doxercalciferol injection Dosage and Administration

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2 DOSAGE AND ADMINISTRATION

2.1 Prior to Initiation of Doxercalciferol Injection

  • Ensure serum calcium is not above the upper limit of normal before initiating treatment with Doxercalciferol Injection [see Warnings and Precautions (5.1)].

2.2 Important Administration Instructions for Doxercalciferol Injection

  • Administer Doxercalciferol Injection intravenously as a bolus dose at the end of dialysis.
  • Inspect Doxercalciferol Injection visually prior to administration; the solution should appear clear and colorless. Do not use if the solution is not clear or particles are present.
  • After initial vial use, store opened multiple-dose vial for up to 14 days at room temperature. Discard unused portion of multiple-dose vial after 14 days [see How Supplied/Storage and Handling (16)].

2.3 Dosage Recommendations for Doxercalciferol Injection

  • Initiate Doxercalciferol Injection at a dose of 4 mcg given by bolus intravenous administration three times weekly at the end of dialysis (no more frequently than every other day).
  • Target the maintenance dose of Doxercalciferol Injection to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits.
  • Monitor serum calcium, phosphorus, and intact PTH levels weekly after initiation of therapy or dose adjustment.
  • Titrate the dose of Doxercalciferol Injection based on intact PTH. The dose may be increased at 8-week intervals by 1 mcg to 2 mcg if intact PTH is not lowered by 50% and fails to reach the target range. The maximum dose is 18 mcg weekly. Prior to raising the dose, ensure serum calcium is within normal limits.
  • Suspend or decrease the dose if intact PTH is persistently and abnormally low to reduce the risk of adynamic bone disease [see Warnings and Precautions (5.4)] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions (5.1)]. If suspended, the drug should be restarted one week later at a dose that is at least 1 mcg lower.

2.4 Drug Interactions that May Require Dosage Adjustments of Doxercalciferol Injection

  • Increased monitoring of serum calcium and dose adjustment of Doxercalciferol Injection may be necessary when given concomitantly with drugs that may increase the risk of hypercalcemia [see Drug Interactions (7)].
  • Increased monitoring of both serum calcium and intact PTH as well as dose adjustment of Doxercalciferol Injection may be necessary when given concomitantly with cytochrome P450 inhibitors or enzyme inducers [see Drug Interactions (7)].

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Prior to Initiation of Doxercalciferol Injection

  • Ensure serum calcium is not above the upper limit of normal before initiating treatment with Doxercalciferol Injection [see Warnings and Precautions (5.1)].

2.2 Important Administration Instructions for Doxercalciferol Injection

  • Administer Doxercalciferol Injection intravenously as a bolus dose at the end of dialysis.
  • Inspect Doxercalciferol Injection visually prior to administration; the solution should appear clear and colorless. Do not use if the solution is not clear or particles are present.
  • After initial vial use, store opened multiple-dose vial for up to 14 days at room temperature. Discard unused portion of multiple-dose vial after 14 days [see How Supplied/Storage and Handling (16)].

2.3 Dosage Recommendations for Doxercalciferol Injection

  • Initiate Doxercalciferol Injection at a dose of 4 mcg given by bolus intravenous administration three times weekly at the end of dialysis (no more frequently than every other day).
  • Target the maintenance dose of Doxercalciferol Injection to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits.
  • Monitor serum calcium, phosphorus, and intact PTH levels weekly after initiation of therapy or dose adjustment.
  • Titrate the dose of Doxercalciferol Injection based on intact PTH. The dose may be increased at 8-week intervals by 1 mcg to 2 mcg if intact PTH is not lowered by 50% and fails to reach the target range. The maximum dose is 18 mcg weekly. Prior to raising the dose, ensure serum calcium is within normal limits.
  • Suspend or decrease the dose if intact PTH is persistently and abnormally low to reduce the risk of adynamic bone disease [see Warnings and Precautions (5.4)] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions (5.1)]. If suspended, the drug should be restarted one week later at a dose that is at least 1 mcg lower.

2.4 Drug Interactions that May Require Dosage Adjustments of Doxercalciferol Injection

  • Increased monitoring of serum calcium and dose adjustment of Doxercalciferol Injection may be necessary when given concomitantly with drugs that may increase the risk of hypercalcemia [see Drug Interactions (7)].
  • Increased monitoring of both serum calcium and intact PTH as well as dose adjustment of Doxercalciferol Injection may be necessary when given concomitantly with cytochrome P450 inhibitors or enzyme inducers [see Drug Interactions (7)].
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