Cinacalcet

Should be taken with food. Take w/ food or shortly after food. Swallow whole, do not divide.

Hypocalcaemia or serum Ca below the lower limit of the normal range. Concomitant use with etelcalcetide.

Patient with known congenital long QT syndrome, history of QT prolongation, family history of long QT syndrome or sudden cardiac death, impaired cardiac function; risk factors for gastrointestinal bleeding (e.g. gastritis, ulcers, oesophagitis, severe vomiting); history of seizure disorders. Smokers. Not indicated for use in chronic kidney disease (CKD) patients not on dialysis. Moderate to severe hepatic impairment. Pregnancy and lactation. Patient who started or discontinued concomitant therapy with strong CYP3A4 inhibitors or inducers. Patient Counselling This drug may cause dizziness and seizures; if affected, do not drive or operate machinery. Monitoring Parameters Monitor for signs and symptoms of hypocalcaemia at the start of therapy and regularly thereafter. For secondary hyperparathyroidism: Closely check serum Ca and phosphorus levels before and within 1 week after initiation, and frequently during dose titrations or adjustments; iPTH measurement 1-4 weeks after initiation or dose adjustments (wait at least 12 hours after a dose). Obtain serum Ca levels monthly after establishing the maintenance dose. For hypercalcaemia in parathyroid carcinoma or primary hyperparathyroidism: Closely monitor serum Ca levels before and within 1 week after initiation or dose titrations or adjustments. Obtain serum Ca levels every 2 months after establishing the maintenance dose.

Significant: QT prolongation and ventricular arrhythmia secondary to hypocalcaemia; hypotension, worsening of heart failure; seizure, gastrointestinal bleeding (mostly upper gastrointestinal bleeding) and ulcer, adynamic bone disease, reduced free testosterone concentrations; decreased level or temporary loss of consciousness. Blood and lymphatic system disorders: Anaemia. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, dyspepsia, constipation, dysgeusia, abdominal pain. General disorders and administration site conditions: Asthenia, malaise. Immune system disorders: Hypersensitivity reactions (e.g. angioedema, urticaria). Metabolism and nutrition disorders: Hyperkalaemia, anorexia, decreased appetite. Musculoskeletal and connective tissue disorders: Myalgia, muscle spasms, back pain. Nervous system disorders: Headache, dizziness, paraesthesia. Psychiatric disorders: Insomnia. Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, cough, dyspnoea. Skin and subcutaneous tissue disorders: Rash, pruritus. Vascular disorders: Hypertension.
Potentially Fatal: Hypocalcaemia.

Increased risk of hypocalcaemia with other agents known to reduce the serum Ca levels. Increased plasma concentration with strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, telithromycin, ritonavir). Significantly increased exposure of drugs primarily metabolised by CYP2D6 (e.g. desipramine, nortriptyline, metoprolol, flecainide, propafenone, dextromethorphan).

Other Agents Affecting Metabolism