doxercalciferol injection Contraindications | Pfizer Medical Information - US

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

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.

4 CONTRAINDICATIONS

Doxercalciferol Injection is contraindicated in patients with:

Hypercalcemia [see Warnings and Precautions (5.1)]
Vitamin D toxicity [see Warnings and Precautions (5.1)]
Known hypersensitivity to doxercalciferol or any of the inactive ingredients of Doxercalciferol Injection; serious hypersensitivity reactions including anaphylaxis and angioedema have been reported [see Warnings and Precautions (5.3), Adverse Reactions (6.2)].

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

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

Pfizer samples (for eligible HCPs)

Requests for samples of prescription medications can be made by contacting Pfizer for Professionals at 1-800-505-4426 or by visiting the PfizerPro website www.pfizerpro.com.
Report an adverse event or concern about the quality of a Pfizer product

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.
If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly by visiting www.fda.gov/medwatch or by calling (800)-332-1088.
Assistance programs (for eligible patients)

Pfizer RxPathways connects eligible patients to a range of assistance programs that offer insurance support, co-pay help, and medicines for free or at a savings. Patients and physicians can contact RxPathways at (866) 706-2400 or visit the website for more information on these programs www.pfizerrxpathways.com.
Resources

Show All Hide All

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...

Read more

Did you find an answer to your question? Yes No

1 INDICATIONS AND USAGE

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

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

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

Read more

Did you find an answer to your question? Yes No

4 CONTRAINDICATIONS

Doxercalciferol Injection is contraindicated in patients with:

Hypercalcemia [see Warnings and Precautions (5.1)]
Vitamin D...

Read more

Did you find an answer to your question? Yes No

5 WARNINGS AND PRECAUTIONS

5.1 Hypercalcemia

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

Read more

Did you find an answer to your question? Yes No

6 ADVERSE REACTIONS

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

Hypercalcemia [see Warnings and Precautions (...

Read more

Did you find an answer to your question? Yes No

7 DRUG INTERACTIONS

Table 2 includes clinically significant drug interactions with doxercalciferol.

Read more

Did you find an answer to your question? Yes No

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

The limited available...

Read more

Did you find an answer to your question? Yes No

10 OVERDOSAGE

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

Read more

Did you find an answer to your question? Yes No

11 DESCRIPTION

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

Read more

Did you find an answer to your question? Yes No

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

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

Read more

Did you find an answer to your question? Yes No

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Read more

Did you find an answer to your question? Yes No

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...

Read more

Did you find an answer to your question? Yes No

16 HOW SUPPLIED/STORAGE AND HANDLING

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

...

Read more

Did you find an answer to your question? Yes No

17 PATIENT COUNSELING INFORMATION

Hypercalcemia

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

Read more

Did you find an answer to your question? Yes No

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

...

Read more

Did you find an answer to your question? Yes No

Did you find an answer to your question? Yes No

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^*

*Contact Medical Information.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

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.