16th March 2017

Safety & Tolerability

In the pivotal study 1 , the adverse events (AEs) profile did not differ significantly between the XIFAXAN® 550 mg bd arm and the placebo arm:

  • The incidence of AEs was 80.0% in the XIFAXAN® arm and 79.9% in the placebo arm (p>0.05 for all comparisons)
  • 9 deaths were reported in the XIFAXAN® arm and 11 in the placebo arm
  • Clostridium difficile infection was reported in 2 patients in the XIFAXAN® arm and in none in the placebo arm. In both patients, XIFAXAN® therapy was continued concomitantly with treatment for the infection, from which they fully recovered

The profile and rates of AEs with long-term rifaximin-α treatment (up to 30 months) 2 appeared similar to data reported in 6-month RCT. 1

Adverse reactions listed by MedDRA system organ class and frequency 3

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

MedDRA* System Organ Class Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to <1/100)
Infections and infestations Clostridial infection, urinary tract infection, candidiasis
Blood and lymphatic system disorders Anaemia
Metabolism and nutrition disorders Anorexia, hyperkalaemia
Respiratory, thoracic, and mediastinal disorders Dyspnoea Pleural effusion
Nervous system disorders Dizziness, headache Balance disorders amnesia, convulsion, attention disorders hypoesthesia, memory impairment
Psychiatric disorders Depression Confusional state, anxiety, hypersomnia, insomnia
Vascular disorders Hot flush
Gastrointestinal disorders Abdominal pain upper, abdominal distension, diarrhoea, nausea, vomiting, ascites Abdominal pain, oesophageal varices haemorrhage, dry mouth, stomach discomfort
Hepatobiliary disorders
Skin and subcutaneous tissue disorders Rashes, pruritus
Musculoskeletal and connective tissue disorders Muscle spasms, arthralgia Myalgia
Renal and urinary disorders Dysuria, pollakiuria
General disorders and administration site conditions Oedema peripheral Oedema, pyrexia
Investigations
Injury, poisoning and procedural complications Fall

*Medical Dictionary for Regulatory Activities.

GL-HEP-XIF-2000171 April 2021
You have reached the TARGAXAN® (rifaximin-α) website developed by Norgine to provide you with information about TARGAXAN®
Please select an option below:
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

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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.

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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.

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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).

References

    1. Bass NM, et al. N Engl J Med 2010;362(12):1071-81
    2. Mullen KD, et al. Clin Gastroenterol Hepatol 2014;12(8):1390-97
    3. XIFAXAN® Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/27427