Sitavig

Basic Dosing Information

One SITAVIG 50 mg buccal tablet should be applied as a single dose to the upper gum region (canine fossa).

Administration Instructions

SITAVIG should be applied within one hour after the onset of prodromal symptoms and before the appearance of any signs of herpes labialis lesions. The tablet should be applied with a dry finger immediately after taking it out of the blister. The tablet should be placed to the upper gum just above the incisor tooth (canine fossa) and held in place with a slight pressure over the upper lip for 30 seconds to ensure adhesion. For comfort the rounded side should be placed to the upper gum, but either side of the tablet can be applied. Tablet should be applied on the same side of the mouth as the herpes labialis symptoms.

Once applied, SITAVIG stays in position and gradually dissolves during the day. [See Clinical Pharmacology (12.3)]. In addition,

• SITAVIG should not be crushed, chewed, sucked or swallowed.
• Food and drink can be taken normally when SITAVIG is in place. Avoid any situations which may interfere with adhesion of the tablet such as chewing gum, touching or pressing the tablet after placement, wearing upper dentures, and brushing teeth. If the teeth need to be cleaned while the tablet is in place, rinse the mouth gently. Drink plenty of liquids in the case of dry mouth.
• If SITAVIG does not adhere or falls off within the first 6 hours, the same tablet should be repositioned immediately. If the tablet cannot be repositioned, a new tablet should be placed.
• If SITAVIG is swallowed within the first 6 hours, the patient should drink a glass of water and a new tablet should be applied. [see Patient Counseling Information (17)].
• SITAVIG does not need to be reapplied if the tablet falls out or is swallowed after the first 6 hours.

Pregnancy

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.

Lactation

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.

Pediatric Use

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.

Geriatric Use

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

Immunocompromised Patients

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

Clinical Trial Experience

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.

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.