SITAVIG Delayed-release tablet Ref.[28039] Active ingredients: Aciclovir

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials 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.

The overall safety of SITAVIG was assessed in 378 adult subjects having at least 4 herpes labialis episodes the previous year.

One randomized, double-blind, placebo controlled trial was conducted in patients with recurrent herpes labialis (cold sores). In this trial, 378 HSV infected subjects used SITAVIG as a single dose, and 397 subjects used placebo.

Selected treatment emergent adverse events without regard to causality and reported in at least 1% of patients can be seen in Table 1.

Table 1. Selected Treatment Emergent Adverse Events reported in at least 1% of patients:

The treatment emergent adverse events considered related to treatment that occurred in greater than or equal to 1% of patients included headache (1% SITAVIG vs. 2% placebo) and application site pain (1% both arms). There was no discontinuation of SITAVIG due to adverse drug reactions. Most treatment related adverse events were mild or moderate in severity. One report of headache from both treatment arms was classified as severe.

No interaction studies have been performed with SITAVIG. Acyclovir is primarily eliminated unchanged in the urine via active tubular secretion. Drugs administered concomitantly that compete with tubular secretion may increase acyclovir plasma concentrations. However, due to the low dose and minimal systemic absorption of SITAVIG, systemic drug interactions are unlikely.

There are no available data on SITAVIG use in pregnant women. However, published observational studies over decades of use of acyclovir have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Systemic exposure of acyclovir following buccal administration of SITAVIG is minimal [see Clinical Pharmacology (12.3)]. Animal reproduction studies have not been conducted with SITAVIG. Animal reproduction studies with systemic exposure of acyclovir have been conducted. Refer to oral and parental acyclovir prescribing information for additional details.

There are no data on the presence of acyclovir in human milk following buccal administration. There are no data on the effects of acyclovir on the breastfed infant or milk production. Systemic exposure following buccal administration of acyclovir is minimal [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SITAVIG and any potential adverse effects on the breastfed child from SITAVIG or from the underlying maternal condition.

Safety and effectiveness of SITAVIG in pediatric patients have not been established. The ability of pediatric patients to comply with the application instructions has not been evaluated. Use in younger children is not recommended due to potential risk of choking.

Clinical studies of SITAVIG did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

8.6 Immunocompromised Patients

The safety of SITAVIG has not been studied in immunocompromised subjects.