Generic Name and Formulations:
Doxercalciferol 0.5mcg, 1mcg, 2.5mcg; caps.
Sanofi Genzyme Company
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).
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.
Hypercalcemia. Vit.D toxicity.
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.
Vit. D analog.
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.
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.
Caps—50; Single-use vial (1mL, 2mL)—1; Multi-dose vial (2mL)—1