Riboflavin 5-Phosphate (Ophthalmic)

Available as an ophthalmic solution, Riboflavin 5-Phosphate is used to treat progressive keratoconus, an eye disease which causes the cornea to thin and bulge.

Overview

Riboflavin 5-Phosphate is available as an ophthalmic solution to help enhance eyesight as part of a cross-linking treatment. It is used in the treatment of progressive keratoconus. This is where the cornea thins and becomes cone-shaped, causing distortion and vision problems.

It is not believed to be genotoxic. There is limited data on usage for under 14-year-olds, over 65-year-olds and pregnant and breastfeeding mothers.

Conditions treated

Type of medicine

  • Preventative solution/ophthalmic treatment

Side Effects

All suspected adverse reactions to Riboflavin 5-Phosphate, should be reported to Avedro using the telephone number 1-844-528-3376 or the FDA using the telephone number 1-800-FDA-1088 or through the FDA's website at www.fda.gov/medwatch.

The following side effects are common but must be reported to your doctor and require medical attention:

  • Photosensitivity - your eyes may be more sensitive to light during treatment. Patients may wish to wear sunglasses and avoid strong light during the course of their treatment.
  • Blindness - if patients experience a sudden loss of vision, they should contact their doctor immediately.
  • Changes in vision, including blurry vision, changes in colour-vision, corneal haze (up to 70% of patients), corneal opacity, corneal epithelium defect
  • Reduced night vision, or difficulty with seeing in low light environments
  • Eye irritation, including eye pain, redness, swelling, inflammation, keratitis, ocular hyperemia and the sensation of a foreign body in the eye

The following side effects are less common but must still be reported to your doctor and require medical attention:

  • Increased discharge from the eye
  • Changes in vision, including flashes, glare, orbs, halos, visual impairment
  • Seeing floating spots before the eyes, or a veil or curtain appearing across part of the vision
  • Changes to the eye, including eyelid edema, vitreous detachment, anterior chamber cell, diplopia, asthenopia

Some side effects do not require urgent medical attention, but if you decide to visit your doctor, they may be able to help you manage them better and reduce any discomfort you experience. These include:

  • Dry eyes
  • Headaches (1-10%)
  • Double vision
  • Redness, swelling, or itching of the eyelid
  • Increased tears, or watery eyes

Dosage

For children aged 14 or older:

This medication must only be given by an appropriately trained professional. The professional should first apply topical anesthesia to the eye that is to be treated. Then they should remove the epithelium until it is at about a 9mm diameter. This should be done using a sterile method to reduce the chance of bacterial infection occurring. After this step, the professional should then put one drop of Riboflavin 5-Phosphate into the eye that has been prepared. This should then be repeated every two minutes for thirty minutes. So in total, fifteen drops, two minutes apart should be added to the patient's eye.

After the thirty minutes and fifteen drops have been instilled into the eye, the professional should have a look at the eye under a slit lamp. The professional should look for a yellow flare in the eye, which shows that the treatment is completed. If no yellow flare is seen, then the professional should continue to put more eye drops in every two minutes, up to a maximum of three additional eye drops, and then the eye checked again for the yellow flare.

If it is still not seen, then the professional may repeat the step, adding up to three drops, until the flare is seen.

Once the flare is seen, the professional should then perform an ultrasound to assess the corneal thickness. It is important that the irradiation only be carried out once corneal thickness is at 400 microns or higher. If the corneal thickness is below this then the professional will need to continue adding more drops to the eye at a rate of two drops every five to ten minutes. After each lot of five to ten minutes, the thickness of the cornea should be reassessed and the process repeated until at least 400 microns of thickness is achieved. Once this is achieved and the yellow flare is visible, the professional can then begin irradiation.

Irradiation should be completed for at least 30 continuous, uninterrupted minutes. It should be completed at 3mW/cm2 and at a wavelength of 365nm. The irradiation must be centered over the cornea to work properly. The irradiation must also be carried out using the KXL System (the system that Riboflavin 5-Phosphate is prescribed for). During the irradiation period, it is very important that the professional continues to add Riboflavin 5-Phosphate drops to the patient's eyes at a rate of one drop every two minutes. This should continue until the thirty-minute irradiation treatment is completed.

It is very important that Riboflavin 5-Phosphate drops are only used topically. Riboflavin 5-Phosphate drops must never be injected. The drops are single use only and must be appropriately disposed of by the professional after treatment. This treatment must not be carried out on children under 14.

