Adverse reactions (including laboratory abnormalities) were observed in 393 (68.6%) of 573 patients evaluated for safety at the time of approval.
The major adverse reactions included digestive symptoms eg, nausea/vomiting (124 events, 21.6%), gastric discomfort (107 events, 18.7%), anorexia (56 events, 9.8%) and abdominal distention (34 events, 5.9%), as well as hypocalcaemia/decreased serum calcium (84 events, 14.7%) and prolonged QT interval (33 events, 5.8%).
Clinically Significant Adverse Reactions: Hypocalcaemia/Decreased Serum Calcium (14.7%): Symptoms considered attributable to hypocalcaemia (prolonged QT interval, paresthesia, cramping, feeling unwell, arrhythmia, decreased blood pressure, seizure, etc) may occur. Therefore the serum calcium level should be determined once a week at the start of administration and during the dose adjustment period, and once every 2 weeks during the maintenance period. If any abnormalities are observed, the serum calcium level should be confirmed and administration of calcium or vitamin D preparations taken into consideration. Moreover, it should also be considered to reduce the dose of Regpara or discontinue the treatment as needed (see Dosage & Administration).
Prolonged QT Intervals (5.8%): The QT interval may be prolonged. If any abnormalities are observed, the serum calcium level should be confirmed and administration of calcium or vitamin D preparations taken into consideration. Moreover, it should also be considered to reduce the dose of Regpara or discontinue the treatment as needed.
Decreased Level of Consciousness (0.2%), Temporary Loss of Consciousness (incidence unknown): Decreased level of consciousness, temporary loss of consciousness, etc may occur. If any abnormalities are observed, appropriate measures including discontinuation of the treatment should be taken.
Sudden Death (0.3%): Unexplained sudden death has been reported in patients treated with Regpara.
Others: If any of the following symptoms are observed, appropriate measures eg, dosage reduction or discontinuation should be taken. See Table 3.
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