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Riboflavin 5'-phosphate (ophthalmic): Drug information

Riboflavin 5'-phosphate (ophthalmic): Drug information
(For additional information see "Riboflavin 5'-phosphate (ophthalmic): Patient drug information" and see "Riboflavin 5'-phosphate (ophthalmic): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Photrexa-Photrexa Viscous Kit
Pharmacologic Category
  • Corneal Collagen Cross-Linking Agent, Ophthalmic;
  • Ophthalmic Agent
Dosing: Adult
Corneal ectasia following refractive surgery; Keratoconus, progressive

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.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling

Dosing: Pediatric

(For additional information see "Riboflavin 5'-phosphate (ophthalmic): Pediatric drug information")

Corneal ectasia following refractive surgery; Keratoconus, progressive

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.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Adverse Reactions

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%)

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Ulcerative keratitis: May occur; monitor for resolution of epithelial defects.

Dosage Forms: US

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]

Generic Equivalent Available: US

No

Pricing: US

Solution Prefilled Syringe (Photrexa-Photrexa Viscous Kit Ophthalmic)

0.146 &0.146-20% (per mL): $830.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

For topical ophthalmic use; do not inject. For use with the KXL System only.

Administration: Pediatric

For topical ophthalmic use; do not inject. For use with the KXL System only.

Use: Labeled Indications

Corneal ectasia following refractive surgery: Treatment of corneal ectasia following refractive surgery with the KXL System in corneal collagen cross-linking.

Keratoconus, progressive: Treatment of progressive keratoconus with the KXL System in corneal collagen cross-linking.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

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).

Breastfeeding Considerations

It is not known if riboflavin 5'-phosphate is excreted in breast milk. According to the manufacturer, the decision to breastfeed during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother.

Monitoring Parameters

Resolution of epithelial defects

Mechanism of Action

Photo enhancer that generates singlet oxygen in corneal collagen cross-linking.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (IN) India: Ribocross;
  • (PR) Puerto Rico: Photrexa
  1. Bilgihan K, Hondur A, Sul S, Ozturk S. Pregnancy-induced progression of keratoconus. Cornea. 2011;30(9):991-994. [PubMed 21705880]
  2. Photrexa and Photrexa Viscous (riboflavin 5'-phosphate) [prescribing information]. Waltham, MA: Avedro; January 2019.
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