doxercalciferol (Rx)

Brand and Other Names:Hectorol
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and doxercalciferol

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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)

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            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

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            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.

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            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)

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            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

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.