Product Dossier

TRAVATAN

Product Dossier for TRAVATAN (travoprost, Novartis Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

Travatan 0.004% eye drops solution contains 40 μg/mL travoprost. Travatan eye drops is a clear, colourless, sterile and preserved solution. Travoprost is an ester prodrug of a prostaglandin F2α analogue that is hydrolysed to the free acid, which acts as a selective, full agonist of the prostaglandin FP receptor, and reduces the intraocular pressure by increasing the outflow of aqueous humour via trabecular meshwork and uveoscleral pathways.

Approved indications

Travatan eye drops are indicated to decrease elevated intraocular pressure in: — ocular hypertension — open angle glaucoma Travatan eye drops may be used as first line monotherapy or as adjunctive therapy.

Dosing overview

Instil one drop of Travatan eye drops in the conjunctival sac of the affected eye(s) each day, with optimal effect obtained if the dose is administered in the evening. If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.

Key safety warnings

Travatan eye drops may gradually change the eye colour by increasing the number of melanosomes in melanocytes, and patients must be informed of the possibility of these changes. Unilateral treatment can result in permanent heterochromia. The change in iris colour occurs slowly and may not be noticeable for months to years and it may be permanent. Periorbital and/or eyelid skin darkening has been reported in association with the use of Travatan eye drops, and deepening of the eyelid sulcus has been observed with prostaglandin analogues. Travatan eye drops may gradually change eyelashes in the treated eye(s), with changes including increased length, thickness, pigmentation, and/or number of lashes. Macular oedema has been reported during treatment with prostaglandin F2α analogues, and travoprost should be used with caution in aphakic patients, pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for macular oedema. Travatan eye drops should be used with caution in patients with active intraocular inflammation, as well as patients with predisposing risk factors for uveitis.

Contraindications

Travatan eye drops are contraindicated in patients with a known hypersensitivity to travoprost or any of the excipients in the product. Travatan eye drops are also contraindicated in pregnant women or women attempting to become pregnant.

PBS listing

Travatan eye drops 40 micrograms per mL, 2.5 mL is listed on the PBS as an unrestricted item with an ex-manufacturer price of A$18.35.

Regulatory history

Travatan 0.004% travoprost 40 microgram/mL eye drop solution was first listed on the ARTG on 27 July 2011.