Lumigan · 4.6 Fertility, pregnancy and lactation · 1

HOS-093252 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile In a 12-month Phase III clinical study approximately 38 % of patients treated with LUMIGAN 0.1 mg/ml eye drops, solution experienced adverse reactions. The most frequently reported adverse reaction was conjunctival hyperaemia (mostly trace to mild and of a non-inflammatory nature) occurring in 29 % of patients. Approximately 4 % of patients discontinued due to any adverse event in the 12-month study. Tabulated list of adverse reactions The following adverse reactions were reported during clinical trials with LUMIGAN 0.1 mg/ml eye drops, solution or in the post-marketing period. Most were ocular, mild and none was serious: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); not known (cannot be estimated from available data) adverse reactions are presented according to System Organ Class in Table 1. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1. List of adverse reactions System Organ class Frequency Adverse reaction Nervous system disorders Uncommon Headache Not known Dizziness Eye disorders Very common Conjunctival hyperaemia, prostaglandin analogue periorbitopathy Common Punctate keratitis, eye irritation, eye pruritus, growth of eyelashes,eye pain, erythema of eyelid, eyelid pruritus Uncommon Asthenopia, blurred vision, conjunctival disorder, conjunctival oedema, iris hyperpigmentation, madarosis, eyelid oedema Not known Blepharal pigmentation, macular oedema, dry eye, eye discharge, eye

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HOS-093264 · has-adverse-reaction-information · PDF-Seite 22

Summary of safety profile In a 3 month clinical study, approximately 29% of patients treated with LUMIGAN 0.3 mg/mL single- dose experienced adverse reactions. The most frequently reported adverse reactions were conjuctival hyperaemia (mostly trace to mild and of a non-inflammatory nature) occurring in 24% of patients, and eye pruritis occurring in 4% of patients. Approximately 0.7% of patients in the LUMIGAN 0.3 mg/mL single-dose group discontinued due to any adverse event in the 3 month study. 22 Tabulated list of adverse reactions The following adverse reactions were reported during clinical trials with LUMIGAN 0.3 mg/ml single-dose or in the post-marketing period. Most were ocular, mild and none was serious: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000) and not known (cannot be estimated from available data) adverse reactions are presented according to System Organ Class in Table 1. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1 List of adverse reactions System Organ class Frequency Adverse reaction Nervous system disorders Uncommon Headache not known Dizziness Eye disorders Very common Conjunctival hyperaemia, prostaglandin analogue periorbitopathy Common Punctate keratitis, eye irritation, foreign body sensation, dry eye, eye pain, eye pruritus, growth of eyelashes, eyelid erythema Uncommon Asthenopia, conjunctival oedema, photophobia, lacrimation increased, iris hyperpigmentation, blurred

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HOS-093258 · has-adverse-reaction-information · PDF-Seite 14

Summary of the safety profile In clinical studies, over 1 800 patients have been treated with LUMIGAN 0.3 mg/ml eye drops, solution. On combining the data from phase III monotherapy and adjunctive LUMIGAN 0.3 mg/ml eye drops, solution 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. Tabulated list of adverse reactions The following adverse reactions were reported during clinical trials with LUMIGAN 0.3 mg/ml eye drops, solution or in the post-marketing period. Most were ocular, mild to moderate, and none was serious: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000) and not known (cannot be estimated from available data) adverse reactions are presented according to System Organ Class in Table 1. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1. List of adverse reactions System Organ class Frequency Adverse reaction Nervous system disorders Common Headache Uncommon Dizziness Eye disorders Very common Conjunctival hyperaemia, ocular pruritus, growth of eyelashes, prostaglandin analogue periorbitopathy Common Superficial punctate keratitis, corneal erosion, ocular burning, ocular i

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HOS-093254 · has-contraindication-information · PDF-Seite 11

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 11 LUMIGAN 0.3 mg/ml is contraindicated in patients who have had a suspected previous adverse reaction to benzalkonium chloride that has led to discontinuation.

HOS-093260 · has-contraindication-information · PDF-Seite 20

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 20

HOS-093248 · has-contraindication-information · PDF-Seite 2

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 2 LUMIGAN 0.1 mg/ml is contraindicated in patients who have had a suspected previous adverse reaction to benzalkonium chloride that has led to discontinuation.

