Zemplar

ZEMPLAR- paricalcitol injection, solution
AbbVie Inc.

1 INDICATIONS AND USAGE

ZEMPLAR is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Information

  • Ensure serum calcium is not above the upper limit of normal before initiating treatment [see Warnings and Precautions ( 5.1)].
  • Administer ZEMPLAR intravenously through a hemodialysis vascular access port at any time during dialysis. ZEMPLAR may be administered intravenously if an access port is unavailable.
  • Inspect ZEMPLAR visually prior to administration; the solution should appear clear and colorless. Do not use if the solution is not clear or particles are present.
  • Discard unused portion of 2 mcg/mL and 5 mcg/mL single-dose vials.

2.2 Starting Dose and Dose Titration in Adults

  • Initiate ZEMPLAR as an intravenous bolus dose of 0.04 mcg/kg to 0.1 mcg/kg (2.8 mcg to 7 mcg) no more frequently than every other day at any time during dialysis.

  • Target the maintenance dose of ZEMPLAR to intact parathyroid hormone (PTH) levels within the desired therapeutic range and serum calcium within normal limits.

  • Monitor serum calcium frequently (e.g., twice weekly) and intact PTH levels every 2 to 4 weeks after initiation of therapy or dose adjustment.

  • Titrate the dose of ZEMPLAR based on intact PTH (see Table 1). Prior to raising the dose, ensure serum calcium is within normal limits. The maximum daily adult dose is 0.24 mcg/kg.

  • Suspend or decrease the dose if intact PTH is persistently and abnormally low to reduce the risk of adynamic bone disease [see Warnings and Precautions ( 5.3)] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions ( 5.1)]. If dose suspension is necessary, restart at a reduced dose after laboratory values have normalized.
Table 1. Recommended ZEMPLAR Adult Dose Titration Based Upon intact PTH
Intact PTH Level At Follow-up Visit Dosage Adjustment
Above target and intact PTH increased Increase* by 2 mcg to 4 mcgevery 2 to 4 weeks
Above target and intact PTH decreased by less than 30% Increase* by 2 mcg to 4 mcgevery 2 to 4 weeks
Above target and intact PTH decreased by 30% to 60% No Change
Above target and intact PTH decreased by more than 60% Decrease per clinical judgement
At target and intact PTH stable No Change
* The maximum daily adult dose is 0.24 mcg/kg

2.3 Starting Dose and Dose Titration for Pediatric Patients 5 Years of Age and Above

  • Initiate ZEMPLAR as an intravenous bolus dose of:

    ○ 0.04 mcg/kg if baseline intact PTH is less than 500 pg/mL, or

    ○ 0.08 mcg/kg if baseline intact PTH is 500 pg/mL or greater

  • Administer ZEMPLAR three times per week, no more frequently than every other day, at any time during dialysis.

  • Target the maintenance dose of ZEMPLAR to intact PTH levels within the desired therapeutic range and serum calcium within normal limits.

  • Monitor serum calcium frequently (e.g., twice weekly) and intact PTH levels every 2 to 4 weeks after initiation of therapy or dose adjustment.

  • Titrate the dose of ZEMPLAR based on intact PTH (see Table 2). 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 [see Warnings and Precautions ( 5.3)] or if serum calcium is consistently above the normal range to reduce the risk of hypercalcemia [see Warnings and Precautions ( 5.1)]. If dose suspension is necessary, restart at a reduced dose after laboratory values have normalized.
Table 2. Recommended ZEMPLAR Pediatric Dose Titration Based Upon intact PTH – Patients 5 years of age and older
Intact PTH Level At Follow-up Visit Dosage Adjustment
Above target and intact PTHdecreased by less than 30% Increase by 0.04 mcg/kgevery 2 to 4 weeks
Intact PTH 150 pg/mL or greater anddecreased by 30% to 60% No Change
Intact PTH less than 150 pg/mL ordecreased by more than 60% Decrease by 0.04 mcg/kg weekly, orby 50% if decreased dose equals zero

2.4 Drug Interactions that May Require Dosage Adjustments of ZEMPLAR

  • Increased monitoring of serum calcium and dose adjustment of ZEMPLAR may be necessary when given concomitantly with drugs that may increase the risk of hypercalcemia [see Drug Interactions ( 7)].
  • Increased monitoring of both serum calcium and intact PTH as well as dose adjustment of ZEMPLAR may be necessary when given concomitantly with strong CYP3A inhibitors [see Drug Interactions ( 7)].

3 DOSAGE FORMS AND STRENGTHS

Injection: clear, colorless solution available as follows:

  • 2 mcg/mL single-dose vial

  • 5 mcg/mL single-dose vial

  • 10 mcg/2 mL (5 mcg/mL) multiple-dose vial

4 CONTRAINDICATIONS

ZEMPLAR is contraindicated in patients with:

  • Hypercalcemia [see Warnings and Precautions ( 5.1)]

  • Vitamin D toxicity [see Warnings and Precautions ( 5.1)]

  • Known hypersensitivity to paricalcitol or any of the inactive ingredients in ZEMPLAR. Hypersensitivity adverse reactions have been reported [e.g., angioedema (including laryngeal edema) and urticaria] [see Adverse Reactions ( 6.2)].

5 WARNINGS AND PRECAUTIONS

5.1 Hypercalcemia

Hypercalcemia may occur during ZEMPLAR treatment. Acute hypercalcemia may increase the risk of cardiac arrhythmias and seizures and may potentiate the effect of digitalis on the heart [see Warnings and Precautions ( 5.2)]. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. Severe hypercalcemia may require emergency attention.

Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium-containing preparations, thiazide diuretics, or other vitamin D compounds [see Drug Interactions ( 7)]. In addition, high intake of calcium and phosphate concomitantly with vitamin D compounds may lead to hypercalciuria and hyperphosphatemia. Patients with a history of hypercalcemia prior to initiating therapy may be at increased risk for development of hypercalcemia with ZEMPLAR. In these circumstances, frequent serum calcium monitoring and ZEMPLAR dose adjustments may be required.

When initiating ZEMPLAR or adjusting ZEMPLAR dose, measure serum calcium frequently (e.g., twice weekly). Once a maintenance dose has been established, measure serum calcium at least monthly. If hypercalcemia occurs, reduce the dose or discontinue ZEMPLAR until serum calcium is normal [see Dosage and Administration ( 2.2, 2.3)].

Inform patients about the symptoms of elevated calcium (feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss) and instruct them to report new or worsening symptoms when they occur.

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