Zemplar Capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3 and 4.

Zemplar Capsules may be administered daily or three times a week. When dosing three times weekly, the dose should be administered no more frequently than every other day. The average weekly doses for both daily and three times a week dosage regimens are similar (See CLINICAL STUDIES).

Zemplar Capsules may be taken without regard to food. No dosing adjustment is required in patients with mild and moderate hepatic impairment.

The initial dose of Zemplar Capsules is based on baseline intact parathyroid hormone (iPTH) levels.

                         * To be administered not more often than every other day

Dose Titration

Dosing must be individualized and based on serum or plasma iPTH levels, with monitoring of serum calcium and serum phosphorus. The following is a suggested approach in titration.

                   * To be administered not more often than every other day

If a patient is taking the lowest dose on the daily regimen and a dose reduction is needed, the dose can be decreased to 1 mcg three times a week. If a further dose reduction is required, the drug should be withheld as needed and can be restarted at a lower dose. If a 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 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).

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 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 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 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

1. 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.

May 20, 2005

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