Cinacalcet

Cinacalcet is indicated in-

• For the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis
• For the treatment of hypercalcemia in patients with parathyroid carcinoma
• For the treatment of hypercalcaemia in patients with primary hyperparathyroidism who still have high calcium level after removal of the parathyroid gland

Cinacalcet is a calcimimetic agent. It lowers parathyroid hormone (PTH) secretion by increasing the sensitivity of the calcium-sensing receptor of the parathyroid gland to activation by extracellular calcium. PTH reduction leads to concomitant decrease in serum calcium and phosphorus concentrations.

Hypercalcaemia associated with parathyroid carcinoma or primary hyperparathyroidism: ≥18 yr, initial: 30 mg bid. Titrate dose every 2-4 wk in sequential doses of 60 mg bid, 90 mg bid, and 90 mg 3-4 times daily as needed until serum calcium levels normalised. Max: 90 mg 4 times/day.

Secondary hyperparathyroisim in patients with chronic kidney disease on dialysis: ≥18 yr, initial: 30 mg once daily. Titrate dose every 2-4 wk in steps of 30 mg as necessary to achieve intact parathyroid hormone (iPTH) levels of 150-300 pg/mL. Max: 180 mg once daily. May be used alone or in combination with vitamin D sterols and/or phosphate binders.

Cinacalcet is a strong CYP2D6 inhibitor and may increase serum concentrations of amitriptyline, nortriptyline and desipramine. Cinacalcet may decrease serum concentrations of tacrolimus. CYP3A4 inhibitors such as ketoconazole, erythromycin may increase plasma concentrations of Cinacalcet.

Cinacalcet is contraindicated in patients with hypersensitivity to any components of this product.

The common side effects of Cinacalcet are nausea, vomiting, anorexia; dizziness, paraesthesia, asthenia; reduced testosterone concentrations; myalgia; rash; less commonly dyspepsia, diarrhoea, and seizures; hypotension and heart failure also reported.

There are no adequate and well-controlled studies in pregnant women. Cinacalcet should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It Only for the use of Medical Professionals is not known whether this drug is excreted in human milk. Considering the potential for clinically significant adverse reactions in infants from Cinacalcet; it is recommended that breast-feeding be discontinued during treatment with Cinacalcet.

Cinacalcet treatment should not be initiated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL). Serum-calcium concentration should be measured before initiation of treatment and within 1 week after starting treatment or adjusting dose, then monthly for secondary hyperparathyroidism and every 2–3 months for primary hyperparathyroidism and parathyroid carcinoma; treatment should not be initiated in patients with hypocalcaemia; in secondary hyperparathyroidism PTH concentration should be measured 1–4 weeks after starting treatment or adjusting dose, then every 1–3 months; dose adjustment may be necessary if smoking started or stopped during treatment; hepatic impairment; pregnancy.

Overdosage may lead to hypocalcaemia. Provide treatment to correct serum calcium levels. Haemodialysis are unlikely to be useful.

Calcium Regulator

Pediatric use: The safety and efficacy of Cinacalcet in pediatric patients have not been established

Geriatric Use: No dosage adjustment is required for geriatric patients over 65 years of age.

Patients with renal impairment: No dosage adjustment is necessary for renal impaired patients

Patients with hepatic impairment: In patients with moderate and severe hepatic impairment, PTH and serum calcium concentrations should be closely monitored throughout treatment with Cinacalcet.

Store in a cool dry place below 30ºC. Protect from light