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Hectorol Generic Name & Formulations
Legal Class
Rx
General Description
Doxercalciferol 0.5mcg, 1mcg, 2.5mcg; caps.
Pharmacological Class
Vit. D analog.
See Also
How Supplied
Caps—50; Single-dose vial (1mL, 2mL)—50; Multi-dose vial (2mL)—50
Manufacturer
Hectorol Indications
Indications
Secondary hyperparathyroidism in patients with Stage 3 or 4 chronic kidney disease (CKD) and patients with CKD on dialysis.
Hectorol Dosage and Administration
Adult
Stage 3 or 4: initially 1mcg once daily; may increase by 0.5mcg at 2-week intervals to desired intact parathyroid hormone (iPTH) therapeutic range; max 3.5mcg/day. Suspend or decrease dose if iPTH persistently or abnormally low or serum calcium consistently above normal range; if suspended, resume after 1 week at a dose that is at least 0.5mcg lower. Dialysis: initially 10mcg three times weekly at dialysis (no more frequently than every other day); may increase by 2.5mcg at 8-week intervals to desired iPTH therapeutic range; max 20mcg three times weekly. Suspend or decrease dose if iPTH persistently or abnormally low or serum calcium consistently above normal range; if suspended, resume after 1 week at a dose that is at least 2.5mcg lower.
Children
Not established.
Hectorol Contraindications
Contraindications
Hypercalcemia. Vit.D toxicity.
Hectorol Boxed Warnings
Not Applicable
Hectorol Warnings/Precautions
Warnings/Precautions
Maintain appropriate calcium, phosphate intake. Monitor iPTH, serum calcium, phosphorus (Stage 3 or 4: every 2 weeks for 3 months during titration, then monthly for 3 months and every 3 months thereafter; dialysis: at baseline and weekly thereafter). Adynamic bone disease. Hepatic impairment: monitor iPTH, calcium, phosphorus levels more frequently. Inj: monitor for hypersensitivity at initiation; discontinue and treat if occurs. Pregnancy. Nursing mothers: monitor infants for hypercalcemia.
Hectorol Pharmacokinetics
See Literature
Hectorol Interactions
Interactions
Concomitant high doses of calcium-containing preparations, thiazides, other Vit.D compounds may increase risk of hypercalcemia; monitor and adjust dose as needed. Hypermagnesemia with magnesium-containing antacids; avoid in patients on chronic dialysis. Monitor serum calcium and for digitalis toxicity when concomitant digitalis compounds. May be affected by CYP450 inhibitors (eg, ketoconazole, erythromycin) or hepatic enzyme inducers (eg, glutethimide, phenobarbital); dose adjustments may be needed. Caps: separate dosing by ≥1hr before or 4–6hrs after cholestyramine, mineral oil, other products that affect fat absorption.
Hectorol Adverse Reactions
Adverse Reactions
Infection, UTI, chest pain, angina, constipation, dyspepsia, anemia, leucopenia, dehydration, edema, depression, hypertonia, insomnia, asthenia, paresthesia, increased cough, dyspnea, pruritus, sinusitis, rhinitis, headache, malaise, nausea/vomiting, dizziness, bradycardia; hypercalcemia.
Hectorol Clinical Trials
See Literature
Hectorol Note
Not Applicable
Hectorol Patient Counseling
See Literature
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