Riboflavin 5-phosphate Ophthalmic
Generic Name: riboflavin 5-phosphate ophthalmic
Brand Names:
Photrexa Cross-linking Kit
11 DESCRIPTION PHOTREXA VISCOUS (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146% and PHOTREXA (riboflavin 5’-phosphate ophthalmic solution) 0.146% are intended for topical ophthalmic administration as part of corneal collagen cross-linking with the KXL System. PHOTREXA VISCOUS and PHOTREXA are supplied as: PHOTREXA VISCOUS in a 3 mL glass syringe containing sterile 1.56 mg/mL riboflavin 5’-phosphate in 20% dextran ophthalmic solution for topical administration.
Overview
11 DESCRIPTION PHOTREXA VISCOUS (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146% and PHOTREXA (riboflavin 5’-phosphate ophthalmic solution) 0.146% are intended for topical ophthalmic administration as part of corneal collagen cross-linking with the KXL System. PHOTREXA VISCOUS and PHOTREXA are supplied as: PHOTREXA VISCOUS in a 3 mL glass syringe containing sterile 1.56 mg/mL riboflavin 5’-phosphate in 20% dextran ophthalmic solution for topical administration.
Uses
1 INDICATIONS AND USAGE PHOTREXA ® VISCOUS and PHOTREXA ® are indicated for use in corneal collagen cross-linking in combination with the KXL ® System for the treatment of PHOTREXA VISCOUS and PHOTREXA are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus ( 1.1 ) and corneal ectasia following refractive surgery ( 1.2 ). 1.1 Progressive Keratoconus 1.2 Corneal Ectasia Following Refractive Surgery
Dosage
2 DOSAGE AND ADMINISTRATION Using topical anesthesia, debride the epithelium to a diameter of approximately 9 mm using standard aseptic technique. Post epithelial debridement, instill 1 drop of PHOTREXA VISCOUS topically on the eye every 2 minutes for 30 minutes. At the end of the 30 minute soaking period, examine the eye under the slit lamp for the presence of a yellow flare in the anterior chamber. If the yellow flare is not detected, instill 1 drop of PHOTREXA VISCOUS every 2 minutes for an additional 2 to 3 drops and recheck for the presence of a yellow flare. This process can be repeated as necessary. Once the yellow flare is observed, perform ultrasound pachymetry.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Ulcerative keratitis [ Warnings and Precautions (5) ] In progressive keratoconus patients, the most common ocular adverse reactions in any CXL-treated eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision ( 6.1 ). In corneal ectasia patients, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity, and blurred vision ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Avedro at 1-844-528-3376 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings
5 WARNINGS AND PRECAUTIONS Ulcerative keratitis can occur. Monitor for resolution of epithelial defects. [See Adverse Reactions (6) ] . Ulcerative keratitis can occur. Monitor for resolution of epithelial defects ( 5 ) 4 CONTRAINDICATIONS None. None ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Animal development and reproduction studies have not been conducted with the PHOTREXA ® VISCOUS/PHOTREXA ® /KXL ® System. Since it is not known whether the corneal collagen cross-linking procedure can cause fetal harm or affect reproduction capacity, it should not be performed on pregnant women.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING PHOTREXA ® VISCOUS and PHOTREXA ® are available in the following packaging configuration: Single-use foil pouches of PHOTREXA ® VISCOUS and PHOTREXA ® are provided in a kit of two (2): one (1) PHOTREXA ® VISCOUS and one (1) PHOTREXA ® (NDC 25357-025-03).
Frequently Asked Questions
What is Riboflavin 5-phosphate Ophthalmic used for?▼
1 INDICATIONS AND USAGE PHOTREXA ® VISCOUS and PHOTREXA ® are indicated for use in corneal collagen cross-linking in combination with the KXL ® System for the treatment of PHOTREXA VISCOUS and PHOTREXA are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus ( 1.1 ) and corneal ectasia following refractive surgery ( 1.2 ). 1.1 Progressive Keratoconus 1.2 Corneal Ectasia Following Refractive Surgery
What are the side effects of Riboflavin 5-phosphate Ophthalmic?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Ulcerative keratitis [ Warnings and Precautions (5) ] In progressive keratoconus patients, the most common ocular adverse reactions in any CXL-treated eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision ( 6.1 ). In corneal ectasia patients, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity, and blurred vision ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Avedro at 1-844-528-3376 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Riboflavin 5-phosphate Ophthalmic during pregnancy?▼
8.1 Pregnancy Risk Summary Animal development and reproduction studies have not been conducted with the PHOTREXA ® VISCOUS/PHOTREXA ® /KXL ® System. Since it is not known whether the corneal collagen cross-linking procedure can cause fetal harm or affect reproduction capacity, it should not be performed on pregnant women.
What are the important warnings for Riboflavin 5-phosphate Ophthalmic?▼
5 WARNINGS AND PRECAUTIONS Ulcerative keratitis can occur. Monitor for resolution of epithelial defects. [See Adverse Reactions (6) ] . Ulcerative keratitis can occur. Monitor for resolution of epithelial defects ( 5 ) 4 CONTRAINDICATIONS None. None ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.