tafluprost + timolol maleate: clinical use

Prescribing considerations

• Confirm inadequate response to relevant topical monotherapy and the need for a preservative-free fixed combination.
• Review cardiovascular, respiratory, vascular, endocrine and corneal history because topical timolol is systemically absorbed.
• Use caution in renal or hepatic impairment because the combination has not been studied in these groups.
• Safety and efficacy have not been established in people younger than 18 years.
• Warn about potentially permanent iris pigmentation and possible eyelid pigmentation, eyelash changes and periocular hair growth.
• Assess aphakia, disrupted posterior lens capsule, anterior-chamber lenses, and risks for cystoid macular oedema or uveitis.
• Inform the anaesthetist before surgery because ophthalmic timolol may block systemic beta-agonist effects.

Contraindications and cautions

• Hypersensitivity to tafluprost, timolol, beta blockers or an excipient
• Current or previous bronchial asthma, reactive airway disease or severe chronic obstructive pulmonary disease
• Sinus bradycardia or sick sinus syndrome, including sinoatrial block
• Unpaced second- or third-degree atrioventricular block
• Overt cardiac failure or cardiogenic shock

Monitoring

• Intraocular pressure and disease progression
• Pulse, blood pressure and symptoms of cardiac deterioration where clinically relevant
• New wheeze, breathlessness or reduced respiratory function
• Ocular surface disease, inflammation and corneal integrity
• Changes in iris, eyelid skin, eyelashes and periocular tissue
• Visual deterioration suggestive of macular oedema or uveitis
• Glucose awareness in people at risk of hypoglycaemia

Clinical pharmacology

Tafluprost is a prodrug hydrolysed to tafluprost acid, a selective prostanoid FP-receptor agonist that increases uveoscleral aqueous outflow. Timolol is a non-selective beta-adrenergic antagonist that predominantly reduces aqueous humour formation. Nasolacrimal occlusion reduces systemic exposure.

Formulation and product differences

• The selected UK product is a clear, preservative-free sterile solution in single-dose containers.
• An opened container is for immediate use and any remaining solution must be discarded.
• The formulation contains phosphate buffer; very rare corneal calcification can occur in patients with severely damaged corneas.
• After opening a foil pouch, containers remain protected from light in the pouch and are subject to the product's specified storage and discard instructions.

Eye drops

Route: Ophthalmic

Strengths: 15 micrograms/mL + 5 mg/mL