GANFORT

What it is

GANFORT contains bimatoprost 0.3 mg/mL and timolol (as maleate) 5.0 mg/mL. It is supplied as eye drops, solution.

Approved indications

— Reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy.

Dosing overview

The recommended dose is one drop of GANFORT in the affected eye(s) once daily, administered in the morning. To minimise systemic absorption, apply pressure to the tear duct for at least 2 minutes immediately following administration. If more than one topical ophthalmic medicinal product is to be used, each one should be instilled at least 5 minutes apart. The dose should not exceed one drop in the affected eye(s) daily.

Key safety warnings

Although rare, cardiac reactions including death due to cardiac failure have been reported. Caution should be exercised in treating patients with cardiovascular disease (such as coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension. Patients with a history of cardiac diseases should be watched for deterioration of these diseases and have their pulse rates checked. Cardiac failure should be adequately controlled before beginning GANFORT therapy. Respiratory reactions have been reported, including death, due to bronchospasm. Patients with chronic obstructive pulmonary diseases of mild or moderate severity should in general not receive products containing beta-blockers, including GANFORT; however, if GANFORT is deemed necessary in such patients, it should be administered with caution and only if the potential benefit outweighs the potential risk. Cystoid macular oedema has been reported with GANFORT, and it has been uncommonly reported following treatment with bimatoprost. Therefore, GANFORT should be used with caution in patients with known risk factors for macular oedema (such as intraocular surgery, retinal vein occlusions, ocular inflammatory disease and diabetic retinopathy) or in aphakic patients and pseudophakic patients with a torn posterior lens capsule. Before treatment is initiated, patients should be informed of the possibility of prostaglandin analogue periorbitopathy and increased iris pigmentation since these have been observed during treatment with bimatoprost and GANFORT. Some of these changes may be permanent and may lead to impaired field of vision and differences in appearance between the eyes if only one eye is treated. There is the potential for hair growth to occur in areas where GANFORT solution comes repeatedly in contact with the skin surface. Thus, it is important to apply GANFORT solution as instructed and to avoid it running onto the cheek or other skin areas.

Contraindications

GANFORT is contraindicated in patients with hypersensitivity to any component of this medication, in patients with bronchospasm, bronchial asthma or patients with a history of bronchial asthma or severe chronic obstructive pulmonary disease, in patients with sinus bradycardia, sick sinus syndrome, sino-atrial nodal block, second or third degree atrioventricular block not controlled with a pacemaker, overt cardiac failure or cardiogenic shock.

Regulatory history

GANFORT 0.3/5 eye drops (bottle formulation) was first listed on the ARTG on 15 May 2009. GANFORT PF 0.3/5 eye drops (preservative-free single-dose formulation) was first listed on the ARTG on 13 November 2013.