For adults:

This medication must only be given by an appropriately trained professional. The professional should first apply topical anesthesia to the eye that is to be treated. Then they should remove the epithelium until it is at about a 9mm diameter. This should be done using a sterile method to reduce the chance of bacterial infection occurring. After this step, the professional should then put one drop of Riboflavin 5-Phosphate into the eye that has been prepared. This should then be repeated every two minutes for thirty minutes. So in total, fifteen drops, two minutes apart should be added to the patient's eye.

After the thirty minutes and fifteen drops have been instilled into the eye, the professional should have a look at the eye under a slit lamp. The professional should look for a yellow flare in the eye, which shows that the treatment is completed. If no yellow flare is seen, then the professional should continue to put more eye drops in every two minutes, up to a maximum of three additional eye drops, and then the eye checked again for the yellow flare.

If it is still not seen, then the professional may repeat the step, adding up to three drops, until the flare is seen.

Once the flare is seen, the professional should then perform an ultrasound to assess the corneal thickness. It is important that the irradiation only be carried out once corneal thickness is at 400 microns or higher. If the corneal thickness is below this then the professional will need to continue adding more drops to the eye at a rate of two drops every five to ten minutes. After each lot of five to ten minutes, the thickness of the cornea should be reassessed and the process repeated until at least 400 microns of thickness is achieved. Once this is achieved and the yellow flare is visible, the professional can then begin irradiation.

Irradiation should be completed for at least 30 continuous, uninterrupted minutes. It should be completed at 3mW/cm2 and at a wavelength of 365nm. The irradiation must be centered over the cornea to work properly. The irradiation must also be carried out using the KXL System (the system that Riboflavin 5-Phosphate is prescribed for). During the irradiation period, it is very important that the professional continues to add Riboflavin 5-Phosphate drops to the patient's eyes at a rate of one drop every two minutes. This should continue until the thirty-minute irradiation treatment is completed.

It is very important that Riboflavin 5-Phosphate drops are only used topically. Riboflavin 5-Phosphate drops must never be injected. The drops are single use only and must be appropriately disposed of by the professional after treatment. Care should be taken that the adult has reported all other medical conditions, especially pre-existing eye conditions such as keratitis, as this treatment can worsen such conditions.

Interactions

  • This medicine is not known to interact with other medications.
  • Consult your physician if you are using more than one type of eye drop at any one time.

Warnings

  • This medicine should be used with caution in children 14 and under.
  • Talk to your consultant if you have other medical conditions as this medicine could make it worse.
  • Not to be used by patients with keratitis as this medicine can make it worse.
  • This medicine must only be taken under the supervision of a medical professional.
  • Patients must not rub their eyes after having eye treatment with this medication.
  • If a patient feels severe eye pain during treatment, they should contact their consultant immediately.
  • If a patient notices a sudden or severe change in their vision during treatment, they should contact their physician.
  • This drug should be used at an irradiation level of 3 mW/cm2 at a wavelength of 365 nm.
  • The KXL System manufacturer product information should be referred to for patient positioning.
  • There is no data on the efficacy of this medication on patients aged 65 or older.
  • This medicine can cause ulcerative keratitis and patients should be monitored carefully for this condition while undergoing treatment.
  • A bandage contact lens will be placed on the patient's eye following treatment. If this becomes dislodged or falls out, it is extremely important that patients do not attempt to put it back in themselves. Instead, they must immediately visit their physician, who will be able to advise them accordingly.

Storage

  • Riboflavin 5-Phosphate comes under the two brand names, Photrexa Viscous® and Photrexa®.
  • Both are provided to professionals in packs of ten. Each individual foil Tyvek® pouch has a 3ml glass syringe, which is suitable for a single treatment.
  • Although the product is provided in a syringe, it must never be injected into a patient. It is for topical application only.
  • The pack should be stored between 15 and 25 degrees Celcius (59 to 77 Degrees Fahrenheit).
  • It should be stored away from light and the individual foil pouches should not be removed from the box until they are ready to be used.
  • Once a syringe is used, it should be appropriately disposed of.

Summary

This medicine is used in the treatment of keratoconus. It aims to stop the condition from getting worse. In some patients this treatment can make a significant difference, halting disease progression and flattening corneas. Vision can be greatly improved. Usually, treatment is carried on a single eye at a time.

 

Resources
Last Reviewed:
January 31, 2018
Last Updated:
January 27, 2018
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