Drug Description A A A . Hectorol Injection Drug Description.

Contact your doctor if you experience any of the following side effects Read All Potential Side Effects for Hectorol Injection ?. Doxercalciferol, the active ingredient in Hectorol?, is a synthetic vitamin D2 analog that undergoes metabolic activation in vivo to form 1α,25-dihydroxyvitamin D2 (1α,25-(OH)2D2), a naturally occurring, biologically active form of vitamin D 2.

Hectorol Injection Indications & Dosage. Hectorol is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis |. 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 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 1 mcg lower.

Pharmacokinetics and Metabolism. After intravenous administration, doxercalciferol is activated by CYP 27 in the liver to form 1α,25-(OH)2D2 (major metabolite) and 1α,24-dihydroxyvitamin D2 (minor metabolite). Activation of doxercalciferol does not require the involvement of the kidneys.

Clinical Studies. . The safety and effectiveness of Hectorol Injection were evaluated in two open-label, single-arm, multi-centered clinical studies (Study C and Study D) in a total of 70 patients with chronic kidney disease on hemodialysis (Stage 5 CKD). Patients in Study C were an average age of 54 years (range: 23-73), were 50% male, and were 61% African-American, 25% Caucasian, and 14% Hispanic, and had been on hemodialysis for an average of 65 months.

Patients in Study D were an average age of 51 years (range: 28-76), were 48% male, and 100% African-American and had been on hemodialysis for an average of 61 months. This group of 70 of the 138 patients who had been treated with Hectorol Capsules in prior clinical studies (Study A and Study B) received Hectorol Injection in an open-label fashion for 12 weeks following an 8-week washout (control) period.

Dosing of Hectorol Injection was initiated at the rate of 4 mcg administered at the end of each dialysis session (3 times weekly) for a total of 12 mcg per week. The dosage of Hectorol was adjusted in an attempt to achieve iPTH levels within a targeted range of 150 to 300 pg/mL. If at any time during the trial iPTH fell below 150 pg/mL, Hectorol Injection was immediately suspended and restarted at a lower dosage the following week

Results. Fifty-two of the 70 patients who were treated with Hectorol Injection achieved iPTH levels ≤ 300 pg/mL. Forty-one of these patients exhibited plasma iPTH levels ≤ 300 pg/mL on at least 3 occasions. Thirty-six patients had plasma iPTH levels < 150 pg/mL on at least one occasion during study participation. Mean weekly doses in Study C ranged from 8.9 mcg to 12.5 mcg.

In Study D, the mean weekly doses ranged from 9.1 mcg to 11.6 mcg Plasma iPTH levels were measured weekly during the 12-week study Table 1: iPTH Summary Data for Patients Receiving Hectorol? Injection In both studies, iPTH levels increased progressively and significantly in 62.9% of patients during the 8-week washout (control) period during which no vitamin D derivatives were administered.

In contrast, Hectorol Injection treatment resulted in a clinically significant reduction (at least 30%) from baseline in mean iPTH levels during the 12-week open-label treatment period in more than 92% of the 70 treated patients . Table 2 shows the numbers of patients who achieved iPTH levels below 300 pg/mL on one, two, or three or more non-consecutive occasions during the 12-week treatment period.

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Hectorol Injection. Hectorol Injection Drug Description. Hectorol Injection Indications & Dosage. Hectorol Injection Side Effects & Drug Interactions. Hectorol Injection Overdosage & Contraindications. Hectorol Injection Consumer. Hectorol Injection Patient.

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