Hectorol
(doxercalciferol)Dosage & Administration
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Hectorol Prescribing Information
- 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.
Prior to Initiation of HECTOROL Capsules or Injection
- Ensure serum calcium is not above the upper limit of normal before initiating treatment with HECTOROL capsules or injection [see Warnings and Precautions (5.1)].
Dosage Recommendations for HECTOROL Capsules in Patients with Stage 3 or 4 CKD
- Initiate HECTOROL capsules at a dose of 1 mcg orally once daily.
- Target the maintenance dose of HECTOROL to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits.
- Monitor serum calcium, phosphorus, and intact PTH 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.
- Titrate the dose of HECTOROL capsules based on intact PTH. The dose may be increased at 2-week intervals by 0.5 mcg to achieve the desired therapeutic range of intact PTH. The maximum recommended dose of HECTOROL capsules is 3.5 mcg administered once daily. Prior to raising the dose, ensure serum calcium is within normal limits.
- Suspend or decrease the dose if intact PTH is persistently and abnormally low to reduce the risk of adynamic bone disease [see Warnings and Precautions (5.4)] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions (5.1)]. If suspended, the drug should be restarted after one week at a dose that is at least 0.5 mcg lower.
Dosage Recommendations for HECTOROL Capsules in Patients with CKD on Dialysis
- Initiate HECTOROL capsules at a dose of 10 mcg orally administered three times weekly at dialysis (no more frequently than every other day).
- Target the maintenance dose of HECTOROL to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits.
- Monitor serum calcium, phosphorus, and intact PTH levels frequently (e.g., weekly) after initiation of therapy or dose adjustment.
- Titrate the dose of HECTOROL capsules based on intact PTH. The dose may be increased at 8-week intervals by 2.5 mcg to achieve the desired therapeutic range of intact PTH. The maximum recommended dose of HECTOROL is 20 mcg administered three times weekly at dialysis for a total dose of 60 mcg weekly. Prior to raising the dose, ensure serum calcium is within normal limits.
- Suspend or decrease the dose if intact PTH is persistently and abnormally low to reduce the risk of adynamic bone disease [see Warnings and Precautions (5.4)] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions (5.1)]. If suspended, the drug should be restarted one week later at a dose that is at least 2.5 mcg lower.
Important Administration Instructions for HECTOROL Injection
- Administer HECTOROL injection intravenously as a bolus dose at the end of dialysis.
- Inspect HECTOROL injection visually prior to administration; the solution should appear clear and colorless. Do not use if the solution is not clear or particles are present.
- After initial vial use:
- discard unused portion of the single-dose vial;
- store opened multiple-dose vial for up to 3 days at 2°C to 8°C (36°F to 46°F). Discard unused portion of multiple-dose vial after 3 days [see How Supplied/Storage and Handling (16)].
Dosage Recommendations for HECTOROL Injection in Patients with CKD on Dialysis
- Initiate HECTOROL injection at a dose of 4 mcg given by bolus intravenous administration three times weekly at the end of dialysis (no more frequently than every other day).
- Target the maintenance dose of HECTOROL to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits.
- Monitor serum calcium, phosphorus, and intact PTH levels weekly after initiation of therapy or dose adjustment.
- Titrate the dose of HECTOROL injection based on intact PTH. The dose may be increased at 8-week intervals by 1 mcg to 2 mcg if intact PTH is not lowered by 50% and fails to reach the target range. The maximum dose is 18 mcg weekly. Prior to raising the dose, ensure serum calcium is within normal limits.
- Suspend or decrease the dose if intact PTH is persistently and abnormally low to reduce the risk of adynamic bone disease [see Warnings and Precautions (5.4)] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions (5.1)]. If suspended, the drug should be restarted one week later at a dose that is at least 1 mcg lower.
Drug Interactions that May Require Dosage Adjustments of HECTOROL
- Increased monitoring of serum calcium and dose adjustment of HECTOROL may be necessary when given concomitantly with drugs that may increase the risk of hypercalcemia [see Drug Interactions (7)].
- Increased monitoring of both serum calcium and intact PTH as well as dose adjustment of HECTOROL may be necessary when given concomitantly with cytochrome P450 inhibitors or enzyme inducers [see Drug Interactions (7)].
