noninvasive simple A diagnose H. pylori 1 in 4 children A ... · ‡ Alarm features include bleeding, anemia, early satiety, unexplained weight loss, progressive dysphagia, odynophagia,

2©2016 Otsuka America Pharmaceutical, Inc. March 2016 05US16EBP0020

90%More than

OF DUODENAL ULCERS6

H. pylori may cause 80%Up to

OF GASTRIC ULCERS6

Use a Test-Treat-Confirm approach with BreathTek UBT

A simple, convenient, noninvasive test that can help diagnose active H. pylori infection and confirm treatment success

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 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. 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 November 25, 2015. 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 November 25, 2015. 7. Gold BD, Colletti RB, Abbott M, et al; North American Society for Pediatric Gastroenterology and Nutrition. Helicobacter pylori infections in children: recommendations for diagnosis and treatment. J Pediatr Gastroenterol Nutr. 2000;31(5):490-497. 8. Uc A, Chong SKF. Treatment of Helicobacter pylori gastritis improves dyspeptic symptoms in children. J Pediatr Gastroenterol Nutr. 2002;34(3):281-285. 9. Vakil N, Fendrick AM. How to test for Helicobacter pylori in 2005. Cleve Clin J Med. 2005;72(suppl 2):S8-S13. 10. Ables AZ, Simon I, Melton ER. Update on Helicobacter pylori treatment. Am Fam Physician. 2007;75(3):351-358. 11. 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. 12. 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. 13. Koletzko S, Jones NL, Goodman KJ, et al; H. pylori Working Groups of ESPGHAN and NASPGHAN. Evidence-based guidelines from ESPGHAN and NASPGHAN for Helicobacter pylori infection in children. J Pediatr Gastroenterol Nutr. 2011;53(2):230-243. 14. Package Insert for BreathTek UBT. Otsuka America Pharmaceutical, Inc; 2016. 15. Vaira D, Vakil N. Blood, urine, stool, breath, money, and Helicobacter pylori. Gut. 2001;48(3):287-289. 16. Maconi G, Vago L, Galletta G, et al. Is routine histological evaluation an accurate test for Helicobacter pylori infection? Aliment Pharmacol Ther. 1999;13(3):327-331. 17. Data on file. Otsuka America Pharmaceutical, Inc. 18. 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. 19. Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010;59(8):1143-1153. 20. Graham DY, Lee Y-C, Wu M-S. Rational Helicobacter pylori therapy: evidence-based medicine rather than medicine-based evidence. Clin Gastroenterol Hepatol. 2014;12(2):177-186. 21. Chiba N, Veldhuyzen Van Zanten SJ. 13C-Urea breath tests are the noninvasive method of choice for Helicobacter pylori detection. Can J Gastroenterol. 1999;13(8):681-683. 22. Altman DG, Bland JM. Diagnostic tests 2: predictive values. BMJ. 1994;309(6947):102. 23. Ore L, Hagoel L, Lavi I, Rennert G. Screening with faecal occult blood test (FOBT) for colorectal cancer: assessment of two methods that attempt to improve compliance. Eur J Cancer Prev. 2001;10(3):251-256. 24. Cullen KP, Broderick BM, Jayaram J, Flynn B, O’Connor HJ. Evaluation of the Helicobacter pylori stool antigen (HpSA) test in routine clinical practice—is it patient-friendly? Ir Med J. 2002;95(10):305-306. 25. Package Insert for Direct Detect System. Meridian Bioscience, Inc; 2012.

Learn more at BreathTek.com or call 888.637.3835.

Please see accompanying BRIEF SUMMARY and enclosed Current Package Insert.

A guideline-recommended testing method

Simple. Convenient. Noninvasive.


H. pylori: A common chronic infection…

…that may lead to more serious medical conditions

• When symptoms occur in adults, they may include burning, bloating, belching, vomiting, flatulence, abdominal pain, halitosis, nausea, and loss of appetite4-6

– Children may present with gnawing or burning pain in the epigastrium, nausea, vomiting, or loss of appetite6-8

– Infection is not often clinically apparent6,7

• H. pylori infection is also associated with a 2- to 6-fold increase in the risk for stomach cancer6

Affects at least

1 in 4of adults and children*30%in the United States1-3

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90%More than

OF DUODENAL ULCERS6


OF GASTRIC ULCERS6









H. pylori: A common chronic infection…






Affects at least


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4TEST TREAT CONFIRMWAIT 4 WEEKS

Use a Test–Treat–Con� rm Approach1,2,9

3

H. pylori can’t hide from BreathTek UBT

• Guidelines recommend† a test-and-treat strategy using noninvasive methods, such as UBT, for adults with uninvestigated dyspepsia2,10-12

– Adults under the age of 55 years and with no alarm features‡2

• UBT is also recommended to con� rm eradication in adults2,11,12

and children§13

* Data from the National Health and Nutrition Examination Survey (NHANES) III of children ages 6 to 19 years.

