Riboflavin 5-Phosphate Ophthalmic
FDA Drug Information • Also known as: Epioxa Cross-Linking, Photrexa Cross-Linking Kit
- Brand Names
- Epioxa Cross-Linking, Photrexa Cross-Linking Kit
- Route
- OPHTHALMIC
- Dosage Form
- KIT
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
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. PHOTREXA in a 3 mL glass syringe containing sterile 1.46 mg/mL riboflavin 5’-phosphate ophthalmic solution for topical administration. PHOTREXA VISCOUS (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146% is a yellow sterile buffered viscous solution containing 1.56 mg/mL riboflavin 5’-phosphate and 20% dextran . The pH of the solution is approximately 7.1 and the osmolality is 284-368 mOsm/kg. Each 1 mL of solution contains 1.64 mg of riboflavin 5’-phosphate sodium (equivalent to 1.284 mg riboflavin). Riboflavin 5’-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate dihydrate, dextran, monobasic sodium phosphate dihydrate, sodium chloride, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. PHOTREXA (riboflavin 5’-phosphate ophthalmic solution) 0.146% is a yellow sterile buffered solution containing 1.46 mg/mL riboflavin 5’-phosphate. The pH of the solution is approximately 7.1 and the osmolality is 157-181 mOsm/kg. Each 1 mL of solution contains 1.53 mg of riboflavin 5’-phosphate sodium (equivalent to 1.20 mg riboflavin). Riboflavin 5’-phosphate sodium is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate dihydrate, monobasic sodium phosphate dihydrate, sodium chloride, and water for injection. Sodium...
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
Dosage and Administration
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. If corneal thickness is less than 400 microns, instill 2 drops of PHOTREXA every 5 to 10 seconds until the corneal thickness increases to at least 400 microns. Irradiation should not be performed unless this 400 micron threshold is met and the yellow flare is seen. Irradiate the eye for 30 continuous minutes at 3mW/cm 2 at a wavelength of 365 nm, centered over the cornea, using the KXL System as per the instructions in the KXL manual. During irradiation, continue topical instillation of PHOTREXA VISCOUS onto the eye every 2 minutes for the 30 minute irradiation period. For topical ophthalmic use. Do not inject. Single use PHOTREXA VISCOUS and PHOTREXA only. Discard syringe(s) after use. PHOTREXA VISCOUS and PHOTREXA are for use with the KXL System only. PLEASE REFER TO THE KXL OPERATOR’S MANUAL FOR SPECIFIC DEVICE INSTRUCTIONS. Debride the epithelium using standard aseptic technique using topical anesthesia ( 2 ). Then instill 1 drop of PHOTREXA VISCOUS topically on the eye every 2 minutes for 30 minutes ( 2 ). After 30 minutes, examine the eye under slit lamp for presence of a yellow flare in the anterior chamber. If flare is not detected, instill 1 drop of PHOTREXA VISCOUS every 2 minutes for an additional 2 to 3 drops and recheck for yellow flare. Repeat as necessary ( 2 ). Once flare is observed, perform ultrasound pachymetry. If corneal thickness is less than 400 microns, instill 2 drops of PHOTREXA every 5 to 10 seconds until the corneal thickness increases to at least 400 microns ( 2 ). Irradiation should not be performed unless this 400 micron threshold is met and the yellow flare is seen ( 2 ). Irradiate the eye for 30 minutes at 3mW/cm 2 using the KXL System as per the instructions in the KXL manual. During irradiation, continue topical instillation of PHOTREXA VISCOUS onto the eye every 2 minutes for the 30 minute irradiation period ( 2 ). Refer to the KXL Operator’s manual for specific device instructions ( 2 ).
Side Effects (Adverse Reactions)
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 . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of the corneal collagen cross-linking procedure was evaluated in 3 randomized, parallel-group, open-label, sham-controlled trials; patients were followed up for 12 months. Study 1 enrolled patients with progressive keratoconus or corneal ectasia following refractive surgery. Study 2 enrolled only patients with progressive keratoconus, and Study 3 enrolled only patients with corneal ectasia following refractive surgery. In each study, only one eye of each patient was designated as the study eye. Study eyes were randomized to receive one of the two study treatments (CXL or sham) at the baseline visit and were followed up at Day 1, Week 1, and Months 1, 3, 6, and 12. At Month 3 or later, sham study eyes and non-study eyes had the option of receiving CXL treatment, and were followed-up for 12 months from the time of receiving CXL treatment. Each CXL treated eye received a single course of CXL treatment only. Safety data were obtained from: 193 randomized CXL study eyes (102 keratoconus, 91 corneal ectasia), 191 control eyes, and 319 nonrandomized CXL non-study eyes (191 keratoconus, 128 corneal ectasia). Overall, 512 eyes (293 keratoconus, 219 corneal ectasia) in 364 patients received CXL treatment. 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 ( Table 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. These events are expected sequelae following epithelial corneal debridement and occurred at a higher incidence than observed in control patients, who did not undergo debridement or exposure to UVA light ( Table 1 ). Adverse events reported in non-study, non-randomized CXL treated were similar in terms of preferred terms and frequency to those seen in randomized study eyes. The majority of adverse events reported resolved during the first month, while events such as corneal epithelium defect, corneal striae, punctate keratitis, photophobia, dry eye and eye pain, and decreased visual acuity took up to 6 months to resolve and corneal opacity or haze took up to 12 months to resolve. In 1-2% of patients, corneal epithelium defect, corneal edema, corneal opacity and corneal scar continued to be observed at 12 months. In 6% of corneal ectasia patients, corneal opacity continued to be observed at 12 months. Table 1: Most Common (≥1%) Ocular Adverse Reactions in CXL-Treated Study Eye in the Pooled Randomized Safety Population – N (%) 1) Results are presented as the number (%) of patients with an event from baseline to Month 3. 2) Almost all cases of corneal opacity were reported as...
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Pregnancy and Breastfeeding
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.
How Supplied
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). Each foil pouch contains a 3 mL glass syringe of PHOTREXA ® VISCOUS or PHOTREXA ® contained within a Tyvek ® pouch. Kits should be stored at 2°C to 8°C (36°F to 46°F). Care should be taken to minimize exposure of the syringe to light once removed from its protective packaging. Discard syringe after use. For topical ophthalmic use. PHOTREXA ® VISCOUS and PHOTREXA ® should be used with the KXL ® System only.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.