Paricalcitol

1.1 Chronic Kidney Disease Stages 3 and 4 Paricalcitol Capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (Paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. …

• Chronic Kidney Disease Stages 3 and 4
• In Adults Administer Paricalcitol Capsules orally once daily or three times a week. [see Clinical Studies ]
• When dosing three times weekly, do not administer more frequently than every other day
• Initial Dose Table 1
• Recommended Paricalcitol Capsules Starting Dose Based upon Baseline iPTH Level Baseline iPTH Level Daily Dose Three Times a Week Dose* Less than or equal to 500 pg/mL 1 mcg 2 mcg More than 500 pg/mL 2 mcg 4 mcg * To be administered not more often than every other day Dose Titration Table 2
• Recommended Paricalcitol Capsules Dose Titration Base upon iPTH Level Dose Adjustment at 2 to 4 Week Intervals iPTH Level Relative to Baseline Paricalcitol Capsule Dose Daily Dosage Three Times a Week Dosage* The same, increased or decreased by less than 30% Increase dose by 1 mcg 2 mcg Decreased by more than or equal to 30% and less than or equal to 60% Maintain dose - - Decreased by more than 60% or iPTH less than 60 pg/mL Decrease dose by 1 mcg 2 mcg * To be administered not more often than every other day If a patient is taking the lowest dose, 1 mcg, on the daily regimen and a dose reduction is needed, the dose can be decreased to 1 mcg three times a week
• If a further dose reduction is required, the drug should be withheld as needed and restarted at a lower dosing frequency. …

Paricalcitol Capsules are available as 1 mcg, 2 mcg, and 4 mcg soft gelatin capsules. 1 mcg-grey colour oval shaped soft gelatin capsules imprinted with "12" in black ink. 2 mcg-brown colour oval shaped soft gelatin capsules imprinted with "14" in black ink. 4 mcg-light yellow colour oval shaped soft gelatin capsules imprinted with "17" in black ink. Capsules: 1 mcg, 2 mcg, and 4 mcg (3).

• Safety and effectiveness of Paricalcitol Capsules
• In pediatric patients under the age of 10 years have not been established
• Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (Paricalcitol) capsules
• However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information

Of the total number (n = 220) of CKD Stages 3 and 4 patients in clinical studies of Paricalcitol capsules, 49% were age 65 and over, while 17% were age 75 and over. Of the total number (n =88) of CKD Stage 5 patients in the pivotal study of Paricalcitol Capsules, 28% were age 65 and over, while 6% were age 75 and over. …

Advise patients of the following: · The most common adverse reactions with use of Paricalcitol Capsules, which include diarrhea, hypertension, nausea, nasopharyngitis dizziness and vomiting. · Patients should adhere adhere to instructions regarding diet and phosphorus restriction. · Patients should contact a health care provider if you develop symptoms of elevated calcium, (e.g. feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss). · Patients should return to the physician's office for routine monitoring. …

• Paricalcitol Capsules should not be given to patients with evidence of hypercalcemia or vitamin D toxicity [see Warnings and Precautions ]
• Evidence of hypercalcemia
• Evidence of vitamin D toxicity

Table 5 shows the clinically significant drug interactions with Paricalcitol capsules. Table 5: Clinically Significant Drug Interactions with Paricalcitol CYP3A Inhibitors Clinical Impact Paricalcitol is partially metabolized by CYP3A. Hence, exposure of paricalcitol will increase upon coadministration with strong CYP3A inhibitors such as but not limited to: boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Intervention Dose adjustment of Paricalcitol capsules may be necessary. …

Excessive administration of vitamin D compounds. including Paricalcitol Capsules, can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. 5.1 Hypercalcemia Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention [ see Overdosage (10) ] . Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. …

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. 6.1 Clinical Trials Experience CKD Stages 3 and 4 Adults The safety of Paricalcitol Capsules has been evaluated in three 24-week (approximately six-month), double-blind, placebo-controlled, multicenter clinical studies involving 220 CKD Stages 3 and 4 patients. Six percent (6%) of Paricalcitol Capsules treated patients and 4% of placebo treated patients discontinued from clinical studies due to an adverse event. …

8.1 Pregnancy Risk Summary Limited data with Paricalcitol capsules in pregnant women are insufficient to inform a drug- associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see Clinical Considerations] . …

Excessive administration of Paricalcitol Capsules can cause hypercalcemia, hypercalciuria, and hyperphosphatemia, and over suppression of PTH [ see Warnings and Precautions (5.1) ]. Treatment of Overdosage The treatment of acute overdosage of Paricalcitol Capsules should consist of general supportive measures. If drug ingestion is discovered within a relatively short time, induction of emesis or gastric lavage may be of benefit in preventing further absorption. If the drug has passed through the stomach, the administration of mineral oil may promote its fecal elimination. …

Prenez-le dès que vous y pensez, sauf s'il est presque l'heure de la dose suivante. Dans ce cas, sautez la dose oubliée. Ne prenez jamais deux doses à la fois pour compenser. Vérifiez votre notice, certains médicaments font exception.