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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 chronic kidney disease (CKD) on dialysis. Predialysis patients with Stage 3 or 4 CKD (oral form only).

Adult:

Dialysis: initially 10mcg three times weekly at dialysis; adjust to maintain intact parathyroid hormone (iPTH) between 150–300pg/mL. If iPTH is not lowered by 50% and fails to reach target range, may increase by 2.5mcg at 8-week intervals. Max 20mcg three times weekly. If iPTH <100pg/mL, suspend for 1 week, then resume at a dose that is at least 2.5mcg lower. Predialysis: initially 1mcg once daily; may increase by 0.5mcg at 2-week intervals to target iPTH levels; max 3.5mcg/day.

Children:

Not established.

Contraindications:

Hypercalcemia. Vit.D toxicity.

Warnings/Precautions:

Maintain appropriate calcium, phosphate, fluid intake. Keep serum calcium times phosphate product (Ca × P) <55 in CKD patients. Monitor iPTH, serum calcium, phosphorus (dialysis: at baseline and weekly thereafter; predialysis: every 2 weeks for 3 months during titration, then monthly for 3 months and every 3 months thereafter). Adjust phosphate binder dose to maintain PTH suppression and serum calcium and phosphate levels. Hepatic impairment. Inj: monitor for hypersensitivity at initiation; discontinue and treat if occurs. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:

Additive effects and hypercalcemia with concomitant other forms of Vit.D. Hypermagnesemia with magnesium-containing antacids. May be affected by CYP450 inhibitors (eg, ketoconazole, erythromycin) or hepatic enzyme inducers (eg, glutethimide, phenobarbital); dose adjustments may be needed.

See Also:

HECTOROL INJ

Pharmacological Class:

Vit. D analog.

Adverse Reactions:

Edema, headache, malaise, nausea, vomiting, arthralgia, weight increase, dizziness, sleep disorder, dyspnea; Vit.D toxicity (eg, hypercalcemia, hypercalciuria, hyperphosphatemia, adynamic bone diseases, arrhythmias, seizures); see full labeling.

How Supplied:

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

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