paricalcitol (Rx)

Brand and Other Names:Zemplar
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mcg/mL
  • 5mcg/mL

capsule

  • 1mcg
  • 2mcg
  • 4mcg

Secondary Hyperparathyroidism

CKD stage 5

  • Indicated for prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) stage 5 in patients on hemodialysis or peritoneal dialysis
  • Initial 0.04-0.1 mcg/kg IV 3 x/week, no more frequently than every other day  
  • Titrate up or down by 2-4 mcg q2-4Weeks
  • Up to 0.24 mcg/kg PO have been administered

CKD stage 3 and 4

  • Indicated for prevention and treatment of secondary hyperparathyroidism associated CKD
  • PTH ≤500 pg/mL: 1 mcg PO qDay OR 2 mcg PO 3 times/week
  • PTH >500 pg/mL: 2 mcg PO qDay OR 4 mcg PO 3 times/week
  • Administer 3 times/week, no more frequently than every other day
  • Titrate dose based on response

Monitoring

Serum PTH, calcium & phosphorus

Monitoring parameters (Stage 5)

  • PTH same or increased: Increase dose
  • PTH level decreased by <30%: Increased dose
  • PTH level decreased by >30% & <60%: Maintain dose
  • PTH level decreased by >60%: Decrease dose
  • PTH level 1.5-3 x ULN: Maintain dose

Monitoring parameters (Stage 3 and 4)

  • Serum PTH at 2-4 week intervals
  • PTH same or increased: Increase by 1 mcg/day OR 2 mcg 3 times/week
  • PTH decreased <30%: Increase by 1 mcg/day OR 2 mcg 3 times/week
  • PTH decreased >30% or <60%: Maintain current dose
  • PTH decreased >60%: Decrease 1 mcg/day OR 2 mcg 3 times/week
  • PTH <60 pg/mL: Decrease 1 mcg/day OR 2 mcg 3 times/week

Dosage Forms & Strengths

injectable solution

  • 2mcg/mL
  • 5mcg/mL

capsule

  • 1mcg
  • 2mcg
  • 4mcg

Secondary Hyperparathyroidism

CKD stage 3 and 4

  • Indicated for prevention and treatment of secondary hyperparathyroidism associated chronic kidney disease (CKD)
  • Oral dosing
    • <10 years: Safety and efficacy not established
    • 10-16 years: 1 mcg PO 3 x/week, no more frequently than every other day
    • Individualize and titrate dose based on iPTH, serum calcium, and phosphorus levels to maintain an iPTH level within target range
    • Increase dose: Dose may be increased in 1-mcg increments q4wk, maintaining the 3 x/week dose schedule
    • Decrease dose: At any time, each administered dose may be decreased by 1 mcg
    • Interrupt dosing: May be stopped if the patient requires reduction while receiving 1 mcg 3 x/week, resuming when appropriate

CKD stage 5

  • Indicated for prevention and treatment of secondary hyperparathyroidism associated with CKD stage 5 in patients on hemodialysis or peritoneal dialysis
  • Oral dosing
    • <10 years: Safety and efficacy not established
    • 10-16 years (initial dose): 3 x/week, no more frequently than every other day based on the following formula
    • Dose (mcg) = baseline iPTH (pg/mL) divided by 120 (round down to nearest whole number)
    • Individualize and titrate dose based on iPTH, serum calcium, and phosphorus levels to maintain an iPTH level within target range
    • Increase dose: Dose may be increased in 1-mcg increments q4wk, maintaining the 3 x/week dose schedule
    • Decrease dose: At any time, each administered dose may be decreased by 2 mcg
    • Interrupt dosing: May be stopped if the patient requires reduction while receiving 1-2 mcg 3 x/week, resuming when appropriate
  • IV dosing
    • <5 years: Safety and efficacy not established
    • ≥5 years, initial dose (iPTH <500 pg/mL): 0.04 mcg/kg IV 3 x/week no more frequently than every other day at any time during dialysis  
    • ≥5 years, initial dose (iPTH ≥500 pg/mL): 0.08 mcg/kg IV 3 x/week no more frequently than every other day at any time during dialysis
    • Individualize and titrate IV dose based on iPTH, serum calcium, and phosphorus levels to maintain an iPTH level within target range
    • Adjust dose by 0.04 mcg/kg increments based on serum iPTH

Monitoring

Serum PTH, calcium, andphosphorus

CDK stage 5 monitoring

  • Same or Increasing PTH level: Increase dose
  • PTH level decreased <30%: Increase dose
  • PTH level decreased >30% & <60%: Maintain current dose
  • PTH level decreased >60%: Decrease dose
  • PTH level 1.5-3 x ULN: Maintain current dose
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Interactions

