13th March 2017 Kym Jacks-Bryant

XIFAXAN® (rifaximin-α)

THE ONLY LICENSED TREATMENT FOR THE REDUCTION IN RECURRENCE OF OVERT HEPATIC ENCEPHALOPATHY (OHE) IN PATIENTS ≥ 18 YEARS 1

When should XIFAXAN® be prescribed?

XIFAXAN®
When to initiate XIFAXAN® How long should XIFAXAN® be prescribed?
After the first OHE episode to reduce the risk of further episodes. 1 Expert clinical opinion suggests that people may continue to use XIFAXAN® until death or until liver transplant. 2

How should you prescribe XIFAXAN®? 1

  • Licensed dose: 550 mg (one tablet) twice a day.
  • Each tablet contains 550 mg rifaximin-α.
  • XIFAXAN® can be administered with or without food.
  • No dosage adjustment needed in elderly patients and patients with renal or hepatic insufficiency.
  • Use with caution in patients with severe hepatic impairment and in patients with MELD (Model for End-Stage Liver Disease) score >25.
  • Use with caution in patients with impaired renal function.
XIFAXAN tablets

XIFAXAN® Tolerability 1

Common adverse reactions are dizziness, headache, depression, dyspnoea, upper abdominal pain, abdominal distension, diarrhoea, nausea, vomiting, ascites, rashes, pruritus, muscle spasms, arthralgia and peripheral oedema.1

Click here for a more detailed look at XIFAXAN® tolerability

GL-HEP-XIF-20000171 April 2021
Adverse events should be reported to your regulatory agency. Adverse events should also be reported to either your local distributor or by emailing GPharmacoVigilance@norgine.com.


Norgine B.V. Antonio Vivaldistraat 150, 1083HP Amsterdam, Nederland Tel: +31 (0)20 567 09 00 Fax: +31 (0)20 567 09 99 Handelsregister: AMSTERDAM 30127007
www.norgine.com © Copyright Norgine 2021
Cookie Policy
Privacy Policy
Terms of Use
This website is intended for healthcare professionals. If you are a member of the public, please click here.
NORGINE and the sail logo are registered trademarks of the Norgine group of companies.

Product under licence from Alfa Wassermann S.p.A. XIFAXAN is a registered trademark of the Alfa Wassermann group of companies, licensed to the Norgine group of companies.

The website and all of its contents are owned, reviewed, approved and updated by Norgine Limited and/ or its appointed agencies

References

  1. XIFAXAN® Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/27427
  2. NICE. Costing report: Implementing the NICE guidance on rifaximin for preventing episodes of overt hepatic encephalopathy (TA337). Available at: https:// www.nice.org.uk/guidance/ta337/resources/costing-report-428453677
You have reached the TARGAXAN® (rifaximin-α) website developed by Norgine to provide you with information about TARGAXAN®
Please select an option below:
I am a healthcare professionalI am a member of the public
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard (United Kingdom) or www.hpra.ie (Ireland)

Adverse events should also be reported to Medical Information at Norgine Pharmaceuticals Ltd on 01895 826606 or Email: medinfo@norgine.com

Product under licence from Alfasigma S.p.A. TARGAXAN is a registered trademark of the Alfasigma group of companies, licensed to the Norgine group of companies

NORGINE and the sail logo are registered trademarks of the Norgine group of companies

Date of preparation: May 2020 Job Code: UKE-HEP-XIF-2000012 © 2019 Norgine

Privacy Policy
Seven UK participating centres agreed a standardised data collection pro-forma. Patients with chronic liver disease who were treated with rifaximin-α for secondary prevention of overt hepatic encephalopathy (OHE) were included.* Details of all causes of HE and emergency hospital admissions were requested at 3, 6 and 12 months before and after rifaxamin-α initiation. Clinical data were recorded at baseline, at 3, 6 and 12 months before and after rifaximin-α initiation.
87% of patients (n=282) were taking concomitant lactulose.
*Some patients included were on 3 x 400 mg daily as this was prior to the launch of the K licensed dose of XIFAXAN® 550 mg twice a day.

