Medical Professional Home Page About Rocaltrol Important Safety Information Dosing and Administration Physician and Patient Checklist Representative Guidelines to Consider Prescribing Information
Welcome to
Rocaltrol® (ro'kal-trol); (Validus brand of calcitriol [kal"si-tri'ol])

Rocaltrol is a synthetic version of the active form of vitamin D3 which occurs naturally in the body.

Information Covered in this Website:

About Rocaltrol:
•  Indications
•  Contraindications
•  Warnings
•  Precautions
•  Side effects
•  Safety summary
Dosing and Administration
•  Predialysis patients
•  Dialysis patients
•  Hypoparathyroid patients
Physician/Patient Checklist
•  What to ask your patient prior to therapy
•  What to tell your patient to tell you while on therapy
Representative Guidelines to Consider
Full Prescribing Information
1. Rocaltrol [package insert]. Parsippany, NJ: Validus Pharmaceuticals; 2009.
2. National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(Suppl 3):S1-S202. Available at:
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.