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

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and paricalcitol

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      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (6)

              • abametapir

                abametapir will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

              • apalutamide

                apalutamide will decrease the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

              • conivaptan

                conivaptan will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • fexinidazole

                fexinidazole will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

              • idelalisib

                idelalisib will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

              • voxelotor

                voxelotor will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

              Monitor Closely (43)

              • atazanavir

                atazanavir increases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. .

              • bosentan

                bosentan will decrease the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • carbamazepine

                carbamazepine will decrease the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • cenobamate

                cenobamate will decrease the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

              • chloramphenicol

                chloramphenicol will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • cholestyramine

                cholestyramine decreases levels of paricalcitol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. (Vitamin D analog).

              • clarithromycin

                clarithromycin will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • cobicistat

                cobicistat will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • colesevelam

                colesevelam decreases levels of paricalcitol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. (Vitamin D analog).

              • colestipol

                colestipol decreases levels of paricalcitol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. (Vitamin D analog).

              • crofelemer

                crofelemer increases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.

              • dabrafenib

                dabrafenib will decrease the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

              • darunavir

                darunavir increases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. .

              • digoxin

                paricalcitol increases toxicity of digoxin by pharmacodynamic synergism. Use Caution/Monitor.

              • efavirenz

                efavirenz will decrease the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • elagolix

                elagolix decreases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.

              • fedratinib

                fedratinib will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

              • fosamprenavir

                fosamprenavir increases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. .

              • fosphenytoin

                fosphenytoin will decrease the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • iloperidone

                iloperidone increases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.

              • indinavir

                indinavir increases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. .

              • istradefylline

                istradefylline will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

              • itraconazole

                itraconazole will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ketoconazole

                ketoconazole will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • lopinavir

                lopinavir increases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity.

              • mifepristone

                mifepristone will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • mitotane

                mitotane decreases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

              • nefazodone

                nefazodone will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • nelfinavir

                nelfinavir increases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. .

              • orlistat

                orlistat decreases levels of paricalcitol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • phenytoin

                phenytoin will decrease the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • posaconazole

                posaconazole will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ribociclib

                ribociclib will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifabutin

                rifabutin will decrease the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ritonavir

                ritonavir increases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity.

              • rucaparib

                rucaparib will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

              • saquinavir

                saquinavir increases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. .

              • stiripentol

                stiripentol, paricalcitol. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

              • tazemetostat

                tazemetostat will decrease the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tecovirimat

                tecovirimat will decrease the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

              • tipranavir

                tipranavir increases levels of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. .

              • voriconazole

                voriconazole will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              Minor (0)

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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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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Zemplar intravenous
                -
                2 mcg/mL vial
                Zemplar intravenous
                -
                5 mcg/mL vial
                Zemplar intravenous
                -
                5 mcg/mL vial
                paricalcitol intravenous
                -
                5 mcg/mL vial
                paricalcitol intravenous
                -
                5 mcg/mL vial
                paricalcitol intravenous
                -
                2 mcg/mL vial
                paricalcitol intravenous
                -
                5 mcg/mL vial
                paricalcitol intravenous
                -
                5 mcg/mL vial
                paricalcitol intravenous
                -
                2 mcg/mL vial
                paricalcitol oral
                -
                2 mcg capsule
                paricalcitol oral
                -
                1 mcg capsule
                paricalcitol oral
                -
                2 mcg capsule
                paricalcitol oral
                -
                1 mcg capsule
                paricalcitol oral
                -
                4 mcg capsule
                paricalcitol oral
                -
                1 mcg capsule
                paricalcitol oral
                -
                4 mcg capsule
                paricalcitol oral
                -
                1 mcg capsule
                paricalcitol oral
                -
                4 mcg capsule
                paricalcitol oral
                -
                2 mcg capsule
                paricalcitol oral
                -
                2 mcg capsule
                Zemplar oral
                -
                1 mcg capsule
                Zemplar oral
                -
                2 mcg capsule
                Zemplar oral
                -
                2 mcg capsule
                Zemplar oral
                -
                1 mcg capsule
                paricalcitol hemodialysis port injection
                -
                5 mcg/mL vial
                paricalcitol hemodialysis port injection
                -
                5 mcg/mL vial
                paricalcitol hemodialysis port injection
                -
                2 mcg/mL vial
                paricalcitol hemodialysis port injection
                -
                2 mcg/mL vial
                paricalcitol hemodialysis port injection
                -
                5 mcg/mL vial
                paricalcitol hemodialysis port injection
                -
                2 mcg/mL vial
                paricalcitol hemodialysis port injection
                -
                5 mcg/mL vial
                paricalcitol hemodialysis port injection
                -
                5 mcg/mL vial
                paricalcitol hemodialysis port injection
                -
                2 mcg/mL vial
                paricalcitol hemodialysis port injection
                -
                5 mcg/mL vial
                paricalcitol hemodialysis port injection
                -
                5 mcg/mL vial
                paricalcitol hemodialysis port injection
                -
                2 mcg/mL vial
                paricalcitol hemodialysis port injection
                -
                5 mcg/mL vial
                paricalcitol hemodialysis port injection
                -
                5 mcg/mL vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Select a drug:
                Patient Education
                paricalcitol intravenous

