Adult Dosing

Secondary hyperparathyroidism on dialysis

• Initial dose (iPTH > 400 pg/mL): 10 mcg PO 3 times/wk
• Titrate: Dose adjustment base on iPTH levels
• Above 300 pg/mL: Increase by 2.5 mcg at eight-week intervals as necessary
• 150-300 pg/mL: Maintain
• <100 pg/mL: Suspend for one week, then resume at a dose that is at least 2.5 mcg lower

Secondary hyperparathyroidism on Pre-dialysis

• Initial dose iPTH >70 pg/mL (Stage 3), >110 pg/mL (Stage 4): 1 mcg once per day
• Titrate: Dose adjustment base on iPTH levels
• Above 70 pg/mL (Stage 3), 110 pg/mL (Stage 4): Increase by 0.5 mcg q2-wk intervals as necessary
• 35-70 pg/mL (Stage 3), 70 -110 pg/mL (Stage 4): Maintain the current dose
• <35 pg/mL (Stage 3), < 70 pg/mL (Stage 4): Suspend for one week, then resume at a dose that is at least 0.5 mcg lower

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Secondary hyperparathyroidism in dialysis patients with chronic kidney disease
• Secondary hyperparathyroidism in pre-dialysis patients with stage 3 or 4 chronic kidney disease

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

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Hepatic impairment: Caution advised, dose adjustments 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 mg ²/dL² in patients with chronic kidney disease
• Avoid doses of vitamin D and its derivatives during treatment to avoid possible additive effects and hypercalcemia
• Use oral calcium-based/other non-aluminum-containing phosphate binders/low phosphate diet to control serum phosphorus levels in patients with chronic kidney disease. Exacerbation of secondary hyperparathyroidism due to uncontrolled serum phosphorus reduces the effectiveness of treatment in reducing blood PTH levels
• Decrease dose of doxercalciferol and/or calcium-containing phosphate binders if hypercalcemia occurs after initiating therapy
• Decrease dose of doxercalciferol and/or increase dose of phosphate binders if hyperphosphatemia occurs after initiating therapy
• Concurrent use of magnesium-containing antacids or other vitamin D supplements is not recommended due to risk of hypermagnesemia
• Dose titration, as well as adjustment in co-therapy is required in order to maximize PTH suppression, maintaining serum calcium and phosphorus within desired ranges
• 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 months after starting therapy or dose adjustment, then every month x 3, then every 3 month thereafter; monitor alkaline phosphatase
• Use with caution in hepatic impairment and monitor iPTH, calcium, and phosphorous levels frequently

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Dialysis patients
• Calcification of heart, arteries and soft tissues
• History of hypercalcemia, hyperphosphatemia
• Evidence of vitamin D toxicity
• Over suppression of PTH

Supplemental Patient Information

• Patient should avoid concurrent treatment with magnesium-containing antacids and 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.

• CV: Edema, arrhythmias, bradycardia, hypertension, vascular calcification
• GI: Nausea, vomiting, anorexia, constipation, dry mouth, abnormal liver function tests, metallic taste, pancreatitis, polydipsia, weight loss
• CNS: Dizziness, headache, malaise, somnolence, weakness, seizures, insomnia
• GU: Albuminuria, azotemia, libido, nocturia, polyuria, acute phosphate nephropathy
• EENT: Conjunctivitis, photophobia, rhinorrhea
• MUSC: Arthralgia, bone pain, metastatic calcification, muscle pain, adynamic bone disease
• DERM: Pruritus, abscess
• RESP: Dyspnea
• METABOLIC: Hyperthermia, hypercalcemia, hyperphosphatemia, hypercalciuria, hypervitaminosis D, soft tissue calcification, weight gain
• ENDO: Oversuppression of PTH

• Vitamin; regulates intestinal calcium and phosphorus absorption, stimulates skeletal growth, decreases PTH synthesis and secretion
• Well absorbed from GI tract
• Metabolized by CYP 27 in the liver to form 1a,25-(OH)2D2 and 1a,24-dihydroxyvitamin D2 major and minor metabolite respectively
• Half-life: 32-37 hrs (ranging up to 96 hours)

US Trade Name(s)

• Hectorol

US Availability

doxercalciferol (generic)

• CAPS: 0.5, 1, 2.5 mcg

Hectorol

• CAPS: 0.5, 1, 2.5 mcg

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

Pricing data from www.DrugStore.com in U.S.A.

• Hectorol 0.5 MCG CAPS [Bottle] (GENZYME)
  50 mcg = $453.99
  150 mcg = $1330.03
• Hectorol 2.5 MCG CAPS [Bottle] (GENZYME)
  50 mcg = $1259.96
  150 mcg = $3750

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Hectorol 0.0005 MG Oral Capsule (Genzyme Corporation)
• Hectorol 0.001 MG Oral Capsule (Genzyme Corporation)
• Hectorol 0.0025 MG Oral Capsule (Genzyme Corporation)