【藥品庫存】 藥品安全警訊 (藥品回收)：本品因亞硝胺類不純物超出建議值，經廠商聯繫自主回收停用。更新日期：2024/12/3。

Chronic kidney disease - Dialysis procedure - Secondary hyperparathyroidism
Hypercalcemia - Parathyroid carcinoma
Primary hyperparathyroidism

Cinacalcet hydrochloride enhances the sensitivity of the calcium sensing receptor to extracellular calcium, thus, directly reducing the levels of parathyroid hormone (PTH) and serum calcium levels.

Distribution:
Vd: approximately 1000 L
Metabolism:
Hepatic; extensive, inhibitor of CYP2D6 ,substrate of CYP3A4, CYP2D6, and CYP1A2.
Excretion:
Renal: Approximately 80% as metabolites
Dialyzable: No (hemodialysis)
Elimination Half Life:30 to 40 hours ;hepatic impairment, 65 to 84 hours

Serum calcium below normal range

C (FDA) ;B3 (AUS)

Infant risk cannot be ruled out.(MDX)

Common:
Cardiovascular: Hypotension (Chronic kidney disease, 11.6% )
Endocrine metabolic: Hypercalcemia (Parathyroid carcinoma, 21%; primary hyperparathyroidism, 12% )
Gastrointestinal: Abdominal pain (Chronic kidney disease, 10.9% ), Constipation (Chronic kidney disease, 5%; parathyroid carcinoma, 10%; primary hyperparathyroidism, 18% ), Diarrhea (Chronic kidney disease, 21% ), Loss of appetite (Chronic kidney disease, 6%; parathyroid carcinoma, 21%; primary hyperparathyroidism, 6% ), Nausea (Chronic kidney disease, 29% to 31%; parathyroid carcinoma, 66%; primary hyperparathyroidism, 30% to 59% ), Vomiting (chronic kidney disease, 26% to 27%; parathyroid carcinoma, 52%; primary hyperparathyroidism, 35% )
Hematologic: Anemia (Parathyroid carcinoma, 17%; intractable primary hyperparathyroidism, 6% )
Musculoskeletal: Arthralgia (Parathyroid carcinoma, 17%; primary hyperparathyroidism, 6% ), Backache (Primary hyperparathyroidism, 12% ), Fracture of bone (Parathyroid carcinoma, 21%; primary hyperparathyroidism, 12% ), Myalgia (Chronic kidney disease, 15% ), Spasm (Primary hyperparathyroidism, 18%; chronic kidney disease, 11.1% )
Neurologic: Asthenia (Chronic kidney disease, 5.4% to 7% ; parathyroid carcinoma, 17% ; primary hyperparathyroidism, 12% ), Dizziness (Chronic kidney disease, 7.3% to 10% ), Headache (Parathyroid carcinoma, 21%; primary hyperparathyroidism or chronic kidney disease, 12% ), Paresthesia (Parathyroid carcinoma, 14%; primary hyperparathyroidism, 29% )
Psychiatric: Depression (Parathyroid carcinoma, 10%; intractable primary hyperparathyroidism, 18% )
Respiratory: Cough (Chronic kidney disease, 11.7% ), Dyspnea (Chronic kidney disease, 13.4% ), Upper respiratory infection (Parathyroid carcinoma, 10%; intractable primary hyperparathyroidism, 12%; chronic kidney disease, 7.6% )
Other: Dehydration (parathyroid carcinoma, 24% ), Fatigue (parathyroid carcinoma, 21%; primary hyperparathyroidism, 12% )
Serious:
Cardiovascular: Prolonged QT interval, Ventricular arrhythmia
Endocrine metabolic: Hypocalcemia (Secondary hyperparathyroidism or chronic kidney disease, 8% to 75%; primary hyperparathyroidism, 6.1% )
Gastrointestinal: Gastrointestinal hemorrhage
Immunologic: Hypersensitivity reaction (Chronic kidney disease, 9.4% )
Neurologic: Seizure (0.7% to 2.5% )

Chronic kidney disease - Dialysis procedure - Secondary hyperparathyroidism:
Initial: 30 mg ORALLY once daily; titrate as necessary no more frequently than every 2 to 4 weeks through sequential doses of 60 mg, 90 mg, 120 mg, and 180 mg ORALLY once daily
Hypercalcemia, In renal transplant recipients with persistent hyperparathyroidism:
Initial: 30 mg orally daily; titrate as necessary every 4 weeks based on intact parathyroid levels and correct total serum calcium; MAX 180 mg/day (study dosage)
Hypercalcemia - Parathyroid carcinoma,Primary hyperparathyroidism:
Initial: 30 mg ORALLY twice daily; titrate as necessary every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg 3 to 4 times daily

General Dosage Information
Safety and efficacy of cinacalcet hydrochloride use in pediatric patients have not been established

Hypocalcemia (serum calcium 7.5 to 8.4 mg/dL or hypocalcemia symptoms), secondary hyperparathyroidism in patients with chronic kidney disease on dialysis: Raise calcium levels with calcium-based phosphate binders and vitamin D sterols .
Hypocalcemia (serum calcium less than 7.5 mg/dL or persistent symptoms and unable to increase vitamin D dose), secondary hyperparathyroidism in patients with chronic kidney disease on dialysis: Stop cinacalcet therapy and reinitiate with the next lowest dose when serum calcium reaches 8 mg/dL or symptoms have resolved .

Hepatic impairment, moderate to severe: Increased cinacalcet exposure; monitor intact parathyroid hormone, serum calcium, and serum phosphorus closely.