Drugplain

Doxercalciferol .5 ug/1

Doxercalciferol · CAPSULE · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

2 Recalls on Record
Plain English

Doxercalciferol is a capsule containing doxercalciferol at .5 ug/1, taken oral. Manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..

Key Facts

Brand Name
Doxercalciferol
Generic Name
Doxercalciferol
NDC Code (Product)
23155-538
Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Strength
.5 ug/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA205360
Drug Class
Vitamin D2 Analog [EPC]
Marketing Start
10/31/2020

Recall History

2 Recalls on Record
Class III04/27/2016

Genzyme Corporation / Genzyme Biosurgery

Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.

TerminatedVoluntary: Firm initiated
Class III04/04/2017

West-Ward Columbus, Inc.

Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea13 reports
acute kidney injury12 reports
fatigue12 reports
renal failure12 reports
end stage renal disease11 reports
vomiting11 reports
chronic kidney disease10 reports
drug hypersensitivity10 reports
nausea9 reports
anxiety8 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis. Doxercalciferol Capsules is a synthetic vitamin D 2 analog: Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Before initiating treatment, ensure serum calcium is not above the upper limit of normal. ( 2.1 ) Dosage for doxercalciferol capsules in patients with: Stage 3 or 4 CKD: Initiate dosing at 1 mcg orally once daily. Maximum dose is 3.5 mcg once daily. ( 2.2 ) CKD on dialysis: Initiate dosing at 10 mcg orally three times weekly at dialysis (no more frequently than every other day). Maximum dose is 20 mcg three times weekly for a total of 60 mcg weekly. ( 2.3 ) Target the maintenance dose of doxercalciferol 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 ) 2.1 Prior to Initiation of Doxercalciferol Capsules Ensure serum calcium is not above the upper limit of normal before initiating treatment with doxercalciferol capsules [see Warnings and Precautions ( 5.1 )]. 2.2 Dosage Recommendations for Doxercalciferol Capsules in Patients with Stage 3 or 4 CKD Initiate doxercalciferol capsules at a dose of 1 mcg orally once daily. Target the maintenance dose of doxercalc…

Contraindications

4 CONTRAINDICATIONS Doxercalciferol 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 capsules; serious hypersensitivity reactions including anaphylaxis and angioedema have been reported [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.2 )]. Hypercalcemia ( 4 ) Vitamin D toxicity ( 4 ) Know hypersensitivity to doxercalciferol or any of the inactive ingredients of doxercalciferol capsules ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Tables 3 and 4 include clinically significant drug interactions with doxercalciferol. Table 3: Clinically Significant Drug Interactions with Doxercalciferol Capsules Drugs that May Increase the Risk of Hypercalcemia Clinical Impact Concomitant administration of high doses of calcium-containing preparations or other vitamin D compounds may increase the risk of hypercalcemia. Thiazide diuretics are known to induce hypercalcemia by reducing excretion of calcium in the urine. Examples Calcium-containing products, other vitamin D compounds or thiazide diuretics Intervention Monitor serum calcium concentrations more frequently and adjust doxercalciferol dose as needed [see Warnings and Precautions ( 5.1 )]. Digitalis Compounds Clinical Impact Doxercalciferol can cause hypercalcemia which can potentiate the risk of digitalis toxicity. Intervention Monitor patients for signs and symptoms of digitalis toxicity and increase frequency of serum calcium monitoring when initiating or adjusting the dose of doxercalciferol in patients receiving digitalis compounds [see Warnings and Precautions ( 5.2 )]. Cytochrome P450 Inhibitors Clinical Impact Doxercalciferol is activated by …

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in another section of the label: Hypercalcemia [see Warnings and Precautions ( 5.1 )] Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Adynamic Bone Disease [see Warnings and Precautions ( 5.4 )] The most common adverse reactions in patients with Stage 3 or 4 CKD (incidence >5%) were infection, urinary tract infection, chest pain, angina pectoris, constipation, dyspepsia, anemia, leukopenia, dehydration, edema, depression, hypertonia, insomnia, asthenia, paresthesia, cough increased, dyspnea, pruritus, sinusitis, and rhinitis. ( 6.1 ) 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 Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clini…

Frequently Asked Questions

What is Doxercalciferol used for?

Doxercalciferol contains Doxercalciferol. It is a capsule taken oral. Consult your doctor for specific uses.

Is Doxercalciferol a controlled substance?

Doxercalciferol is not classified as a controlled substance by the DEA.

What is the generic name for Doxercalciferol?

The generic name for Doxercalciferol is Doxercalciferol. There are 1 other brand versions of Doxercalciferol.

What is the NDC code for Doxercalciferol .5 ug/1?

The NDC (National Drug Code) for Doxercalciferol .5 ug/1 is 23155-538, listed by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc..

Product NDC

23155-538

Package NDC

23155-538-25

Other Doxercalciferol Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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