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Patients with hypocalcaemia: Hypocalcaemia may be aggravated. (See Important Precautions as follows.)
Patients with seizure or a history of seizure: It has been reported in overseas studies that seizure occurred in patients with a history of seizure.
Patients with hepatic function disorder: The exposure amount will be increased since cinacalcet is metabolized in the liver.
Patients with gastrointestinal hemorrhage and/or gastrointestinal ulcer or a history of gastrointestinal hemorrhage and/or gastrointestinal ulcer: The symptoms may worsen or recur.
Important Precautions: During treatment with Cinaca, sufficient caution should be exercised to avoid hypocalcaemia by periodical measurement of the serum calcium level. If hypocalcaemia occurs or may occur, it should be taken into account to use calcium or vitamin D preparations, as well as to reduce the dose of Cinaca. (See Precautions related to dosage and administration as follows.) If administration of calcium or vitamin D preparations is discontinued during treatment with Cinaca, caution should be exercised for possible occurrence of hypocalcaemia. Symptoms likely to be associated with hypocalcaemia such as prolonged QT interval, paresthesia, cramping, feeling unwell, arrhythmia, decreased blood pressure, and seizure, etc. have been reported in clinical studies on the drug.
At the start of administration and during the dose adjustment period, the patient's symptoms should be frequently monitored and caution should be exercised for possible occurrence of adverse reactions.
Precautions related to dosage and administration: Secondary hyperparathyroidism in patients undergoing maintenance dialysis: Cinaca has an effect of decreasing calcium in blood. Therefore, it should be confirmed that the patient's serum calcium level is not low (9.0 mg/dL or more) prior to administration.
The serum calcium level should be determined once a week at the start of administration and during the dose adjustment period, and at least once every two weeks during the maintenance period. If serum calcium level decreases to 8.4 mg/dL or less, the following measures should be taken. If it is difficult to control serum calcium and PTH, dose decreased by 12.5 mg at a time should be considered. (See Table 2.)
Click on icon to see table/diagram/imageThe serum calcium level should be determined before administration of Cinaca so that the effect and safety of the drug may be properly evaluated. Furthermore, it is recommended that corrected serum calcium values* should be used as a guide in patients with hypoalbuminemia (serum albumin <4.0 g/dL).
The serum PTH level should be periodically determined so that it may be maintained at the target level for management. It is recommended that the serum PTH level should be determined twice a month at the start of administration and during the dose adjustment period (about 3 months after the start of administration), and at least once a month after the serum PTH level is confirmed to be almost stable. The serum PTH level should be determined before administration of Cinaca so that the effect and safety of the drug may be properly evaluated.
* A corrected serum calcium value is to be calculated as follows: Corrected serum calcium (mg/dL) = Serum calcium (mg/dL) - Serum albumin (g/dL) + 4.0.
Other Precautions: In an overseas clinical study in which cinacalcet hydrochloride was used in patients with chronic renal failure accompanied by secondary hyperthyroidism who had not yet started dialysis, it has been reported that the serum calcium level tended to be lower than the lower limit of the normal range (8.4 mg/dL) compared to that in patients receiving dialysis. Use of the drug in patients with chronic renal failure accompanied by secondary hyperthyroidism who had not yet been on dialysis has not been approved.
It has been reported abroad that adynamic bone disease occurred due to an excessive decrease in PTH following administration of cinacalcet.
It has been reported abroad that hungry bone syndrome accompanied by hypocalcaemia and hypophosphatemia occurred due to a rapid decrease in PTH following administration of cinacalcet.
Use in the Elderly: Caution should be exercised when Cinaca is administered to patients aged 65 years or older, because they have been reported to show higher incidences of adverse reactions (prolonged QT interval in particular) than those younger than 65 years. If any adverse reactions are observed, appropriate measures such as reducing the dose should be taken.
Use in Children: The safety of Cinaca in low birth weight infants, newborns, sucklings, infants and children has not been established. No clinical experience.
