Varibar Nectar

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 VARIBAR NECTAR is contraindicated in patients with: 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 prior 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 for 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 VARIBAR NECTAR Known or suspected perforation of the GI tract ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of GI perforation ( 4 ) Patients with tracheo-esophageal fistula ( 4 ) Known severe hypersensitivity to barium sulfate or any of the excipients of VARIBAR NECTAR ( 4 )

11 DESCRIPTION VARIBAR NECTAR (barium sulfate) is a radiographic contrast agent for oral administration that is supplied as a 40% w/v, smooth, off- white to lightly colored free-flowing suspension with an apple aroma. The active ingredient is designated chemically as BaSO 4 which has a density of 4.5 g/cm 3 , a molecular weight of 233.4 g/mol, and the following chemical structure: VARIBAR NECTAR has a viscosity of 300 cPs and 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 For oral use only – administered by syringe, spoon, or cup. The recommended dose is: Adults: 5 mL Pediatric patients 6 months and older: 1-3 mL Pediatric patients younger than 6 months of age: 0.5-1 mL Maximum cumulative dose: 30 mL During a single modified barium swallow examination, multiple doses of VARIBAR NECTAR may be administered. ( 2 ) 2.1 Recommended Dosing The recommended dose of VARIBAR NECTAR administered orally by syringe, spoon, or cup: Adults 5 mL Pediatric patients 6 months and older 1-3 mL Pediatric patients younger than 6 months of age 0.5-1 mL (This amount may be administered by an oral syringe or, alternatively, an infant bottle) During a single modified barium swallow examination, multiple doses of VARIBAR NECTAR may be administered as appropriate to assess the patient during multiple swallows and different radiographic views. The maximum cumulative dose is 30 mL. Once opened, write the discard after date on the immediate container label. Discard any unused product after 21 days. 2.2 Important Administration Instructions For oral use only. Encourage patients to hydrate following the barium sulfate procedure.

1 INDICATIONS AND USAGE VARIBAR NECTAR is indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR NECTAR is a radiographic contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. ( 1 )

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Due to its high atomic number, barium (the active ingredient in VARIBAR NECTAR) 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.

20201009

6

3 DOSAGE FORMS AND STRENGTHS Oral suspension: barium sulfate (40% w/v) supplied in a multiple dose HDPE plastic bottle as a suspension for oral administration. Each bottle contains 240 mL of suspension. Oral suspension — 40% (w/v) in a 240 mL multiple-dose HDPE plastic bottle for oral administration ( 3 )

Varibar Nectar barium sulfate Barium Sulfate Barium Sulfate anhydrous citric acid carboxymethylcellulose sodium dimethicone 350 dimethicone 1000 glycerin maltodextrin polysorbate 80 potassium sorbate saccharin sodium silicon dioxide sodium benzoate trisodium citrate dihydrate water xanthan gum xylitol Varibar Nectar barium sulfate Barium Sulfate Barium Sulfate anhydrous citric acid carboxymethylcellulose sodium dimethicone 350 dimethicone 1000 glycerin maltodextrin polysorbate 80 potassium sorbate saccharin sodium silicon dioxide sodium benzoate trisodium citrate dihydrate water xanthan gum xylitol

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

Varibar Nectar

barium sulfate

32909-116

HUMAN PRESCRIPTION DRUG

ORAL

Varibar ® Nectar - Barium Sulfate Oral Suspension NDC: 32909-116-00 Varibar ® Nectar Internal Label NDC: 32909-115-00 varibar nectar internal label NDC 32909-116-00 varibar nectar internal label NDC 32909-115-00

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 for Bracco Diagnostics Inc. Monroe Township, NJ 08831 by EZEM Canada Inc Anjou (Quebec) Canada H1J 2Z4 Revised February 2020 CL10FD01

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary VARIBAR NECTAR 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 VARIBAR NECTAR is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to VARIBAR NECTAR [see Clinical Pharmacology ( 12.3 )] . 8.4 Pediatric Use The efficacy of VARIBAR NECTAR in pediatric patients from birth to less than 17 years of age is based on successful opacification of the oropharynx during modified barium swallow examinations [see Clinical Pharmacology ( 12.1 )] . Safety and dosing recommendations in pediatric patients are based on clinical experience [see Dosage and Administration ( 2.1 )] . VARIBAR NECTAR is contraindicated in pediatric patients with tracheo-esophageal fistula [see Contraindications ( 4 )] . Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] . Patients with cystic fibrosis or Hirschsprung disease should be monitored for small bowel obstruction after use [see Warnings and Precautions ( 5.3 )] 8.5 Geriatric Use Clinical studies of VARIBAR NECTAR 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 How Supplied VARIBAR NECTAR is supplied in a multiple-dose HDPE bottle containing 240 mL of barium sulfate (40% w/v). Provided as: 12 x 240 mL bottles (NDC 32909-116-00) Storage and Handling Store at USP controlled room temperature 20 to 25°C (68 to 77° F). Protect from freezing. Once opened, VARIBAR NECTAR may be used for up to 21 days when stored at USP controlled room temperature, 20 to 25°C (68 to 77° F).