witched to a non-calcium-based phosphate binder. If hypercalcemia or an elevated Ca x P is observed, the dose of Zemplar should be reduced or interrupted until these parameters are normalized.
Serum calcium and phosphorus levels should be closely monitored after initiation of Zemplar Capsules and during dose titration periods and coadministration with strong P450 3A inhibitors (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
CKD Stage 5
Zemplar Capsules are to be administered three times a week, no more frequently than every other day.
Zemplar Capsules may be taken without regard to food. No dosing adjustment is required in patients with mild and moderate hepatic impairment.
Initial Dose
The initial dose of Zemplar Capsules in micrograms is based on a baseline iPTH level (pg/mL)/80. To minimize the risk of hypercalcemia patients should be treated only after their baseline serum calcium has been adjusted to 9.5 mg/dL or lower (see CLINICAL PHARMACOLOGY; Pharmacodynamics and CLINICAL STUDIES; CKD Stage 5).
Dose Titration
Subsequent dosing should be individualized and based on iPTH, serum calcium and phosphorus levels. A suggested dose titration of paricalcitol capsules is based on the following formula:
Titration dose (micrograms) = most recent iPTH level (pg/ml)/80
Serum calcium and phosphorus levels should be closely monitored after initiation, during dose titration periods, and with co-administration of strong P450 3A inhibitors. If an elevated serum calcium or elevated Ca x P is observed and the patient is on a calcium-based phosphate binder, the binder dose may be decreased or withheld, or the patient may be switched to a non-calcium-based phosphate binder. If serum calcium or Ca x P are elevated, the dose should be decreased by 2 to 4 micrograms lower than that calculated by the most recent iPTH/80. If further adjustment is required, the dose of paricalcitol capsules should be reduced or interrupted until these parameters are normalized.
As iPTH approaches the target range, small, individualized dose adjustments may be necessary in order to achieve a stable iPTH. In situations where monitoring of iPTH, Ca or P occurs less frequently than once per week, a more modest initial and dose titration ratio may be warranted.
HOW SUPPLIED
Zemplar Capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules.
The 1 mcg capsule is an oval, gray, soft gelatin capsule imprinted with Abbott “A” logo and ZA, and is available in the following package size:
Bottles of 30 (NDC 0074-4317-30)
The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule imprinted with Abbott “A” logo and ZF, and is available in the following package size:
Bottles of 30 (NDC 0074-4314-30)
The 4 mcg capsule is an oval, gold soft gelatin capsule imprinted with Abbott “A” logo and ZK, and is available in the following package size:
Bottles of 30 (NDC 0074-4315-30)
Storage
Store Zemplar Capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.
U.S. patents: 5,246,925; 5,587,497
REFERENCES
K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease. Am J Kidney Dis 2003; Volume 42(4): Supplement 3.
Abbott Laboratories
North Chicago, IL 60064, U.S.A.
NDC 0074–4317–73
Zemplar® (paricalcitol) Capsules
Professional Sample — Not For Sale
Contains 1 Patient Sample of 7 Capsules
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