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Zemplar Capsules

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Zemplar Capsules

Indications
Dosage
How Supplied

INDICATIONS

Chronic Kidney Disease Stages 3 And 4

Zemplar Capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.

Chronic Kidney Disease Stage 5

Zemplar Capsules are indicated for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).

DOSAGE AND ADMINISTRATION

Chronic Kidney Disease Stages 3 And 4

Zemplar Capsules may be administered daily or three times a week. When dosing three times weekly, the dose should be administered not more frequently than every other day. The total 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.

Initial Dose

The initial dose of Zemplar Capsules for CKD Stages 3 and 4 patients is based on baseline intact parathyroid hormone (iPTH) levels.

Baseline iPTH Level Daily Dose Three Times a Week Dose*
≤ 500 pg/mL 1 mcg 2 mcg
> 500 pg/mL 2 mcg 4 mcg
* 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 to dose titration.

iPTH Level Relative to Baseline Zemplar Capsule Dose Dose Adjustment at 2 to 4 Week Intervals
Daily Dosage Three Times a Week Dosage*
The same, increased or decreased by < 30% Increase dose by 1 mcg 2 mcg
Decreased by ≥ 30% and ≤ 60% Maintain dose - -
Decreased by > 60% or iPTH < 60 pg/mL Decrease dose by 1 mcg 2 mcg
* To be administered not more often than every other day

If a patient is taking the lowest dose, 1 mcg, 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 restarted at a lower dosing frequency. If a patient is on a calcium-based phosphate binder, the phosphate-binder dose may be decreased or withheld, or the patient may be switched to a non-calcium-based phosphate binder. If hypercalcemia is observed, the dose of Zemplar should be reduced or withheld until these parameters are normalized.

Serum calcium and phosphorus levels should be closely monitored after initiation of Zemplar Capsules, during dose titration periods and during co-administration with strong CYP3A inhibitors [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Chronic Kidney Disease Stage 5

Zemplar Capsules are to be administered three times a week, not 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 and Clinical Studies].

Dose Titration

Subsequent dosing should be individualized and based on iPTH, serum calcium and phosphorus levels. A suggested dose titration of Zemplar 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 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 is 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 withheld 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 (e.g., iPTH/100) may be warranted.

HOW SUPPLIED

Dosage Forms And Strengths

Zemplar Capsules are available as 1 mcg, 2 mcg, and 4 mcg soft gelatin capsules.

  • 1 mcg: oval, gray capsule imprinted with the “a” logo and “ZA”
  • 2 mcg: oval, orange-brown capsule imprinted with the “a” logo and “ZF”
  • 4 mcg: oval, gold capsule imprinted with the “a” logo and “ZK”

Storage And Handling

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 the “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 the “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 the “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.

Manufactured for : AbbVie Inc., North Chicago, IL 60064, U.S.A. Revised: Aug 2014

Last reviewed on RxList: 9/24/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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