Product Dossier

XOROX

Product Dossier for XOROX (aciclovir, Agepha Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

Xorox is an eye ointment containing 30 mg of aciclovir per gram. It is a white to whitish grey, homogeneous sterile eye ointment. Aciclovir is a purine nucleoside analogue that shows in vitro high activity against herpes simplex virus type 1 and 2, as well as against the Varicella-Zoster virus.

Approved indications

— Treatment of Herpes simplex keratitis.

Dosing overview

For adults, 1 cm ribbon of ointment should be placed inside the lower conjunctival sac five times a day at approximately 4 hourly intervals. Treatment should be continued for 14 days or at least 3 days after healing is completed, whichever is shorter. The paediatric population and elderly people (65 years and over) use the same dose as adults, with no adjustment in dosage required.

Key safety warnings

There is insufficient clinical data on the use of Xorox eye ointment for deep corneal defects and the combined use of Xorox eye ointment with topical corticosteroids. In case of bacterial co-infection, an additional antibiotic therapy must be carried out. Patients should be informed that transient mild stinging immediately following application may occur. Patients should avoid wearing contact lenses when using Xorox eye ointment. Xorox eye ointment can affect visual ability and therefore caution is advised when driving or using machines. Very common adverse effects include superficial punctate keratopathy. Uncommon adverse effects include transient mild stinging or burning occurring immediately following application and conjunctivitis; rare effects include blepharitis. Very rare immune system adverse effects include immediate hypersensitivity reactions, including angioedema and urticaria.

Contraindications

Xorox is contraindicated in patients with hypersensitivity to aciclovir or to any of the excipients, or hypersensitivity to valaciclovir.

PBS listing

Xorox 30 mg per gram eye ointment in a 4.5 gram tube is listed on the PBS with 2 items, restriction type restricted, and an ex-manufacturer price of A$14.08.

Regulatory history

Xorox received its first approval on 15 September 2020. The product was first listed on the ARTG on 2020-09-21 under licence category RE.