renal: <1% |
| Half-life | 5-6 hours (verteporfin); clinical context: supports once-daily dosing for photodynamic therapy |
| Protein binding | >90% bound to plasma lipoproteins (HDL and LDL) |
| Volume of Distribution | 0.5-1.5 L/kg; indicates extensive tissue distribution |
| Bioavailability | Intravenous: 100% (only route of administration) |
| Onset of Action | Intravenous: within 15 minutes of light activation |
| Duration of Action | Photosensitivity persists 24-48 hours after infusion; advise patients to avoid sunlight and bright indoor light during this period |
| Action Class | Vascular endothelial growth factor (VEGF) inhibitor for AMD |
6 mg/m2 body surface area administered as a 10-minute intravenous infusion, followed by laser light activation at 689 nm 15 minutes after start of infusion.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for renal impairment; no specific GFR-based guidelines established. |
| Liver impairment | Use with caution in moderate hepatic impairment (Child-Pugh class B); no specific dose modification established. Contraindicated in severe hepatic impairment (Child-Pugh class C). |
| Pediatric use | Safety and efficacy not established for pediatric patients; no weight-based dosing guidelines available. |
| Geriatric use | No specific dose adjustment required; clinical studies included patients aged 65-89 years with no observed differences in safety or efficacy. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VISUDYNE (VISUDYNE).
| Breastfeeding | No human data on excretion in breast milk. M/P ratio unknown. Discontinue breastfeeding or drug due to potential for infant exposure. |
| Teratogenic Risk | Visudyne (verteporfin) is contraindicated in pregnancy. Animal studies show fetal harm (ossification delays, malformations) at clinically relevant doses. No adequate human data; risk in all trimesters is high. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Porphyria (history of porphyria or known hypersensitivity to porphyrins)","Severe hepatic impairment","Hypersensitivity to verteporfin or any component of the formulation"]
| Precautions | ["Photosensitivity: Patients may become sensitive to sunlight or bright indoor light for 5 days after infusion; avoid exposure.","Extravasation: Can cause severe pain, inflammation, or necrosis at injection site; ensure proper IV administration.","Ocular safety: Treatment is only for eyes with subfoveal CNV; not for occult CNV without classic component.","Hepatic impairment: Use caution in moderate to severe hepatic impairment; may increase systemic exposure.","Anaphylaxis: Severe allergic reactions reported; monitor during infusion.","Vision loss: Transient or permanent decrease in visual acuity may occur."] |
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| Pregnancy test before treatment. Monitor liver function and photosensitivity reactions. Fetal ultrasound if exposure occurs. |
| Fertility Effects | No specific human fertility data. Animal studies show no impairment of fertility at clinically relevant doses. |