Brief Summary about BreathTek UBT
Intended Use
The BreathTek ® UBT for H . pylori Kit ( BreathTek UBT Kit ) 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 therapy . For these purposes , the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13 CO 2 to 12 CO 2 in breath 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 ® -Citric solution is taken orally as part of the diagnostic procedure and contains Phenylalanine ( one of the protein components of Aspartame ), 84 mg per dosage unit , and should be used with caution in diabetic patients . ( 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 , retest with a new sample or an 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 antimicrobials , 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 observed in humans such as Helicobacter heilmannii or achlorhydria .
• If particulate matter is visible in the reconstituted Pranactin-Citric solution after thorough mixing , the solution should not be used .
• 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 in patients with difficulty swallowing or who may be at high risk of aspiration due to medical or physical conditions .
• No information is available on use of the Pranactin-Citric solution during pregnancy .
• For pediatric test results , the Urea Hydrolysis Rate ( UHR ) results must be calculated . The Delta over Baseline ( DOB ) results are only used to calculate the UHR metrics to determine H . pylori infection in pediatric patients . 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 , the following adverse events have been identified : 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 ® -IR300 and POCone ® 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 .
May 2014 05US14EBP1200
References : 1 . Vakil N , Megraud F . Eradication therapy for Helicobacter pylori . Gastroenterology . 2007 ; 133 ( 3 ): 985-1001 . 2 . Vakil N , Fendrick AM . How to test for Helicobacter pylori in 2005 . Cleve Clin J Med . 2005 ; 72 ( suppl 2 ): S8-S13 . 3 . Chu Y-T , Wang Y-H , Wu J-J , Lei H-Y . Invasion and multiplication of Helicobacter pylori in gastric epithelial cells and implications for antibiotic resistance . Infect Immun . 2010 ; 78 ( 10 ): 4157-4165 . 4 . Chey WD , Wong BCY ; 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 . 5 . Package Insert for BreathTek UBT . Otsuka America Pharmaceutical , Inc ; 2014 .
© 2015 Otsuka America Pharmaceutical , Inc . April 2015 05US15EBP0019