Cinacalcet

Indications
 Oral
Secondary hyperparathyroisim in patients with chronic kidney disease on dialysis
Adult: ≥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 150-300pg/mL. Max: 180 mg once daily. May be used alone or in combination with vitamin D sterols and/or phosphate binders.
Oral
Hypercalcaemia associated with parathyroid carcinoma or primary hyperparathyroidism
Adult: ≥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.
Warnings / Precautions
 Moderate-to-severe hepatic impairment, CV diseases. Not indicated for chronic kidney disease patients who are not receiving dialysis. Do not initiate Cinacalcet in hypocalcaemic patients. For secondary hyperparathyroidism, measure serum calcium and phosphorus (prior to- and within 1 wk after initiation/dose adjustment; mthly during maintenance) and iPTH (prior to- and within 1-4 wk after initiation/dosage adjustment; every 1-3 mth during maintenance). iPTH levels should drawn at least 12 hr after Cinacalcet dosing. For parathyroid carcinoma and primary parathyroidism, measure serum calcium prior-to and within 1 wk after initiation/dose adjustment; and every 2-3 mth during maintenance. Vitamin D sterols, calcium-containing phosphate binder and/or adjustment of calcium contents of dialysis fluid can be used to raise serum calcium in the event of hypocalcaemia. Reduce dose or withhold therapy if hypocalcaemia persists; may reinstate treatment at the next lowest dose after calcium levels normalised. Significant reduction in serum calcium may lower seizure threshold. Adynamic bone disease may develop if iPTH level is suppressed to < 100 pg/mL. May decrease total and free testosterone levels. Safety and efficacy not established in patients ≤18 yr. Pregnancy and lactation.
Adverse Reactions
 Nausea, vomiting, diarrheoa, anorexia, dizziness, myalgia, paraesthesia, asthenia, chest pain (non-cardiac), rash, urticaria, seizure, decreased testosterone levels, hypocalcaemia, hypotension, hypertension.
Potentially Fatal: Hypersensitivity reaction including angioedema.
Overdose Reactions
 Overdosage may lead to hypocalcaemia. Provide treatment to correct serum calcium levels. Haemodialysis are unlikely to be useful.
Drug Interactions
 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.
See Below for More cinacalcet Drug Interactions
Food Interactions
 Increased exposure and maximum plasma concentration (Cmax) when administered with a high fat meal.
Mechanism of Actions
 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.
Onset: Nadir in intact PTH (iPTH) level occurs at about 2-6 hr following admin.
Absorption: Tmax: About 2-6 hr. Steady state concentrations achieved within 7 days.
Distribution: Protein binding: About 93-97%. Vd: About 1000 L.
Metabolism: Extensive hepatic metabolism, mainly via CYP3A4, CYP2D6 and CYP1A2 to form inactive metabolites.
Excretion: Biphasic clearance; terminal half-life: About 30-40 hr; prolonged in patients with moderate and severe hepatic impairment. Excreted in urine (about 80%); faeces (about 15%).
Administration
 Should be taken with food. (Take w/ food or shortly after food. Swallow whole, do not divide.)
Storage Conditions
 Oral: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Storage
 Oral: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Available As
  • Cinacalcet 30 mg
  • Cinacalcet 60 mg

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