Regpara Special Precautions

Precautions Concerning Patients with Specific Backgrounds: Patients with Complication or History of Diseases, etc.: Patients with hypocalcemia [Hypocalcemia may be aggravated.] (See ''Precautions related to dosage and administration'' under Dosage & Administration, "Important Precautions" as follows and "Clinically Significant Adverse Reactions" under Adverse Reactions.)
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.] (See "Patient with Specific Backgrounds" under Pharmacology: Pharmacokinetics under Actions.)
Patients with active or a history of gastrointestinal hemorrhage, gastrointestinal ulcer [Symptoms may worsen or recur.] (See ''Clinically Significant Adverse Reactions" under Adverse Reactions).
Important Precautions: During treatment with Regpara, sufficient caution should be exercised to avoid hypocalcemia by periodical measurement of the serum calcium level. If hypocalcemia occurs or may occur, administration of calcium or vitamin D preparations should be considered, as well as reducing the dose of Regpara. If administration of calcium or vitamin D preparations is discontinued during treatment with Regpara, caution should be exercised for possible occurrence of hypocalcemia. (See "Precautions related to dosage and administration" under Dosage & Administration, "Precautions Concerning Patients with Specific Backgrounds" under Pharmacology: Pharmacokinetics under Actions and "Clinically Significant Adverse Reactions" under Adverse Reactions).
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.
Other Precautions: lnformation Based on Clinical Use: In a clinical study outside Japan in which cinacalcet hydrochloride was used in patients with chronic renal failure accompanied by secondary hyperparathyroidism 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 (2.1 mmol/L)) compared to that in patients receiving dialysis. Use of the drug in patients with chronic renal failure accompanied by secondary hyperparathyroidism who have 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 aboard that hungry bone syndrome accompanied by hypocalcemia and hypophosphatemia occurred due to a rapid decrease in PTH following administration of cinacalcet.
Use in Children: Clinical trials on the efficacy and safety in children have not been conducted.
Use in the Elderly: If any adverse reactions are observed, appropriate measures such as reducing the dose should be taken. Patients aged 65 years or older have been reported to show higher incidences of adverse reactions (prolonged QT interval in particular) than those younger than 65 years.