Interaction Checker

and paricalcitol

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nausea (13%)

            1-10%

            Vomiting

            Edema

            Palpitation

            Chills

            Pneumonia

            Lightheadedness

            GI bleeding

            Flulike symptoms

            Sepsis

            Hypokalemia

            Hypercalcemia

            Increase in blood creatinine

            Postmarketing Reports

            Angioedema

            Headache

            Constipation

            Abdominal pain

            Hyperphosphatemia

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            Warnings

            Contraindications

            Hypercalcemia, hypervitaminosis D

            Cautions

            Monitor serum calcium, serum phosphorus, and serum or plasma iPTH during initial dosing or following any dose adjustment; in pre-dialysis patients, paricalcitol capsules may increase serum creatinine and therefore decrease the estimated GFR (eGFR); monitor intact PTH levels to avoid over suppression and adjust dose, if needed

            Monitor serum calcium and phosphorus frequently; reduce dose or stop the drug if calcium (in mg/dL) times phosphorus (in mg/dL) product >75; once maintenance dose has been established, measure serum calcium at least monthly; if hypercalcemia occurs, reduce dose or discontinue therapy until serum calcium is normal

            Avoid excessive use of aluminum containing compounds

            Patients receiving digitalis; digitalis toxicity is potentiated by hypercalcemia; monitor serum calcium and patients for signs and symptoms of digitalis toxicity;increase frequency of monitoring when initiating or adjusting dose

            Strong CYP3A4 inhibitors may increase paricalcitol AUC

            Injection solution doesn't contain preservatives; discard unused portions

            Use caution in hepatic impairment

            Hypercalcemia

            • Excessive administration of drug can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease; prescription-based doses of vitamin D and its derivatives should be withheld during therapy; severe hypercalcemia may require emergency attention; frequent serum calcium monitoring and dose adjustments may be required
            • Acute hypercalcemia may increase risk of cardiac arrhythmias and seizures and may potentiate effect of digitalis on heart
            • Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification
            • Hypercalcemia may be exacerbated by concomitant administration of high doses of calcium-containing preparations, thiazide diuretics, or other vitamin D compounds
            • Patients with a history of hypercalcemia prior to initiating therapy may be at increased risk for development of hypercalcemia
            • When initiating therapy or adjusting dose, measure serum calcium frequently (e.g., twice weekly); once a maintenance dose established, measure serum calcium at least monthly; if hypercalcemia occurs, reduce dose or discontinue therapy until serum calcium is normal
            • Inform patients about 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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            Pregnancy & Lactation

            Pregnancy

            Limited data with Paricalcitol Injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage; there are risks to mother and fetus associated with chronic kidney disease in pregnancy

            Animal data

            • In animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered another paricalcitol product intravenously during period of organogenesis at doses 2 and 0.5 times, respectively, a human dose of 14 mcg (equivalent to 0.24 mcg/kg), based on body
            • surface area (mg/m2); adverse reproductive outcomes were observed at doses that caused maternal toxicity
            • Chronic kidney disease in pregnancy increases risk for maternal hypertension and preeclampsia, miscarriage, preterm delivery, polyhydramnios, still birth, and low birth weight infants

            Lactation

            There is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or effects of drug on milk production; studies in rats have shown that drug and/or its metabolites are present in milk of lactating rats; when a drug is present in animal milk, it is likely that drug will be present in human milk

            Infants exposed to drug through breast milk should be monitored for signs and symptoms of hypercalcemia; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition

            Infants exposed to drug through breast milk should be monitored for signs and symptoms

            of hypercalcemia, including seizures, vomiting, constipation, and weight loss; monitoring of serum calcium in the infant should be considered

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Synthetic vitamin D analog, reduces parathyroid hormone (PTH)

            Absorption

            Bioavailability (PO): 72%

            Distribution

            Protein Bound: 99.8%

            Vd: 44-46 L in CRF; healthy patients 34 L

            Metabolism

            Extensively metabolized in liver

            At least 5 unknown metabolites

            Elimination

            Half-Life: 14-20 hr in ESRD

            Total Body Clearance: 2.5-4 L/hr

            Excretion: Feces 74%; urine 16%

            Hemodialysis: Not dialyzable

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            Administration

            Oral Administration

            May take with or without food

            IV Administration

            Administer as an IV bolus no more frequently than every other day at any time during dialysis

            Storage

            IV

            • Store at room temperature of 25°C (77°F); excursions permitted between15-30°C (59-86°F)
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.