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 and aspartate aminotransferases (ALT and AST) with infrequent cases of concomitant elevations in bilirubin-total (BT).
Tabulated list of adverse reactions: The incidences of the Adverse Drug Reactions (ADRs) associated with tolvaptan therapy are tabulated as follows. The table is based on adverse events reported during clinical trials and/or post-marketing use.
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". (See Table 3.)

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Description of selected adverse reactions: To mitigate the risk of significant or irreversible liver injury, blood testing for hepatic transaminases is required prior to initiation of Jinarc treatment, continuing monthly for 18 months and at regular 3-monthly intervals thereafter (see Precautions).
The most frequent adverse reactions are related to water loss. It is therefore of greatest importance that patients have access to water and are able to drink sufficient amounts of fluids. The volume status of patients taking tolvaptan must be monitored to prevent dehydration (see Precautions).
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.