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Zemplar

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Zemplar Injection

Indications
Dosage
How Supplied

INDICATIONS

Zemplar is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stage 5.

DOSAGE AND ADMINISTRATION

The currently accepted target range for iPTH levels in CKD Stage 5 patients is no more than 1.5 to 3 times the non-uremic upper limit of normal.

The recommended initial dose of Zemplar is 0.04 mcg/kg to 0.1 mcg/kg (2.8 – 7 mcg) administered as a bolus dose no more frequently than every other day at any time during dialysis.

If a satisfactory response is not observed, the dose may be increased by 2 to 4 mcg at 2- to 4-week intervals. During any dose adjustment period, serum calcium and phosphorus levels should be monitored more frequently, and if an elevated calcium level or a Ca × P product greater than 75 is noted, the drug dosage should be immediately reduced or interrupted until these parameters are normalized. Then, Zemplar should be reinitiated at a lower dose. If a patient is on a calcium-based phosphate binder, the dose may be decreased or withheld, or the patient may be switched to a non­calcium-based phosphate binder. Zemplar doses may need to be decreased as the PTH levels decrease in response to therapy. Thus, incremental dosing must be individualized.

The following table is a suggested approach in dose titration:

Suggested Dosing Guidelines

PTH Level Zemplar Dose
the same or increasing increase
decreasing by < 30% increase
decreasing by > 30%, < 60% maintain
decreasing by > 60% decrease
one and one-half to three times upper limit of normal maintain

The influence of mild to moderately impaired hepatic function on paricalcitol pharmacokinetics is sufficiently small that no dosing adjustment is required.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

After initial vial use, the contents of the multi-dose vial remain stable up to seven days when stored at controlled room temperature (see HOW SUPPLIED). Discard unused portion of the single-dose vial.

HOW SUPPLIED

Zemplar Injection (paricalcitol injection fliptop vial) is available as 2 mcg/mL (NDC 0074-4637-01) and 5 mcg/mL (NDC 0074-1658-01, NDC 0074-1658-02, and NDC 0074-1658-05) in trays of 25 vials.

List No. Volume/Container Concentration Total Content Vial Type
4637-01 1 mL/Fliptop Vial 2 mcg/mL 2 mcg Single-dose
1658-01 1 mL/Fliptop Vial 5 mcg/mL 5 mcg Single-dose
1658-02 2 mL/Fliptop Vial 5 mcg/mL 10 mcg Single-dose
1658-05 2 mL/Fliptop Vial 5 mcg/mL 10 mcg Multi-dose

Store at 25°C (77°F). Excursions permitted between 15° - 30°C (59° - 86°F).

Manufactured by Hospira Inc. Lake Forest, IL 60045 USA. For Abbott Laboratories North Chicago, IL 60064, U.S.A. Rev. 03/2011

Last reviewed on RxList: 5/20/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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