Calcelar 25 Special Precautions

Careful administration in the following patients: Patients with hypocalcemia [Hypocalcemia may be aggravated.] (See Important Precautions as follows.)
Patients with seizure or 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 CALCELAR 25 mg Film Coated Tablet, sufficient caution should be exercised to avoid hypocalcemia by periodical measurement of the serum calcium level. If hypocalcemia occurs or may occur, it should be taken into account the use of Calcium or Vitamin D preparations, as well as to reduce the dose of CALCELAR 25 mg Film Coated Tablet (See Precautions related to Dosage and Administration under Dosage & Administration). If administration of Calcium or Vitamin D preparations is discontinued during the treatment with CALCELAR 25 mg film Coated Tablet, caution should be exercised for possible occurrence of hypocalcemia. Symptoms likely to be associated with hypocalcemia such as prolonged QT interval, numbness, cramping, feeling unwell, arrhythmia, decreased blood pressure, etc. have been reported in clinical studies.
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: In an overseas clinical study in which Cinacalcet was used in patients with chronic renal failure accompanied by secondary hyperthyroidism who had not yet started dialysis, it has been reported that the blood 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 not yet 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 hypocalcemia and hypophosphatemia occurred due to a rapid decrease in PTH following administration of Cinacalcet.
Effects on ability to drive and use machine: CALCELAR 25 mg Film Coated Tablet may have major influence on the ability to drive a vehicle or operate heavy machinery. Dizziness and seizures have been reported by patients taking CALCELAR 25 mg Film Coated Tablet.
Use in Children: The safety of Cinacalcet in low birth weight infants, newborns, sucklings, infants and children has not been established.
Use in the Elderly: Caution should be exercised when Cinacalcet 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.