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In the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease
Previous macrolide exposure
puts your H. pylori treatment
success at risk
Choose PYLERA® Capsules plus omeprazole
Previous macrolide exposure increases the
risk of clarithromycin resistance1,2
• ACG* Guidelines recommend an OBMT† treatment as
first-line therapy3
PYLERA® Capsules plus omeprazole is an
OBMT-based treatment regimen that does
not contain macrolides4
“The first course of therapy offers the greatest
likelihood of eradicating H. pylori infection”3
• Failure to eradicate results in regrowth of H. pylori up to
pretreatment levels5
*ACG = American College of Gastroenterology.
†
OBMT = omeprazole, bismuth, metronidazole, tetracycline.
INDICATION
• PYLERA® Capsules (bismuth subcitrate potassium, metronidazole, and tetracycline
hydrochloride), in combination with omeprazole, are indicated for the treatment of patients
with Helicobacter pylori (H. pylori) infection and duodenal ulcer disease (active or history of
within the past 5 years) to eradicate H. pylori
• The eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence
• To reduce the development of drug-resistant bacteria and maintain the effectiveness of
PYLERA® and other antibacterial drugs, PYLERA® should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by susceptible bacteria
• When culture and susceptibility information are
available, they should be considered in selecting or
modifying antibacterial therapy. In the absence of such
data, local epidemiology and susceptibility patterns
may contribute to the empiric selection of therapy
Please see Important Safety Information on
page 3 and back.
Please see accompanying full US Prescribing
Information.
Previous macrolide exposure changes the
Prior macrolide exposure increases the risk
of clarithromycin resistance1,2
• 61.2% of the US population has been exposed to at least one course of
macrolide antibiotics during the last 9 years6
• In one study, 92% of patients who had a clarithromycin-resistant H. pylori
strain had been treated with a macrolide antibiotic in the past 10 years2
11-fold
increase
80%
80%
The Likelihood of
ClarithromycinResistant
H. pylori Infection
Increases With
Multiple Macrolide
Courses Prescribed
Before Diagnosis*2
Adapted from McMahon et al.
Ann Intern Med; 2003.
*P<.001.
70%
60%
7-fold
increase
50%
50%
40%
4-fold
increase
Up to
28%
30%
20%
10%
0%
7%
0
1-2
3-4
Previous courses of macrolides
≥5
Data from a retrospective cohort analysis of the relationship between previous antimicrobial use and
antimicrobial resistance in H. pylori infections, based on data collected from 1998 to 2002 in 125 Alaskan native
adults with culture-confirmed H. pylori infection. Forty-five percent of patients in this study had hemorrhagic
or superficial ulcerations of the gastric mucosa, 3% had duodenal ulcers, and 6% had gastric ulcers. Previous
antibiotic use was determined from computerized records of antimicrobial courses prescribed in the 10 years
before diagnosis. The antimicrobial susceptibility of H. pylori isolates was determined using agar dilution.2
• ACG Guidelines recommend asking patients if they have previously
used a macrolide for any reason, such as for the treatment of upper
respiratory infection2,3
“Clinicians may want to reconsider the use of
traditional triple therapy in patients with previous
macrolide exposure.”1
—Chey WD. Gastroenterol Hepatol; 2009
2
References: 1. Chey WD. Selecting a therapeutic regimen and optimizing outcomes. Gastroenterol Hepatol. 2009;5(4)(suppl 13):7-8. http://www.clinicaladvances.com/article_pdfs/gh-article-200904-sup13.pdf. Accessed September 20, 2011.
2. McMahon BJ, Hennessy TW, Bensler JM, et al. The relationship among previous antimicrobial use, antimicrobial resistance, and treatment outcomes for Helicobacter pylori infections. Ann Intern Med. 2003;139(6):463-469. 3. 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. 4. PYLERA® [package insert]. Birmingham,
AL: Axcan Pharma US, Inc.; 2011. 5. Vakil N. Management of refractory H. pylori infection. Gastroenterol Hepatol. 2009;5(4)(suppl 13):10-11. http://www.clinicaladvances.com/article_pdfs/gh-article-200904-sup13.pdf. Accessed September 20, 2011.
