Adult Dosing

Secondary hyperparathyroidism on dialysis

• Initial dose (iPTH >400 pg/mL): 4 mcg IV 3 times per week at the end of dialysis, or approximately every other day. Max: 18 mcg/wk

Titrate: Dose adjustment based on iPTH levels

• <50% and >300 pg/mL: Increase by 1-2 mcg IV q8-wks intervals as necessary
• >50% and <300 pg/mL: Maintain the current dose
• 150-300 pg/mL: Maintain the current dose
• <100 pg/mL: Suspend the therapy for one week, then resume at a dose that is at least 1 mcg IV lower

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Secondary hyperparathyroidism in patients with chronic kidney disease on dialysis

• Hypersensitivity to any of the ingredients of the product
• Hypercalcemia
• Hyperphosphatemia
• Vitamin D toxicity

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised; dose adjustment not defined

See Supplemental Patient Information

• Overdosage of doxercalciferol is dangerous and may require emergency attention. Acute hypercalcemia increases risk of cardiac arrhythmias and seizures and may potentiate the action of digitalis drugs. Generalized vascular calcification and other soft-tissue calcification may occur with chronic hypercalcemia. Maintain serum calcium times serum phosphorus (Ca X P) product at <55 mg²/dL² in patients with chronic kidney disease
• Hypercalcemia, hyperphosphatemia and oversuppression of PTH are the adverse effects reported due to treatment with this drug and these potential adverse effects should be managed by regular patient monitoring and appropriate dosage adjustments
• Withhold pharmacologic doses of vitamin D and its derivatives during doxercalciferol therapy to avoid possible additive effects and hypercalcemia
• Oral calcium-based or other non-aluminum-containing phosphate binders and a low phosphate diet allows controlling serum phosphorus levels in patients with chronic kidney disease
• Decrease dose of doxercalciferol and/or calcium-containing phosphate binders in the event of hypercalcemia. Decrease dose of doxercalciferol and increase dose of phosphate binders in the event of hyperphosphatemia
• Do not use active vitamin D sterols as initial therapy of nutritional vitamin D deficiency; monitor and treat patients for nutritional vitamin D deficiency before starting treatment
• In dialysis patients, do not administer if recent history of hypercalcemia or hyperphosphatemia, or evidence of vitamin D toxicity
• Concurrent use of magnesium-containing antacids or other vitamin D supplements is not recommended due to risk of hypermagnesemia
• Dialysis patients: Monitor serum Ca, PO4, iPTH at baseline, then qwk x 12, then periodically; monitor alkaline phosphatase
• Predialysis: Monitor serum Ca, PO4, iPTH q2 wks x 3 mo after starting therapy or dose adjustment, then qmo x 3, then q3 mo thereafter; monitor alkaline phosphatase
• Use with caution in hepatic impairment and monitor iPTH, calcium, and phosphorous levels frequently

Cautions: Use cautiously in

• Patients receiving digoxin
• Lactation

Supplemental Patient Information

• Patient should avoid concurrent treatment with magnesium-containing antacids or Vitamin D

Pregnancy Category:B

Breastfeeding: Probably Safe; not known whether doxercalciferol is excreted in human milk, due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.

• GI: Nausea, vomiting, anorexia, constipation, dyspepsia, polydipsia, dry mouth, metallic taste, pancreatitis, weight loss, dehydration
• CNS: Dizziness, headache, malaise, drowsiness, sleep disorder, sensory disturbances, overt psychosis, apathy, seizures, insomnia
• CV: Edema, arrhythmias, bradycardia, hypertension, vascular calcification
• EENT: Conjunctivitis, photophobia, rhinorrhea
• ENDO: Hyperparathyroidism
• RESP: Dyspnea
• DERM: Pruritus
• MUSC: Arthralgia, metastatic calcification, muscle pain, bone pain
• GU: Albuminuria, azotemia, decreased libido, nocturia, polyuria, UTI, acute phosphate nephropathy
• HEMA: Elevated blood urea nitrogen, albuminuria, hypercholesteromia, increased AST and ALT, hypercalcemia, hyperphosphatemia
• METABOLIC: Weight gain, hyperthermia, arrested growth, hypervitaminosis D
• MISC: Abscess, soft tissue calcification, adynamic bone disease

• Synthetic vitamin D2 analog; controls intestinal absorption of dietary calcium and tubular reabsorption of calcium by the kidney, mobilizes calcium from the skeleton in conjunction with parathyroid hormone (PTH), and suppress PTH synthesis and secretion
• Activated by CYP 27 in the liver to metabolically active forms of vitamin D
• Half-life: 32-37 hrs

US Trade Name(s)

• Hectorol

US Availability

doxercalciferol (generic)

• INJ: 4 mcg/2 mL (vial)

Hectorol

• INJ: 4 mcg/2 mL (vial)
• INJ: 2 mcg/mL (vial)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Endocrine/Metabolic

Vitamins