Calcelar 25 Dosage/Direction for Use

Administer with a food or shortly after a meal.
Do not break or divide tablet; should be taken whole.
Do not titrate dose more frequently than every 2 to 4 weeks.
May be used alone or in combination with vitamin D and/or phosphate binders.
Dosage adjustment may be required in patients on concurrent CYP3A4 inhibitors.
Secondary hyperparathyroidism: The starting dosage for adult is 25 mg of cinacalcet once daily, to be orally administered. With careful management of the patient's serum parathyroid hormone (PTH) and calcium levels, the dose may then be adjusted with a range of 25-75 mg once daily. If no improvement is found in PTH, the dose may be increased up to 100 mg once daily. If dose increase is required, dose should be increased by 25 mg at a time, at intervals of at least 3 weeks.
Dosage adjustment for hypocalcemia: Hypocalcemia (serum calcium 7.5 to 8.4 mg/dL or hypocalcemia symptoms): Raise calcium levels with calcium-containing 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): Stop cinacalcet therapy and reinitiate with the next lowest dose when serum calcium reaches 8 mg/dL or symptoms resolve.
If iPTH <150 pg/dL: Reduce dose or discontinue cinacalcet and/or vitamin D.
Dosage adjustment for renal impairment: No dosage adjustment necessary.
Dosage adjustment for hepatic impairment: Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
Moderate to severe impairment (Child-Pugh class B or C): May have an increased exposure to cinacalcet and increased half-life. Dosage adjustment may be necessary based on serum calcium, serum phosphorus and/or iPTH.