6. IMS Health, 2011. 7. Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010;59(8):1143-1153. 8. Sasaki M, Ogasawara N, Utsumi K, et al. Changes in 12-year first-line eradication rate of Helicobacter
pylori based on triple therapy with proton pump inhibitor, amoxicillin and clarithromycin. J Clin Biochem Nutr. 2010;47(1):53-58. 9. Laine L, Hunt R, El-Zimaity H, Nguyen B, Osato M, Spénard J. Bismuth-based quadruple therapy using a single capsule of bismuth
biskalcitrate, metronidazole, and tetracycline given with omeprazole versus omeprazole, amoxicillin, and clarithromycin for eradication of Helicobacter pylori in duodenal ulcer patients: a prospective, randomized, multicenter, North American trial. Am J Gastroenterol.
2003;98(3):562-567. 10. O’Morain C, Borody T, Farley A, et al. Efficacy and safety of single-triple capsules of bismuth biskalcitrate, metronidazole and tetracycline, given with omeprazole, for the eradication of Helicobacter pylori: an international multicentre
study. Aliment Pharmacol Ther. 2003;17(3):415-420. 11. Malfertheiner P, Bazzoli F, Delchier J-C, et al, for the Pylera Study Group. Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline
given with omeprazole versus clarithromycin-based triple therapy: a randomised, open-label, non-inferiority, phase 3 trial. Lancet. 2011;377(9769):905-913. 12. Pavičić MJAMP, Namavar F, Verboom T, van Winkelhoff AJ, de Graaff J. In vitro susceptibility
of Helicobacter pylori to several antimicrobial combinations. Antimicrob Agents Chemother. 1993;37(5):1184-1186. 13. Van Caekenberghe DL, Breyssens J. In vitro synergistic activity between bismuth subcitrate and various antimicrobial agents against
Campylobacter pyloridis (C. pylori). Antimicrob Agents Chemother. 1987;31(9):1429-1430.
perspective on first-line treatment of H. pylori
Increasing clarithromycin resistance often
leads to treatment failure3,7
• Clarithromycin resistance is one of the main causes of treatment failure
and declining eradication rates7
100%
The Relationship
Between
Clarithromycin
Resistance and
Eradication Rates
Over a Decade8
80%
91.2%
80.2%
76.0%
60%
40%
26.7%
23.5%
20%
0%
69.0%
34.4%
8.7%
1995-2000
2001-2003
Year
2004-2006
2007-2008
Eradication rate after clarithromycin-based triple therapy (n=709)
Primary resistance to clarithromycin (n=453)
Data from a retrospective investigation of the H. pylori eradication rate and primary resistance to
clarithromycin from January 1995 to December 2008 in 750 patients in Japan. Patients were eligible
if they had been diagnosed with H. pylori infection by at least 1 positive result from culture test,
microscopy, or I3C-urea breath test. Over 34% of patients in this study had gastric ulcer, 25.1% had
duodenal ulcer, and 7.6% had gastroduodenal ulcer. Patients had received a clarithromycin-based triple
therapy consisting of a proton pump inhibitor (omeprazole 20 mg, lansoprazole 30 mg, or rabeprazole 10 mg
bid), amoxicillin (750 mg bid), and clarithromycin (200 mg or 400 mg bid).8
The goal of first-line therapy is to achieve ≥90% eradication.7
IMPORTANT SAFETY INFORMATION:
DRUG INTERACTIONS
Drug interactions exist with PYLERA®. Please refer
to the full US Prescribing Information for complete
details.
