Paricalcitol

Paricalcitol is a prescription medication used for the treatment of secondary hyperparathyroidism associated with chronic kidney disease.

• Paricalcitol is available under various brand names: Zemplar.

Common side effects of Paricalcitol include:

• headache,
• nausea,
• chills, and
• fever.

Serious side effects of Paricalcitol include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• constipation,
• drowsiness,
• dry mouth,
• muscle, bone, and joint pain,
• metallic taste in the mouth,
• weakness,
• vomiting,
• loss of appetite,
• unusual weight loss,
• eye pain,
• redness of the eye,
• sensitivity to light,
• severe runny nose,
• stomach pain,
• dizziness,
• fast, irregular, or pounding heartbeat,
• swelling of the hands, ankles, or feet,
• severe mood changes,
• agitation,
• confusion,
• easy bleeding,
• unusual bleeding,
• bloody or tarry stools,
• vomit that looks like coffee grounds,
• rash,
• itching, and
• severe dizziness

Rare side effects of Paricalcitol include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 2 mcg/mL
• 5 mcg/mL

Capsule

• 1 mcg
• 2 mcg
• 4 mcg

Secondary Hyperparathyroidism

Adult dosage

CKD stage 5

• 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 every 2-4 weeks
• Up to 0.24 mcg/kg orally have been administered

CKD stage 3 and 4

• PTH less than or equal to 500 pg/mL: 1 mcg orally every day OR 2 mcg orally 3 times/week
• PTH above 500 pg/mL: 2 mcg orally every day OR 4 mcg orally 3 times/week

Pediatric dosage

CKD stage 3 and 4

Oral dosing

• Aged below 10 years: Safety and efficacy not established
• Aged between 10-16 years: 1 mcg orally thrice per 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 every 4 weeks, 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

Oral dosing

• Aged below 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 every 4 weeks, 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

• Aged below 5 years: Safety and efficacy not established
• Aged above 5 years, initial dose (iPTH below 500 pg/mL): 0.04 mcg/kg IV 3 x/week no more frequently than every other day at any time during dialysis  
• Aged above 5 years, initial dose (iPTH above 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

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Paricalcitol has severe interactions with no other drugs.
• Paricalcitol has serious interactions with the following drugs:
  • abametapir
  • apalutamide
  • conivaptan
  • fexinidazole
  • idelalisib
  • voxelotor
• Paricalcitol has moderate interactions with at least 44 other drugs.
• Paricalcitol has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypercalcemia, hypervitaminosis D

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Paricalcitol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Paricalcitol?”

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

• 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
• 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