Jinarc Adverse Reactions

Summary of the safety profile: The pharmacodynamically predictable and most commonly reported adverse reactions are thirst, polyuria, nocturia, and pollakiuria occurring in approximately 55%, 38%, 29% and 23% of patients, respectively. Furthermore, tolvaptan has been associated with idiosyncratic elevations of blood alanine aminotransferase (ALT; 4.4%) and aspartate aminotransferases (AST; 3.1%) with infrequent cases of concomitant elevations in bilirubin-total (BT; 0.2%).
Tabulated list of adverse reactions: The incidences of the Adverse Drug Reactions (ADRs) associated with tolvaptan therapy are tabulated as follows. Table 3 is based on adverse events reported during clinical trials and/or post-marketing use. (See Table 3.)
All ADRs are listed by system organ class and frequency: 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) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports. Consequently, the frequency of these adverse events is qualified as "not known".

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Description of selected adverse reactions: Laboratory results: Elevation (>3 × upper limit of normal [ULN]) of ALT was observed in 4.4% (42/958) of patients on tolvaptan and 1.0% (5/484) of patients on placebo, while elevation (>3 × ULN) of AST was observed in 3.1% (30/958) of patients on tolvaptan and 0.8% (4/484) patients on placebo in a double-blind, placebo-controlled trial in patients with ADPKD. Two (2/957, 0.2%) of these tolvaptan-treated patients, as well as a third patient from an extension open-label trial, exhibited increases in hepatic enzymes (>3 × ULN) with concomitant elevations in BT (>2 × ULN).
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 to the company and Drug Office, Department of Health.