"The U.S. Food and Drug Administration today approved Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before transplant, or after renal (kidney) transplantation in which there is re"...
- Patient Information:
Details with Side Effects
Hectorol (doxercalciferol injection) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.
DOSAGE AND ADMINISTRATION
For intravenous use only. The optimal dose of Hectorol (doxercalciferol injection) must be carefully determined for each patient. The recommended initial dose of Hectorol (doxercalciferol injection) is 4 mcg administered intravenously as a bolus dose three times weekly at the end of dialysis (approximately every other day). The initial dose should be adjusted, as needed, in order to lower blood iPTH into the range of 150 to 300 pg/mL. The dose may be increased at 8-week intervals by 1 to 2 mcg if iPTH is not lowered by 50% and fails to reach the target range. Dosages higher than 18 mcg weekly have not been studied. Drug administration should be suspended if iPTH falls below 100 pg/mL and restarted one week later at a dose that is at least 1 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 phosphorus product greater than 55 mg2/dL2is noted, the dose of Hectorol (doxercalciferol injection) 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 1 mcg lower.
Dosing must be individualized and based on iPTH levels with monitoring of serum calcium and serum phosphorus levels. Table 5 presents a suggested approach in dose titration.
Table 5: Initial Dosing
|iPTH Level||Hectorol Dose|
|> 400 pg/mL||4 mcg three times per week at the end of dialysis, or approximately every other day|
|iPTH Level||Hectorol Dose|
|Decreased by < 50% and above 300 pg/mL||Increase by 1 to 2 mcg at eight-week intervals as necessary|
|Decreased by > 50% and above 300 pg/mL||Maintain|
|150 - 300 pg/mL||Maintain|
|< 100 pg/mL||Suspend for one week, then resume at a dose that is at least 1 mcg lower|
Discard unused portion.
Hectorol (doxercalciferol injection) (doxercalclferol injection) is supplied in single-use amber glass vials containing 4 mcg doxercalclferol in 2 mL of solution or 2 mcg in 1 mL of solution. The closure consists of a fluorocarbon-coated chlorobutyl stopper, with an aluminum seal and either a yellow (4 mcg/2 mL) or green (2 mcg/mL) plastic flip-off cap.
NDC 58468-0123-1 4 mcg/2 mL vial
NDC 58468-0126-1 2 mcg/mL vial
Store at 25°C (77°F): excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]
Protect from light.
Manufactured by: Genzyme Biosurgery For: Genzyme Corporation 500 Kendall Street Cambridge, MA 02142
Last reviewed on RxList: 1/24/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Hectorol Injection Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.