Riboflavin 5-phosphate (ophthalmic)

FDA label, Glaukos Corporation, ophthalmic, effective 2025-11-18. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

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Preparation and administration

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Important Administration Instructions EPIOXA HD and EPIOXA are for topical ophthalmic use. NOT for injection or intraocular use. EPIOXA HD and EPIOXA are supplied in single-dose syringes. Discard opened syringes after use. EPIOXA HD and EPIOXA are for use with the O 2 n System and Boost Goggles only. Refer to the O 2 n System Operator's Manual and Boost Goggles User Guide for device instructions.

Recommended Dosage and Administration Instructions Apply topical anesthetic and insert a lid speculum. Using a cellulose spear sponge soaked with EPIOXA HD, remove the mucin layer from the corneal surface without debriding the corneal epithelium (epithelium-on) by swiping the sponge 4 to 10 times horizontally and vertically.

Apply two drops of EPIOXA HD topically on the eye every 60 seconds for 4 minutes (STEP 1), followed by two drops of EPIOXA topically on the eye every 30 seconds for 6 minutes (STEP 2). Gently rinse the corneal surface with approximately 5 mL of balanced salt solution (BSS). Perform ultrasound pachymetry. If corneal thickness is less than 325 microns, irradiation should not be performed.

Apply the Boost Goggles and turn on the oxygen flow as per the instructions in the Boost Goggles User Guide . Center the optical head of the O 2 n System over the cornea and irradiate the eye as per the instructions in the O 2 n System Operator's Manual . The O 2 n System automatically delivers irradiation to the eye for 11 minutes 6 seconds at 30 mW/cm 2 with an on/off cycle of 1 second UV-A on/1 second UV-A off at a wavelength of 365 nm.

Instill BSS on the cornea every 2 minutes, or more frequently as needed, to maintain corneal hydration during UV-A irradiation. When the UV-A irradiation has stopped, shut off the oxygen flow, and remove the Boost Goggles and lid speculum. Apply a bandage contact lens.

Contraindications

Hypersensitivity ( 4.1 ) Aphakic and pseudophakic patients without a UV-blocking intraocular lens ( 4.2 )

4.1 Hypersensitivity EPIOXA HD and EPIOXA are contraindicated in patients with known hypersensitivity to benzalkonium chloride or any ingredients in EPIOXA HD and EPIOXA.

4.2 Aphakic and Pseudophakic Patients Epithelium-on corneal collagen cross-linking is contraindicated in aphakic patients and pseudophakic patients without a UV-blocking intraocular lens.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary Animal development and reproduction studies have not been conducted with EPIOXA HD and EPIOXA with the O 2 n System and Boost Goggles. Since it is not known whether the epithelium-on corneal collagen cross-linking procedure can cause fetal harm or affect reproduction capacity, it should not be performed on pregnant women.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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