Hectorol

DRUG DESCRIPTION

Doxercalciferol, the active ingredient in Hectorol® (doxercalciferol liquid filled capsule) , is a synthetic vitamin D2 analog that undergoes metabolic activation in vivo to form l?,25-dihydroxyvitamin D2 (l?,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D2. Hectorol (doxercalciferol liquid filled capsule) is available as soft gelatin capsules containing 0.5 mcg, 1 mcg or 2.5 mcg doxercalciferol. Each capsule also contains fractionated triglyceride of coconut oil, ethanol, and butylated hydroxyanisole (BHA). The capsule shells contain gelatin, glycerin and titanium dioxide. In addition, the 0.5 mcg capsule shells contain yellow iron oxide and FD&C Red No. 40, the 1 mcg capsule shells contain FD&C Yellow No. 6, and the 2.5 mcg capsule shells contain yellow iron oxide.

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 (l?,3?,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-l,3-diol. The structural formula is presented in Figure 1 below:

Figure 1: Chemical Structure of Doxercalciferol

KLONOPIN®
  (doxercalciferol) Structural Formula Illustration

Other names frequently used for doxercalciferol are la-hydroxyvitamin D2, l?-OH-D2, and la-hydroxyergocalciferol.

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 »

What are the precautions when taking doxercalciferol liquid filled capsule (Hectorol)?

Before taking doxercalciferol, tell your doctor or pharmacist if you are allergic to it; or to vitamin D products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., irregular heartbeat), liver disease, high calcium blood levels (hypercalcemia), high phosphate blood levels (hyperphosphatemia), seizure.

Tell your doctor if you are pregnant before using this medication.

It is not known whether this medication passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Hectorol »


Hectorol Consumer (continued)

SIDE EFFECTS: Headache, upset stomach, constipation, nausea, vomiting, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: bone/joint/muscle pain, loss of appetite, increased thirst, increased urination, fast/slow/irregular heartbeat, mental/mood changes (e.g., drowsiness, disturbed/irrational thoughts or beliefs), metallic taste in mouth, weakness, unexplained weight gain or loss.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking doxercalciferol, tell your doctor or pharmacist if you are allergic to it; or to vitamin D products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., irregular heartbeat), liver disease, high calcium blood levels (hypercalcemia), high phosphate blood levels (hyperphosphatemia), seizure.

Tell your doctor if you are pregnant before using this medication.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.


Hectorol Patient Information Including Side Effects

Brand Names: Hectorol

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

  • What is doxercalciferol (Hectorol)?
  • What are the possible side effects of doxercalciferol (Hectorol)?
  • What is the most important information I should know about doxercalciferol (Hectorol)?
  • Who should not take doxercalciferol (Hectorol)?
  • How should I take doxercalciferol (Hectorol)?
  • What happens if I miss a dose (Hectorol)?
  • What happens if I overdose (Hectorol)?
  • What should I avoid while taking doxercalciferol (Hectorol)?
  • What other drugs will affect doxercalciferol (Hectorol)?
  • Where can I get more information?

What is doxercalciferol (Hectorol)?

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)?

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)?

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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