doxercalciferol injection Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DOXERCALCIFEROL INJECTION safely and effectively. See full prescribing information for DOXERCALCIFEROL INJECTION.

DOXERCALCIFEROL injection, for intravenous use
Initial U.S. Approval: 2000

INDICATIONS AND USAGE

DOXERCALCIFEROL Injection is a synthetic vitamin D2 analog indicated for treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis. (1)

DOSAGE AND ADMINISTRATION

  • Before initiating treatment, ensure serum calcium is not above the upper limit of normal. (2.1)
  • Initiate dosing at 4 mcg by bolus intravenous administration three times weekly at the end of dialysis (no more frequently than every other day). Maximum dose is 18 mcg weekly. (2.3)
  • Target the maintenance dose of Doxercalciferol Injection to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits. (2)
  • See Full Prescribing Information for dose titration, laboratory monitoring, and important administration instructions. (2)

DOSAGE FORMS AND STRENGTHS

Injection: (3)

  • 4 mcg/2 mL (2 mcg/mL) multiple-dose 2 mL vial
  • 10 mcg/5 mL (2 mcg/mL) multiple-dose 5 mL vial

CONTRAINDICATIONS

  • Hypercalcemia. (4)
  • Vitamin D toxicity. (4)
  • Known hypersensitivity to doxercalciferol or any of the inactive ingredients of Doxercalciferol Injection. (4)

WARNINGS AND PRECAUTIONS

  • Hypercalcemia: Can occur during treatment with Doxercalciferol Injection and can lead to cardiac arrhythmias and seizures. Severe hypercalcemia may require emergency attention. Risk may be increased when used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. Monitor serum calcium prior to initiation and during treatment and adjust dose accordingly. (2, 5.1)
  • Digitalis Toxicity: Hypercalcemia increases the risk of digitalis toxicity. In patients using digitalis compounds, monitor serum calcium and patients for signs and symptoms of digitalis toxicity. Increase frequency of monitoring when initiating or adjusting the dose of Doxercalciferol Injection. (5.2)
  • Serious Hypersensitivity Reactions: Anaphylaxis, with symptoms of angioedema, hypotension, unresponsiveness, chest discomfort, shortness of breath, and cardiopulmonary arrest, has been reported in hemodialysis patients after administration of Doxercalciferol Injection. Monitor patients upon treatment initiation for hypersensitivity reactions. Should a reaction occur, discontinue and treat. (5.3)
  • Adynamic Bone Disease: May develop and increase risk of fractures if intact PTH levels are suppressed to abnormally low levels. Monitor intact PTH levels to avoid oversuppression and adjust dose if needed. (5.4)

ADVERSE REACTIONS

The most common adverse reactions in patients with CKD on dialysis (incidence >5%) were headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus, and bradycardia. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Cytochrome P450 inhibitors: Formation of the active doxercalciferol moiety may be hindered and may necessitate dosage adjustment. Monitor intact PTH and serum calcium concentrations closely. (7)
  • Enzyme inducers: Formation of the active doxercalciferol moiety may be affected and may necessitate dosage adjustment. Monitor intact PTH and serum calcium concentrations closely. (7)
  • Magnesium-containing products: Combined use may cause hypermagnesemia. Monitor serum magnesium concentrations more frequently and adjust dose as needed. (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2019

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DOXERCALCIFEROL INJECTION safely and effectively. See full prescribing information for DOXERCALCIFEROL INJECTION.

DOXERCALCIFEROL injection, for intravenous use
Initial U.S. Approval: 2000

INDICATIONS AND USAGE

DOXERCALCIFEROL Injection is a synthetic vitamin D2 analog indicated for treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis. (1)

DOSAGE AND ADMINISTRATION

  • Before initiating treatment, ensure serum calcium is not above the upper limit of normal. (2.1)
  • Initiate dosing at 4 mcg by bolus intravenous administration three times weekly at the end of dialysis (no more frequently than every other day). Maximum dose is 18 mcg weekly. (2.3)
  • Target the maintenance dose of Doxercalciferol Injection to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits. (2)
  • See Full Prescribing Information for dose titration, laboratory monitoring, and important administration instructions. (2)

DOSAGE FORMS AND STRENGTHS

Injection: (3)

  • 4 mcg/2 mL (2 mcg/mL) multiple-dose 2 mL vial
  • 10 mcg/5 mL (2 mcg/mL) multiple-dose 5 mL vial

CONTRAINDICATIONS

  • Hypercalcemia. (4)
  • Vitamin D toxicity. (4)
  • Known hypersensitivity to doxercalciferol or any of the inactive ingredients of Doxercalciferol Injection. (4)

WARNINGS AND PRECAUTIONS

  • Hypercalcemia: Can occur during treatment with Doxercalciferol Injection and can lead to cardiac arrhythmias and seizures. Severe hypercalcemia may require emergency attention. Risk may be increased when used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds. Monitor serum calcium prior to initiation and during treatment and adjust dose accordingly. (2, 5.1)
  • Digitalis Toxicity: Hypercalcemia increases the risk of digitalis toxicity. In patients using digitalis compounds, monitor serum calcium and patients for signs and symptoms of digitalis toxicity. Increase frequency of monitoring when initiating or adjusting the dose of Doxercalciferol Injection. (5.2)
  • Serious Hypersensitivity Reactions: Anaphylaxis, with symptoms of angioedema, hypotension, unresponsiveness, chest discomfort, shortness of breath, and cardiopulmonary arrest, has been reported in hemodialysis patients after administration of Doxercalciferol Injection. Monitor patients upon treatment initiation for hypersensitivity reactions. Should a reaction occur, discontinue and treat. (5.3)
  • Adynamic Bone Disease: May develop and increase risk of fractures if intact PTH levels are suppressed to abnormally low levels. Monitor intact PTH levels to avoid oversuppression and adjust dose if needed. (5.4)

ADVERSE REACTIONS

The most common adverse reactions in patients with CKD on dialysis (incidence >5%) were headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus, and bradycardia. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Cytochrome P450 inhibitors: Formation of the active doxercalciferol moiety may be hindered and may necessitate dosage adjustment. Monitor intact PTH and serum calcium concentrations closely. (7)
  • Enzyme inducers: Formation of the active doxercalciferol moiety may be affected and may necessitate dosage adjustment. Monitor intact PTH and serum calcium concentrations closely. (7)
  • Magnesium-containing products: Combined use may cause hypermagnesemia. Monitor serum magnesium concentrations more frequently and adjust dose as needed. (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2019

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