Xerese
(acyclovir / hydrocortisone)Dosage & Administration
Topically apply XERESE 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms (i.e., during the prodrome or when lesions appear). (2)
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Xerese Prescribing Information
XERESE, a combination of acyclovir, a herpes simplex virus deoxynucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and children (6 years of age and older).
Topically apply XERESE 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms (i.e., during the prodrome or when lesions appear).
For each dose, topically apply a quantity of XERESE sufficient to cover the affected area, including the outer margin. Avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. For children 6 years of age and older, the dosage is the same as in adults.
Each gram of XERESE contains 50 mg (equivalent to 5%, w/w) acyclovir and 10 mg (equivalent to 1%, w/w) hydrocortisone in an aqueous cream base.
Pregnancy
Risk Summary
There are no available data on XERESE use in pregnant women. However, published observational studies over decades of use of topical acyclovir and low and medium potency topical corticosteroids during pregnancy have not established any association between use of these products and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).
Animal reproduction studies have not been conducted with XERESE. Systemic exposure of acyclovir and hydrocortisone following topical administration of XERESE is expected to be minimal. Animal reproduction studies with systemic exposure of acyclovir and hydrocortisone have been conducted. Refer to acyclovir and hydrocortisone prescribing information for additional details.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data
Human Data
While available studies cannot definitively establish the absence of risk, published data from multiple large observational studies have not established an association with the use of topical acyclovir or low and medium potency topical corticosteroids (including hydrocortisone) during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Available studies have methodological limitations including whether women who filled a prescription actually took the medication, non-randomized design, retrospective data collection, and the inability to control for confounders such as underlying maternal disease and use of concomitant medications.
Lactation
- Risk Summary
- There are no data on the presence of acyclovir or hydrocortisone in human milk following topical administration. There are no data on the effects of acyclovir or hydrocortisone on the breastfed infant or on milk production. Systemic exposure following topical administration of either drug is expected to be minimal. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for XERESE and any potential adverse effects on the breastfed child from XERESE or from the underlying maternal condition.
Pediatric Use
Safety and effectiveness in pediatric subjects less than 6 years of age have not been established.
Geriatric Use
In clinical studies, there were insufficient subjects above 65 years of age to reach a firm conclusion regarding safety and efficacy of XERESE in this group, although the available results were similar to lower age subjects.
Immunocompromised Subjects
Even though the safety of XERESE has been studied in immunocompromised subjects, data are insufficient to support use in this population. Immunocompromised subjects should be encouraged to consult a physician concerning the treatment of any infection.
Benefit has not been adequately assessed in immunocompromised patients. A randomized, double-blind trial was conducted in 107 immunocompromised subjects with stable HIV infection and recurrent herpes labialis. Subjects had on average 3.7 episodes of herpes labialis in the previous 12 months. The median age was 30 years (range 19 to 64 years), 46% were female, and all Caucasian. Median CD4+ T-cell count at screening was 344/mm3 (range 100-500/mm3). Subjects were treated with XERESE or 5% acyclovir in XERESE vehicle. The primary objective was to exclude a doubling of the healing time in either treatment arm. The mean healing time for cold sores was similar between the two treatment groups: 6.6 days for XERESE and 6.9 days for 5% acyclovir in XERESE vehicle.
None.
General
XERESE is intended for cutaneous use only for herpes labialis of the lips and around the mouth. XERESE should not be used in the eye, inside the mouth or nose, or on the genitals.
There are other orofacial lesions, including bacterial and fungal infections, which may be difficult to distinguish from a cold sore. Patients should be encouraged to seek medical advice when a cold sore fails to heal within 2 weeks.
XERESE has a potential for irritation and contact sensitization [see Adverse Reactions (6.1)].