Risavie 550 Adverse Reactions

Clinical Trials: The safety of rifaximin in patients in remission from hepatic encephalopathy (HE) was evaluated in two studies, a randomised, double-blind, placebo-controlled phase 3 study RFHE3001 and a long-term, open-label study RFHE3002.
Study RFHE3001 compared 140 patients treated with rifaximin (dose of 550 mg twice daily for 6 months) to 159 patients treated with placebo, while study RFHE3002 treated 322 patients, of whom 152 from the RFHE3001 study, with rifaximin 550 mg twice daily for 12 months (66% of patients) and for 24 months (39% of patients), for a median exposition of 512.5 days.
In addition, in three supportive studies 152 HE patients were treated with varying doses of rifaximin from 600 mg to 2400 mg per day for up to 14 days.
All adverse reactions that occurred in patients treated with rifaximin at an incidence ≥5% and at a higher incidence (≥1%) than placebo patients in RFHE3001 are reported in the following table. (See Table 1.)

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Table 2 includes adverse reactions observed in the placebo-controlled study RFHE3001, long term study RFHE3002 and from post-marketing experience, listed by MedDRA system organ class and frequency category.
Frequency categories are defined using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000), Not known (frequency cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 2.)

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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Health Product Pharmacovigilance Center at: http://thaihpvc.fda.moph.go.th.