Romark IVA - Digital PDF interaction 10.5(Client feedback R4 10.8)
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
When diarrhea persists more than 14 days…
…which pathogens do you suspect?
ALINIA ® is the only FDA-approved product for the treatment of
diarrhea caused by both Cryptosporidium parvum and Giardia lamblia
in patients 1 year of age and older.*
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
IDSA Guidelines
2
Guidelines
Per 2017 Infectious Disease Society of America (IDSA) guidelines, for patients
with diarrhea that persists ≥ 14 days, consider parasitic pathogens 1
Clinical presentation of chronic diarrhea may be associated with the following pathogens 1 :
Cryptosporidium spp., Giardia lamblia, Cyclospora caytanensis † , Cystoisospora belli † , and Entamoeba histolytica †
†
Nitazoxanide is not indicated for diarrhea caused by these parasites
Considerations when evaluating patients
with infectious diarrhea 1
• International Travel
• Immunocompromised Hosts
• Foodborne/Waterborne Vectors
• Animal Exposure (Zoonoses)
• Antimicrobial Association
• Certain Sexual Practices
• Long-Term Care Facilities
• Child Care Facilities
• Healthcare Associated
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
AGA Clinical Guidelines
In 2019 guidelines, the American Gastroenterology Association (AGA) strongly
recommends: patients with chronic diarrhea should be tested for Giardia 2
Summary of Recommendations on the Laboratory Evaluation of Functional Diarrhea
and Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) † in Adults 2
3
Guidelines
Statement
recommendation
Recommendation 1: In patients presenting with chronic diarrhea, the AGA suggests the use of either fecal
calprotectin or fecal lactoferrin to screen for IBD.
Recommendation 2: In patients presenting with chronic diarrhea, the AGA suggests against the use of ESR or CRP
to screen for IBD.
Strength of
recommendation
Conditional
Conditional
Quality of evidence
Low
Low
Recommendation 3: In patients presenting with chronic diarrhea, the AGA recommends testing for Giardia. Strong High
Recommendation 4: In patients presenting with chronic diarrhea with no travel history to or recent immigration
from high-risk areas, the AGA suggests against testing stools for ova and parasites (other than Giardia).
Recommendation 5: In patients presenting with chronic diarrhea, the AGA recommends testing for celiac disease
with IgA-tTG and a second test to detect celiac disease in the setting of IgA deficiency
Conditional
Strong
Low
Moderate
Recommendation 6: In patients presenting with chronic diarrhea, the AGA suggests testing for bile acid diarrhea. Conditional Low
Recommendation 7: In patients presenting with chronic diarrhea, the AGA makes no recommendation for the use
of currently available serologic tests for diagnosis of IBS
†
Nitazoxanide is not indicated for diarrhea caused by IBD, IBS, or IBS-D
None
Knowledge gap
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
Patient Journey: CDC Study
4
In a recent publication of U.S. insurance claims of 3,000 patients with giardiasis evaluating
diagnosis and treatment practices, it was observed that patient care can be improved 3
Missteps in diagnosis or treatment
Only 18% of patients had a Giardia-specific test followed
by an antiparasitic medication effective against giardiasis 3
Chronic or persistent disease
22% of patients (n = 657) waited >30 days from their first GI
symptom visit to their first visit with a giardiasis diagnosis 3
CDC Studies
27% of patients received a systemic antibiotic ineffective
against Giardia 3
Of 1,000 surveyed pediatricians, approximately 10% said
they would suspect parasites in patients with persistent
diarrhea lasting more than 1 – 2 weeks 4
50% of patients had 3 or more visits to the clinic during
the study window 3
†
Nitazoxanide is not indicated for diarrhea caused by IBS
Nearly 40% of patients (n=1,192) endured symptoms or
waited for a diagnosis for more than 1-month 3
Following acute infection, giardiasis might also lead to
long-term chronic disease, including IBS 3,5 †
Awareness of parasitic infections can enhance
selection of appropriate treatments and potentially
alleviate the patient’s symptoms earlier.
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
About Giardia
5
In the U.S., Giardia is the most common intestinal parasitic infection 6,7
About Giardia
CDC Studies
Causes an estimated 1.2 million episodes
of illness annually with the highest incidence
among children aged 1-9 years 3,6,7
Although giardiasis is frequently reported
among travelers returning from endemic
areas, only 7-8% of U.S. giardiasis cases
are travel-associated 3,6,8
Following acute infection, giardiasis may
also lead to long-term chronic disease,
including irritable bowel syndrome (IBS) 3,5 †
Data indicates that in the U.S. there is often a
delayed diagnosis for Giardia 3
When Giardia is diagnosed, over ¼ of those patients
are prescribed a systemic antibiotic ineffective
against giardiasis
Most cases of giardiasis are not accurately
diagnosed. Additionally, many are not properly
treated with the right medications. 3,6,7
†
Nitazoxanide is not indicated for diarrhea caused by IBS
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
About Crypto
6
Cryptosporidiosis is a highly underdiagnosed parasitic illness 6,9
About Cryptosporidiosis (Crypto)
CDC Studies
Responsible 89% of all infectious cases of
recreational water disease 9 99% of cases in the U.S. go undiagnosed 6
- Commonly missed by a variety of diagnostic
tests, including ova & parasite (O&P) 10
- In two controlled clinical trials, oocysts were
undetected in 27% to 46% of symptomatic
patients known to have Crypto 11,12
Protected by an outer shell that makes
it tolerant to chlorine and able to live
outside the body for long periods of time 9
There’s only one FDA-approved
medication for treating diarrhea caused by
Cryptosporidium parvum.
