Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (45)
- 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.
- ceritinib
ceritinib will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- 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.
- levoketoconazole
levoketoconazole 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 (4)
- acetazolamide
acetazolamide will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- anastrozole
anastrozole will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- cyclophosphamide
cyclophosphamide will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- larotrectinib
larotrectinib will increase the level or effect of paricalcitol by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
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
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
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.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
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)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| paricalcitol oral - | 4 mcg capsule |  | |
| paricalcitol oral - | 1 mcg capsule |  | |
| paricalcitol oral - | 2 mcg capsule |  | |
| paricalcitol oral - | 2 mcg capsule |  | |
| paricalcitol oral - | 4 mcg capsule |  | |
| paricalcitol oral - | 2 mcg capsule |  | |
| paricalcitol oral - | 1 mcg capsule |  | |
| paricalcitol oral - | 1 mcg capsule |  | |
| paricalcitol oral - | 4 mcg capsule |  | |
| paricalcitol oral - | 1 mcg capsule |  | |
| Zemplar oral - | 2 mcg capsule | | |
| Zemplar oral - | 1 mcg capsule | | |
| 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 - | 5 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 - | 2 mcg/mL vial |  | |
| paricalcitol hemodialysis port injection - | 5 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 |  | |
| Zemplar intravenous - | 5 mcg/mL vial |  | |
| Zemplar intravenous - | 2 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 - | 2 mcg/mL vial |  | |
| paricalcitol intravenous - | 5 mcg/mL vial |  | |
| paricalcitol intravenous - | 5 mcg/mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
paricalcitol oral
PARICALCITOL - ORAL
(pear-ih-KAL-sit-ole)
COMMON BRAND NAME(S): Zemplar
USES: Paricalcitol is used to treat and prevent high levels of a certain natural substance made by the body (parathyroid hormone) in patients with long-term kidney disease. In these patients, the high level of parathyroid hormone is caused by a low level of calcium and a certain kind of vitamin D. Too much parathyroid hormone can cause serious problems such as bone disorders. Paricalcitol is a man-made form of vitamin D. It helps to reduce parathyroid hormone levels and may help your body absorb calcium and phosphorus.
HOW TO USE: Take this medication by mouth with or without food, usually once daily or 3 times a week or as directed by your doctor. If you are taking this medication 3 times a week, do not take it more often than every other day.Dosage is based on your medical condition, laboratory tests, and response to treatment.Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day. If you are taking this medication on a schedule other than every day (such as 3 times a week), it may help to mark your calendar with a reminder.It is very important to follow the diet recommended by your doctor to get the most benefit from this medication and to prevent serious side effects. Do not take other supplements/vitamins (such as calcium, vitamin D) unless ordered by your doctor.
SIDE EFFECTS: 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.Tell your doctor right away if you have any serious side effects, including: fast/slow/irregular heartbeat, seizures, weakness, loss of appetite, back/bone/joint/muscle pain, constipation, dry mouth, eye pain/redness/sensitivity to light, headache, nausea/vomiting, drowsiness, stomach/abdominal pain, increased thirst, signs of kidney problems (such as change in the amount of urine), mental/mood changes (such as psychosis).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 taking 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), heart disease (such as irregular heartbeat, coronary artery disease), seizures.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).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, other vitamin D products (such as ergocalciferol), products that contain aluminum (such as certain antacids, phosphate binders), corticosteroids (such as prednisone).Check the labels on all your prescription and nonprescription/herbal products (such as antacids, vitamins) because they may contain aluminum, calcium, phosphate, or vitamin D. Ask your pharmacist about using those products safely.Certain medications can decrease the absorption of vitamin D (bile acid sequestrants such as cholestyramine/colestipol, mineral oil, orlistat). Separate your doses of these medications as far as possible from your doses of vitamin D. It may be easiest to take vitamin D at bedtime if you are also taking these other medications. Ask your doctor or pharmacist about how long you should wait between doses and for help finding a dosing schedule that will work with all your medications.This medication may interfere with certain laboratory tests (including cholesterol tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
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. Symptoms of overdose may include: weakness, headache, loss of appetite, nausea, vomiting, stomach cramps, drowsiness.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as calcium, phosphorus, parathyroid hormone levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2022. Copyright(c) 2023 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.
Formulary
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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.
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