Alinia® is the only FDA-approved product for treating diarrhea caused by Cryptosporidium parvum and Giardia lamblia in patients 1 year of age and older.
Alinia Unique Mechanism of Action
- 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.1
- Nitazoxanide is absorbed through the intestine and rapidly converted to the active metabolite, tizoxanide, circulating in the blood.
- No significant inhibitory effect on cytochrome P450 enzymes.1
- Alinia treats diarrhea caused by an intracellular pathogen (Cryptosporidium parvum) and a luminal anaerobic pathogen (Giardia lamblia)
- Approximately 2/3 of the oral dose of nitazoxanide is excreted in the feces and 1/3 in the urine.1
Alinia Safety Profile
Clinical Trials Experience – Treatment for Diarrhea Caused by Cryptosporidium parvum or Giardia lamblia 1
In pooled controlled clinical trials involving 536 HIV-uninfected subjects treated with Alinia tablets or Alinia for Oral Suspension. The most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia and nausea.
Safety data was analyzed for multiple controlled clinical trials in HIV-uninfected subjects 1 year or older using either Alinia Tablets or the Oral Suspension at the recommended dose for at least three days and there were no differences between adverse reactions reported for Alinia treated subjects based on age.
– Adverse events similar to placebo in clinical trials using recommended dose2
– Less than 1% of patients discontinued in clinical trials due to adverse events2
The following adverse reactions have been identified during post approval use of Alinia. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following is a list of adverse reactions spontaneously reported with Alinia Tablets which were not included in clinical trial listings:
Gastrointestinal disorders: diarrhea, gastroesophageal reflux disease
Nervous System disorders: dizziness
Respiratory, thoracic and mediastinal disorders: dyspnea
Skin and subcutaneous tissue disorders: rash, urticaria
1 Alinia [prescribing information]. Tampa, FL: Romark, L.C.; April 2017.
2 Romark, L.C., Data on File
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.
- 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 nitazoxanide concurrently 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 or www.fda.gov/medwatch.
Alinia is a registered trademark of Romark, L.C.
Intended only for Healthcare Professionals of the United States of America. ©2017 Romark, L.C., Tampa, Florida 33607-8416