INDICATIONS AND USAGE
XELPROS™ (latanoprost ophthalmic emulsion) 0.005% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
IMPORTANT SAFETY INFORMATION
XELPROS is contraindicated in patients with a known hypersensitivity to latanoprost, or any other ingredients in this product.
WARNINGS AND PRECAUTIONS
Pigmentation: XELPROS may cause changes to pigmented tissues. The most frequently reported changes are increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as XELPROS is administered. After discontinuation of XELPROS, iris pigmentation is likely to be permanent. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known.
Eyelash Changes: XELPROS may gradually change eyelashes and vellus hair in the treated eye, including increased length, thickness, pigmentation, and number of lashes. The changes are usually reversible upon discontinuation of treatment.
Intraocular Inflammation: XELPROS should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.
Macular Edema: XELPROS 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.
Herpetic Keratitis: XELPROS should be used with caution in patients with a history of herpetic keratitis. XELPROS should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated.
Bacterial Keratitis: There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.
Use with Contact Lenses: Contact lenses should be removed prior to administration of XELPROS and may be reinserted 15 minutes following administration.
The most common ocular adverse reactions in clinical trials (incidence ≥5%) for XELPROS were eye pain/stinging, ocular hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes, and eyelash thickening.
Precipitation may occur if drugs containing thimerosal are used concomitantly with XELPROS. If such drugs are used, they should be administered at least 5 minutes apart.Please see the Full Prescribing Information.