Usual Adult Dose for Secondary Hyperparathyroidism

Intravenous dosing for patients on dialysis:
Initial dose:

• Intact parathyroid hormone (iPTH) over 400 pg/mL: 4 mcg IV 3 times per week at the end of dialysis, or approximately every other day

• iPTH decreased less than 50% AND above 300 pg/mL: increase 1 to 2 mcg every 8 weeks as needed
• iPTH decreased more than 50% AND above 300 pg/mL: maintain previous dose
• iPTH 150 to 300 pg/mL: maintain previous dose
• iPTH below 100 pg/mL: suspend dosing for 1 week, then resume at a dose at least 1 mcg lower
• Doses higher than 18 mcg weekly have not been studied

• iPTH over 400 pg/mL: 10 mcg orally 3 times per week at the end of dialysis, or approximately every other day

• iPTH decreased less than 50% AND above 300 pg/mL: increase 2.5 mcg every 8 weeks as needed
• iPTH 150 to 300 pg/mL: maintain previous dose
• iPTH below 100 pg/mL: suspend dosing for 1 week, then resume at a dose at least 2.5 mcg lower

• iPTH over 70 pg/mL (Stage 3 CKD): 1 mcg, orally, once a day
• iPTH over 110 pg/mL (Stage 4 CKD): 1 mcg, orally, once a day

• iPTH over 70 pg/mL (Stage 3 CKD): increase by 0.5 mcg at 2 week intervals, as needed
• iPTH over 110 pg/mL (Stage 4 CKD): increase by 0.5 mcg at 2 week intervals, as needed
• iPTH 35 to 70 pg/mL (Stage 3 CKD): maintain previous dose
• iPTH 70 to 110 pg/mL (Stage 4 CKD): maintain previous dose
• iPTH below 35 pg/mL (Stage 3 CKD): suspend dosing for 1 week, then resume at a dose at least 0.5 mcg lower
• iPTH below 70 pg/mL (Stage 4 CKD): suspend dosing for 1 week, then resume at a dose at least 0.5 mcg lower

• Individualize dosing based on iPTH levels with monitoring of serum calcium and phosphorus.
• Reduce dose or suspend treatment for hypercalcemia, hyperphosphatemia, or a serum calcium times phosphorus product greater than 55 mg(2)/dL(2).

Renal Dose Adjustments

See Usual Adult Dose

Data not available for Stage 2 chronic kidney disease

Liver Dose Adjustments

Use with caution.

• More frequent monitoring of intact parathyroid hormone (iPTH), calcium, and phosphorus levels is recommended.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

See Usual Adult Dose

Other Comments

Storage requirements:

• Store at controlled room temperature (77F).

• Determine serum calcium, phosphorus, and iPTH prior to treatment.
• Weekly monitoring of serum calcium, phosphorus, and iPTH is recommended during treatment of dialysis patients.
• Every other week monitoring of serum calcium, phosphorus, and iPTH is recommended during treatment initiation and dose adjustments in pre-dialysis patients; monitor monthly for 3 months once stabilized, then every 3 months thereafter.

• Advise patients and caregivers about adherence to diet, calcium supplementation, and avoidance of nonprescription drugs without physician approval.
• Inform patients of the symptoms of hypercalcemia.