Medical Professional Home Page About Rocaltrol Important Safety Information Dosing and Administration Physician and Patient Checklist Representative Guidelines to Consider Prescribing Information
 
Physician/Patient Checklist
What to ask your patient prior to therapy:
•  If they have any known hypersensitivity to either Rocaltrol (or drugs of the same class), or any of the inactive ingredients:
Inquire about allergies to calcitriol, other forms of vitamin D such as calcifediol, dihydrotachysterol, doxercalciferol, ergocalciferol, paricalcitol, or any other medications or vitamins.
•  If they have renal disease:
Lower predose and peak calcitriol levels were observed in patients with nephritic syndrome and in patients undergoing hemodialysis compared with healthy subjects.
•  If they are pregnant or plan to become pregnant:
Rocaltrol should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
•  If they are nursing or plan to nurse:
Calcitriol from ingested Rocaltrol may be excreted in human milk. To avoid the potential for serious adverse reactions from Rocaltrol in nursing infants, a mother should not nurse while taking Rocaltrol.
•  If they are taking digitalis:
Hypercalcemia in patients on digitalis may precipitate cardiac arrhythmias.
•  If they are taking or plan to start taking any other prescription or non-prescription medications, or herbal products:
Drug interactions have been shown to occur with cholestyramine, phenytoin/phenobarbital, thiazide diuretics, digitalis, ketoconozale, and corticosteroids. Some representative drugs are as follows: cholestyramine; colestipol; digoxin; diuretics; ketoconazole; lanthanum; oral steroids such as dexamethasone, methylprednisolone, and prednisone; phenobarbital; phenytoin; and sevelamer.
•  If they are taking ergocalciferol or have stopped taking it in the past few months:
If so, the initial dosage and titration of Rocaltrol will have to be adjusted accordingly.
•  If they are taking vitamins or nutritional supplements containing vitamin D or calcium:
Excess vitamin D in nutritional supplements in combination with Rocaltrol may result in hypercalcemia. Uncontrolled intake of additional calcium-containing preparations should be avoided.
•  If they are taking any laxatives, anti-diarrheal, or antacids:
These common products can contain phosphate-binding agents or magnesium. Since Rocaltrol also has an effect on phosphate transport in the intestines, kidneys and bones, the dosage of phosphate-binding agents must be adjusted in accordance with the serum phosphate concentration.
•  Finally, if they fully understand the need for compliance with dosing instructions for Rocaltrol, the need for adherence to instructions regarding diet and calcium supplementation, and the avoidance of the use of unapproved prescription drugs, and the potential signs and symptoms of hypercalcemia.
References:
1. Rocaltrol [package insert]. Parsippany, NJ: Validus Pharmaceuticals; 2009.
 
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.