Dosing and uses of Visudyne (verteporfin)
Adult dosage forms and strengths
lyophylized power for reconstitution
- 15mg/vial
Macular Degeneration with Classic Subfoveal Choroidal Neovascularization
6 mg/m² IV infusion, total volume 30 mL over 10 min
Follow with 50 J/cm² of 689 nm laser light on retina at intensity of 600 mW/cm² x 83 sec
Administration
After IV infusion, eyedrops are used to numb eye
Approximately 15 min after infusion & no later than 5 min after eyedrop application, a special ophthalmic lens is placed over eye
Next the cold laser light spot-sized to match treatment area is applied
Central Serous Chorioretinopathy (Orphan)
Designation for the potential treatment of chronic or recurrent central serous chorioretinopathy
Orphan sponsor
- QLT Inc.; Vancouver, British Columbia, Canada
Pediatric dosage forms and strengths
Safety and efficacy not established
Visudyne (verteporfin) adverse (side) effects
Frequency Not Determined
Visual disturbances
Injection site reactions including extravasation and rashes
Edema
Hemorrhage
Inflammation
Flashes of light
Severe vision loss (1-4%)
Photosensitivity
Headache
Conjunctivitis
Dry eyes
Ocular itching
SubconjunctivaL
Subretinal or vitreous hemorrhage
Back pain during infusion
Asthenia
Fever
Flu-like syndrome
Atrial fibrillation
Hypertension
Peripheral vascular disorder
Varicose veins
Eczema
Constipation
GI cancers
Nausea
Anemia
WBC incr/decr
Elev LFTs
Albuminuria
Leukocyte count increase/decrease
Increased liver function test results
Albuminuria
Increased serum creatinine
Arthralgia
Arthrosis
Myasthenia
Hypesthesia
Sleep disorder
Vertigo
Pharyngitis
Pneumonia
Hearing decrease
Lacrimation disorder
Prostatic disorder
Warnings
Contraindications
Hypersensitivity, porphyria
Cautions
Avoid bright light for 5 days after injection
Moderate/severe hepatic impairment
Chest pain, hypersensitivity, and vasovagal reactions reported (observe patient during infusion)
Use with caution in patients with biliary obstruction
Patients under anesthesia not studied
Use in both eyes concurrently not studied (if required, apply to the agressive lesion first followed by the second eye a week later; may apply concurrently to both eyes thereafter)
Use precaution to avoid extravasation (stop infusion immediately if it occurs)
Safety and efficacy of use >2 years not established
Patients who experience severe decrease of vision of 4 lines or more within 1 week, following treatment, should not be retreated, at least until vision completely recovers to pretreatment levels and potential benefits and risks of subsequent treatment are carefully considered by treating physician
Pregnancy and lactation
Pregnancy category: C
Lactation: Distributed in milk; not recommended
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Visudyne (verteporfin)
Mechanism of action
Produces oxygen free radicals in presence of light that damage neovascular endothelium, which in turn leads to temporary vessel occlusion
Pharmacokinetics
Half-Life: 5-6 hr
Metabolism: To a small extent by liver and plasma esterases to a diacid metabolite that exhibits pharmacologic activity similar to that of verteporfin
Excretion: Feces
Administration
IV Preparation
Reconstitute 15 mg drug with 7 mL SWI to obtain a 2 mg/mL opaque dark-green solution
Protect from light & use within 4 hr
Further dilute in D5W to match 6 mg/sq.meter dose and infusion volume of 30 mL
After dilution protect from light & use within 4 hr
IV Administration
Infuse the 30 mL solution at rate of 3 mL/min over 10 min
Large antecubital veins are preferred to avoid extravasation
Extravasation Management
Stop infusion immediately & apply cold compresses
Protect extravasation site from light
