Sitavig

SITAVIG- acyclovir tablet, delayed release
Innocutis Holdings, LLC

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use SITAVIG safely and effectively. See full prescribing information for SITAVIG.

SITAVIG (acyclovir) buccal tablets 50mg

Initial U.S. Approval: 1982

INDICATIONS AND USAGE

SITAVIG is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults (1).

DOSAGE AND ADMINISTRATION

  • Application of one SITAVIG 50 mg buccal tablet as a single dose to the upper gum (canine fossa) region (2.1).
  • SITAVIG should be applied within one hour after the onset of prodromal symptoms and before the appearance of any signs of herpes labailis.
  • Do not crush, chew, suck or swallow tablets (2.2)

DOSAGE FORMS AND STRENGTHS

50 mg buccal tablets (3).

CONTRAINDICATIONS

Known hypersensitivity to acyclovir, milk protein concentrate, or any other component of the product (4).

ADVERSE REACTIONS

Most common adverse reactions (> or =1%) are: headache and application site pain (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Innocutis Holdings, LLC at 1-800-499-4468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Due to low dose and minimal systemic absorption of SITAVIG, drug interactions are unlikely (7).

USE IN SPECIFIC POPULATIONS

  • Nursing Mothers: Caution should be exercised when administered to a nursing woman (8.3).

See 17 for PATIENT COUNSELING INFORMATION AND FDA-Approved Patient Labeling

Revised: 04/2013

FULL PRESCRIBNG INFORMATION: CONTENTS *

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Basic Dosing Information

2.2 Administration Instructions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Labor and Delivery

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Immunocompromised Patients

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment ofFertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Instructions for Use

17.2 Adverse Reactions

* Sections or subsections omitted from the full prescribing informationare not listed.

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

SITAVIG is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.

2 DOSAGE AND ADMINISTRATION

2.1 Basic Dosing Information

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

2.2 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 situation which may interfere with adhesion of the tablet such as chewing gum, touching or pressing the tablet after placement, wearing upper denture, 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 swalloed after the first 6 hours

3 DOSAGE FORMS AND STRENGTHS

SITAVIG is a buccal tablet containing 50 mg of acyclovir. SITAVIG tablets are round, off-white tablets, with a rounded side and a flat side. The tablets are marked with an “AL21″ on the flat side.

4 CONTRAINDICATIONS

SITAVIG is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to acyclovir, milk protein concentrate, or any other component of the product.

6 ADVERSE REACTIONS

6.1 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 controled 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
Event

SITAVIG

N = 378

Placebo

N = 397

Nervous System Disorders

Headache

Dizziness

Lethargy

3%

1%

1%

3%

1%

0

Gastrointestinal system Disorders

Gingival Pain

Aphthous Stomatitis

1%

1%

0.38%

0

Administration Site Conditions

Application Site Pain

Application Site Irritation

1%

1%

1%

0

Skin and Subcutaneous Disorders

Erythema

Rash

1%

1%

0.3%

0.3%

The treatment emergent adverse events considered related to the 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 to adverse events were mild or moderate in severity. One report of headache from both treatment arms was classified as severe.

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