Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland
Hypersensitivity to bromfenac or to any of the excipients listed in section 6.1, or to other non- steroidal anti-inflammatory medicinal products (NSAIDs).
Yellox is contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other medicinal products with prostaglandin synthetase inhibiting activity.
All topical NSAIDs may slow or delay healing like topical corticosteroids. Concomitant use of NSAIDs and topical steroids may increase the potential for healing problems.
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Therefore, treating individuals who have previously exhibited sensitivities to these medicinal products has to be avoided (see section 4.3).
In susceptible patients, continued use of topical NSAIDs, including bromfenac may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health. Consequently in at risk patients concomitant use of ophthalmic corticosteroids with NSAIDs may lead to a higher risk of corneal adverse events.
Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus and ocular surface diseases e.g. dry eye syndrome, rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight threatening. Topical NSAIDs should be used with caution in these patients.
There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaema) in conjunction with ocular surgery. Yellox should be used with caution in patients with known bleeding tendencies or who are receiving other medicinal products which may prolong bleeding time.
It has been observed in rare cases that upon withdrawal of Yellox, a flare-up of the inflammatory response, e.g. in the form of macular oedema, due to the cataract operation may occur.
An acute ocular infection may be masked by the topical use of anti-inflammatory medicinal products.
In general, contact lens wear is not recommended during the postoperative period following cataract surgery. Therefore, patients should be advised not to wear contact lenses during treatment with Yellox.
Since Yellox contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.
Benzalkonium chloride is known to discolour soft contact lenses. Contact with soft contact lenses must be avoided.
Benzalkonium chloride has been reported to cause eye irritation, punctuate keratopathy and/or toxic ulcerative keratopathy.
Yellox contains sodium sulphite which may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible patients.
No interaction studies have been performed. No interactions with antibiotic eye drops used in conjunction with surgery have been reported.
There are no adequate data from the use of bromfenac in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Since the systemic exposure in non-pregnant women is negligible after treatment with Yellox, the risk during pregnancy could be considered low.
However, because of the known effects of prostaglandin biosynthesis-inhibiting medicinal products on the foetal cardiovascular system (closure of ductus arteriosus), the use of Yellox during third trimester pregnancy should be avoided. The use of Yellox is in general not recommended during pregnancy unless the benefit outweighs the potential risk.
It is unknown whether bromfenac or its metabolites are excreted in human milk. Animal studies have shown excretion of bromfenac in the milk of rats following very high oral doses (see section 5.3). No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding woman to bromfenac is negligible. Yellox can be used during breast-feeding.
No effects of bromfenac on the fertility were observed in animal studies. In addition the systemic exposure to bromfenac is negligible; for this reason no pregnancy testing or contraceptive measures are required.
Yellox has minor influence on the ability to drive and use machines. Transient blurring of vision may occur on instillation. If blurred vision occurs at instillation patients should be advised to refrain from driving or using machines until vision is clear.
Based on clinical data available, a total of 3.4% of patients experienced one or more adverse reactions. The most common or most important reactions in the pooled studies were abnormal sensation in eye (0.5%), corneal erosion (mild or moderate) (0.4%), eye pruritus (0.4%), eye pain (0.3%) and eye redness (0.3%). Corneal adverse reactions were only observed in the Japanese population. Adverse reactions rarely led to withdrawal, with a total of 8 (0.8%) patients who prematurely discontinued treatment in a study due to an adverse reaction. These comprised 3 (0.3%) patients with mild corneal erosion, 2 (0.2%) patients with eyelid oedema and 1 (0.1%) patient each with abnormal sensation in eye, corneal oedema, or eye pruritus.
The following adverse reactions were classified according to the following convention: 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The table below describes adverse reactions by system organ class and frequency.
Uncommon: Visual acuity reduced, Haemorrhagic retinopathy, Corneal epithelium defect**, Corneal erosion (mild or moderate), Corneal epithelium disorder, Corneal oedema, Retinal exudates, Eye pain, Eyelid bleeding, Vision blurred, Photophobia, Eyelid oedema, Eye discharge, Eye pruritus, Eye irritation, Eye redness, Conjunctival hyperaemia, Abnormal sensation in eye, Ocular discomfort
Rare: Corneal perforation*, Corneal ulcer*, Corneal erosion, serious*, Scleromalacia*, Corneal infiltrates*, Corneal disorder*, Corneal scar*
Uncommon: Epistaxis, Cough, Nasal sinus drainage
Rare: Asthma*
Uncommon: Face swelling
* Serious reports from post-marketing experience of more than 20 million patients
** Observed with four times daily dose
Patients with evidence of corneal epithelial breakdown should be instructed to immediately discontinue use of Yellox and should be monitored closely for corneal health (see section 4.4).
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Not applicable.
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