Hectorol

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• feeling tired
• difficulty thinking clearly
• loss of appetite
• nausea
• vomiting
• constipation
• increased thirst
• increased urination
• weight loss

Hectorol is part of the drug class:

• Other anti parathyroid agents

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 maintain healthy blood levels of calcium and intact parathyroid hormone (iPTH) in people with chronic kidney disease who may also be on dialysis.

Doxercalciferol may also be used for purposes not listed in this medication guide.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• cholestyramine, colestipol;

• digoxin (Lanoxin, Lanoxicaps);

• a diuretic or "water pill";

• mineral oil; or

• a vitamin D supplement.

This list is not complete. Other drugs may interact with doxercalciferol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

A synthetic vitamin D analog.1 3 4 7

Absorption

Bioavailability

Absorbed from GI tract, with peak blood concentrations of 1α,25-dihydroxyergocalciferol (major metabolite) usually attained within 11–12 hours after repeated oral dosing.1 Following IV administration, peak blood concentrations of 1,25-dihydroxyergocalciferol are achieved in about 8 hours.7

Elimination

Metabolism

Hydroxylated to the active moiety, 1α,25-dihydroxyergocalciferol (1α,25-dihydroxyvitamin D2) via the hepatic cytochrome P-450 (CYP) isoenzyme 27.1 7

Half-life

Active moiety (1α,25-dihydroxyvitamin D2): 32–37 hours (ranging up to 96 hours).1

Special Populations

Temporary increases in mean concentrations of 1α,25-dihydroxyvitamin D2 (major metabolite) occur in patients undergoing hemodialysis.1

This section provides information on the proper use of a number of products that contain vitamin d and related compounds. It may not be specific to Hectorol. Please read with care.

For use as a dietary supplement:

• Do not take more than the recommended daily amount. Vitamin D is stored in the body, and taking too much over a period of time can cause poisoning and even death.

If you have any questions about this, check with your health care professional.

For individuals taking the oral liquid form of this dietary supplement:

• This preparation should be taken by mouth even though it comes in a dropper bottle.
• This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

While you are taking alfacalcidol, calcifediol, calcitriol, dihydrotachysterol, doxercalciferol or paricalcitol , your health care professional may want you to follow a special diet or take a calcium supplement. Be sure to follow instructions carefully. If you are already taking a calcium supplement or any medicine containing calcium, make sure your health care professional knows.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For alfacalcidol
• To treat bone disease in kidney patients undergoing kidney dialysis:
  • For oral dosage form (capsules):
    • Adults and teenagers—At first, 1 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day.
  • For oral dosage form (drops):
    • Adults and teenagers—At first, 1 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day.
  • For oral dosage form (solution):
    • Adults and teenagers—At first, 1 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 3 mcg a day.
  • For parenteral dosage form (injection):
    • Adults and teenagers—At first, 1 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 12 mcg a week.
• To treat diseases in which calcium is not used properly by the body:
  • For oral dosage form (capsules):
    • Adults and teenagers—At first, 0.25 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day.
  • For oral dosage form (drops):
    • Adults and teenagers—At first, 0.25 microgram (mcg) a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day.
  • For oral dosage form (solution):
    • Adults and teenagers—At first, 0.25 mcg a day. Your doctor may change your dose if needed. However, most people will take not more than 1 mcg a day.

For calcifediol
• To treat diseases in which calcium is not used properly by the body or to treat bone disease in kidney patients undergoing kidney dialysis:
  • For oral dosage form (capsules):
    • Adults, teenagers, and children over 10 years of age—At first, 300 to 350 micrograms (mcg) a week, taken in divided doses either once a day or every other day. Your doctor may change your dose if needed.
    • Children 2 to 10 years of age—50 mcg a day.
    • Children up to 2 years of age—20 to 50 mcg a day.
• To treat diseases in which calcium is not used properly by the body or to treat bone disease in kidney patients undergoing kidney dialysis:
  • For oral dosage forms (capsules and solution):
    • Adults, teenagers, and children—At first, 0.25 micrograms (mcg) a day. Your doctor may change your dose if needed.
  • For parenteral dosage forms (injection):
    • Adults and teenagers—At first, 0.5 mcg injected into a vein three times a week. Your doctor may change your dose if needed.
    • Children—Use and dose must be determined by your doctor.

For dihydrotachysterol
• To treat diseases in which calcium is not used properly by the body:
  • For oral dosage forms (capsules, solution, or tablets):
    • Adults and teenagers—At first, 100 micrograms (mcg) to 2.5 milligrams (mg) a day. Your doctor may change your dose if needed.
    • Children—At first, 1 to 5 mg a day. Your doctor may change your dose if needed.

For doxercalciferol
• To treat an overactive parathyroid gland in patients with kidney failure:
  • For oral dosage form (capsules):
    • Adults—10 micrograms (mcg) three times weekly at dialysis. The doctor may change your dose if needed.
    • Children—Use and dose must be determined by your doctor.