• Methoxyflurane: Risk of fatal renal toxicity; do not
co-administer
• Disulfiram: Psychotic reactions can occur; do not
take concurrently or within the last 2 weeks of
disulfiram
• Alcohol: Abdominal cramps, nausea, vomiting,
headaches, and flushing can occur; do not consume
during therapy and for at least 3 days afterwards
• Oral Contraceptives: Decreased efficacy possibly
resulting in pregnancy; use a different or additional
form of contraception
• Anticoagulants: Potentiation of the anticoagulant
effect; prothrombin time, international normalized
ratio (lNR), or other suitable anticoagulation tests
should be closely monitored
• Lithium: Increased lithium serum concentrations;
measure serum lithium and serum creatinine
concentrations during therapy
• Antacids, Multivitamins, or Dairy Products:
Decreased absorption of PYLERA®; do not take
concomitantly
Please see additional Important Safety Information on back.
Please see accompanying full US Prescribing Information.
3
Exposure to Macrolide Antibiotics by State
61.2% of the US population has been exposed to at least one course
of macrolide antibiotics during the last 9 years
Previous macrolide exposure rates by state: percentage of population exposed to macrolide antibiotics from 2002–2011*
AK
41.5%
WA
41.7%
MT
54.5%
OR
40.4%
MN
48.0%
ID
48.2%
WY
66.2%
NV
45.7%
UT
48.8%
CA
44.7%
AZ
48.2%
VT
59.3%
ND
61.3%
IL
59.4%
KS
72.2%
OK
70.2%
NM
49.2%
MO
74.3%
HI
35.0%
IN
76.4%
OH
74.2%
WV
85.4%
MA
59.3%
VA
62.0%
CT 60.0%
64.0%
NJ
71.9%
DE
DC 70.9%
47.4%
MD
59.6%
NC
74.1%
TN
81.3%
AR
83.6%
NH
61.0%
RI
PA
65.7%
KY
85.6%
SC
89.8%
MS
85.1%
TX
62.6%
NY
69.7%
MI
63.7%
IA
75.9%
NE
57.9%
CO
43.7%
WI
49.0%
SD
65.4%
ME
63.9%
AL
81.5%
GA
64.1%
LA
78.9%
30-40%
FL
64.9%
40-50%
50-60%
60-70%
70-80%
*Projected population of patients based on data collected from October 2002 to September 2011, combined with the 2010 census.
Reference: IMS Health, 2011.
80-90%
Exposure to Macrolide Antibiotics by State
Percentage of population exposed to 3–4 courses
and ≥5 courses of macrolide antibiotics from 2009–2011*
Courses of antibiotics
Courses of antibiotics
Courses of antibiotics
State
3–4
≥5
State
3–4
≥5
1.6%
Kentucky
8.5%
3.0%
Ohio
6.9%
2.3%
6.6%
2.0%
Louisiana
6.6%
2.0%
Oklahoma
5.2%
1.4%
2.1%
0.6%
Maine
5.4%
1.7%
Oregon
2.6%
0.7%
4.6%
1.4%
Pennsylvania
6.5%
2.3%
State
3–4
≥5
United States
5.0%
Alabama
Alaska
Arizona
3.0%
0.8%
Maryland
Arkansas
7.4%
2.3%
Massachusetts
5.2%
1.7%
Rhode Island
6.1%
2.2%
California
3.2%
1.0%
Michigan
4.9%
1.6%
South Carolina
7.0%
2.1%
Colorado
2.7%
0.8%
Minnesota
3.2%
1.0%
South Dakota
5.6%
1.9%
Connecticut
5.6%
1.8%
Mississippi
7.3%
2.3%
Tennessee
7.5%
2.5%
Delaware
6.7%
2.2%
Missouri
6.0%
2.0%
Texas
4.5%
1.2%
District of Columbia
2.6%
0.8%
Montana
3.7%
1.1%
Utah
3.2%
1.0%
Florida
4.0%
1.1%
Nebraska
4.0%
1.2%
Vermont
4.9%
1.6%
2.9%
0.9%
Virginia
5.1%
1.6%
Georgia
5.0%
1.5%
Nevada
Hawaii
2.0%
0.6%
New Hampshire
4.9%
1.5%
Washington
2.8%
0.8%
Idaho
3.2%
0.9%
New Jersey
7.3%
2.5%
West Virginia
9.1%
3.6%
Illinois
5.1%
1.7%
New Mexico
3.7%
1.1%
Wisconsin
3.4%
1.0%
Indiana
6.0%
1.9%
New York
6.2%
2.1%
Wyoming
5.6%
1.8%
Iowa
6.0%
2.0%
North Carolina
5.7%
1.6%
Kansas
6.1%
2.0%
North Dakota
5.7%
1.9%
Axcan Pharma US, Inc.,
a subsidiary of Aptalis Pharma Inc.
