E-Z-Disk

1 INDICATIONS AND USAGE E-Z-DISK is indicated for the evaluation of esophageal patency in adults and pediatric patients aged 12 years and older. E-Z-DISK is a radiographic contrast agent indicated for the evaluation of esophageal patency in adults and pediatric patients aged 12 years and older. ( 1 )

2 DOSAGE AND ADMINISTRATION The recommended dose of E-Z-DISK in adults and pediatric patients aged 12 years and older is one 700 mg tablet orally during imaging. Swallow one tablet whole with the aid of one or two swallows of water. Do not cut, crush, or chew the tablet. Advise patients to hydrate following the E-Z-DISK imaging procedure [see Warnings and Precautions ( 5.3 )] . E-Z-DISK is formulated to disintegrate within the gastrointestinal (GI) tract. In the event of prolonged retention, consider implementing appropriate interventions. The recommended dose is one 700 mg tablet orally during imaging. Swallow one tablet whole with the aid of one or two swallows of water. Do not cut, crush, or chew the tablet. ( 2 )

4 CONTRAINDICATIONS E-Z-DISK is contraindicated in patients with: Known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-DISK [see Warnings and Precautions ( 5.1 )] Known, suspected, or high risk of perforation of the GI tract such as patients with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, recent GI surgery or biopsy, acute GI injury, or recent radiotherapy to the pelvis [see Warnings and Precautions ( 5.2 )] Known obstruction of the GI tract [see Warnings and Precautions ( 5.3 )] High risk of aspiration such as patients with known or suspected tracheoesophageal fistula or obtundation [see Warnings and Precautions ( 5.4 )] Known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-DISK ( 4 ) Known or suspected perforation of the gastrointestinal (GI) tract or conditions associated with high risk of GI perforation ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of aspiration ( 4 )

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Have emergency equipment and trained personnel immediately available during the procedure. ( 5.1 ) Intra-abdominal Barium Leakage: Barium leakage may occur in conditions such as GI fistula, ulcer, inflammatory bowel disease, appendicitis, diverticulitis, and severe stenosis or obstructing lesions of the GI tract and has been associated with peritonitis and granuloma formation. ( 5.2 ) Baroliths and Bowel Obstruction: Maintain adequate hydration following a barium sulfate procedure and monitor patients at risk for delayed GI transit for development of signs and symptoms of bowel obstruction. ( 5.3 ) Aspiration Pneumonitis: Patients with a history of food aspiration or compromised swallowing mechanism may be at high risk. ( 5.4 ) 5.1 Hypersensitivity Reactions E-Z-DISK may induce serious hypersensitivity reactions with manifestations including hypotension, bronchospasm and other respiratory impairments, and dermal reactions including rashes, urticaria and itching. A history of bronchial asthma, atopy, food allergies, or a reaction to a contrast agent may increase the risk for hypersensitivity reactions. E-Z-DISK is contraindicated in patients with known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-DISK [see Contraindications ( 4 )]. Have emergency equipment and trained personnel immediately available during the procedure. 5.2 Intra-abdominal Barium Leakage Barium leakage from the GI tract has been associated with peritonitis and granuloma formation. Barium sulfate from orally administered E-Z-DISK may leak in the presence of conditions such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with severe stenosis of the GI tract, especially if it is distal to the stomach. E-Z-DISK is contraindicated in patients with known, suspected, or high risk of perforation of the GI tract [see Contraindications ( 4 )] . 5.3 Baroliths and Bowel Obstruction Barium sulfate from orally administered E-Z-DISK may accumulate in the GI tract, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, or perforation. Patients with the following are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility, electrolyte imbalance, dehydration, low residue diet, medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and advanced age . E-Z-DISK is contraindicated in patients with known obstruction of the GI tract [see Contraindications ( 4 )]. To reduce the risk of delayed GI transit and obstruction, maintain adequate hydration after the E-Z-DISK procedure. Monitor patients at risk for delayed gastrointestinal transit for development of signs and symptoms of bowel obstruction. 5.4 Aspiration Pneumonitis Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. E-Z-DISK is contraindicated in patients with high risk of aspiration such as known or suspected tracheoesophageal fistula or obtundation [see Contraindications ( 4 )] . 5.5 Systemic Embolization Barium sulfate from orally administered E-Z-DISK may intravasate into the venous drainage of the GI tract and enter the circulation as a "barium embolus" leading to potentially fatal complications, which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia, and prolonged severe hypotension.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Intra-abdominal Barium Leakage [see Warnings and Precautions ( 5.2 )] Baroliths and Bowel Obstruction [see Warnings and Precautions ( 5.3 )] Aspiration Pneumonitis [see Warnings and Precautions ( 5.4 )] The following adverse reactions associated with the use of E-Z-DISK or other barium sulfate products were identified in postmarketing reports or published clinical studies. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure: Cardiovascular disorders : Vasovagal and syncopal episodes Gastrointestinal disorders: Barium sulfate impaction, nausea, vomiting, diarrhea, abdominal cramping Respiratory disorders : Aspiration pneumonitis Adverse Reactions in Pediatric Patients No additional safety signals have been reported in pediatric patients aged 12 years and older. Common adverse reactions include nausea, vomiting, diarrhea, and abdominal cramping. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

8.1 Pregnancy Risk Summary Barium sulfate is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to E-Z-DISK [see Clinical Pharmacology ( 12.3 )]