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
ALINIA ® Clinical Study Design
7
Clinical study design*
In clinical trials, patients were enrolled with diarrhea and with
or without enteric symptoms, including 13 :
• Diarrhea
• Nausea
• Fever
• Loss of appetite
• Abdominal pain/cramps
• Vomiting
• Bloating
• Gas
Clinical Studies
ALINIA demonstrated efficacy against diarrhea with a “well”
response defined as 13 :
• No symptoms, no watery stools and no more than two soft stools with no
hematochezia within the past 24 hours, or
• No symptoms and no unformed stools within the past 48 hours
*Study design for OS in pediatric patients can be found on page 9 of this presentation
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
ALINIA ® Tablets Efficacy
8
ALINIA Tablets, 500 mg, demonstrated efficacy against diarrhea
caused by Cryptosporidium parvum and Giardia lamblia 13
Pathogen and
Clinical Response Rate (%)
Study Number
Alinia Tablets (n) Placebo Control (n)
Cryptosporidium 1 96% (28) 41% (27)
Clinical Studies
Cryptosporidium 2 71% (21) 43% (21)
Giardia 1 85% (54) 44% (27)
Giardia 2 100% (8) 30% (10)
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
ALINIA ® OS Studies
9
ALINIA OS study design & efficacy data
In clinical trials, pediatric patients were enrolled with diarrhea
and with or without enteric symptoms, including 13 :
• Abdominal distention
• Colic
• Nausea
• Left/right iliac fossa tenderness
• Vomiting
ALINIA demonstrated efficacy against diarrhea with a “well” clinical
response defined as 13 :
• No symptoms, no watery stools and no more than two soft stools with no
hematochezia within the past 24 hours, or
• No symptoms and no unformed stools within the past 48 hours
Clinical Studies
ALINIA for Oral Suspension (OS), 100 mg/5 mL
demonstrated efficacy in pediatric patients
with Cryptosporidium parvum 13
Population
Outpatient study
(3 days treatment) age 1-11 years
Clinical Response Rates
Alinia for OS (n)*
Placebo Control (n)
88% (24) 38% (24)
* Clinical response rates statistically significantly higher compared to placebo
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
ALINIA ® OS Head-to-Head Data
10
ALINIA efficacy vs. metronidazole in pediatric patients with Giardia lamblia 13 :
ALINIA for Oral Suspension (OS), 100 mg/5 mL
Clinical Response Rates a (Percent “Well”)
Nitazoxanide (3 days treatment) 90% (43/48)
95%
}
Per Protocol b CI Diff
Metronidazole (5 days treatment) 83% (39/47)
-8%, 21%
Clinical Studies
0% 20% 40% 60% 80% 100%
Randomized, controlled study of 110 pediatric patients treated with ALINIA for Oral Suspension a
a
ALINIA for Oral Suspension 100 mg BID (24-47 months) and 200 mg BID (ages 4-11 years) x 3 days, was compared to metronidazole 125 mg BID (ages
2-5 years) and 250 mg BID (ages 6-11 years) x 5 days; clinical response evaluated 7-10 days after treatment initiation
b
Per protocol analysis includes only patients who took all of their medication and completed the study. Seven patients in each treatment group missed at
least 1 dose of medication and 1 in the metronidazole treatment group was lost to follow-up
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
How & Where ALINIA ® Works 11
How ALINIA works
ALINIA is the first in class and only FDA-approved thiazolide
• The antiprotozoal activity of ALINIA is believed to be due to interference with
PFOR enzyme-dependent electron transfer reaction, which is essential to
anaerobic energy metabolism. This may not be the only pathway by which
nitazoxanide exhibits antiprotozoal activity 13
• Nitazoxanide is absorbed through the intestine and rapidly converted to the
active metabolite, tizoxanide, circulating in the blood 13
• No significant inhibitory effect on cytochrome P450 enzymes 13
Where ALINIA works
Approximately 2 ⁄3 of the oral dose of nitazoxanide is excreted in
the feces and 1⁄3 in the urine 13
• ALINIA treats diarrhea caused by an intracellular pathogen (Cryptosporidium
parvum) and a lumenal anaerobic pathogen (Giardia lamblia) 13
Mechanism of Action
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
ALINIA ® Safety Profile
Adverse events similar to placebo in clinical trials using the
recommended dose 14
12
Most Common Adverse Reactions
≥2% of Patients †
Abdominal pain
Headache
Chromaturia
Nausea
†
In pooled controlled clinical trials involving 536 HIV-uninfected subjects treated with ALINIA tablets or ALINIA for oral suspension 14
• Less than 1% of patients discontinued in clinical trials due to adverse events 14
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Safety
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
ALINIA ® Dosing
13
ALINIA Tablets dosing and administration
For patients 12 years and older:
1 tablet (500 mg) po BID x 3 days with food
+
+
+
ALINIA OS dosing and administration
For patients 12 months and up,
dosing as easy as…
Age Dosage Duration
1
dose
1-3 years
5 mL of ALINIA for Oral Suspension (100 mg nitazoxanide) BID with food
2
times per day
4-11 years
10 mL of ALINIA for Oral Suspension (200 mg nitazoxanide) BID with food
3 Days
3
day course of treatment -
taken with food
≥12 years
25 mL of ALINIA for Oral Suspension (500 mg nitazoxanide) BID with food
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
Safety
ALINIA ® Patient Savings
14
With the ALINIA co-pay program, your eligible commercially insured
patients may pay as little as $10 per prescription*
• ALINIA is covered by most managed care plans
• Your commercially insured patients can use the ALINIA co-pay card, or if they do not have one,
an e-Voucher may be available
• E-Vouchers are applied automatically for eligible patients at eVoucherRx TM pharmacies
Visit eVoucherRx.RelayHealth.com/storelookup
to find a local participating store.