HOS-093253 · has-indication-information · PDF-Seite 11

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

HOS-093259 · has-indication-information · PDF-Seite 20

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

HOS-093247 · has-indication-information · PDF-Seite 2

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

HOS-093262 · has-interaction-information · PDF-Seite 22

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 with bimatoprost 0.3 mg/ml eye drops, solution (multi-dose formulation). 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 0.3 mg/mL (multi-dose formulation) 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. There is a potential for the IOP-lowering effect of prostaglandin analogues (e.g. LUMIGAN) to be reduced in patients with glaucoma or ocular hypertension when used with other prostaglandin analogues (see section 4.4).

HOS-093250 · has-interaction-information · PDF-Seite 4

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 with bimatoprost 0.3 mg/ml eye drops, solution. 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, bimatoprost 0.3 mg/ml eye drops, solution 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. There is a potential for the IOP-lowering effect of prostaglandin analogues (e.g. LUMIGAN) to be reduced in patients with glaucoma or ocular hypertension when used with other prostaglandin analogues (see section 4.4).

HOS-093256 · has-interaction-information · PDF-Seite 13

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 with bimatoprost 0.3 mg/ml eye drops, solution. 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. There is a potential for the IOP-lowering effect of prostaglandin analogues (e.g. LUMIGAN) to be reduced in patients with glaucoma or ocular hypertension when used with other prostaglandin analogues (see section 4.4).

HOS-093251 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are no adequate data from the use of bimatoprost in pregnant women. Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3). LUMIGAN should not be used during pregnancy unless clearly necessary. Breast-feeding It is unknown whether bimatoprost is excreted in human breast milk. Animal studies have shown excretion of bimatoprost in breast milk. A decision must be made whether to discontinue breast-feeding or to discontinue from LUMIGAN therapy taking into account the benefit of breast- feeding for the child and the benefit of therapy for the woman. Fertility There are no data on the effects of bimatoprost on human fertility. 4

HOS-093257 · has-pregnancy-information · PDF-Seite 13

Pregnancy There are no adequate data from the use of bimatoprost in pregnant women. Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3). LUMIGAN should not be used during pregnancy unless clearly necessary. Breast-feeding It is unknown whether bimatoprost is excreted in human breast milk. Animal studies have shown excretion of bimatoprost in breast milk. A decision must be made whether to discontinue breast- feeding or to discontinue from LUMIGAN therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility There are no data on the effects of bimatoprost on human fertility. 13

HOS-093263 · has-pregnancy-information · PDF-Seite 22

Pregnancy There are no adequate data from the use of bimatoprost in pregnant women. Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3). LUMIGAN should not be used during pregnancy unless clearly necessary. Breast-feeding It is unknown whether bimatoprost is excreted in human breast milk. Animal studies have shown excretion of bimatoprost in breast milk. A decision must be made whether to discontinue breast- feeding or to discontinue from LUMIGAN therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility There are no data on the effects of bimatoprost on human fertility.

HOS-093249 · has-warning-information · PDF-Seite 3

Ocular Before treatment is initiated, patients should be informed of the possibility of prostaglandin analogue periorbitopathy (PAP) and increased iris pigmentation, since these have been observed during treatment with LUMIGAN. 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 (see section 4.8). Cystoid macular oedema has been uncommonly reported (≥1/1 000 to <1/100) following treatment with bimatoprost 0.3 mg/ml eye drops, solution. 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. 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. 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 t

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HOS-093261 · has-warning-information · PDF-Seite 21

Ocular Before treatment is initiated, patients should be informed of the possibility of prostaglandin analogue periorbitopathy (PAP) and increased iris pigmentation, since these have been observed during treatment with LUMIGAN. 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 (see section 4.8). 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 ha

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HOS-093255 · has-warning-information · PDF-Seite 12

Ocular Before treatment is initiated, patients should be informed of the possibility of prostaglandin analogue periorbitopathy (PAP) and increased iris pigmentation, since these have been observed during treatment with LUMIGAN. 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 (see section 4.8). Cystoid macular oedema has been uncommonly reported (≥1/1 000 to <1/100) following treatment with bimatoprost 0.3 mg/ml eye drops. 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. 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. 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 do

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