SAFLUTAN

What it is

SAFLUTAN is an ophthalmic solution (eye drops) containing 15 micrograms of tafluprost per mL. One single-dose container contains 4.5 micrograms of tafluprost. SAFLUTAN does not contain preservatives such as benzalkonium chloride. Tafluprost is a fluorinated analogue of prostaglandin F2α, and tafluprost acid, the biologically active metabolite of tafluprost, is a highly potent and selective agonist of the human prostanoid FP receptor.

Approved indications

— Reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension, as monotherapy or as adjunctive therapy to beta blockers.

Dosing overview

The recommended dose is one drop of SAFLUTAN in the conjunctival sac of the affected eye(s) once daily in the evening. The dose should not exceed once daily as more frequent administration may lessen the intraocular pressure lowering effect. For single use only, one container is sufficient to treat both eyes. If more than one topical ophthalmic product is being used, each one should be administered at least 5 minutes apart.

Key safety warnings

Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation. Some of these changes may be permanent, and may lead to differences in appearance between the eyes when only one eye is treated. The change in iris pigmentation occurs slowly and may not be noticeable for several months. The change in eye colour has predominantly been seen in patients with mixed coloured irises, such as blue-brown, grey-brown, yellow-brown and green-brown. Macular oedema, including cystoid macular oedema, has been reported during treatment with prostaglandin F2α analogues. These reports have mainly occurred in aphakic patients, pseudophakic patients with a torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for macular oedema. Therefore, caution is recommended when using tafluprost in these patients. Tafluprost has not been studied in patients with compromised lung function and should therefore be used with caution in these patients. Cases of dyspnoea and the worsening of asthma have been observed in post-marketing experience.

Contraindications

Hypersensitivity to tafluprost or to any of the excipients.

Regulatory history

SAFLUTAN was approved on 16 December 2011. The TGA initially rejected the submission for SAFLUTAN. However, the sponsor appealed this decision to the Administrative Appeals Tribunal (AAT), which subsequently set aside the TGA's decision and approved the registration of SAFLUTAN. SAFLUTAN tafluprost 15 micrograms per mL single dose eye drop ampoule was first listed on the ARTG on 14 February 2012.