COMBINED HECTOROL® (doxercalciferol) injection and capsules
Indication
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HECTOROL capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.
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HECTOROL injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis.
Important Safety Information
Contraindications
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Hectorol is contraindicated in patients with hypercalcemia or vitamin D toxicity.
- Hectorol is contraindicated in patients with known hypersensitivity to doxercalciferol or any of its inactive ingredients.
Warnings and Precautions
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Hypercalcemia can occur during Hectorol treatment and can lead to cardiac arrhythmias and seizures. Severe hypercalcemia may require emergency attention. Concomitant use of high dose calcium, thiazide diuretics or vitamin D may increase the risk of hypercalcemia. Monitor serum calcium before initiating therapy and during treatment with Hectorol and adjust dose accordingly. Inform patients about the symptoms of elevated calcium (feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss) and instruct them to report new or worsening symptoms when they occur.
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Hypercalcemia increases the risk of digitalis toxicity. In patients using digitalis compounds, monitor serum calcium and patients for signs and symptoms of digitalis toxicity. Increase frequency of monitoring when initiating or adjusting the dose of HECTOROL.
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Anaphylaxis with symptoms of angioedema, hypotension, unresponsiveness, chest discomfort, shortness of breath, and cardiopulmonary arrest has been reported in hemodialysis patients after administration of HECTOROL. Monitor patients upon treatment initiation for hypersensitivity reactions. Should a reaction occur, discontinue and treat.
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Adynamic bone disease may develop and increase the risk of fractures if intact parathyroid hormone (iPTH) levels are suppressed to abnormally low levels. Monitor iPTH levels to avoid oversuppression and adjust dose if needed.
Patient Monitoring
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For patients with CKD on dialysis monitor serum calcium, phosphorus, and iPTH levels weekly after initiation of therapy or dose adjustment.
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For patients with CKD Stage 3 and 4, monitor serum calcium, phosphorus, and iPTH levels at least every two weeks for 3 months after initiation of therapy or dose adjustment, then monthly for 3 months, and every 3 months thereafter.
Adverse Events
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Adverse events occurring at a frequency of ≥5% in patients taking Hectorol capsules with Stage 3 or Stage 4 chronic kidney disease were infection, urinary tract infection, chest pain, angina pectoris, constipation, dyspepsia, anemia, leukopenia, dehydration, edema, depression, hypertonia, insomnia, asthenia, paresthesia, increased cough, dyspnea, pruritus, sinusitis, and rhinitis.
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The most common adverse events reported by ≥5% of the Hectorol-treated dialysis patients included edema, headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus and bradycardia.
Drug Interactions
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Cytochrome P450 inhibitors: Formation of the active doxercalciferol moiety may be hindered and may necessitate dosage adjustment. Monitor intact PTH and serum calcium concentrations closely.
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Enzyme inducers: Formation of the active doxercalciferol moiety may be affected and may necessitate dosage adjustment. Monitor intact PTH and serum calcium concentrations closely.
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Magnesium-containing products: Combined use may cause hypermagnesemia. Monitor serum magnesium concentrations more frequently and adjust dose as needed.
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Cholestyramine: May impair absorption of HECTOROL capsules. Administer HECTOROL capsules at least 1 hour before or 4 to 6 hours after taking cholestyramine.
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Mineral Oil or Other Substances That May Affect Absorption of Fat: May impair absorption of HECTOROL capsules. Administer HECTOROL capsules at least 1 hour before or 4 to 6 hours after taking substances that may affect absorption.
Special Populations
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This drug should be used during pregnancy only if clearly needed.
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Nursing mothers should discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Infants exposed to HECTOROL through breast milk should be monitored for signs and symptoms of hypercalcemia.
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Patients with hepatic impairment may not metabolize HECTOROL appropriately. More frequent monitoring of intact PTH, calcium, and phosphorus levels should be done in patients with hepatic impairment.
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