Romark IVA - Digital PDF interaction 10.13
How & Where ALINIA ® Works 12How 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 withPFOR enzyme-dependent electron transfer reaction, which is essential toanaerobic energy metabolism. This may not be the only pathway by whichnitazoxanide exhibits antiprotozoal activity 13• Nitazoxanide is absorbed through the intestine and rapidly converted to theactive metabolite, tizoxanide, circulating in the blood 13Where ALINIA works• Approximately 2⁄3 of the oral dose of nitazoxanide is excreted in the fecesand 1⁄3 in the urine 13• ALINIA treats diarrhea caused by an intracellular pathogen (Cryptosporidiumparvum) and a lumenal anaerobic pathogen (Giardia lamblia) 13*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 ® Safety Profile13Most Common Adverse Reactions≥2% of Patients †Abdominal painHeadacheChromaturiaNausea†In pooled controlled clinical trials involving 536 HIV-uninfected subjects treated with ALINIA tablets or ALINIA for oral suspension 14• Adverse events similar to placebo in clinical trials using the recommended dose 14• Less than 1% of patients discontinued in clinical trials due to adverse events 14• No significant inhibitory effect on cytochrome P450 enzymes 13*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.
- Page 1 and 2: When diarrhea persists more than 14
- Page 3 and 4: AGA Clinical Guidelines3In 2019 gui
- Page 5 and 6: About Giardiasis5In the U.S., Giard
- Page 7 and 8: ALINIA ® Tablets Clinical Study De
- Page 9 and 10: ALINIA ® Tablets Efficacy9ALINIA T
- Page 11: ALINIA ® OS Head-to-Head Data11ALI
- Page 15 and 16: ALINIA ® Patient Savings15With the
How & Where ALINIA ® Works 12
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
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
*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.
Change language