External Link
You are now leaving the Norgine sponsored website and entering an external website.
Norgine is not responsible for the content of external websites

Please confirm you wish to follow this link.

External Link
You are now leaving the Norgine sponsored website and entering an external website.
Norgine is not responsible for the content of external websites

Please confirm you wish to follow this link.

External Link
You are now leaving the Norgine sponsored website and entering an external website.
Norgine is not responsible for the content of external websites

Please confirm you wish to follow this link.

External Link
You are now leaving the Norgine sponsored website and entering an external website.
Norgine is not responsible for the content of external websites

Please confirm you wish to follow this link.

An observational study including 127 patients from the Netherlands. Conducted between September 2015 to May 2018.
AIM: To assess hospital resource use, bacterial infections and adverse events in the 6 months before and after rifaximin-α initiation in patients with overt hepatic encephalopathy.

External Link
You are now leaving the Norgine sponsored website and entering an external website.
Norgine is not responsible for the content of external websites

Please confirm you wish to follow this link:

Costing Details

Inpatient costs were estimated in UK£ at 2013/14 prices from published NHS sources at a mean cost of £513(€569.43)* per day for non-elective admissions for liver disease.1

Rifaximin-α drug costs were calculated from the price published in the British National Formulary of £259(€287.75)* for 56 550mg tablets2, giving an annual drug treatment cost per patient of £3,379(€3750.69)* for the licensed dose of 550mg twice daily.

Please note that costs from this study were based on UK NHS sources and the UK BNF and have been calculated by using GBP to Euro conversion rate mentioned below. These prices may differ from local EU prices of XIFAXAN®.
*Values in Euros converted from values in Pound Sterling at an exchange rate of £1:€1.11 (correct as 03.11.20).

References

  1. NHS reference costs. Available at: www.gov.uk/government/publications/nhs-reference-costs-2013-to-2014, 2013-14
  2. Joint Formulary Committee. British National Formulary. Available at: https://bnf.nice.org.uk/medicinal-forms/rifaximin.html
A retrospective, observational, multicentre study including 145 patients from 11 UK NHS centres. Conducted from Aug 2014 to Jun 2015.
AIM: To compare resource use in the 6 and 12 months before and after rifaximin-α initiation in UK patients with HE.
INCLUSION CRITERIA: Clinical diagnosis of HE. HE diagnosed prior to rifaximin-α initiation. Initiated on rifaximin-α at least 12 months prior data collection.
EXCLUSION CRITERIA: Rifaximin-α initiated at other hospitals. Medical records unavailable.

Details of hospitalisations and hospital visits were extracted from NHS Trust electronic databases. Analysis included only alive patients at the end of 6 and 12 month periods.
IMPRESS study was sponsored and funded by Norgine

Rifaximin-α initiation dose was 1100mg/day (licensed dose) in 30%, 1200 mg/day in 64%, and other doses in 6% of patients, respectively.
This study included patients started on rifaximin-a prior to the launch of XIFAXAN® 550mg bd. 82% of patients (n=119) were taking concomitant lactulose at baseline.

An observational study including 127 patients from the Netherlands. Conducted between September 2015 to May 2018.
AIM: To assess hospital resource use, bacterial infections and adverse events in the 6 months before and after rifaximin-α initiation in patients with overt hepatic encephalopathy.

The study was sponsored by the Foundation for Liver and Gastrointestinal Research Rotterdam (SLO) to which an educational grant was provided by Norgine B.V., Amsterdam, the Netherlands.


Rifaximin-α initiation dose was 1100 mg per day (licensed dose) and was raised to 1650 mg per day in 11 patients due to recurrence of overt hepatic encephalopathy while on 1100 mg per day. 97.6% of patients (n=124) were taking concomitant lactulose at baseline.


* Optional use of lactulose (~90% patients in 'All rifaximin-α' group received concomitant lactulose).