lcemia occur, calcium-containing phosphate binders and/or vitamin D sterols can be used to raise serum calcium. If serum calcium falls below 7.5 mg/dL, or if symptoms of hypocalcemia persist and the dose of vitamin D cannot be increased, withhold administration of Sensipar® until serum calcium levels reach 8.0 mg/dL, and/or symptoms of hypocalcemia have resolved. Treatment should be re-initiated using the next lowest dose of Sensipar® (see DOSAGE AND ADMINISTRATION).
In the 26-week studies of patients with CKD on dialysis, 66% of patients receiving Sensipar® compared with 25% of patients receiving placebo developed at least one serum calcium value < 8.4 mg/dL. Less than 1% of patients in each group permanently discontinued study drug due to hypocalcemia.
Sensipar® is not indicated for CKD patients not on dialysis. In CKD patients with secondary HPT not on dialysis, the long-term safety and efficacy of Sensipar® have not been established. Clinical studies indicate that Sensipar®-treated CKD patients not on dialysis have an increased risk for hypocalcemia compared to Sensipar®-treated CKD patients on dialysis, which may be due to lower baseline calcium levels. In a phase 3 study of 32 weeks duration and including 404 subjects (302 cinacalcet, 102 placebo), in which the median dose for cinacalcet was 60 mg at the completion of the study, 80% of Sensipar®-treated patients experienced at least one serum calcium value < 8.4 mg/dL compared to 5% of patients receiving placebo.
Adynamic Bone Disease
Adynamic bone disease may develop if iPTH levels are suppressed below 100 pg/mL when assessed using the standard Nichols IRMA. One clinical study eva luated bone histomorphometry in patients treated with Sensipar® for one year. Three patients with mild hyperparathyroid bone disease at the beginning of the study developed adynamic bone disease during treatment with Sensipar®. Two of these patients had iPTH levels below 100 pg/mL at multiple time points during the study. In the three 6-month, phase 3 studies conducted in CKD patients on dialysis, 11% of patients treated with Sensipar® had mean iPTH values below 100 pg/mL during the efficacy-assessment phase. If iPTH levels decrease below the NKF-K/DOQI recommended target range (150-300 pg/mL) 1 in patients treated with Sensipar®, the dose of Sensipar® and/or vitamin D sterols should be reduced or therapy discontinued.
Hepatic Insufficiency
Cinacalcet exposure as assessed by AUC(0-inf) in patients with moderate and severe hepatic impairment (as indicated by the Child-Pugh method) were 2.4 and 4.2 times higher, respectively, than that in normals. Patients with moderate and severe hepatic impairment should be monitored throughout treatment with Sensipar® (see CLINICAL PHARMACOLOGY, Pharmacokinetics and DOSAGE AND ADMINISTRATION).
Information for Patients
It is recommended that Sensipar® be taken with food or shortly after a meal. Tablets should be taken whole and should not be divided.
Laboratory tests
Patients with CKD on Dialysis with Secondary Hyperparathyroidism
Serum calcium and serum phosphorus should be measured within 1 week and iPTH should be measured 1 to 4 weeks after initiation or dose adjustment of Sensipar®. Once the maintenance dose has been established, serum calcium and serum phosphorus should be measured approximately monthly, and PTH every 1 to 3 months (see DOSAGE AND ADMINISTRATION). All iP |
