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warnings and cautions
5 WARNINGS AND PRECAUTIONS AVACLYR is indicated for topical ophthalmic use. ( 5.1 ) Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with AVACLYR. ( 5.2 ) 5.1 Topical Ophthalmic Use AVACLYR is indicated for topical ophthalmic use. 5.2 Avoidance of Contact Lenses Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with AVACLYR. 5.3 Risk of Contamination This product is sterile when packaged. Patients should be advised to not allow the tip of the container to touch any surface, as this may contaminate the ointment. If pain develops, or if redness, itching, or inflammation becomes aggravated, the patient should be advised to consult a physician.
6 ADVERSE REACTIONS The most common adverse reactions (2-10%) reported in patients were eye pain (stinging), punctate keratitis and follicular conjunctivitis. Rare reports of blepharitis and very rare reports of immediate hypersensitivity reactions including angioedema and urticaria have been observed post-marketing in patients taking AVACLYR. The most common adverse reactions (2 to 10%) reported in patients were eye pain (stinging), punctate keratitis and follicular conjunctivitis. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fera Pharmaceuticals, LLC at (414) 434-6604 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .