Table 2. Adverse Event Incidence (≥ 5%) in Patients on Dialysis   Placebo Sensipar®
  (n = 470) (n = 656)
   
Event*:  (%) (%)
*
Included are events that were reported at a greater incidence in the Sensipar® group than in the placebo group. 
   
Nausea 19 31
Vomiting 15 27
Diarrhea 20 21
Myalgia 14 15
Dizziness 8 10
Hypertension 5 7
Asthenia 4 7
Anorexia 4 6
Pain Chest, Non­Cardiac 4 6
Access Infection 4 5

The incidence of serious adverse events (29% vs. 31%) was similar in the Sensipar® and placebo groups, respectively.

12-Month Experience with Sensipar®: Two hundred and sixty-six patients from 2 phase 3 studies continued to receive Sensipar® or placebo treatment in a 6-month double-blind extension study (12-month total treatment duration). The incidence and nature of adverse events in this study were similar in the two treatment groups, and comparable to those observed in the phase 3 studies.

Postmarketing Experience with Sensipar®: Isolated, idiosyncratic cases of hypotension and/or worsening heart failure have been reported in Sensipar®-treated patients with impaired cardiac function in postmarketing safety surveillance. Diarrhea and myalgia have been identified as adverse reactions during post-approval use of Sensipar®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Parathyroid Carcinoma
The most frequent adverse events in this patient group were nausea and vomiting.

Laboratory values: Serum calcium levels should be closely monitored in patients receiving Sensipar® (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).
OVERDOSAGE
Doses titrated up to 300 mg once daily have been safely administered to patients on dialysis. Overdosage of Sensipar® may lead to hypocalcemia. In the event of overdosage, patients should be monitored for signs and symptoms of hypocalcemia and appropriate measures taken to correct serum calcium levels (see PRECAUTIONS).  

Since Sensipar® is highly protein bound, hemodialysis is not an effective treatment for overdosage of Sensipar®.
DOSAGE AND ADMINISTRATION
Sensipar® tablets should be taken whole and should not be divided. Sensipar® should be taken with food or shortly after a meal.

Dosage must be individualized.
Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis
The recommended starting oral dose of Sensipar® is 30 mg once daily. 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®. Sensipar® should be titrated no more frequently than every 2 to 4 weeks through sequential doses of 60, 90, 120, and 180 mg once daily to target iPTH consistent with the NKF-K/DOQI recommendation for CKD patients on dialysis of 150-300 pg/mL.
Sensipar® can be used alone or in combination with vitamin D sterols and/or phosphate binders.
During dose titration, serum calcium levels should be monitored frequently and if levels decrease below the normal range, appropriate steps should be taken to increase serum calcium levels, such as by providing supplemental calcium, initia