paricalcitol injection Contraindications | Pfizer Medical Information

4 CONTRAINDICATIONS

Paricalcitol Injection is contraindicated in patients with:

Hypercalcemia [see Warnings and Precautions (5.1)]
Vitamin D toxicity [see Warnings and Precautions (5.1)] or
Known hypersensitivity to paricalcitol or any inactive ingredient in Paricalcitol Injection. Hypersensitivity adverse reactions have been reported [e.g., angioedema (including laryngeal edema) and urticaria] [see Adverse Reactions (6.2)]

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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 a Pfizer product 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 to report an adverse event related to a Pfizer product, please call Pfizer Medical Information 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.