Travoprost

Travoprost has harmful pharmacological effects on pregnancy and/or the fetus/new-born child. Travoprost should not be used during pregnancy unless clearly necessary.

It is unknown whether travoprost from the eye drops is excreted in human breast milk. Animal studies have shown excretion of travoprost and metabolites in breast milk. The use of travoprost by breast-feeding mothers is not recommended.

Women of child-bearing potential/contraception

Travoprost must not be used in women of child bearing age/potential unless adequate contraceptive measures are in place.

Fertility

There are no data on the effects of travoprost on human fertility. Animal studies showed no effect of travoprost on fertility at doses more than 250 times the maximum recommended human ocular dose.

Travoprost has no or negligible influence on the ability to drive and use machines, however as with any eye drop, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.

Summary of the safety profile

In clinical trials with travoprost, the most common adverse reactions were ocular hypearemia and iris hyperpigmentation, occurring in approximately 20% and 6% of patients respectively.

List of adverse reactions

The following adverse reactions are 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), or not known (frequency cannot be estimated from the available data). Within each frequency group, adverse reactions are presented in decreasing order of seriousness. The adverse reactions were obtained from clinical studies and post-marketing data with travoprost.

Immune system disorders

Uncommon: hypersensitivity, seasonal allergy

Psychiatric disorders

Not known: depression, anxiety, insomnia

Nervous system disorder

Uncommon: headache

Rare: dizziness, visual field defect, dysgeusia

Eye disorders

Very common: ocular hyperaemia

Common: iris hyperpigmentation, eye pain, ocular discomfort, dry eye, eye pruritus, eye irritation

Uncommon: corneal erosion, uveitis, iritis, anterior chamber inflammation, keratitis, punctate keratitis, photophobia, eye discharge , blepharitis, erythema of eyelid, periorbital oedema, eyelids pruritus, visual acuity reduced, vision blurred, lacrimation increased, conjunctivitis, ectropion, cataract, eyelid margin crusting, growth of eyelashes

Rare: iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eczema eyelids, conjunctival oedema, halo vision, conjunctival follicles, hypoaesthesia eye, trichiasis, meibomianitis, anterior chamber pigmentation, mydriasis, asthenopia, eyelash hyperpigmentation, eyelash thickening

Not known: macular oedema, lid sulcus deepened

Ear and labyrinth disorders

Not known: vertigo, tinnitus

Cardiac disorders

Uncommon: palpitations

Rare: heart rate irregular, heart rate decreased

Not known: chest pain, bradycardia, tachycardia, arrhythmia

Vascular disorders

Rare: blood pressure diastolic decreased, blood pressure systolic increased, hypotension, hypertension

Respiratory, thoracic and mediastinal disorders

Uncommon: cough, nasal congestion, throat irritation

Rare: dyspnoea, asthma, respiratory disorder, oropharyngeal pain, dysphonia, rhinitis allergic, nasal dryness

Not known: asthma aggravated, epistaxis

Gastrointestinal disorders

Rare: peptic ulcer reactivated, gastrointestinal disorder, constipation, dry mouth

Not known: diarrhoea, abdominal pain, nausea, vomiting

Skin and subcutaneous tissue disorders

Uncommon: skin hyperpigmentation (periocular), skin discolouration, hair texture abnormal, hypertrichosis

Rare: dermatitis allergic, dermatitis contact, erythema, rash, hair colour changes, madarosis

Not known: pruritus, hair growth abnormal

Musculoskeletal and connective tissue disorders

Rare: musculoskeletal pain, arthralgia

Renal and urinary disorders

Not known: dysuria, urinary incontinence

General disorders and administration site conditions

Rare: asthenia

Investigations

Not known: prostatic specific antigen increased

Paediatric Population

In a 3 month phase 3 study and a 7 days pharmacokinetic study, involving 102 paediatric patients exposed to travoprost, the types and characteristics of adverse reactions reported were similar to what has been observed in adult patients. The short-term safety profiles in the different paediatric subsets were also similar. The most frequent adverse reactions reported in the paediatric population were ocular hyperaemia (16.9%) and growth of eyelashes (6.5%). In a similar 3 month study in adult patients, these events occurred at an incidence of 11.4% and 0.0%, respectively.

Additional adverse drug reactions reported in paediatric patients in the 3 month paediatric study (n=77) compared to a similar trial in adults (n=185) included erythema of eyelid, keratitis, lacrimation increased, and photophobia all reported as single events with an incidence of 1.3% versus 0.0% seen in adults.