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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: 800-981-2491

COMBINED HECTOROL® (doxercalciferol) injection and capsules

Indication

  • HECTOROL capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis.
  • HECTOROL injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis.

Important Safety Information

Contraindications

  • Hectorol is contraindicated in patients with hypercalcemia or vitamin D toxicity.
  • Hectorol is contraindicated in patients with known hypersensitivity to doxercalciferol or any of its inactive ingredients.

Warnings and Precautions

  • Hypercalcemia can occur during Hectorol treatment and can lead to cardiac arrhythmias and seizures. Severe hypercalcemia may require emergency attention. Concomitant use of high dose calcium, thiazide diuretics or vitamin D may increase the risk of hypercalcemia. Monitor serum calcium before initiating therapy and during treatment with Hectorol and adjust dose accordingly. Inform patients about the symptoms of elevated calcium (feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss) and instruct them to report new or worsening symptoms when they occur.
  • Hypercalcemia increases the risk of digitalis toxicity. In patients using digitalis compounds, monitor serum calcium and patients for signs and symptoms of digitalis toxicity. Increase frequency of monitoring when initiating or adjusting the dose of HECTOROL.
  • Anaphylaxis with symptoms of angioedema, hypotension, unresponsiveness, chest discomfort, shortness of breath, and cardiopulmonary arrest has been reported in hemodialysis patients after administration of HECTOROL. Monitor patients upon treatment initiation for hypersensitivity reactions. Should a reaction occur, discontinue and treat.
  • Adynamic bone disease may develop and increase the risk of fractures if intact parathyroid hormone (iPTH) levels are suppressed to abnormally low levels. Monitor iPTH levels to avoid oversuppression and adjust dose if needed.

Patient Monitoring

  • For patients with CKD on dialysis monitor serum calcium, phosphorus, and iPTH levels weekly after initiation of therapy or dose adjustment.
  • For patients with CKD Stage 3 and 4, monitor serum calcium, phosphorus, and iPTH levels at least every two weeks for 3 months after initiation of therapy or dose adjustment, then monthly for 3 months, and every 3 months thereafter.

Adverse Events

  • Adverse events occurring at a frequency of ≥5% in patients taking Hectorol capsules with Stage 3 or Stage 4 chronic kidney disease were infection, urinary tract infection, chest pain, angina pectoris, constipation, dyspepsia, anemia, leukopenia, dehydration, edema, depression, hypertonia, insomnia, asthenia, paresthesia, increased cough, dyspnea, pruritus, sinusitis, and rhinitis.
  • The most common adverse events reported by ≥5% of the Hectorol-treated dialysis patients included edema, headache, malaise, edema, nausea/vomiting, dyspnea, dizziness, pruritus and bradycardia.

Drug Interactions

  • Cytochrome P450 inhibitors: Formation of the active doxercalciferol moiety may be hindered and may necessitate dosage adjustment. Monitor intact PTH and serum calcium concentrations closely.
  • Enzyme inducers: Formation of the active doxercalciferol moiety may be affected and may necessitate dosage adjustment. Monitor intact PTH and serum calcium concentrations closely.
  • Magnesium-containing products: Combined use may cause hypermagnesemia. Monitor serum magnesium concentrations more frequently and adjust dose as needed.
  • Cholestyramine: May impair absorption of HECTOROL capsules. Administer HECTOROL capsules at least 1 hour before or 4 to 6 hours after taking cholestyramine.
  • Mineral Oil or Other Substances That May Affect Absorption of Fat: May impair absorption of HECTOROL capsules. Administer HECTOROL capsules at least 1 hour before or 4 to 6 hours after taking substances that may affect absorption.

Special Populations

  • 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. Infants exposed to HECTOROL through breast milk should be monitored for signs and symptoms of hypercalcemia.
  • Patients with hepatic impairment may not metabolize HECTOROL appropriately. More frequent monitoring of intact PTH, calcium, and phosphorus levels should be done in patients with hepatic impairment.

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: 800-981-2491

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