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Validus Pharmaceuticals LLC
119 Cherry Hill Road – Suite 310
Parsippany, NJ 07054

 

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IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

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Predialysis Patients: Rocaltrol is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients: Rocaltrol is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis. In these patients, Rocaltrol administration enhances calcium absorption, reduces serum alkaline phosphatase levels, and may reduce elevated parathyroid hormone levels and the histological manifestations of osteitis fibrosa cystica and defective mineralization. Hypoparathyroidism Patients: Rocaltrol is also indicated in the management of hypocalcemia and its clinical manifestations in patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism, and pseudohypoparathyroidism.

 

CONTRAINDICATIONS

Rocaltrol should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. Use of Rocaltrol in patients with known hypersensitivity to Rocaltrol (or drugs of the same class) or any of the inactive ingredients is contraindicated.

 

WARNINGS

Rocaltrol should not be taken if there are symptoms of abnormally elevated vitamin D or calcium levels or if you are allergic to any product ingredient. Taking too much vitamin D can cause high calcium levels, which could trigger serious health problems and may require immediate medical attention. Dosage adjustments of Rocaltrol may be required if other medications are initiated or discontinued; do not stop taking other medications without your physician’s knowledge. Potential side effects of Rocaltrol are, in general, similar to effects of taking too much vitamin D. Report early symptoms of elevated vitamin D or calcium including weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle or bone pain, metallic taste, and anorexia, abdominal pain or stomach ache, to your doctor.

Laboratory tests should be done routinely and more frequently when Rocaltrol is initiated or during dose changes to measure parathyroid hormone PTH), minerals such as calcium and phosphorus levels in the blood and creatinine. Rocaltrol doses will be adjusted accordingly to maintain blood levels of minerals within targeted levels to ensure optimum PTH reduction/levels. It is important to adhere to a diet low in phosphorus if advised by your physician and to take phosphate binders as prescribed. Do not take any medications or vitamin/mineral supplements without your Health Care Provider’s permission.

 

PRECAUTIONS

Excessive dosage of Rocaltrol induces hypercalcemia and in some instances hypercalciuria; therefore, early in treatment during dosage adjustment, serum calcium should be determined twice weekly. In dialysis patients, a fall in serum alkaline phosphatase levels usually antedates the appearance of hypercalcemia and may be an indication of impending hypercalcemia.

Should hypercalcemia develop, treatment with Rocaltrol should be stopped immediately. During periods of hypercalcemia, serum calcium and phosphate levels must be determined daily. When normal levels have been attained, treatment with Rocaltrol can be continued, at a daily dose 0.25 mcg lower than that previously used. An estimate of daily dietary calcium intake should be made and the intake adjusted when indicated. Rocaltrol should be given cautiously to patients on digitalis, because hypercalcemia in such patients may precipitate cardiac arrhythmias.

Immobilized patients, e.g., those who have undergone surgery, are particularly exposed to the risk of hypercalcemia.

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. Rocaltrol therapy should always be started at the lowest possible dose and should not be increased without careful monitoring of the serum calcium. An estimate of daily dietary calcium intake should be made and the intake adjusted when indicated.

Patients with normal renal function taking Rocaltrol should avoid dehydration. Adequate fluid intake should be maintained.

 

Drug Interactions: Cholestyramine: Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; as such it may impair intestinal absorption of Rocaltrol. Phenytoin/Phenobarbital: The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of calcitriol, but may reduce endogenous plasma levels of 25(OH)D3 by accelerating metabolism. Since blood level of calcitriol will be reduced, higher doses of Rocaltrol may be necessary if these drugs are administered simultaneously. Thiazides: Thiazides are known to induce hypercalcemia by the reduction of calcium excretion in urine. Digitalis: Calcitriol dosage must be determined with care in patients undergoing treatment with digitalis, as hypercalcemia in such patients may precipitate cardiac arrhythmias. Ketoconazole: Ketoconazole may inhibit both synthetic and catabolic enzymes of calcitriol. Corticosteroids: A relationship of functional antagonism exists between vitamin D analogues, which promote calcium absorption, and corticosteroids, which inhibit calcium absorption. Phosphate-Binding Agents: Since Rocaltrol also has an effect on phosphate transport in the intestine, kidneys and bones, the dosage of phosphate-binding agents must be adjusted in accordance with the serum phosphate concentration. Vitamin D: Since calcitriol is the most potent active metabolite of vitamin D3, pharmacological doses of vitamin D and its derivatives should be withheld during treatment with Rocaltrol to avoid possible additive effects and hypercalcemia. Calcium Supplements: Uncontrolled intake of additional calcium-containing preparations should be avoided. Magnesium: Magnesium-containing preparations (e.g., antacids) may cause hypermagnesemia and should therefore not be taken during therapy with Rocaltrol by patients on chronic renal dialysis.

 

Use in Special Populations: Nursing Mothers: Calcitriol from ingested Rocaltrol may be excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from Rocaltrol in nursing infants, a mother should not nurse while taking Rocaltrol. Geriatric Use: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Pediatric Use: Safety and effectiveness of Rocaltrol in pediatric patients undergoing dialysis have not been established. Dosing guidelines have not been established for pediatric patients under 1 year of age with hypoparathyroidism or for pediatric patients less than 6 years of age with pseudohypoparathyroidism.

 

Adverse Reactions

Adverse effects are, in general, similar to those encountered with excessive vitamin D intake, i.e., hypercalcemia syndrome or calcium intoxication, depending on the severity and duration of hypercalcemia. The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include: Early: weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia, abdominal pain or stomach ache. Late: polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated SGOT (AST) and SGPT (ALT), ectopic calcification, nephrocalcinosis, hypertension, cardiac arrhythmias, dystrophy, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis.

To report suspected Adverse Reactions, call Validus Pharmaceuticals LLC at 1-866-982-5438 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In case of emergency, call 911.