Dosing & Uses
Dosage Forms & Strengths
capsule
- 0.5mcg
- 2.5mcg
injectable solution
- 4mcg/2mL multidose 2-mL vial
- 10mcg/5mL multidose 5-mL vial
Dialysis
Initial dose
- 10 mcg PO 3 times/week at end of dialysis, may increase by 2.5 mcg/dose, no more than 20 mcg/dose 3 times/week OR
- 4 mcg IV bolus 3 times/week following dialysis, may increase by 1-2 mcg/dose q8Weeks
Dose Modifications
- If intact parathyroid hormone (iPTH) <100 pg/mL, withhold for 1 week; then reinitiate at reduced dose of at least 2.5 mcg PO lower than last dose or at least 1 mcg IV lower than last dose
- Reduce dose or stop the drug if calcium and phosphorus are persistently above normal range; if interrupted, reinitiate at lower doses as above
- Monitor: Serum calcium and phosphorus, iPTH
Pre-dialysis
Initial: 1 mcg PO qDay, may increase by 0.5 mcg/dose q2Weeks
Reduce or interrupt dose if iPTH concentration falls or calcium and phosphorus are persistently above normal range (consult package insert); reinitiate at least 0.5 mcg lower than last dose
Renal Impairment
Dose adjustment not necessary
Hepatic Impairment
Caution; guidelines not available
Other Indications & Uses
Secondary hyperparathyroidism associated with chronic kidney disease
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (7)
- cholestyramine
cholestyramine decreases levels of doxercalciferol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. (Vitamin D analog).
- colesevelam
colesevelam decreases levels of doxercalciferol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. (Vitamin D analog).
- colestipol
colestipol decreases levels of doxercalciferol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. (Vitamin D analog).
- magnesium supplement
magnesium supplement will increase the level or effect of doxercalciferol by Other (see comment). Modify Therapy/Monitor Closely. Drug may increase absorption of magnesium in the intestine and colon, which increases risk of hypermagnesemia
- orlistat
orlistat decreases levels of doxercalciferol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.
- sodium sulfate/?magnesium sulfate/potassium chloride
doxercalciferol increases levels of sodium sulfate/?magnesium sulfate/potassium chloride by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Doxercalciferol may enhance the hypermagnesemic effect of magnesium salts. .
- sodium sulfate/potassium sulfate/magnesium sulfate
doxercalciferol increases levels of sodium sulfate/potassium sulfate/magnesium sulfate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Doxercalciferol may enhance the hypermagnesemic effect of magnesium salts. .
Minor (5)
- magnesium chloride
doxercalciferol increases levels of magnesium chloride by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- magnesium citrate
doxercalciferol increases levels of magnesium citrate by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- magnesium hydroxide
doxercalciferol increases levels of magnesium hydroxide by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- magnesium oxide
doxercalciferol increases levels of magnesium oxide by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- magnesium sulfate
doxercalciferol increases levels of magnesium sulfate by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
Adverse Effects
Frequency Not Defined
Edema
Palpitation
Chills
Dizziness
Headache
Malaise
Nausea
Vomiting
Hypercalcemia
Hypercalciuria
Anorexia
Constipation
Dyspepsia
Arthralgia
Edema
Weight increase
Sleep disorder
Dyspnea Pruritus
Postmarketing Reports
Hypersensitivity reactions (patients on hemodialysis)
Warnings
Contraindications
Hypersensitivity
Hypercalcemia, hyperphosphatemia, hypervitaminosis D
Cautions
Monitor serum calcium and phosphorus frequently; reduce dose or stop the drug if Ca x P product >75 mg²/dL²
Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate action of digitalis drugs; chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification; in chronic kidney disease maintain Ca x P product at <55 mg²/dL²
Use with caution in patients receiving digitalis; digitalis toxicity is potentiated by hypercalcemia
Decrease dose if hypercalcemia or hyperphosphatemia occurs
Serious hypersensitivity reactions, including fatal outcome, in patients on hemodialysis, reported post marketing; hypersensitivity reactions include anaphylaxis with symptoms of angioedema (involving face, lips, tongue and airways), hypotension, unresponsiveness, chest discomfort, shortness of breath, and cardiopulmonary arrest; reactions may occur separately or together
Use oral calcium-based or other non-aluminum-containing phosphate binders and a low phosphate diet to control serum phosphorus levels in patients undergoing dialysis
Pregnancy & Lactation
Pregnancy
Limited available data in pregnant women are insufficient to identify drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes; there are risks to mother and fetus associated with chronic kidney disease in pregnancy as it increases risk for maternal hypertension and preeclampsia, miscarriage, preterm delivery polyhydramnios, stillbirth, and low-birth-weight infants
Animal data
- In reproduction studies in rats and rabbits treated during organogenesis at up to 20 mcg/kg/day and 0.1 mcg/kg/day, respectively (approximately 25 times (rats) and less than (rabbits) maximum recommended human oral dose of 60 mcg/week based on mcg/m2 body surface area), no adverse developmental effects observed
Lactation
There is no information available on presence of doxercalciferol in human milk, effects of drug on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Infants exposed to drug through breast milk should be monitored for signs and symptoms of hypercalcemia, including seizures, vomiting, constipation and weight loss; consider monitoring of serum calcium in infant
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Doxercalciferol is metabolized to the active form of vitamin D, which in turn controls the reabsorption of calcium by the kidneys, controls the intestinal absorption of dietary calcium, and along with parathyroid hormone controls the mobilization of calcium from the skeleton.
