Tagitol V

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 TAGITOL V is contraindicated in patients with: - known or suspected perforation of the gastrointestinal (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 prior aspiration, tracheo-esophageal fistula, or obtundation; - known hypersensitivity to barium sulfate or any of the excipients of TAGITOL V. TAGITOL V is contraindicated in patients with: 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 TAGITOL V ( 4 )

11 DESCRIPTION TAGITOL V (barium sulfate) is a radiographic contrast agent that is supplied as a 40% w/v, off-white to lightly colored, free-flowing, ready-to-use suspension with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO 4 with a molecular weight of 233.4 g/mol and the following chemical structure: TAGITOL V contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, maltodextrin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum, and xylitol. barium-sulfate-structure

2 DOSAGE AND ADMINISTRATION The recommended dose is: One 20 mL bottle (8g barium sulfate) with each meal (breakfast, lunch and dinner) the day before the CT colonography examination ( 2.1 ). Total dose = 3 bottles (24 g barium sulfate) For oral use only ( 2.2 ). 2.1 Recommended Dosing The recommended oral dose of TAGITOL V is one 20 mL bottle (8 g barium sulfate) with each meal (breakfast, lunch and dinner) the day before the colonography examination. Total dose = 3 bottles (24 g barium sulfate). 2.2 Important Administration Instructions TAGITOL V is typically provided to the patient for self-administration. Advise patients to carefully read and follow the Patient Instructions for Use to be provided to the patient. Shake bottle for 15 seconds prior to administration. For oral use only. Encourage patients to hydrate following the barium sulfate procedure. Discard any unused suspension.

1 INDICATIONS AND USAGE TAGITOL V is indicated for use in adult patients for use in computed tomography (CT) colonography as a fecal tagging agent. TAGITOL V is a radiographic contrast agent indicated in adult patients for use in computed tomography (CT) colonography as a fecal tagging agent ( 1 )

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Due to its high atomic number, barium (the active ingredient in TAGITOL V) 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 pharmacologically insignificant amounts.

12.1 Mechanism of Action Due to its high atomic number, barium (the active ingredient in TAGITOL V) 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 pharmacologically insignificant amounts.

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3 DOSAGE FORMS AND STRENGTHS Oral suspension: barium sulfate (40% w/v) supplied as a ready-to-use suspension in a 20 mL, single-dose, bottle for oral administration. Each 20 mL bottle contains 8 g of barium sulfate. Oral suspension : barium sulfate (40% w/v) 20 mL single dose bottles as a ready to use suspension for oral administration ( 3 )

Tagitol V Barium Sulfate Barium Sulfate Barium Sulfate anhydrous citric acid dimethicone 350 dimethicone 1000 glycerin maltodextrin polysorbate 80 potassium sorbate saccharin sodium silicon dioxide sodium benzoate trisodium citrate dihydrate water xanthan gum xylitol CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM

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.

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

Tagitol V

Barium Sulfate

32909-814

HUMAN PRESCRIPTION DRUG

ORAL

Tagitol V Internal Label NDC: 32909-814-53 Tagitol V Internal 32909-814-53

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 )] . Administration Instructions TAGITOL V is typically provided to the patient for self-administration. Advise patients to carefully read and follow the Patient Instructions for Use to be provided to the patient. Provide the patient with any site specific instructions regarding their procedure and when to take meals. Rx only Manufactured by EZEM Canada Inc Anjou (Quebec) Canada H1J 2Z4 For Bracco Diagnostics Inc. Monroe Township, NJ 08831 CLC8503 rev. 05/22

INSTRUCTIONS FOR USE TAGITOL V (tag-i-täl vē) (barium sulfate) oral suspension Read this Instructions for Use before you drink TAGITOL V (barium sulfate) oral suspension. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Important: Take TAGITOL V exactly as your healthcare provider tells you . Your healthcare provider will prescribe the dose that is right for you. You can ask your healthcare provider or pharmacist if you have any questions about how to take TAGITOL V. How should I store TAGITOL V? Before using TAGITOL V store at room temperature between 68°F and 77°F (20°C and 25°C). Do not freeze. Keep TAGITOL V and all medicines out of the reach of children. Supplies you will need: 1 box containing 3 bottles of TAGITOL V. Each bottle contains 20 mL of TAGITOL V How should I take TAGITOL V The day before your procedure you will drink 1 bottle of TAGITOL V with each meal: Breakfast: Shake 1 bottle of TAGITOL V for 15 seconds, open the bottle, and drink the liquid with breakfast. Lunch: Shake 1 bottle of TAGITOL V for 15 seconds, open the bottle, and drink the liquid with lunch. Dinner: Shake 1 bottle of TAGITOL V for 15 seconds, open the bottle, and drink the liquid with dinner. Throw away any unused TAGITOL V with normal household trash. Do not throw away by flushing down the drain. What should I do if the TAGITOL V spills? If you spill the liquid while shaking or drinking it, you can clean it up. TAGITOL V is not harmful and can be thrown away with normal household trash. If you spilled any of the liquid, check with your healthcare provider to find out if you need to change the date of the appointment for your procedure. This Instructions for Use has been approved by the U.S. Food and Drug Administration Approved: August 2017 COE5502

8.5 Geriatric Use Clinical studies of TAGITOL V do 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.

8.2 Lactation Risk Summary TAGITOL V 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 [see Clinical Pharmacology ( 12.3 )]

8.4 Pediatric Use TAGITOL V is not indicated for pediatric use.

8.1 Pregnancy Risk Summary TAGITOLV is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )] .

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary TAGITOLV is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology ( 12.3 )] . 8.2 Lactation Risk Summary TAGITOL V 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 [see Clinical Pharmacology ( 12.3 )] 8.4 Pediatric Use TAGITOL V is not indicated for pediatric use. 8.5 Geriatric Use Clinical studies of TAGITOL V do 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 TAGITOL V (barium sulfate) is an oral suspension (40% w/v) supplied as a box of three 20 mL bottles. Each bottle contains 8 grams barium sulfate. Provided as: 24 boxes, each containing 3 (20 mL) bottles (NDC 32909-814) 16.2 Storage and Handling Store at room temperature 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do Not Freeze.