LUMIGAN 0.3 mg/mL eye drops, solution, in single-dose container
4.1 Therapeutic indications
Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers).
4.2 Posology and method of administration
Posology
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.
For single use only, one container is sufficient to treat both eyes. Any unused solution should be discarded immediately after use.
Paediatric population:
The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not yet been established.
Patients with 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 alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, bimatoprost 0.3 mg/mL eye drops (multi-dose formulation), solution had no adverse effect on liver function over 24 months.
Method of administration
If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Ocular
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. Increased iris pigmentation is likely to be permanent. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. The long term effects of increased iris pigmentation are not known. Iris colour changes seen with ophthalmic administration of bimatoprost may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts become more brownish. Neither naevi nor freckles of the iris appear to be affected by the treatment. At 3 months, the incidence of iris hyperpigmentation with bimatoprost 0.3 mg/mL single dose was 0.3%. At 12 months, the incidence of iris pigmentation with bimatoprost 0.3 mg/mL (multi-dose formulation) was 1.5% (see section 4.8) and did not increase following 3 years treatment. Periorbital tissue pigmentation has been reported to be reversible in some patients.
Cystoid macular oedema has been uncommonly reported (=1/1,000 to <1/100) following treatment with bimatoprost 0.3 mg/mL eye drops (multi-dose formulation). Therefore, LUMIGAN should 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).
There have been rare spontaneous reports of reactivation of previous corneal infiltrates or ocular infections with bimatoprost 0.3 mg/mL eye drops, solution (multi-dose formulation). LUMIGAN should be used with caution in patients with a prior history of significant ocular viral infections (e.g. herpes simplex) or uveitis/iritis.
LUMIGAN has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
Skin
There is a potential for hair growth to occur in areas where LUMIGAN solution comes repeatedly in contact with the skin surface. Thus, it is important to apply LUMIGAN as instructed and avoid it running onto the cheek or other skin areas.
Respiratory
LUMIGAN has not been studied in patients with compromised respiratory function. While there is limited information available on patients with a history of asthma or COPD, there have been reports of exacerbation of asthma, dyspnoea and COPD, as well as reports of asthma, in post marketing experience. The frequency of these symptoms is not known. Patients with COPD, asthma or compromised respiratory function due to other conditions should be treated with caution.
Cardiovascular
LUMIGAN has not been studied in patients with heart block more severe than first degree or uncontrolled congestive heart failure. There have been a limited number of spontaneous reports of bradycardia or hypotension with bimatoprost 0.3 mg/mL eye drops, solution (multi-dose formulation). LUMIGAN should be used with caution in patients predisposed to low heart rate or low blood pressure.
Other Information
In studies of bimatoprost 0.3 mg/ml in patients with glaucoma or ocular hypertension, it has been shown that the more frequent exposure of the eye to more than one dose of bimatoprost daily may decrease the IOP-lowering effect. Patients using LUMIGAN with other prostaglandin analogues should be monitored for changes to their intraocular pressure.
LUMIGAN 0.3 mg/mL single-dose has not been studied in patients wearing contact lenses.
Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.
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