SAFETY & DOSING
- In this section:
- How XIFAXAN Works
- Safety Profile
- Dosing
How XIFAXAN is believed to work in overt HE
Gut-derived toxins, such as ammonia, are thought to be central to the pathogenesis of HE.1,2 XIFAXAN is believed to modulate gastrointestinal flora, including aerobic bacteria (Gram-negative bacteria and Escherichia coli).3
XIFAXAN has a demonstrated safety profile3
Trial 1 safety data (occurring in ≥10% of patients)
Adverse reactions that occurred in ≥5% but <10% of patients receiving XIFAXAN and greater than in patients who received placebo: muscle spasms, pruritus, abdominal pain, anemia, depression, nasopharyngitis, abdominal pain upper, arthralgia, dyspnea, pyrexia, and rash.
Trial 2 safety data (occurring in ≥10% of patients)*
Adverse reactions that occurred in ≥5% but <10% of patients receiving XIFAXAN in either treatment group: dyspnea, anxiety, abdominal pain, decreased appetite, headache, cough, renal failure acute, vomiting.
*Trial 2 safety data described in Table 2 reflect randomized patient exposure to XIFAXAN + lactulose or XIFAXAN monotherapy in an open-label, active-controlled, multicenter, 6-month trial in adults with hepatic encephalopathy.
The safety profile of XIFAXAN was evaluated for 24 months in an open-label extension study4
Rates of HE-related hospitalizations (post hoc analysis)4
- ≥24-month open-label maintenance (OLM) study of XIFAXAN 550 mg twice daily in patients with HE to assess long-term safety and hospitalization data between the group given placebo in the original randomized controlled trial (RCT) (n=159) and those given XIFAXAN (n=140)
- Historical XIFAXAN group: Patients treated with XIFAXAN in the RCT. Patients with Conn scores of 2 were included in the OLM study
- Historical placebo group: Patients treated with placebo in the RCT
- New XIFAXAN group: New patients treated with XIFAXAN during the OLM study
- All-XIFAXAN population: Historical XIFAXAN group and the new XIFAXAN group, 89.8% of whom concomitantly used lactulose
- Concomitant lactulose therapy was optional in the OLM study. Lactulose was used concomitantly by 91% of patients in both arms of the RCT
Safety from ≥24-month open-label study4
- Adverse event (AE) rates were calculated as number of patients/PYE, in which PYE=total exposure in days divided by 365.25; PYE reflected the exposure up until the AE occurrence and therefore may have differed from the PYE for the entire patient group4
- AEs were comparable to those observed during the 6-month randomized study4
- Infections did not increase during the 24-month evaluation4
- Six patients (~1%) developed a C. difficile infection4
Accuracy matters: correctly prescribe XIFAXAN for the reduction in risk of OHE recurrence in adults3
Adherence is important for the treatment of any chronic condition.
One 550-mg tablet, twice daily—no dose adjustments or titrations needed3
- There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients
Can be taken with or without food3
Can be continued for as long as patient is at risk of recurrent OHE3
XIFAXAN Dosing Flashcard
A summary of dosing information for prescribing XIFAXAN.
When prescribing XIFAXAN, use the ICD-10 code for OHE5,†
K76.82 Hepatic encephalopathy
Indicate lactulose history if applicable
XIFAXAN 550 mg
One tablet, twice daily
#60, 5 refills†The ICD-10 code and all other patient-access–related information are provided for informational purposes only. It is the treating physician’s responsibility to determine the proper diagnosis, treatment, and applicable ICD-10 code. Salix Pharmaceuticals does not guarantee coverage or reimbursement for the product.
HE, hepatic encephalopathy; OHE, overt hepatic encephalopathy.
References: 1. Vince AJ, Burridge S. Ammonia production by intestinal bacteria: the effects of lactose, lactulose and glucose. J Med Microbiol. 1980;13(2):177-191. 2. Khan A, Ayub M, Khan WM. Hyperammonemia is associated with increasing severity of both liver cirrhosis and hepatic encephalopathy. Int J Hepatol. 2016;2016:6741754. 3. XIFAXAN. Prescribing information. Salix Pharmaceuticals; 2023. Accessed January 3, 2024. https://shared.salix.com/globalassets/pi/xifaxan550-pi.pdf 4. Mullen KD, Sanyal AJ, Bass NM, et al. Rifaximin is safe and well tolerated for long-term maintenance of remission from overt hepatic encephalopathy. Clin Gastroenterol Hepatol. 2014;12(8):1390-1397. 5. ICD-10. Centers for Medicare & Medicaid Services. Updated December 1, 2021. Accessed January 4, 2024. www.cms.gov/Medicare/Coding/ICD10.
INDICATIONS
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.
IMPORTANT SAFETY INFORMATION
- XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
- Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
XIF.0182.USA.23V3.0