Hectorol Injection

DRUG DESCRIPTION

Doxercalciferol, the active ingredient in Hectorol (doxercalciferol injection) , is a synthetic vitamin D₂ analog that undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D₂ (1α,25-(0H)₂D₂), a naturally occurring, biologically active form of vitamin D₂. Hectorol (doxercalciferol injection) is available as a sterile, clear, colorless aqueous solution for intravenous injection. Mectorol Injection is supplied as either 4 mcg/2mL or 2 mcg/mL each in a stoppered, single use 2 mL amber glass vial, with an aluminum seal and yellow (4 mcg/2mL) or green (2 mcg/mL) flip-off cap. Each milliliter (mL) of solution contains doxercalciferol, 2 meg; ethanol, 100%, 0.05 mL; Polysorbate 20,10 mg; sodium chloride, 1.5 mg; butylated hydroxytoluene, 0.02 mg; sodium phosphate dibasic, heptahydrate, 14.4 mg; sodium phosphate monobasic, monohydrate, 1.8 mg; and disodium edetate, 1.1 mg.

Doxercalciferol is a colorless crystalline compound with a calculated molecular weight of 412.66 and a molecular formula of C28H44O2. It is soluble in oils and organic solvents, but is relatively insoluble in water. Chemically, doxercalciferol is (1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-1,3-diol and has the structural formula presented in Figure 1.

Figure 1: Chemical Structure of Doxercalciferol

Other names frequently used for doxercalciferol are 1a-hydroxyvitamin D₂,1a-0H-D₂, and 1a-hydroxy-ergocalciferol.

What are the possible side effects of doxercalciferol (Hectorol)?

If you experience any of the following serious side effects, stop taking doxercalciferol and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);


• an irregular heartbeat;


• increased nighttime urination; or


• abdominal pain.

Contact your doctor if you experience any of the following side effects:

• nausea, vomiting, or decreased...

Read All Potential Side Effects and See Pictures of Hectorol Injection »

Hectorol Injection Patient Information Including Side Effects

Brand Names: Hectorol

Generic Name: doxercalciferol (Pronunciation: dock sir kal SIH fer all)

• What is doxercalciferol (Hectorol Injection)?


• What are the possible side effects of doxercalciferol (Hectorol Injection)?


• What is the most important information I should know about doxercalciferol (Hectorol Injection)?


• Who should not take doxercalciferol (Hectorol Injection)?


• How should I take doxercalciferol (Hectorol Injection)?


• What happens if I miss a dose (Hectorol Injection)?


• What happens if I overdose (Hectorol Injection)?


• What should I avoid while taking doxercalciferol (Hectorol Injection)?


• What other drugs will affect doxercalciferol (Hectorol Injection)?


• Where can I get more information?

What is doxercalciferol (Hectorol Injection)?

Doxercalciferol is a synthetic (man-made) form of vitamin D. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Doxercalciferol is used to reduce elevated intact parathyroid hormone (iPTH) levels in the treatment of secondary hyperparathyroidism in patients undergoing chronic renal dialysis.

Doxercalciferol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of doxercalciferol (Hectorol Injection)?

If you experience any of the following serious side effects, stop taking doxercalciferol and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);


• an irregular heartbeat;


• increased nighttime urination; or


• abdominal pain.

Contact your doctor if you experience any of the following side effects:

• nausea, vomiting, or decreased appetite;


• dry mouth;


• constipation;


• weakness;


• headache;


• dizziness;


• a metallic taste;


• muscle or bone pain;


• increased thirst or urination;


• shortness of breath; or


• itching.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about doxercalciferol (Hectorol Injection)?

Contact your doctor if you experience weakness, headache, nausea and vomiting, dry mouth, constipation, a metallic taste in the mouth, increased thirst and/or urination, or decreased appetite. These can be early signs of too much calcium in the body.

Do not take antacids that contain magnesium while taking doxercalciferol, unless otherwise directed by your doctor.

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