For ergocalciferol
• The amount of vitamin D to meet normal daily recommended intakes will be different for different individuals. The following information includes only the average amounts of vitamin D.
• To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
  • For oral dosage form (capsules):
    For the U.S.
    • Adults and teenagers—5 to 10 micrograms (mcg) (200 to 400 Units) per day.
    • Pregnant and breast-feeding females—10 mcg (400 Units) per day.
    • Children 4 to 10 years of age—10 mcg (400 Units) per day.
    • Children birth to 3 years of age—7.5 to 10 mcg (300 to 400 Units) per day.
    For Canada
    • Adults and teenagers—2.5 to 5 mcg (100 to 200 Units) per day.
    • Pregnant and breast-feeding females—5 to 7.5 mcg (200 to 300 Units) per day.
    • Children 7 to 10 years of age—2.5 to 5 mcg (100 to 200 Units) per day.
    • Children 4 to 6 years of age—5 mcg (200 Units) per day.
    • Children birth to 3 years of age—5 to 10 mcg (200 to 400 Units) per day.
• To treat deficiency:
  • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on severity of deficiency.
• To treat diseases in which calcium and phosphate are not used properly by the body:
  • Adults and teenagers—At first, 1000 to 500,000 Units a day. The doctor may change your dose if needed.
  • Children—At first, 1000 to 200,000 Units a day. The doctor may change your dose if needed.

For paricalcitol
• To treat an overactive parathyroid gland in patients with kidney failure:
  • For oral dosage form (capsules):
    • Adults—1 to 2 micrograms (mcg) one time per day or 2 to 4 mcg three times a week (not more often than every other day). The doctor may change your dose if needed.
    • Children—Use and dose must be determined by your doctor.
  • For parenteral dosage form (injection):
    • Adults—0.04 to 0.1 micrograms (mcg) per kg no more than every other day during dialysis. The doctor may change your dose if needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

For use as a dietary supplement: If you miss taking a dietary supplement for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in vitamins. However, if your health care professional has recommended that you take this dietary supplement, try to remember to take it as directed every day.

If you are taking this medicine for a reason other than as a dietary supplement and you miss a dose and your dosing schedule is:

• One dose every other day—Take the missed dose as soon as possible if you remember it on the day it should be taken. However, if you do not remember the missed dose until the next day, take it at that time. Then skip a day and start your dosing schedule again. Do not double doses
• One dose a day—Take the missed dose as soon as possible. Then go back to your regular dosing schedule. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• More than one dose a day—Take the missed dose as soon as possible. Then go back to your regular dosing schedule. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you have any questions about this, check with your health care professional.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Dialysis:

Hectorol has been evaluated for safety in clinical studies in 165 patients with chronic kidney disease on hemodialysis. In two placebo-controlled, double-blind, multicenter studies, discontinuation of therapy due to any adverse event occurred in 2.9% of 138 patients treated with Hectorol for four to six months (dosage titrated to achieve target iPTH levels, see CLINICAL PHARMACOLOGY/Clinical Studies) and in 3.3% of 61 patients treated with placebo for two months. Adverse events occurring in the Hectorol group at a frequency of 2% or greater and more frequently than in the placebo group are presented in Table 3 below:

Pre-dialysis:

Hectorol has been evaluated for safety in clinical studies in 55 patients (27 active and 28 placebo) with chronic kidney disease, Stages 3 or 4. In two placebo-controlled, double-blind, multicenter studies, discontinuation of therapy due to any adverse event occurred in one (3.7%) of 27 patients treated with Hectorol for 24 weeks (dosage titrated to achieve target iPTH levels, see CLINICAL PHARMACOLOGY/Clinical Studies) and in three (10.7%) of 28 patients treated with placebo for 24 weeks. Adverse events occurring in the Hectorol group at a frequency of 5% or greater and more frequently than in the placebo group are as follows: Body as a Whole – Infection, Chest Pain; Digestive System – Constipation, Dyspepsia; Hematologic and Lymphatic – Anemia; Metabolic and Nutritional – Dehydration; Nervous System – Depression, Hypertonia, Insomnia, Paresthesia; Respiratory System – Cough increased, Dyspnea, Rhinitis.

Potential adverse effects of Hectorol are, in general, similar to those encountered with excessive vitamin D intake. The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include:

Weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, and anorexia.

Polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated blood urea nitrogen (BUN), albuminuria, hypercholesterolemia, elevated serum aspartate transaminase (AST) and alanine transaminase (ALT), ectopic calcification, hypertension, cardiac arrhythmias, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis.

NDC 58468-0121-1

Hectorol®

(doxercalciferol capsules)

2.5 mcg

50 Capsules

Rx only

Applies to doxercalciferol: oral capsules, parenteral injection

Side effects include:

In dialysis patients: edema, headache, malaise, nausea/vomiting, dizziness, dyspnea, pruritus, bradycardia.

In predialysis patients with stage 3 or 4 CKD: infection, chest pain, constipation, dyspepsia, anemia, dehydration, depression, hypertonia, insomnia, paresthesia, increased cough, dyspnea, rhinitis.

Excessive vitamin D intake (early manifestations): weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, bone pain, metallic taste, anorexia.

Excessive vitamin D intake (late manifestations): polyuria, polydipsia anorexia, weight loss, nocturia, calcific conjunctivitis, pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, increased BUN, albuminuria, hypercholesterolemia, increased serum AST and ALT concentrations, ectopic calcification, hypertension, cardiac arrhythmias, sensory disturbances, dehydration, apathy, growth arrest, urinary tract infections.