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HECTOROL
Secondary hyperparathyroidism or hypocalcemia
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Drug Name:

HECTOROL Rx

Generic Name and Formulations:
Doxercalciferol 0.5mcg, 1mcg, 2.5mcg; caps.

Company:
Sanofi Genzyme Company

Therapeutic Use:

Indications for HECTOROL:

Secondary hyperparathyroidism in patients with Stage 3 or 4 chronic kidney disease (CKD) and patients with CKD on dialysis.

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.

Contraindications:

Hypercalcemia. Vit.D toxicity.

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.

See Also:

HECTOROL INJ

Pharmacological Class:

Vit. D analog.

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.

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.

How Supplied:

Caps—50; Single-dose vial (1mL, 2mL)—50; Multi-dose vial (2mL)—50

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