Doxercalciferoldosage

Before initiating treatment, ensure serum calcium is not above the upper limit of normal. Dosage for doxercalciferol capsules in patients with: Stage 3 or 4 CKD: Initiate dosing at 1 mcg orally once daily. Maximum dose is 3.5 mcg once daily.

CKD on dialysis: Initiate dosing at 10 mcg orally three times weekly at dialysis (no more frequently than every other day). Maximum dose is 20 mcg three times weekly for a total of 60 mcg weekly. Target the maintenance dose of doxercalciferol to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits. See Full Prescribing Information for dose titration, laboratory monitoring, and important administration instructions.

2.1 Prior to

Initiation of Doxercalciferol Capsules Ensure serum calcium is not above the upper limit of normal before initiating treatment with doxercalciferol capsules.

2.2 Dosage Recommendations for

Doxercalciferol Capsules in Patients with Stage 3 or 4 CKD Initiate doxercalciferol capsules at a dose of 1 mcg orally once daily. Target the maintenance dose of doxercalciferol 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 doxercalciferol 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 doxercalciferol 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 or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia. If suspended, the drug should be restarted after one week at a dose that is at least 0.5 mcg lower.

2.3 Dosage Recommendations for

Doxercalciferol Capsules in Patients with CKD on Dialysis Initiate doxercalciferol 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 doxercalciferol 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 doxercalciferol 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 doxercalciferol 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 or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia. If suspended, the drug should be restarted one week later at a dose that is at least 2.5 mcg lower.

2.6 Drug Interactions that

May Require Dosage Adjustments of Doxercalciferol Increased monitoring of serum calcium and dose adjustment of doxercalciferol may be necessary when given concomitantly with drugs that may increase the risk of hypercalcemia. Increased monitoring of both serum calcium and intact PTH as well as dose adjustment of doxercalciferol may be necessary when given concomitantly with cytochrome P450 inhibitors or enzyme inducers.