Product Dossier

LUMIGAN

Product Dossier for LUMIGAN (bimatoprost 300 microgram/mL, AbbVie). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

LUMIGAN is an eye drop solution containing bimatoprost . Each millilitre contains 300 micrograms of bimatoprost . LUMIGAN is a clear, isotonic, colourless, sterile ophthalmic solution practically free from visible particles . Bimatoprost is a synthetic prostamide analogue with potent ocular hypotensive activity . LUMIGAN reduces intraocular pressure by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow .

Approved indications

— Reduction of elevated intraocular pressure or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers .

Dosing overview

The recommended dose is one drop of LUMIGAN in the affected eye or eyes once daily, administered in the evening, whether used as monotherapy or adjunctive therapy . More frequent administration has not been shown to provide increased efficacy . If more than one topical ophthalmic medication is to be used, the other medication should not be used within 5 minutes of using LUMIGAN .

Key safety warnings

LUMIGAN should be used with caution in patients predisposed to low heart rate or low blood pressure . LUMIGAN has not been studied in patients with compromised respiratory function and should be used with caution in such patients, although in clinical studies no significant untoward respiratory effects have been seen in those with a history of compromised respiratory function . Before treatment is initiated, patients should be informed of the possibility of prostaglandin analogue periorbitopathy and increased iris pigmentation, as some of these changes may be permanent and may lead to impaired field of vision and differences in appearance between the eyes when only one eye is treated . There is potential for hair growth to occur in areas where LUMIGAN solution comes repeatedly in contact with the skin surface, so it is important to apply LUMIGAN as instructed and avoid it running onto the cheek or other skin areas . LUMIGAN should be used with caution in patients with active intraocular inflammations such as uveitis because the inflammation may be exacerbated . LUMIGAN should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular oedema including intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy .

Contraindications

LUMIGAN is contraindicated in patients with hypersensitivity to bimatoprost or to any component of the medication .

PBS listing

LUMIGAN eye drops 300 micrograms per mL in single dose units of 0.4 mL (pack of 30) is listed on the PBS with unrestricted and restricted items, with an ex-manufacturer price of A$15.41 .

Regulatory history

LUMIGAN was first approved on 17 January 2020 . The PBAC recommended LUMIGAN in July 2020 as a new treatment for reduction of elevated intraocular pressure or open angle glaucoma .