"The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first medication in a new class of drugs, called lymphocyt"...
The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label:
- Iris pigmentation changes [see WARNINGS AND PRECAUTIONS]
- Eyelid skin darkening [see WARNINGS AND PRECAUTIONS]
- Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see WARNINGS AND PRECAUTIONS]
- Intraocular inflammation (iritis/uveitis) [see WARNINGS AND PRECAUTIONS]
- Macular edema, including cystoid macular edema [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
XALATAN was studied in three multicenter, randomized, controlled clinical trials. Patients received 50 mcg/mL XALATAN once daily or 5 mg/mL active-comparator (timolol) twice daily. The patient population studied had a mean age of 65±10 years. Seven percent of patients withdrew before the 6-month endpoint.
Table 1: Ocular Adverse Reactions and ocular signs/symptoms
reported by 5-15% of patients receiving Latanoprost
|Symptom/Finding||Adverse Reactions (incidence (%))|
|Latanoprost (n=460)||Timolol (n=369)|
|Foreign body sensation||13||8|
|Punctate epithelial keratopathy||10||9|
|Increased pigmentation of the iris||7||0|
Less than 1% of the patients treated with XALATAN required discontinuation of therapy because of intolerance to conjunctival hyperemia.
Table 2: Adverse Reactions
that were reported in 1-5% of patients receiving Latanoprost
|Adverse Reactions (incidence (%))|
|Ocular Events/Signs and Symptoms|
|Upper respiratory tract infection/cold/flu||3||3|
|Rash/allergic skin reaction||1||0.3|
The following reactions have been identified during postmarketing use of XALATAN in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to XALATAN, or a combination of these factors, include:
Nervous System disorders: dizziness, headache, and toxic epidermal necrolysis
Eye Disorders: eyelash and vellus hair changes (increased length, thickness, pigmentation, and number); keratitis; corneal edema and erosions; intraocular inflammation (iritis/uveitis); macular edema, including cystoid macular edema; misdirected eyelashes sometimes resulting in eye irritation; periorbital and lid changes resulting in deepening of the eyelid sulcus
Skin and Subcutaneous Tissue Disorders: eyelid skin darkening
Infections and Infestations: Herpes keratitis
Read the Xalatan (latanoprost ophthalmic) Side Effects Center for a complete guide to possible side effects
In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with XALATAN. If such drugs are used, they should be administered at least five (5) minutes apart.
The combined use of two or more prostaglandins, or prostaglandin analogs including XALATAN is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP.
Read the Xalatan Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 12/16/2014
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