Paricalcitol

Indications

Paricalcitol is used for: Secondary hyperparathyroidism

Adult Dose

Oral Prevention & Treatment of Secondary Hyperparathyroidism Associated with Chronic Kidney Disease (Stage 3 & 4) 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 Do not administer 3 times/week dosing no more frequently than every other day Titrate dose based on response. Monitoring parameters (Stage 3 & 4) Serum PTH at 2-4 week intervals PTH same or increased: Increase by 1 mcg/day OR 2 mcg three times/week PTH decreased <30%: Increase by 1 mcg/day OR 2 mcg three times/week PTH decreased >30% or <60%: Maintain current dose PTH decreased >60%: Decrease 1 mcg/day OR 2 mcg three times/week PTH <60 pg/mL: Decrease 1 mcg/day OR 2 mcg three times/week

Child Dose

Renal Dose

Administration

May be taken with or without food.

Contra Indications

Hypersensitivity, Hypercalcemia, hypervitaminosis D

Precautions

Monitor serum calcium and phosphorus frequently; reduce dose or stop the drug if calcium (in mg/dL) times phosphorus (in mg/dL) product >75 Patients receiving digitalis; digitalis toxicity is potentiated by hypercalcemia Strong CYP3A4 inhibitors may increase paricalcitol AUC. May increase serum creatinine in pre-dialysis patients. Hepatic impairment Lactation: not known if distributed into breast milk, use caution

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 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

Interactions

Digitalis; ketoconazole & other strong P450 3A inhibitors including atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole. May interfere absorption w/ cholestyramine (cap only). Increased risk of hypercalcemia w/ prescription-based phosphate or vit D-related medicinal products & Ca-containing prep or thiazide diuretics. Mg- & Al-containing prep (eg, antacids, phosphate-binders).

Adverse Effects

Side effects of Paricalcitol : >10% Nausea (13%) 1-10% Vomiting, Edema, Palpitation, Chills, Pneumonia, Lightheadedness, GI bleeding, Flu, Sepsis, Hypokalemia, Hypercalcemia, Increase in blood creatinine

Mechanism of Action

Synthetic vitamin D analog, reduces parathyroid hormone (PTH).