Unoprostone isopropyl has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as unoprostone isopropyl is administered, but has been reported to be reversible upon discontinuation of unoprostone isopropyl ophthalmic solution in most patients.
RESCULA should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.
Macular edema, including cystoid macular edema, has been reported. RESCULA should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip. Keep bottle tightly closed when not in use. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.
RESCULA contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.
In clinical studies, ocular adverse events above 5% with use of RESCULA were burning/stinging (22.4%), burning/stinging upon drug instillation (18.6%), itching (13.2%), injection (11.6%), dry eyes (10.7%), foreign body sensation (9.0%), abnormal vision (8.2%), lacrimation disorder (6.2%) and eyelid disorder (5.8%). Approximately 10-14% of patients were observed to have an increase in the length of eyelashes (≥ 1mm) at 12 months, while 7% of patients were observed to have a decrease in the length of eyelashes. Corneal lesions were reported in 2.3% of patients.
The most frequently reported nonocular adverse event associated with the use of RESCULA in the clinical trials was flu-like syndrome, observed in approximately 6% of patients.
Use in specific populations
Pregnancy Category C - There are no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, RESCULA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.