paricalcitol injection Other | Pfizer Medical Information

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...

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1 INDICATIONS AND USAGE

Paricalcitol Injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with...

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2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Information

Ensure serum calcium is not above the...

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3 DOSAGE FORMS AND STRENGTHS

Paricalcitol Injection is a clear, colorless solution available in multiple-dose vials as follows:

2 mcg/mL
5 mcg/mL
10 mcg/2 mL (5 mcg/mL)

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4 CONTRAINDICATIONS

Paricalcitol Injection is contraindicated in patients with:

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5 WARNINGS AND PRECAUTIONS

5.1 Hypercalcemia

Hypercalcemia may occur during Paricalcitol Injection treatment....

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6 ADVERSE REACTIONS

The following serious adverse reactions are described below and elsewhere in the labeling:

Hypercalcemia [see Warnings and Precautions (5.1)...

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7 DRUG INTERACTIONS

Table 4 includes clinically significant drug interactions with Paricalcitol Injection.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Limited data with...

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10 OVERDOSAGE

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

The treatment...

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11 DESCRIPTION

Paricalcitol, USP, the active ingredient in Paricalcitol Injection, is a synthetically manufactured active vitamin D2 analog. It is a white powder chemically designated as 19-nor-1α,3β...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Paricalcitol is a synthetic, biologically active vitamin D2 analog. Preclinical and...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 104-week carcinogenicity study in CD-1 mice conducted with another...

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14 CLINICAL STUDIES

The safety and efficacy of Paricalcitol Injection have been established based on adult studies of another paricalcitol injection product in patients with CKD on hemodialysis. Below is a display of the...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Paricalcitol Injection is a clear, colorless solution available in trays of 25 vials 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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Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), 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 either 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/medwatchor by calling
(800)-332-1088.