Cinaca Adverse Reactions

Secondary hyperparathyroidism in patients undergoing maintenance dialysis: Adverse reactions (including laboratory abnormalities) were observed in 393 (68.6%) of 573 patients evaluated for safety in Japanese clinical studies.
The major adverse reactions included digestive symptoms such as 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%). [Data at the time of approval.]
Clinically significant adverse reactions: Hypocalcaemia/decreased serum calcium (13.7%): Symptoms considered attributable to hypocalcaemia (prolonged QT interval, numbness, cramping, feeling unwell, arrhythmia, decreased blood pressure, seizure, etc.) may occur. Therefore, the serum calcium level should be periodically determined with reference to Precautions related to dosage and administration under Precautions. If any abnormalities are observed, the serum calcium level should be confirmed and administration of calcium or vitamin D preparations should be taken into consideration. Moreover, it should also be considered to reduce the dose of Cinaca or discontinue the treatment as needed.
Prolonged QT interval (5.3%): 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 should be taken into consideration. Moreover, it should also be considered to reduce the dose of Cinaca or discontinue the treatment as needed.
Gastrointestinal hemorrhage, gastrointestinal ulcer (incidence unknown): Gastrointestinal hemorrhage and/or gastrointestinal ulcer may develop. Patients must therefore be carefully monitored. If any abnormalities are observed, administration should be discontinued and appropriate measures taken.
Decreased level of consciousness (0.2%), temporary loss of consciousness (0.2%): 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 Cinaca.
Other adverse reactions: If any of the following symptoms are observed, appropriate measures such as dosage reduction or discontinuation should be taken. (See Table 3.)

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