16th March 2017

Safety & Tolerability

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

  • The incidence of AEs was 80.0% in the TARGAXAN® arm and 79.9% in the placebo arm (p>0.05 for all comparisons)
  • 9 deaths were reported in the TARGAXAN® arm and 11 in the placebo arm
  • Clostridium difficile infection was reported in 2 patients in the TARGAXAN® arm and in none in the placebo arm. In both patients, TARGAXAN® 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.

UK/XIF5/0719/0522   DOP: October 2019

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. TARGAXAN® Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/27427