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About Cryptosporidiosis (Crypto)6Cryptosporidiosis is a highly underdiagnosed parasitic illness 6,9Responsible for 89% of all infectious casesof recreational water disease 9 99% of cases in the U.S. go undiagnosed 6- Commonly missed by a variety of diagnostictests, including ova & parasite (O&P) 10- In two controlled clinical trials, oocysts wereundetected in 27% to 46% of symptomaticpatients known to have Crypto 11,12Crypto is protected by an outer shell thatmakes it tolerant to chlorine and ableto live outside the body for long periodsof time 9There’s only one FDA-approvedmedication for treating diarrhea caused byCryptosporidium parvum*IndicationsALINIA ® 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 thetreatment 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 hypersensitivityto nitazoxanide or any other ingredient in the formulations.
ALINIA ® Tablets Clinical Study Design † †Study design for OS in pediatric patients can be found on page 10 of this presentation7In clinical trials, patients were enrolled with diarrhea and withor without enteric symptoms, including 13 :• Diarrhea• Nausea• Fever• Loss of appetite• Abdominal pain/cramps• Vomiting• Bloating• GasALINIA 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 nohematochezia within the past 24 hours, or• No symptoms and no unformed stools within the past 48 hours*IndicationsALINIA ® 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 byGiardia 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 parvumin HIV-infected or immunodeficient patients.Important Safety Information• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivityto nitazoxanide or any other ingredient in the formulations.• The most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia and nausea.• Tizoxanide (the active metabolite of nitazoxanide) is highly bound to plasma protein (>99.9%). Therefore, monitor for adverse reactions when administering nitazoxanideconcurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g., warfarin).• ALINIA tablets and ALINIA for Oral Suspension should be taken with food.• Safety and efficacy of ALINIA for Oral Suspension in pediatric patients less than one year of age has not been studied.*Please read the Full Prescribing Information.To report suspected adverse reactions, contact Romark at 1-813-282-8544 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
Page 1 and 2: When diarrhea persists more than 14
Page 3 and 4: AGA Clinical Guidelines3In 2019 gui
Page 5: About Giardiasis5In the U.S., Giard
Page 9 and 10: ALINIA ® Tablets Efficacy9ALINIA T
Page 11 and 12: ALINIA ® OS Head-to-Head Data11ALI
Page 13 and 14: ALINIA ® Safety Profile13Most Comm
Page 15 and 16: ALINIA ® Patient Savings15With the

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