† American Academy of Family Physicians (2007),10 American College of Gastroenterology (2007),2 Maastricht/Florence Group IV (2010),11 and Second Asia-Paci� c Group (2009).12

‡ Alarm features include bleeding, anemia, early satiety, unexplained weight loss, progressive dysphagia, odynophagia, recurrent vomiting, family history of GI cancer, and previous esophagogastric malignancy.2

§ North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN).

Approved as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in

adults and children ages 3 to 17 years

Approximately 60% of adult patients are already taking a PPI when they initially present with GI symptoms.17

60%

SEN

SITI

VIT

YSP

EC

IFIC

ITY

93%

93%

93%

90%

89%

89%

PRE POST PRE PREPOST POST

STOOL (HpSA)15 ENDOSCOPIC BIOPSY

SEROLOGY (ELISA)2,15

85 NotRecommended

NotRecommended

%

79%

BREATHTEK UBT IN ADULT PATIENTS14

95% 96%

90% 96%

(Routine Histology)16

54


BreathTek UBT may be administered to patients currently taking PPIs

Citric acid–based UBT methods minimize false negative results by reducing pH effects of PPIs17

• It is still recommended that antibiotics, PPIs, or bismuth preparations not be taken within 2 weeks prior to administering BreathTek UBT14

• If patients currently taking PPIs test positive for H. pylori, the result is considered positive and eradication therapy can be started immediately. If the test is negative, it may be a false negative and results should be con� rmed with a second breath test 2 weeks after discontinuing PPIs14

• The effect of histamine 2-receptor antagonists (H2RAs) may reduce urease activity on urea breath tests. H2RAs may be discontinued for 24–48 hours before the BreathTek UBT14

• Use of antacids does not appear to affect the accuracy of the BreathTek UBT14

• Pooled data from 9 published studies of H. pylori–positive patients (N=626) con� rm the performance of the UBT method in patients taking PPIs17

All registered trademarks are the property of their respective owners.

BreathTek UBT:simple, convenient, noninvasive

Excellent sensitivity (96%) and speci� city (96%) when con� rming eradication in adults*14

* Data are weighted mean values. Compilation of data is not the result of a comparative study.

† Serology is not effective in post-treatment testing because it cannot distinguish between active and past infection.

ELISA, enzyme-linked immunosorbent assay.

When using BreathTek UBT, 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 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

25%Eradication therapy may fail in 25% of patients—partly because of increased antibiotic resistance9,18

76


ACG guidelines do not support serologic testing in populations with low H. pylori prevalence2

Stool testing is associated with relatively low patient compliance23

• Serologic tests cannot distinguish active H. pylori infection from past infection2

• If serology is used, positive results should be con� rmed with a test of active infection2

• In one study, more patients returned for a post-treatment UBT vs a stool test (N=29)24

• In a separate study of fecal occult blood testing, the overall compliance rate was 17.9% (N=1940)23

†Assumes a 30% H. pylori prevalence rate.

With serologic testing,

1 out of every 3positive test results may be wrong†2,21,22

Con� rm the cure with BreathTek UBT

Symptom resolution does not always mean treatment success

• Antibiotic resistance is on the rise9—and may be the strongest predictor of treatment failure19

• Patients may not complete their full course of therapy20

ACG* calls the UBT method “the most reliable nonendoscopic test…” to con� rm

H. pylori eradication.2

*ACG, American College of Gastroenterology.

STEP 1

STEP 2

STEP 3

STEP 4

STEP 5

98


BreathTek UBT—easy for you and your patient

BreathTek UBT

It takes only 4 simple steps to administer

1. Collect baseline sample by having the patient inhale, hold their breath momentarily, then exhale into the blue bag. Place cap on the bag and press down until it snaps to prevent sample loss.

2. Thoroughly mix the entire Pranactin®-Citric packet with water in the plastic container. Close the lid securely by pressing down until you hear a click and swirl until dissolved up to 2 minutes. The patient must drink the solution using the plastic straw provided.

3. Wait 15 minutes.

4. Collect the second breath sample in the pink bag using the same procedure as Step 1. Breath sample may be collected no later than 30 minutes POST-DOSE. Place cap on the bag and press down until it snaps to prevent sample loss.

Samples are good for 7 days, at room temperature, after collection.

The patient experience with fecal antigen testing (FAT)

Your patient is responsible for completing the 5 steps of testing25

Patient inserts dish in toilet and ensures the sample does not touch water or urine

Patient uses a collection spoon to scoop a sample

Patient washes hands with soap and water

Patient places sample container in bag and refrigerates

Patient transports sample to physician or lab within 24 to 48 hours

FAT

10

Brief Summary about BreathTek UBT

Intended UseThe 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 13CO2 to 12CO2 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. (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 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 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.

11

• 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.

• 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 EventsDuring 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.

January 2016 05US16IBR0001

Please see Current Package Insert enclosed in front pocket.

Gluestrip

Gluestrip

Gluestrip

PI

BC


90%More than

OF DUODENALULCERS6


OF GASTRICULCERS6









H. pylori:A common chronic infection…






Affects at least


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Documents

noninvasive simple A diagnose H. pylori 1 in 4 children A ... · ‡ Alarm features include bleeding, anemia, early satiety, unexplained weight loss, progressive dysphagia, odynophagia,