Maximum benefit up to $300 for ALINIA Tablets*
Maximum benefit up to $75 for ALINIA for Oral Suspension*
* Terms and conditions apply. Get more information here
You can also eScribe to one of ALINIA national pharmacy
partners for fast and discreet home delivery:
• Foundation Care Pharmacy: Earth City, MO (NCPDP Provider ID: 26355)
• PantherRx: Pittsburgh, PA 15275 (NPI: 1316213531)
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.
Patient Savings
References
15
1. Shane AL, Mody RK, Crump JA, et al. 2017 Infectious Diseases Society of America Clinical Practices Guidelines for the Diagnosis and Management of Infectious Diarrhea.
Clin Infect Dis 2017;65(12):e45-e80.
2. Smalley W, Falck-Ytter C, Carrasco-Labra A, Wani S, Lytvyn L, Falck-Ytter Y. AGA Clinical Practice Guidelines on the Laboratory Evaluation of Functional Diarrhea and
Diarrhea-Predominant Irritable Bowel Syndrome in Adults (IBS-D). Gastroenterology 2019;157(3):851-854.
3. Beer KD, Collier SA, Du F, Gargano JW. Giardiasis Diagnosis and Treatment Practices Among Commercially Insured Persons in the United States. Clin Infect Dis
2017;64(9):1244-1250.
4. Attias E, Czinn SJ, Harro C, Munoz FM, Sockolow RE, Black JT. Emerging Issues in Managing Pediatric Parasitic Infections: An Assessment of Clinical and Epidemiological
Knowledge of Giardiasis and Cryptosporidiosis. Pediatr Therapeutics 2015;5(3):1-7.
5. Litleskare S, Rortveit G, Eide GE, Hanevik K, Langeland N, Wensaas K-A. Prevalence of Irritable Bowel Syndrome and Chronic Fatigue 10 Years After Giardia Infection.
Clin Gastroenterol H 2018;16(7): 1064-1072.e4.
6. Scallan E, Hoekstra RM, Angulo FJ, et al. Foodborne illness acquired in the United States—major pathogens. Emerg Infect Dis 2011;17:7–15.
7. Painter JE, Gargano JW, Collier SA, Yoder JS; Centers for Disease Control and Prevention. Giardiasis surveillance—United States, 2011–2012. MMWR Morb Mortal Wkly
Rep Suppl 2015; 64(3):15–25.
8. Chute CG, Smith RP, Baron JA. Risk factors for endemic giardiasis. Am J Public Health. 1987;77:585–7.
9. Hlavsa MC, Cikesh BL, Roberts VA, et al. Outbreaks Associated with Treated Recreational Water — United States, 2000–2014. MMWR Morb Mortal Wkly Rep
2018;67:547–551.
10. Painter JE, Hlavsa MC, Collier SA, et al. Cryptosporidiosis Surveillance, 2011-2012. MMWR Morb Mortal Wkly Rep Suppl 2015;64(3):1-13.
11. Okhuysen PC, et al. Infectivity of a Cryptosporidium parvum Isolate of Cervine Origin for Healthy Adults and Interferon-y Knockout Mice. J Infect Dis. 2002;185:1320-9.
12. Okhuysen PC, et al. Virulence of Three Distinct Cryptosporidium parvum Isolates for Healthy Adults. J Infect Dis. 1999;180:1275-81
13. ALINIA (nitazoxanide) Prescribing Information. April 2017.
14. Romark L.C., data on file.
RM-AL-094-01V1 R10.20
*Indications
ALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)
are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.
Important Safety Information
• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity
to nitazoxanide or any other ingredient in the formulations.