                PARICALCITOL - INJECTION

                (PAR-i-KAL-si-tol)

                COMMON BRAND NAME(S): Zemplar

                USES: Paricalcitol is a man-made active form of vitamin D, which is needed for building and keeping strong bones. Paricalcitol is used in patients with long-term kidney disease to treat or prevent high levels of a certain natural substance made by the body (parathyroid hormone). Too much parathyroid hormone can cause serious problems such as bone disorders.Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., dairy products, vitamins). Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. People with kidney disease cannot make enough of the active form of vitamin D. Vitamin D helps control parathyroid hormone and the levels of certain minerals (e.g., calcium, phosphorus) that are needed for building and keeping strong bones.

                HOW TO USE: Read the Patient Information Leaflet if one is available from your pharmacist before you start using paricalcitol. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.This medication is given by injection into a vein during dialysis, usually by a health care professional. It is given as directed by your doctor, usually 3 times a week (every other day). The dosage is based on your condition, weight, laboratory tests, and response to treatment. Your doctor will do blood tests to find the best dose for you.It is very important to follow the diet recommended by your doctor to get the most benefit from this medication and to prevent side effects. Do not take other supplements/vitamins (e.g., calcium, vitamin D) unless ordered by your doctor.

                SIDE EFFECTS: Headache, nausea, chills, or fever may occur. If any of these effects persist or worsen, tell your doctor promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may raise your vitamin D and calcium levels too high. Tell your doctor right away if any of these unlikely but serious effects of too much vitamin D/calcium occur: constipation, drowsiness, dry mouth, muscle/bone/joint pain, metallic taste in mouth, weakness, vomiting.Tell your doctor right away if any of these rare but serious side effects of very high vitamin D levels occur: loss of appetite, unusual weight loss, eye pain/redness/sensitivity to light, severe runny nose, stomach/abdominal pain.Tell your doctor right away if you have any serious side effects, including: dizziness, fast/irregular/pounding heartbeat, swelling hands/ankles/feet, severe mental/mood changes (e.g., agitation, confusion), easy bleeding/bruising, bloody/tarry stool, vomit that looks like coffee grounds.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using paricalcitol, tell your doctor or pharmacist if you are allergic to it; or to other vitamin D products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: high levels of calcium (hypercalcemia), high levels of vitamin D (hypervitaminosis D), regular use/abuse of alcohol, brain problems (e.g., seizures, brain injury), heart problems (e.g., arrhythmias, coronary artery disease), liver disease.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication contains alcohol. It may make you dizzy or drowsy. Marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: burosumab, products that contain aluminum/magnesium (e.g., certain antacids, phosphate binders), corticosteroids (e.g., prednisone), calcium supplements, other products that contain vitamin D or phosphate (e.g., ergocalciferol, sodium phosphate).Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.Check the labels on all your prescription and nonprescription/herbal products (e.g., antacids, vitamins) because they may contain calcium, phosphate, or vitamin D. Ask your pharmacist about using those products safely.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Laboratory and/or medical tests (e.g., blood levels of aluminum, calcium, magnesium, phosphorus, and parathyroid hormone) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

                STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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.

                Adding plans allows you to:

                • 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.
                Additional Offers
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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.