ENTERO Vu 24%

6 ADVERSE REACTIONS The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the 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: Nausea, vomiting, diarrhea and abdominal cramping Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes 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

4 CONTRAINDICATIONS ENTERO VU 24% is contraindicated in patients with the following conditions: known or suspected perforation of the GI tract known obstruction of the GI tract high risk of GI perforation such as those with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to the pelvis high risk of aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation known severe hypersensitivity to barium sulfate or any of the excipients of ENTERO VU 24% Known or suspected perforation of the gastrointestinal (GI) tract ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of GI perforation or aspiration ( 4 ) Known hypersensitivity to barium sulfate or any of the excipients of ENTERO VU 24% ( 4 )

11 DESCRIPTION ENTERO VU 24% (barium sulfate) is a radiographic contrast agent that is supplied as a suspension (24% w/v) for oral administration. The active ingredient barium sulfate is designated chemically as BaSO 4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm 3 , and the following chemical structure ENTERO VU 24% contains the following excipients: acacia, carrageenan, citric acid, methylcellulose, natural and artificial blueberry flavor, polysorbate 80, potassium chloride, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution, and xanthan gum. Barium Sulfate Chemical Structure

2 DOSAGE AND ADMINISTRATION For oral use only: Adults: Recommended dose is 600 mL ( 2.1 ) 2.1 Recommended Dosing The recommended oral dose of ENTERO VU 24% is: Adults: 600 mL 2.2 Administration Instructions For oral use only Shake bottle vigorously prior to oral administration to fully suspend product Administer undiluted Discard any unused suspension Advise patients to hydrate following the barium sulfate procedure Advise patient at risk for constipation or delayed gastrointestinal transit to monitor for worsening of their condition after administration of barium sulfate and seek medical attention if worsening and advise using laxatives to enhance gastrointestinal transit.

1 INDICATIONS AND USAGE ENTERO VU 24% is indicated for use in small bowel radiographic examinations to visualize the gastrointestinal (GI) tract in adult patients. ENTERO VU 24% is a radiographic contrast agent indicated for use in small bowel radiographic examinations to visualize the gastrointestinal (GI) tract in adult patients ( 1 )

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Due to its high atomic number, barium (the active ingredient in ENTERO VU 24%) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies. 12.2 Pharmacodynamics Barium sulfate is biologically inert and has no known pharmacological effects. 12.3 Pharmacokinetics Under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in small, pharmacologically insignificant amounts.

12.1 Mechanism of Action Due to its high atomic number, barium (the active ingredient in ENTERO VU 24%) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.

12.2 Pharmacodynamics Barium sulfate is biologically inert and has no known pharmacological effects.

12.3 Pharmacokinetics Under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in small, pharmacologically insignificant amounts.

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3 DOSAGE FORMS AND STRENGTHS Oral suspension: barium sulfate (24% w/v) supplied in a single-dose white HDPE plastic bottle as a ready-to-use suspension for oral administration. Each bottle contains 600 mL of suspension. Oral Suspension: barium sulfate (24% w/v) supplied in single dose bottle ( 3 )

ENTERO Vu 24% barium sulfate BARIUM SULFATE BARIUM SULFATE ACACIA ANHYDROUS CITRIC ACID CARRAGEENAN SODIUM DIMETHICONE 350 DIMETHICONE 1000 METHYLCELLULOSE (400 MPA.S) POLYSORBATE 80 POTASSIUM CHLORIDE POTASSIUM SORBATE SACCHARIN SODIUM SILICON DIOXIDE SODIUM BENZOATE SORBITOL TRISODIUM CITRATE DIHYDRATE WATER XANTHAN GUM ENTERO Vu 24% barium sulfate BARIUM SULFATE BARIUM SULFATE ACACIA ANHYDROUS CITRIC ACID CARRAGEENAN SODIUM DIMETHICONE 350 DIMETHICONE 1000 METHYLCELLULOSE (400 MPA.S) POLYSORBATE 80 POTASSIUM CHLORIDE POTASSIUM SORBATE SACCHARIN SODIUM SILICON DIOXIDE SODIUM BENZOATE SORBITOL TRISODIUM CITRATE DIHYDRATE WATER XANTHAN GUM

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No animal studies have been performed to evaluate the carcinogenic potential of barium sulfate or potential effects on fertility.

NDA208143

ENTERO Vu 24%

barium sulfate

32909-146

HUMAN PRESCRIPTION DRUG

ORAL

Entero Vu™ 24% - 600 ml - Inner Package Barium Sulfate Suspension NDC: 32909-146-06 Entero Vu™ 24% - 600 ml - Outer Package Barium Sulfate Suspension NDC: 32909-146-06 Entero Vu 24% Inner Package Label Entero Vu 24% Outer Package Label

17 PATIENT COUNSELING INFORMATION After administration, advise patients to: Maintain adequate hydration [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.3 )] . Seek medical attention for worsening of constipation or slow gastrointestinal passage [see Warnings and Precautions ( 5.3 )] . Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty [see Warnings and Precautions ( 5.1 )] . Rx only Manufactured by EZEM Canada Inc Anjou (Quebec) Canada H1J 2Z4 For Bracco Diagnostics Inc. Monroe Township, NJ 08831 CL10F501 rev.06/20

8.5 Geriatric Use Clinical studies of ENTERO VU 24% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.4 Pediatric Use ENTERO VU 24% is not indicated for pediatric use.

8.1 Pregnancy Risk Summary ENTERO VU 24% is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary ENTERO VU 24% is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. 8.2 Lactation Risk Summary ENTERO VU 24% is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to the drug. 8.4 Pediatric Use ENTERO VU 24% is not indicated for pediatric use. 8.5 Geriatric Use Clinical studies of ENTERO VU 24% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied ENTERO VU 24% (barium sulfate) is supplied as a suspension (24% w/v) in a single-dose HDPE plastic bottle containing 600 mL of barium sulfate suspension (24% w/v). Provided as: 6 x 600 mL bottles (NDC 32909-146-06) 16.2 Storage and Handling Store at USP controlled room temperature 20°C to 25°C (68°F to 77° F). Protect from freezing.