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(see PRECAUTIONS section of full prescribing information for complete labeling information)
General Comments:
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Rocaltrol therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of the serum calcium. |
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Early in treatment during dosage adjustment, serum calcium should be determined twice weekly to check for hypercalcemia. |
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An estimate of daily dietary calcium intake should be made and the intake adjusted when indicated. |
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An abrupt increase in calcium intake may trigger hypercalcemia. |
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Should hypercalcemia develop, treatment with Rocaltrol should be stopped immediately. |
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During periods of hypercalcemia, serum calcium and phosphate levels must be determined daily. |
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When normal levels have been attained, treatment with Rocaltrol can be continued, at a daily dose 0.25 mcg lower than that previously used. |
Patients with Normal Renal Function:
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Patients with normal renal function taking Rocaltrol should avoid dehydration. |
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In patients with normal renal function, chronic hypercalcemia may be associated with an increase
in serum creatinine. While this is usually reversible, it is important in such patients to pay careful attention
to those factors which may lead to hypercalcemia. |
Dialysis Patients:
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In dialysis patients, a fall in serum alkaline phosphatase levels usually antedates
the appearance of hypercalcemia and may be an indication of impending hypercalcemia. |
Rocaltrol and Digitalis:
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Rocaltrol should be given cautiously to patients on digitalis, because hypercalcemia in such patients may
precipitate cardiac arrhythmias. |
Immobilized Patients:
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Immobilized patients, eg, those who have undergone surgery, are particularly exposed to the risk of
hypercalcemia. |
Drug Interactions:
please refer to the attached full prescribing information
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References:
1. Rocaltrol [package insert]. Parsippany, NJ: Validus Pharmaceuticals; 2009.
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| © February 2012 Validus Pharmaceuticals LLC. All rights reserved. ROC-034-09 |
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Important Safety Information for Rocaltrol® (calcitriol) Capsules and Oral solution
Rocaltrol should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. If hypercalcemia develops in a
patient receiving Rocaltrol, treatment should be immediately discontinued. In treating chronic hypocalcemia and resultant metabolic
bone disease in patients undergoing chronic dialysis, the optimal dose must be carefully determined for each patient. During the
titration period of treatment with Rocaltrol, serum calcium levels should be checked at least twice daily. Reassessment and
correction of dosage may be necessary.
Since Rocaltrol is believed to be the active hormone which exerts vitamin D activity in the body, adverse effects are, in general,
similar to those encountered with excessive vitamin D intake, ie, hypercalcemia syndrome or calcium intoxication (depending on
the severity and duration of hypercalcemia). Normalization of elevated serum calcium occurs within a few days of treatment withdrawal
(ie, faster than in treatment with vitamin D3 preparations). Chronic hypercalcemia may lead to generalized calcification,
nephrocalcinosis and other soft tissue calcification. The serum calcium times phosphate (Ca X P) product should not exceed 70
mg2/dL2. Overdose may require immediate medical attention.
Use with caution in patients receiving digitalis, as this may cause cardiac arrhythmias.
The information on this site is intended for reference only. It should not be used for prescribing or dispensing products; consult
the attached full prescribing information. |
