HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the informationneeded to use AVACLYR (acyclovir ophthalmicointment) 3% safely and effectively. See full
prescribing information for AVACLYR.AVACLYRTM (acyclovir ophthalmic ointment) 3%
For topical ophthalmic use
Initial U.S. Approval: 1982
INDICATIONS AND USAGE
AVACLYR (acyclovir ophthalmic ointment) 3%, a herpessimplex virus nucleoside analog DNA polymerase inhibitor,is indicated in the treatment of acute herpetic keratitis
(dendritic ulcers) in patients with herpes simplex (HSV-1and HSV-2) virus.
DOSAGE AND ADMINISTRATION
Apply a 1 cm ribbon in the lower cul-de-sac of the affectedeye 5 times per day until healed then 3 times per day for 7days.
DOSAGE FORMS AND STRENGTHS
AVACLYR is a topical sterile ointment containing 3%acyclovir.
CONTRAINDICATIONS
AVACLYR is contraindicated in patients with a knownhypersensitivity to acyclovir or valacyclovir.
ADVERSE REACTIONS
The most common adverse reactions (2-10%) reported inpatients were eye pain (stinging), punctate keratitis andfollicular conjunctivitis.
To report SUSPECTED ADVERSE REACTIONS, contactFera Pharmaceuticals, LLC at (414) 434-6604, or FDA at1-800-FDA-1088, or www.FDA.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION
Revised: 12/2018
--------------------------------------------------------------
FULL PRESCRIBING INFORMATION:CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment
of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full
prescribing information are not listed

--------------------------------------------------------------
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
AVACLYR is a sterile topical antiviral indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpessimplex (HSV-1 and HSV-2) virus.
2 DOSAGE AND ADMINISTRATION
The recommended dosing regimen is to apply a 1 cm ribbon of ointment in the lower cul-de-sac of the affected eye 5 times perday (approximately every 3 hours while awake) until the corneal ulcer heals and then a 1 cm ribbon 3 times per day for 7 days.
3 DOSAGE FORMS AND STRENGTHS
AVACLYR is a topical sterile ointment containing 3% acyclovir.
4 CONTRAINDICATIONS
AVACLYR is contraindicated for patients who develop sensitivity to acyclovir or valacyclovir.
6 ADVERSE REACTIONS
The most common adverse reactions (2-10%) reported in patients were eye pain (stinging), punctuate keratitis and follicularconjunctivitis. Rare reports of blepharitis and very rare reports of immediate hypersensitivity reactions including angioedema andurticaria have been observed post-marketing in patients taking AVACLYR.
7 DRUG INTERACTIONS
No clinically significant interactions have been identified resulting from topical administration of other drugs concomitantly with
AVACLYR.
8 USE IN SPECIFIC POPULATIONS