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doxercalciferol injection

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doxercalciferol injection Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis.

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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...
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3 DOSAGE FORMS AND STRENGTHS

Injection: clear and colorless solution available as follows:

  • 4 mcg/2 mL (2 mcg/mL) multiple-dose 2 mL vial
  • 10 mcg/5 mL (2 mcg/mL) multiple-dose 5 mL vial
  • ...
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5 WARNINGS AND PRECAUTIONS

5.1 Hypercalcemia

Hypercalcemia may occur during Doxercalciferol Injection treatment. Acute hypercalcemia may increase the risk of cardiac...

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6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in another section of the label:

  • Hypercalcemia [see

    6.1 Clinical Trials Experience

    ...
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7 DRUG INTERACTIONS

Table 2 includes clinically significant drug interactions with doxercalciferol.

Table 2: Clinically Significant Drug Interactions with Doxercalciferol...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

The limited available...

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10 OVERDOSAGE

Overdosage of Doxercalciferol Injection may lead to hypercalcemia, hypercalciuria, and hyperphosphatemia [see Warnings and Precautions (5.1)]. The treatment of...

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11 DESCRIPTION

Doxercalciferol is a synthetic vitamin D2 analog. Doxercalciferol undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Doxercalciferol is a synthetic vitamin D2 analog that requires metabolic activation to form...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 104-week carcinogenicity study in rats, there was an increased incidence of...

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14 CLINICAL STUDIES

The safety and efficacy of Doxercalciferol Injection have been established based on adult studies of doxercalciferol injection in patients with CKD on hemodialysis. Below is a display of the results of...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Doxercalciferol Injection is a clear, colorless solution in multiple-dose amber glass vials supplied as follows:

...
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17 PATIENT COUNSELING INFORMATION

Hypercalcemia

Advise patients to contact a health care provider if they develop symptoms of elevated...

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This product's label may have been updated. For the current prescribing information, please visit www.pfizer.com.

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