Sitivig (Page 3 of 4)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Systemic exposure following buccal administration of acyclovir is minimal. Results from previous studies of carcinogenesis, mutagenesis
and fertility for acyclovir are not included in the full prescribing information for SITAVIG due to the minimal exposure that results
from buccal administration. Information on these studies following systemic exposure is available in the full prescribing information for
acyclovir products approved for oral and parenteral administration.

14 Clinical Studies

Study in Patients with Recurrent Herpes Labialis (cold sores)

The efficacy and safety of SITAVIG was evaluated in a randomized, double-blind, placebo-controlled, patient-initiated, multicenter trial comparing SITAVIG 50 mg administered as a single dose (n = 378) to placebo (n = 397) in patients with recurrent herpes labialis (cold sores). A total of 376 SITAVIG treated patients and 395 placebo treated patients were included in the Intent to Treat (ITT) efficacy population defined as all patients who took study treatment and who had a start date and time of treatment initiation recorded. The mean age was 41.0 years (range: 18-80 years) and the majority of patients were female (68.6%), and Caucasian (94.9%). All patients had at least 4 herpes episodes in the previous year of whom 68.4% had ≥ 5 episodes. Patients were instructed to initiate treatment within one hour after the onset of prodromal symptoms and before the appearance of any signs of herpes labialis lesions by applying the tablet to the buccal mucosa in the canine fossa. If the tablet was detached within the first 6 hours, subjects were instructed to reapply a tablet.


The mean and median durations of the recurrent herpes labialis episode (ITT population, n=771) were approximately half a day shorter in patients treated with SITAVIG compared with patients treated with placebo.

16 HOW SUPPLIED/STORAGE AND HANDLING

SITAVIG 50 mg buccal tablets are supplied as off-white tablets containing 50 mg of acyclovir. SITAVIG tablets have a rounded side and
a flat side. SITAVIG tablets are packaged in blisters (NDC 68712-049-02).

SITAVIG should be stored at 20 to 25°C (68 to 77°F) [see USP controlled room temperature]; excursions between 15 and 30°C (59-86°F)
permitted at room temperature. Protect from moisture, and keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

Patients should be informed that SITAVIG is not a cure for cold sores. See FDA-approved patient labeling (Patient Information and Instructions for Use) .

17.1 Instructions For Use

Read the Instructions for Use that comes with SITAVIG before you start using it. Talk to your doctor or pharmacist if you have any questions.

Important:
SITAVIG should be applied to the area of the upper gum above the incisor tooth.
SITAVIG tablets should not be crushed, sucked, chewed or swallowed.

If it comes out before 6 hours have gone by, reapply it.
If this does not work then a new tablet should be applied.
It should not be applied to the inside of the lip or cheek.
• Tablet should be applied on the same side of the mouth as the herpes labialis symptoms.
• Do not remove SITAVIG if it sticks to your upper gum. If SITAVIG does not stick or falls off of your upper gum within the first 6
hours that you apply it, place it back onto your upper gum. If it still does not stick, replace it with a new SITAVIG tablet.
• Do not re-apply SITAVIG if it falls out or you swallow it after it has been in place 6 hours or longer.
• If you swallow SITAVIG within the first 6 hours of applying it, drink a glass of water and place a new SITAVIG tablet onto your upper gum.

17.2 Adverse Reactions

Patients may experience adverse reactions including headache, and application site pain.

Patient Information

SITAVIG (SIT-a-vig) (acyclovir) buccal tablets


What is SITAVIG?
• SITAVIG is a prescription medicine used to treat cold sores (herpes labialis) in adults with normal immune systems.
• It is not known if SITAVIG is safe and effective in children.

Who should not use SITAVIG?
Do not use SITAVIG if you are allergic to:
• acyclovir or any of the ingredients in SITAVIG. See the end of this leaflet for a complete list of ingredients in SITAVIG.
• milk protein concentrate

Before using SITAVIG, tell your healthcare provider about all of your medical conditions, including if you:
• are pregnant or plan to become pregnant. It is not known if SITAVIG will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if SITAVIG passes into your breast milk.
• Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements.

H ow should I use SITAVIG?
See the detailed Instructions for Use for information about how to use SITAVIG.
• Use SITAVIG exactly as your healthcare provider tells you to use it.
• Use SITAVIG within 1 hour after you have the first symptom of a cold sore, such as itching, redness, burning, or tingling,
and before a cold sore appears.
• You may eat and drink while using SITAVIG.
• Do not crush, chew, suck, or swallow SITAVIG tablets.
• SITAVIG will slowly dissolve over time while in your mouth and should be left in place.
• Gently rinse your mouth with water to clean your teeth while SITAVIG is in place.
• Drink more liquids if your mouth becomes dry while using SITAVIG.


What should I avoid while using SITAVIG?
You should avoid activities that may prevent SITAVIG from sticking to your gum, including: touching or pressing SITAVIG
after you apply it, wearing upper dentures, chewing gum, and brushing your teeth during the treatment day.

What are the possible side effects of SITAVIG?
The most common side effects of SITAVIG include: headache and pain where SITAVIG is applied.
These are not all the possible side effects of SITAVIG. Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.


How should I store SITAVIG?
• Store SITAVIG between 68°F to 77°F (20°C to 25°C). Keep SITAVIG tablets dry.

Keep SITAVIG and all medicines out of the reach of children.

General information about the safe and effective use of SITAVIG
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use
SITAVIG for a condition for which it was not prescribed. Do not give SITAVIG to other people, even if they have the same
symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about
SITAVIG that is written for health professionals.

What are the ingredients in SITAVIG?
Active ingredient: acyclovir
Inactive ingredients: hypromellose, milk protein concentrate, sodium lauryl sulfate, magnesium stearate,microcrystalline cellulose, povidone, colloidal silicon dioxide.


Manufactured By: Farméa,10 rue Bouché Thomas, ZAC d’orgemont, 49 000 Angers — France

For more information call 1-800-499-4468.

This Patient Information has been approved by the U.S. Food and DrugAdministration. Issue: April/2013

INSTRUCTIONS FOR USE

SITAVIG (SIT-a-vig) (acyclovir) buccal tablets

Read the Instructions for Use that comes with SITAVIG before you start using it. Talk to your healthcare provider or pharmacist if you have any questions.

Important:
• SITAVIG should be applied within 1 hour after you have the first symptom of a cold sore, such as itching, redness, burning, or tingling, and before a cold sore appears.
• SITAVIG should be applied on the same side of your mouth as the cold sore symptoms.
• SITAVIG should be applied to your upper gum, just above your incisor tooth.
• SITAVIG should not be applied to the inside of your lip or your cheek.
• If SITAVIG does not stick to your upper gum or falls off of your upper gum within the first 6 hours after you apply it, the same tablet should be placed back onto your upper gum right away. If this SITAVIG tablet does not stay in place, apply another SITAVIG tablet to your upper gum.
• Do not re-apply SITAVIG if it falls out or you swallow it after it has been in place 6 hours or longer.
• If you swallow SITAVIG within the first 6 hours of applying it, drink a glass of water and place a new SITAVIG tablet onto your upper gum.

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