Absorption
Onset: IV: 10-12 wk, PO: 3-4 months
Peak Plasma Time: 8-12 hr
Metabolism
Metabolism: in liver to hepatic vitamin D 25-hydroxylases to 1,25-dihydroxyvitamin D2 (active)
Metabolites: 1,25-dihydroxyvitamin D2 (active), responsible for most of metabolic effects of doxercalciferol and 1,24-dihydroxyvitamin D2 (minor metabolite)
Elimination
Half-Life: 32-37 hr (active metabolite 1,25-dihydroxyvitamin D2)
Dialyzable: No (HD)
Administration
IV Administration
Administer by IV bolus at end of dialysis session
Storage
Capsule: 15-30ºC (59-86ºF)
Unopened vial: 15-30ºC (59-86ºF)
Opened multiple-dose vial: May store up to 3 days at 2-8ºC (36-46ºF); discard unused portion in vial after 3 days
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| doxercalciferol oral - | 1 mcg capsule |  | |
| doxercalciferol oral - | 0.5 mcg capsule |  | |
| doxercalciferol oral - | 2.5 mcg capsule |  | |
| doxercalciferol oral - | 0.5 mcg capsule |  | |
| doxercalciferol intravenous - | 4 mcg/2 mL vial |  | |
| doxercalciferol intravenous - | 4 mcg/2 mL vial |  | |
| Hectorol intravenous - | 4 mcg/2 mL vial |  | |
| Hectorol intravenous - | 4 mcg/2 mL vial |  | |
| Hectorol intravenous - | 2 mcg/mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
doxercalciferol oral
DOXERCALCIFEROL - ORAL
(dox-er-kal-SIF-e-role)
COMMON BRAND NAME(S): Hectorol
USES: This medication is used to treat people with serious kidney disease who have high levels of a certain natural substance (parathyroid hormone-PTH), which your body normally makes. High PTH levels affect the balance of other minerals in your body (calcium and phosphorus) and may result in weak bones. Doxercalciferol is a man-made form of vitamin D. It works by decreasing PTH levels and increasing calcium/phosphorus levels in the body.
HOW TO USE: Take this medication by mouth with or without food, usually 3 times a week on dialysis days (such as Monday, Wednesday, Friday) or as directed by your doctor.Dosage is based on your medical condition and response to treatment. Your doctor may adjust your dose or temporarily stop this drug based on laboratory test results (PTH levels). Do not increase your dose, take it more frequently, or stop taking this medication without your doctor's approval.It is very important to follow the diet recommended by your doctor to get the most benefit from this medication and to prevent serious side effects. Do not take more than 2 grams of calcium a day while you are taking this medication. Sources of calcium include your diet, phosphate binders, or calcium supplements. If you have any questions about how much calcium you take in a day, ask your doctor or pharmacist. Do not take other supplements/vitamins (such as vitamin D) unless otherwise directed by your doctor. (See also Drug Interactions section.)Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day that you have a prescribed dose.
SIDE EFFECTS: Headache, upset stomach, constipation, nausea, vomiting, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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 right away 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 (such as 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 or at www.fda.gov/medwatch.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 (such as irregular heartbeat), liver disease, high calcium blood levels (hypercalcemia), high phosphate blood levels (hyperphosphatemia), seizure.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: burosumab.Certain medications (such as bile acid sequestrants such as cholestyramine/colestipol, mineral oil, orlistat) can decrease the effect of doxercalciferol if taken at the same time. Avoid taking these medications within 2 hours before or after this medication.Check the labels on all your prescription and nonprescription/herbal products (such as antacids, laxatives, vitamins/nutritional supplements) because they may contain calcium, magnesium, phosphate, or vitamin D. Ask your pharmacist about using those products safely.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: metallic taste in the mouth, irregular heartbeat, severe mental/mood changes.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as PTH levels, calcium/magnesium/phosphorus levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. Ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised March 2022. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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