Capsules: soft gelatin, oval capsules with imprinted "g" available as follows:
- 0.5 mcg (salmon color)
- 1 mcg (peach color)
- 2.5 mcg (butter-yellow color)
Injection: clear and colorless solution available as follows:
- 2 mcg/mL single-dose vial
- 4 mcg/2 mL (2 mcg/mL) single-dose vial
- 4 mcg/2 mL (2 mcg/mL) multiple-dose vial
Pregnancy
Risk Summary
The limited available data with HECTOROL in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see Clinical Considerations]. In reproduction studies in rats and rabbits administered doxercalciferol during organogenesis at up to 20 mcg/kg/day and 0.1 mcg/kg/day, respectively (approximately 25 times (rats) and less than (rabbits) the maximum recommended human oral dose of 60 mcg/week based on mcg/m2 body surface area), no adverse developmental effects were observed [see Data].
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively.
Clinical Considerations
Disease-associated maternal and/or embryo/fetal risk
Chronic kidney disease in pregnancy increases the risk for maternal hypertension and preeclampsia, miscarriage, preterm delivery polyhydramnios, stillbirth, and low-birth-weight infants.
Data
Animal data
There were no adverse effects on fetal development when doxercalciferol was administered at doses up to 20 mcg/kg/day in pregnant rats or doses up to 0.1 mcg/kg/day in pregnant rabbits during the period of organogenesis.
Lactation
Risk Summary
There is no information available on the presence of doxercalciferol in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Infants exposed to HECTOROL through breast milk should be monitored for signs and symptoms of hypercalcemia [see Clinical Considerations].
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HECTOROL and any potential adverse effects on the breastfed child from HECTOROL or from the underlying maternal condition.
Clinical Considerations
Infants exposed to Doxercalciferol Injection through breast milk should be monitored for signs and symptoms of hypercalcemia, including seizures, vomiting, constipation and weight loss. Monitoring of serum calcium in the infant should be considered.
Pediatric Use
Safety and efficacy of HECTOROL in pediatric patients have not been established.
Geriatric Use
Clinical studies of HECTOROL did not include sufficient numbers of patients 65 years or over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic or cardiac function, and of concomitant disease or other drug therapy.
Hepatic Impairment
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.
HECTOROL is contraindicated in patients with:
- Hypercalcemia [see Warnings and Precautions (5.1)]
- Vitamin D toxicity [see Warnings and Precautions (5.1)]
- Known hypersensitivity to doxercalciferol or any of the inactive ingredients of HECTOROL capsules or HECTOROL injection; serious hypersensitivity reactions including anaphylaxis and angioedema have been reported [see Warnings and Precautions (5.3), Adverse Reactions (6.2)].
Hypercalcemia
Hypercalcemia may occur during HECTOROL treatment. Acute hypercalcemia may increase the risk of cardiac arrhythmias and seizures and may potentiate the effect of digitalis on the heart [see Warnings and Precautions (5.2)]. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. Severe hypercalcemia may require emergency attention.
Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium-containing preparations, thiazide diuretics, or other vitamin D compounds [see Drug Interactions (7)]. In addition, high intake of calcium and phosphate concomitantly with vitamin D compounds may lead to hypercalciuria and hyperphosphatemia. Patients with a history of hypercalcemia prior to initiating therapy may be at increased risk for development of hypercalcemia with HECTOROL. In these circumstances, frequent serum calcium monitoring and HECTOROL dose adjustments may be required.
When initiating HECTOROL or adjusting HECTOROL dose, measure serum calcium frequently (weekly in patients with CKD on dialysis or every 2 weeks for patients with stage 3 or 4 CKD). Once a maintenance dose has been established, measure serum calcium monthly for 3 months and then every 3 months. If hypercalcemia occurs, reduce the dose or discontinue HECTOROL until serum calcium is normal [see Dosage and Administration (2)].
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.
Digitalis Toxicity
HECTOROL can cause hypercalcemia [see Warnings and Precautions (5.1)] which increases the risk of digitalis toxicity. In patients using HECTOROL concomitantly with digitalis compounds, monitor both serum calcium and patients for signs and symptoms of digitalis toxicity. Increase the frequency of monitoring when initiating or adjusting the dose of HECTOROL [see Drug Interactions (7)].
Serious Hypersensitivity Reactions
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 upon initiation of treatment for hypersensitivity reactions. Should a hypersensitivity reaction occur, discontinue HECTOROL, monitor and treat if indicated [see Contraindications (4)].
Adynamic Bone Disease
Adynamic bone disease with subsequent increased risk of fractures may develop if intact PTH levels are suppressed by HECTOROL to abnormally low levels. Monitor intact PTH levels to avoid oversuppression and adjust the HECTOROL dose, if needed [see Dosage and Administration (2)].