Tafluprost

Caution is recommended when using tafluprost in aphakic patients, pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema or iritis/uveitis.

There is no experience in patients with severe asthma. Such patients should therefore be treated with caution.

There are no adequate data from the use of tafluprost in pregnant women. Tafluprost can have harmful pharmacologic effects on pregnancy and/or the fetus/newborn child. Studies in animals have shown reproductive toxicity. Therefore, tafluprost should not be used during pregnancy unless clearly necessary (in case no other treatment options are available).

It is unknown whether tafluprost and/or its metabolites are excreted in human milk. A study in rats has shown excretion of tafluprost and/or its metabolites in breast milk after topical administration. Therefore tafluprost should not be used during breastfeeding.

Women of childbearing potential/contraception

Tafluprost must not be used in women of childbearing age/potential unless adequate contraceptive measures are in place.

Fertility

In female and male rats, mating performance and fertility was unaffected by intravenous tafluprost doses up to 100 μg/kg/day.

Tafluprost has minor influence on the ability to drive and use machines. If transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.

In clinical studies, over 1,400 patients have been treated with preserved tafluprost either as monotherapy or as adjunctive therapy to timolol 0.5%. The most frequently reported treatment-related adverse event was ocular hyperaemia. It occurred in approximately 13% of the patients participating in the clinical studies with preserved tafluprost in Europe and the US. It was mild in most cases and led to discontinuation on an average in 0.4% of patients participating in the pivotal studies. In a 3-month, phase III study in the US comparing the non-preserved formulation of tafluprost with the non-preserved timolol formulation, ocular hyperemia occurred in 4.1% (13/320) of patients treated with tafluprost.

The following undesirable effects related to treatment were reported during clinical trials with tafluprost in Europe and the US after a maximum follow-up of 24 months:

Within each frequency grouping, adverse reactions are presented in order of decreasing frequency.

Nervous system disorders

Common (≥1/100 to <1/10): headache

Eye disorders

Common (≥1/100 to <1/10): eye pruritus, eye irritation, eye pain, conjunctival/ocular hyperaemia, changes in eyelashes (increased length, thickness and number of lashes), dry eye, foreign body sensation in eyes, eyelash discolouration, erythema of eyelid, superficial punctate keratitis (SPK), photophobia, increased lacrimation, blurred vision, reduced visual acuity and increased iris pigmentation.

Uncommon (≥1/1,000 to <1/100): blepharal pigmentation, eyelid oedema, asthenopia, conjunctival oedema, eye discharge, blepharitis, anterior chamber cells, ocular discomfort, anterior chamber flare, conjunctival pigmentation, conjunctival follicles, allergic conjunctivitis and abnormal sensation in eye.

Not known (cannot be estimated from the available data): iritis/uveitis, lid sulcus deepened, macular oedema/cystoid macular oedema.

Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Respiratory, thoracic, and mediastinal disorders

Not known (cannot be estimated from the available data): exacerbation of asthma, dyspnea

Skin and subcutaneous tissue disorders

Uncommon (≥1/1,000 to <1/100): hypertrichosis of eyelid