22 Inverness Center Parkway
Birmingham, Alabama 35242 USA
Tel (800) 472-2634
Fax (205) 991-8426
www.aptalispharma.com
*Projected population of patients based on data collected from January 1, 2009, to September 30, 2011.
Reference: Data on file, Adheris study, Aptalis Pharma US, Inc.; 2011.
11/11
PY150-1111A
©2011 Axcan Pharma US, Inc.
PYLERA is a registered trademark used under license by Axcan Pharma US, Inc.
In the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease
PYLERA® Capsules plus omeprazole—the #1 prescribed
branded OBMT therapy6
An OBMT-based treatment regimen that does not contain macrolides4
• Up to 93% eradication after 10 days of treatment9-11
• Up to 90% eradication in the presence of clarithromycin resistance9
• Generally well tolerated4
Innovative 3-in-1 Capsule
• PYLERA® Capsules contain a unique form of bismuth (bismuth subcitrate potassium)
that has demonstrated synergism with both metronidazole and tetracycline,
as seen in vitro12,13
Generically available?
No
Yes
No*
PYLERA® component
140 mg bismuth subcitrate potassium
125 mg metronidazole
125 mg tetracycline
*Each course of PYLERA® therapy provides 375 mg tetracycline. Available generic solid oral dosage
forms are either 250 mg or 500 mg, which either undermedicate or overmedicate.
Dispense:
120 capsules
3 PYLERA Capsules
taken 4 times a day
for 10 days, after
meals and at bedtime
Dispense:
20 capsu
les
1 omepra
zole
20-mg ca
psule tak
en
with PYL
ERA twic
e a
day, afte
r mornin
g
and even
ing meals
IMPORTANT SAFETY INFORMATION:
CONTRAINDICATIONS
• Patients with renal impairment
• Patients with known hypersensitivity to product
components
ADVERSE REACTIONS
The most frequently reported adverse reactions (≥5%)
during clinical trials were:
• Abnormal feces • Nausea
• Diarrhea • Headache
WARNINGS AND PRECAUTIONS
• Fetal Toxicity: Advise pregnant women of the risk for
permanent discoloration of teeth with tetracycline if
used during the second or third trimester
• Maternal Toxicity: Risk of hepatotoxicity in pregnant
women with high doses of intravenous tetracycline
also resulting in stillborn or premature birth
• Central and Peripheral Nervous System Effects:
Encephalopathy and peripheral neuropathy with
metronidazole, pseudotumor cerebri with tetracycline
and neurotoxicity with bismuth-containing products;
monitor patients with CNS conditions closely and
discontinue promptly if abnormal neurologic
signs develop
• Development of Superinfection: If superinfection
occurs, discontinue PYLERA® and institute
appropriate therapy
• Photosensitivity: Avoid exposure to sun and sun lamps
USE IN SPECIFIC POPULATIONS
• Nursing Mothers: Discontinue drug or nursing,
taking into consideration the importance of the drug
to the mother
• Pediatric Use: Tetracycline may cause permanent
discoloration of the teeth. Enamel hypoplasia has also
been reported. Do not use in children less than 8 years
of age
Please see additional Important Safety Information on page 3.
Please see accompanying full US Prescribing Information.
Axcan Pharma US, Inc.,
a subsidiary of Aptalis Pharma Inc.
22 Inverness Center Parkway
Birmingham, Alabama 35242 USA
Tel (800) 472-2634
Fax (205) 991-8426
www.aptalispharma.com
11/11
PY150-1111
©2011 Axcan Pharma US, Inc.
PYLERA is a registered trademark used under license by Axcan Pharma US, Inc.
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