Brief Summary about BreathTek UBT UBT for H. pylori Kit (BreathTek UBT Kit)
Intended Use The BreathTek®
is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post- treatment monitoring of H. pylori infection in adult patients and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of
the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13
CO2 in breath
observed in humans such as Helicobacter heilmannii or achlorhydria.
— Oral contamination associated with urease containing bacteria especially when not using the straw provided in the BreathTek UBT Kit.
• If particulate matter is visible in the reconstituted Pranactin-Citric solution after thorough mixing, the solution should not be used.
therapy. For these purposes, CO2 to 12
samples, in clinical laboratories or point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results.
The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner.
Warnings and Precautions • For in vitro diagnostic use only. The Pranactin®
solution is taken orally as part of the diagnostic procedure and contains Phenylalanine (one of
-Citric the
protein components of Aspartame), 84 mg per dosage unit. (For reference, 12 ounces of typical diet cola soft drinks contain approximately 80 mg of Phenylalanine.)
• A negative result does not rule out the possibility of H. pylori infection. False negative results do occur with this procedure. If clinical signs are suggestive of H. pylori infection, alternate method.
• False negative test results may be caused by:
— Ingestion of proton pump inhibitors (PPIs) within 2 weeks prior to performing the BreathTek UBT. If a negative result is obtained from a patient ingesting a PPI within 2 weeks prior to the BreathTek UBT, it may be a false-negative result and the test should be repeated 2 weeks after discontinuing the PPI treatment. A positive result for a patient on a PPI could be considered positive and be acted upon.
— Ingestion of antibiotics, or bismuth preparations within 2 weeks prior to performing the BreathTek UBT
— Premature POST-DOSE breath collection time for a patient with a marginally positive BreathTek UBT result
— Post-treatment assessment with the BreathTek UBT less than 4 weeks after completion of treatment for the eradication of H. pylori.
• False positive test results may be caused by: — Urease associated with other gastric spiral organisms
References: 1. Graham-Lomax K, Graham DY. Contemporary Diagnosis and Management of H. Pylori-Associated Gastrointestinal Diseases. 3rd ed. Newtown, PA: Handbooks in Health Care Co; 2005. 2. Chey WD, Wong BC; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007;102(8):1808-1825. 3. Staat MA, Kruszon- Moran D, McQuillan GM, Kaslow RA. A population-based serologic survey of Helicobacter pylori infection in children and adolescents in the United States. J Infect Dis. 1996;174(5):1120-1123. 4. Meurer LN, Bower DJ. Management of Helicobacter pylori infection. Am Fam Physician. 2002;65(7):1327-1336. 5. H. pylori infection. Mayo Clinic website.
http://www.mayoclinic.org/diseases- conditions/h-pylori/basics/symptoms/con-20030903. Published June 5, 2014. Accessed October 28, 2014. 6. Helicobacter pylori and peptic ulcer disease: the key to cure. Centers for Disease Control and Prevention website. http://www.
cdc.gov/ulcer/keytocure.htm. Updated September 28, 2006. Accessed October 29, 2014. 7. Gold BD, Colletti RB, Abbott M, et al; North American Society
retest with a new sample or an
• Patients who are hypersensitive to mannitol, citric acid or Aspartame should avoid taking the drug solution as this drug solution contains these ingredients. Use with caution risk of aspiration due to medical or physical conditions.
• The safety of using the BreathTek UBT Kit during pregnancy and lactation is not established.
• For pediatric test results, the Urea Hydrolysis Rate (UHR) results must be calculated. Delta over Baseline (DOB) results in conjunction with the Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. DOB results cannot be used to determine the infection status of pediatric patients. Use the web-based pUHR-CA (
https://BreathTekKids.com) to calculate the UHR.
• Safety and effectiveness has not been established in children below the age of 3 years.
Adverse Events
During post-approval use of the BreathTek UBT in adults, anaphylactic
reaction, hypersensitivity, rash, burning
sensation in the stomach, tingling in the skin, vomiting and diarrhea. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure.
In two clinical studies conducted in 176 (analyzed) pediatric patients ages 3 to 17 years to determine the initial diagnosis and post treatment monitoring of H. pylori, the following adverse events experienced by >1% of these patients were: vomiting (5.1%), oropharyngeal pain (4.5% to include throat irritation, sore throat, throat burning), nausea (2.3%), restlessness (2.3%), stomach ache/belly pain (1.1%), and diarrhea (1.1%). Most of the adverse events were experienced by patients within minutes to hours of ingestion of the Pranactin-Citric solution.
In another clinical study comparing the UBiT® and POCone®
-IR300 in pediatric patients ages 3 to 17 years,
the following adverse events were observed among the 99 subjects enrolled: 2 incidences of headache, and 1 incidence each of cough, dry mouth and acute upper respiratory infection.
January 2016 05US16IBR0001
for Pediatric Gastroenterology and Nutrition. Helicobactor pylori infection in children: recommendations for diagnosis and treatment. J Pediatr Gastroenterol Nutr. 2000;31(5):490-497. 8. Uc A, Chong SKF. Treatment of Helicobactor pylori gastritis improves dyspeptic symptoms in children. J Pediatr Gastroenterol Nutr. 2002;34(3):281-285. 9. Ables AZ, Simon I, Melton ER. Update on Helicobacter pylori treatment. Am Fam Physician. 2007;75(3):351-358. 10. Malfertheiner P, Megraud F, O’Morain CA, et al; European Helicobacter Study Group. Management of Helicobacter pylori infection—the Maastricht IV/Florence Consensus Report. Gut. 2012;61(5):646-664. 11. Fock KM, Katelaris P, Sugano K, et al; Second Asia- Pacific Conference. Second Asia-Pacific Consensus Guidelines for Helicobacter pylori infection. J Gastroenterol Hepatol. 2009;24(10):1587-1600. 12. Koletzko S, Jones NL, Goodman KJ, et al; H. pylori Working Groups of ESPGHAN, NASPGHAN. Evidence-based guidelines from ESPGHAN and NASPGHAN for Helicobacter pylori infection in children. J Pediatr Gastroenterol Nutr. 2011;53(2):230-243.
©2016 Otsuka America Pharmaceutical, Inc.
August 2016 05US16EBP0056
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