doxercalciferol injection 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)].

Find doxercalciferol injection medical information:

Find doxercalciferol injection medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

doxercalciferol injection Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

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)].
Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.