Corneal ectasia following refractive surgery; Keratoconus, progressive: Adolescents ≥14 years: Ophthalmic: Instill 1 drop of viscous solution every 2 minutes for 30 minutes following debridement of the epithelium to a diameter of ~9 mm. After 30 minutes, examine the eye under the slit lamp for the presence of a yellow flare in the anterior chamber. If flare is not detected, instill 1 drop of viscous solution every 2 minutes for an additional 2 to 3 drops and recheck for flare. Repeat as necessary. Once the flare is observed, perform ultrasound pachymetry. If corneal thickness is <400 microns, instill 2 drops of nonviscous solution every 5 to 10 seconds until the corneal thickness increases to ≥400 microns. Once the 400 micron threshold is met, irradiate the eye for 30 continuous minutes using the KXL System. During irradiation, instill riboflavin 5’-phosphate viscous solution onto the eye every 2 minutes for the 30-minute irradiation period.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
(For additional information see "Riboflavin 5'-phosphate (ophthalmic): Drug information")
Corneal ectasia following refractive surgery; Keratoconus, progressive: Ophthalmic: Instill 1 drop every 2 minutes for 30 minutes following debridement of the epithelium to a diameter of ~9 mm. After 30 minutes, examine the eye under the slit lamp for the presence of a yellow flare in the anterior chamber. If flare is not detected, instill 1 drop every 2 minutes for an additional 2 to 3 drops and recheck for flare. Repeat as necessary. Once the flare is observed, perform ultrasound pachymetry. If corneal thickness is <400 microns, instill 2 drops every 5 to 10 seconds until the corneal thickness increases to ≥400 microns. Once the 400 micron threshold is met, irradiate the eye for 30 continuous minutes using the KXL System. During irradiation, instill riboflavin 5’-phosphate onto the eye every 2 minutes for the 30 minute irradiation period.
There are no dosage adjustments provided in the manufacturer’s labeling
There are no dosage adjustments provided in the manufacturer’s labeling
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Ophthalmic: Blurred vision (16% to 17%), corneal disease (striae: 9% to 24%), corneal opacity (64% to 71%), decreased visual acuity (10% to 11%), dry eye syndrome (6% to 14%), epithelial keratopathy (24% to 28%), eye pain (17% to 26%), foreign body sensation of eye (14% to 15%), ocular hyperemia (8% to 14%), photophobia (11% to 19%), punctate keratitis (20% to 25%)
1% to 10%:
Nervous system: Headache (4% to 8%)
Ophthalmic: Anterior chamber inflammation (2% to 6%), asthenopia (2%), conjunctival edema (7%), corneal edema (3%), diplopia (1% to 2%), eye discharge (2%), eye discomfort (9%), eye pruritus (2%), eyelid disease (Meibomian gland dysfunction: 3%), eyelid edema (5% to 6%), increased lacrimation (5% to 10%), keratitis (1% to 3%), visual halos around lights (1% to 2%), visual impairment (2% to 4%; including glare), vitreous detachment (2%)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Ulcerative keratitis: May occur; monitor for resolution of epithelial defects.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Ophthalmic:
Photrexa-Photrexa Viscous Kit: Photrexa 0.146%; Photrexa Viscous 0.146% in Dextran 20% (6 mL) [contains dextran]
No
Solution Prefilled Syringe (Photrexa-Photrexa Viscous Kit Ophthalmic)
0.146 &0.146-20% (per mL): $830.00
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For topical ophthalmic use; do not inject. For use with the KXL System only.
For topical ophthalmic use; do not inject. For use with the KXL System only.
Store at 2°C to 8°C (36°F to 46°F); protect from light once removed from packaging.
Treatment of corneal ectasia following refractive surgery in combination with the KXL System in corneal collagen cross-linking; treatment of progressive keratoconus in combination with the KXL System in corneal collagen cross-linking (FDA approved in ages ≥14 years and adults)
None known.
There are no known significant interactions.
Animal reproduction studies have not been conducted with riboflavin 5'-phosphate. The manufacturer recommends that the corneal collagen cross-linking procedure not be done during pregnancy. Pregnancy may be a risk factor for the progression of keratoconus (Bilgihan 2011).
Resolution of epithelial defects
Photo enhancer that generates singlet oxygen in corneal collagen cross-linking.
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