Other antiglaucoma preparations

Benzalkonium Chloride

One ml of solution contains 0.3 mg bimatoprost. Excipient: benzalkonium chloride 0.05 mg/ml.

Eye drops, solution. Colourless to slightly yellow solution.

Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).

The recommended dose is one drop in the affected eye(s) once daily, administered in the evening. The dose should not exceed once daily as more frequent administration may lessen the intraocular pressure lowering effect.

If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.

Use in children and adolescents (under the age of 18):

LUMIGAN has only been studied in adults and therefore its use is not recommended in children or adolescents.

Use in hepatic and renal impairment:

LUMIGAN has not been studied in patients with renal or moderate to severe hepatic impairment and should therefore be used with caution in such patients. In patients with a history of mild liver disease or abnormal ALT, AST and/or bilirubin at baseline, LUMIGAN had no adverse effect on liver function over 24 months.

Use in children and adolescents (under the age of 18): LUMIGAN has only been studied in adults and therefore its use is not recommended in children or adolescents.

Hypersensitivity to the active substance or to any of the excipients.

Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation since these have been observed during treatment with LUMIGAN. 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. At 12 months, the incidence was 1.5% and did not increase following 3 years treatment.

LUMIGAN contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.

Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since LUMIGAN contains benzalkonium chloride, monitoring is required with frequent or prolonged use in dry eye patients or where the cornea is compromised.

LUMIGAN has not been studied in patients with compromised respiratory function and should therefore be used with caution in such patients. In clinical studies, in those patients with a history of a compromised respiratory function, no significant untoward respiratory effects have been seen.

LUMIGAN has not been studied in patients with heart block more severe than first degree or uncontrolled congestive heart failure.

LUMIGAN has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.

Cystoid macular oedema has been uncommonly reported (1/1000 to <1/100) following treatment with LUMIGAN and should therefore be used with caution in patients with known risk factors for macular oedema (e.g. aphakic patients, pseudophakic patients with a torn posterior lens capsule).

No interaction studies have been performed.

No interactions are anticipated in humans, since systemic concentrations of bimatoprost are extremely low (less than 0.2 ng/ml) following ocular dosing. Bimatoprost is biotransformed by any of multiple enzymes and pathways, and no effects on hepatic drug metabolising enzymes were observed in preclinical studies.

In clinical studies, LUMIGAN was used concomitantly with a number of different ophthalmic beta-blocking agents without evidence of interactions.

Concomitant use of LUMIGAN and antiglaucomatous agents other than topical beta-blockers has not been evaluated during adjunctive glaucoma therapy.

In clinical studies, over 1800 patients have been treated with LUMIGAN. On combining the data from phase III monotherapy and adjunctive LUMIGAN usage, the most frequently reported treatment-related adverse events were: growth of eyelashes in up to 45% in the first year with the incidence of new reports decreasing to 7% at 2 years and 2% at 3 years, conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in up to 44% in the first year with the incidence of new reports decreasing to 13% at 2 years and 12% at 3 years and ocular pruritus in up to 14% of patients in the first year with the incidence of new reports decreasing to 3% at 2 years and 0% at 3 years. Less than 9% of patients discontinued due to any adverse event in the first year with the incidence of additional patient discontinuations being 3% at both 2 and 3 years.

The following undesirable effects definitely, probably or possibly related to treatment were reported during clinical trials with LUMIGAN. Most were ocular, mild to moderate, and none was serious:

With each frequency grouping, undesirable effects are presented in order of decreasing seriousness

Infections and infestations

Uncommon (1/1000 to <1/100): infection (primarily colds and upper respiratory tract infections)

Nervous system disorders

Common (1/100 to <1/10): headache

Uncommon (1/1000 to <1/100): dizziness

Eye disorders

Very common (1/10): conjunctival hyperaemia, growth of eyelashes, ocular pruritus

Common (1/100 to <1/10): allergic conjunctivitis, asthenopia, blepharitis, cataract, conjunctival oedema, corneal erosion, eye discharge, eyelash darkening, eye pain, foreign body sensation, increased iris pigmentation, ocular burning, ocular dryness, ocular irritation, photophobia, superficial punctate keratitis, tearing, visual disturbance and worsening of visual acuity

Uncommon (1/1000 to <1/100): blepharospasm, cystoid macular oedema, eyelid retraction, iritis, retinal haemorrhage, uveitis.

Vascular disorders

Common (1/100 to <1/10): hypertension

Skin and subcutaneous tissue disorders

Common (1/100 to <1/10): eyelid erythema, eyelid pruritus, pigmentation of periocular skin

Uncommon (1/1000 to <1/100): eyelid oedema, hirsutism.

General disorders and administration site conditions

Uncommon (1/1000 to <1/100): asthenia, peripheral oedema

Investigations

Common (1/100 to < 1/10): liver function test abnormal

Allergan

(POM)

12 August 2009