DOXERCALCIFEROL

Vitamin / Supplement

Brand names: Doxercalciferol

Oral

Mechanism of Action

12.1 Mechanism of Action Doxercalciferol is a synthetic vitamin D 2 analog that requires metabolic activation to form the active 1α,25-(OH) 2 D 2 metabolite, which binds to the vitamin D receptor (VDR) to result in the selective activation of vitamin D responsive pathways. Vitamin D and doxercalciferol have been shown to reduce PTH levels by inhibiting PTH synthesis and secretion.

Indications

See full prescribing information

Contraindications

• 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 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Hypercalcemia: Can occur during treatment with doxercalciferol and can lead to cardiac arrhythmias and seizures
Risk may be increased when used concomitantly with high dose calcium preparations, thiazide diuretics, or vitamin D compounds
1 ) Digitalis Toxicity: Hypercalcemia increases the risk of digitalis toxicity
2 ) Serious Hypersensitivity Reactions: Anaphylaxis, with symptoms of angioedema, hypotension, unresponsiveness, chest discomfort, shortness of breath, and cardiopulmonary arrest, has been reported in hemodialysis patients after administration of doxercalciferol

Known Side Effects

8 documented side effects by frequency

Shortness of Breath

1-10%

Fatigue

1-10%

Vomiting

1-10%

Nausea

1-10%

Anxiety

1-10%

Weakness

1-10%

Chest Pain

0.1-1%

Diarrhea

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral