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Hectorol
Injection Prescribing Information
Hectorol
Capsules Prescribing Information
Patients For U.S. Residents Only

Dosing Capsules

  • Hectorol capsules are indicated for the treatment of SHPT in patients with Stage 3 or Stage 4 CKD not on dialysis and patients with CKD on dialysis.3,4 Hectorol capsules are available as soft gelatin capsules containing 0.5 mcg, 1 mcg, or 2.5 mcg doxercalciferol.5

    Table 5: Capsule dosing for dialysis patients

    Initial dosing
    iPTH level Hectorol dose
    >400 pg/ml 10 mcg three times per week at dialysis
    Dose titration
    iPTH level Hectorol dose
    Above 300 pg/ml Increase by 2.5 mcg at eight-week intervals as necessary
    150 - 300 pg/ml Maintain
    <100 pg/ml Suspend for one week, then resume at a dose that is at least 2.5 mcg lower


    Table 6: Pre-dialysis Dosing Recommendations

    Initial dosing
    iPTH level Hectorol dose
    > 70 pg/mL (Stage 3)
    > 110 pg/mL (Stage 4)
    1 mcg once per day
    Dose titration
    iPTH level Hectorol dose
    Above 70 pg/mL (Stage 3)
    110 pg/mL (Stage 4)
    Increase by 0.5 mcg at two-week intervals as necessary
    35 - 70 pg/mL (Stage 3)
    70 - 110 pg/mL (Stage 4)
    Maintain
    < 35 pg/mL (Stage 3)
    < 70 pg/mL (Stage 4)
    Suspend for one week, then resume at a dose that is at least 0.5 mcg lower


  • Dosing of Hectorol® Capsules

    The optimal dose of Hectorol capsules must be carefully determined for each patient.1 The following table provides the current recommended therapeutic target levels for intact parathyroid hormone (iPTH) in patients with chronic kidney disease (CKD):

    Target range of iPTH by stage of CKD

    CKD stage GRF*
    (mL/min/1.73 m2)
    Target iPTH
    (pg/mL)
    3 30-59 35-70
    4 15-29 70-110
    5 <15 (or dialysis) 150-300
    * GFR: glomerular filtration rate.

    Abbreviation: GFR, glomerular filtration rate.

  • Hectorol capsules for predialysis patients

    The recommended initial dose of Hectorol is 1 mcg administered once daily and should be adjusted as needed in order to lower iPTH to within target ranges.2 The dose may be increased at 2-week intervals by 0.5 mcg to achieve the target range of iPTH.2 The maximum recommended dose of Hectorol is 3.5 mcg administered once per day.2

    Serum levels of calcium, phosphorus, and plasma levels of iPTH should be monitored at least every 2 weeks for 3 months after initiation of Hectorol therapy or following dose adjustments in Hectorol therapy, then monthly for 3 months, and every 3 months thereafter. If hypercalcemia, hyperphosphatemia, or a serum calcium times phosphorus product greater than 55 mg2/dL2 is noted, the dose of Hectorol should be decreased or suspended and/or the dose of phosphate binders should be appropriately adjusted. If suspended, the drug should be restarted at a dose that is at least 0.5 mcg lower.

    Dosing must be individualized and based on iPTH levels with monitoring of serum calcium and serum phosphorus levels.3 More information about recommended dose titrations for Hectorol capsules can be found in the full Hectorol Prescribing Information (PDF).

  • Hectorol capsules for dialysis patients

    The recommended initial dose of Hectorol is 10 mcg administered 3 times weekly at dialysis (approximately every other day).4 The initial dose should be adjusted, as needed, in order to lower blood iPTH into the KDOQI-recommended range of 150 to 300 pg/mL.4 The dose may be increased at 8-week intervals by 2.5 mcg if iPTH is not lowered by 50% and fails to reach the target range. The maximum dose of Hectorol is 20 mcg administered 3 times weekly at dialysis for a total of 60 mcg per week.4 Drug administration should be suspended if iPTH falls below 100 pg/mL and restarted 1 week later at a dose that is at least 2.5 mcg lower than the last administered dose. During titration, iPTH, serum calcium, and serum phosphorus levels should be obtained weekly. If hypercalcemia, hyperphosphatemia, or a serum calcium times serum phosphorus product greater than 55 mg2/dL2 is noted, the dose of Hectorol should be decreased or suspended and/or the dose of phosphate binders should be appropriately adjusted. If suspended, the drug should be restarted at a dose that is at least 2.5 mcg lower.

    Dosing must be individualized and based on iPTH levels with monitoring of serum calcium and serum phosphorus levels.5 More information about recommended dose titrations can be found in the full Hectorol Prescribing Information (PDF).

Contact Us

Contact Hectorol® for more informationSanofi US
500 Kendall Street
Cambridge, MA 02142
Contact Hectorol® for more informationToll free: 800-847-0069 Contact Hectorol® for more informationFax: 617-591-5986

Indication

  • Hectorol Injection is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
  • Hectorol capsules are indicated for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease not on dialysis and patients with chronic kidney disease on dialysis.

Important Safety Information

  • Hectorol is contraindicated in patients with a tendency towards hypercalcemia, or evidence of vitamin D toxicity.
  • Hectorol injection is contraindicated in patients with previous hypersensitivity to doxercalciferol or any of its ingredients.
  • Overdosage of any form of vitamin D is dangerous and may lead to progressive hypercalcemia, which if severe, may require emergency attention.
  • Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis drugs.
  • Chronic hypercalcemia can lead to generalized vascular and other soft tissue calcification.
  • Pharmacologic doses of vitamin D and its derivatives should be withheld during Hectorol treatment to avoid possible additive effects and hypercalcemia.
  • The patient should be informed about adherence to instructions about diet, calcium supplementation, and avoidance of the use of nonprescription drugs without prior physician approval. Patients should also be carefully informed about the symptoms of hypercalcemia such as weakness, headache, drowsiness, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste and loss of appetite.
  • Uncontrolled serum phosphorus in patients undergoing dialysis may lessen the effectiveness of Hectorol.
  • Magnesium-containing antacids and Hectorol should not be administered concomitantly.
  • Serious hypersensitivity reactions, including fatal outcome, have been reported post marketing in patients on hemodialysis following administration of Hectorol Injection. Hypersensitivity reactions include anaphylaxis with symptoms of angioedema (involving face, lips, tongue and airways), hypotension, unresponsiveness, chest discomfort, shortness of breath, and cardiopulmonary arrest. These reactions may occur separately or together
  • Monitor patients receiving Hectorol Injection upon initiation of treatment for hypersensitivity reactions. Should a hypersensitivity reaction occur, discontinue Hectorol, monitor and treat if indicated
  • Patients should be checked and treated for nutritional vitamin D deficiency prior to initiating treatment with Hectorol capsules.
  • Cholestyramine may impair intestinal absorption of doxercalciferol capsules.
  • Enzyme inducers may affect the 25-hydroxylation of Hectorol and may necessitate dosage adjustments. Cytochrome P450 inhibitors may inhibit the 25-hydroxylation of Hectorol. Formation of the active Hectorol moiety may be hindered.
  • Adverse effects of Hectorol injection treatment are: hypercalcemia, hyperphosphatemia, and oversuppression of iPTH. Adverse effects of Hectorol capsules treatment are hypercalcemia, hyperphosphatemia, hypercalciuria, and oversuppression of PTH. These should be managed by regular patient monitoring and appropriate dosage adjustments.
  • Serum levels of iPTH, calcium and phosphorus should be determined prior to initiation of Hectorol treatment. During the early phase of treatment they should be determined weekly.
  • Adverse events reported by ≥5% of the Hectorol-treated dialysis patients included: edema, headache, malaise, nausea/vomiting, dizziness, dyspnea, pruritus and bradycardia.
  • Adverse events occurring at a frequency of ≥5% in patients taking Hectorol capsules with Stage 3 or Stage 4 chronic kidney disease not on dialysis were infection, chest pain, constipation, dyspepsia, anemia, dehydration, depression, hypertonia, insomnia, paresthesia, increased cough, dyspnea and rhinitis.
  • This drug should be used during pregnancy only if clearly needed.
  • Nursing mothers should discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
  • This drug should be used with caution in patients with impaired hepatic function.

Please click here for Hectorol Capsules Full Prescribing Information or click here for Hectorol Injection Full Prescribing Information.

References:
  1. Hectorol Capsules PI/p 2/col 2/para 8
  2. Hectorol Capsules PI/p 2/col 3/para 3
  3. Hectorol Capsules PI/p 2/para 4, 5
  4. Hectorol Capsules PI/p 2/col 2/para 10
  5. Hectorol Capsules PI/p 2/col 2/para 10/col 3/para 11

Contact Us

Contact Hectorol® for more informationSanofi US
500 Kendall Street
Cambridge, MA 02142
Contact Hectorol® for more information Toll Free: 800-847-0069 Contact Hectorol® for more information Fax: 617-591-5986

IMPORTANT SAFETY INFORMATION
Hectorol is contraindicated in patients with a tendency towards hypercalcemia, or evidence of vitamin D toxicity. VIEW MORE