July 31, 2016
Recommended Topic Related To:

Hectorol Injection

"The US Food and Drug Administration (FDA) has approved soluble ferric pyrophosphate (Triferic, Rockwell Medical) to replace iron and maintain hemoglobin in adults with chronic kidney disease who are undergoing dialysis.

Delivered d"...

A A A

Hectorol Injection




Indications
Dosage
How Supplied

INDICATIONS

Hectorol is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

DOSAGE AND ADMINISTRATION

Adult Administration

For intravenous use only. The optimal dose of Hectorol must be carefully determined for each patient. The recommended initial dose of Hectorol 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 mg 2/d2L 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 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
Dose Titration
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

Multi-Dose Vial

After initial vial use, the contents of the multi-dose vial remain stable up to 3 days when stored at 2- 8.C (36-46.F). Discard unused portion of multi-dose vial after 3 days. (See HOW SUPPLIED and Storage).

HOW SUPPLIED

Single-Use Vial

Hectorol (doxercalciferol injection) is supplied in single-use amber glass vials containing 4 mcg doxercalciferol 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. Discard unused portion of single-use vial.

NDC 58468-0123-1 4 mcg/2 mL single-use vial
NDC 58468-0126-1 2 mcg/mL single-use vial

Multi-Dose Vial

Hectorol is also supplied in multi-dose amber glass vials containing 4 mcg doxercalciferol in 2 mL of solution. The closure consists of a fluorocarbon-coated chlorobutyl stopper, with an aluminum seal and an orange plastic flip-off cap.

NDC 58468-0127-1 4 mcg/2 mL multi-dose vial

Storage

Single-Use Vial

Store at 25.C (77.F): excursions permitted to 15-30.C (59-86.F) [see USP controlled room temperature]

Protect from light.

Multi-Dose Vial

Store unopened multi-dose vials at 25.C (77.F): excursions permitted to 15-30.C (59-86.F) [see USP controlled room temperature]

Store opened multi-dose vials at 2-8oC (36-46.F)

Protect from light.

Manufactured by: Genzyme Biosurgery. For: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142. Revised: June 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 6/9/2016

Indications
Dosage
How Supplied

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.


Women's Health

Find out what women really need.