Paricalcitol (Page 6 of 6)

14.2 Chronic Kidney Disease Stage 5

Adults

The safety and efficacy of paricalcitol capsules were evaluated in a Phase 3, 12-week, double blind, placebo-controlled, randomized, multicenter study in patients with CKD Stage 5 on HD or PD. The study used a three times a week dosing design. A total of 61 patients received paricalcitol capsules and 27 patients received placebo. The mean age of the patients was 57 years, 67% were male, 50% were Caucasian, 45% were African-American, and 53% were diabetic. The average baseline serum iPTH was 701 pg/mL (range: 216 to 1933 pg/mL). The average time since first dialysis across all subjects was 3.3 years.

The initial dose of paricalcitol capsules was based on baseline iPTH/60. Subsequent dose adjustments were based on iPTH/60 as well as primary chemistry results that were measured once a week. Starting at Treatment Week 2, study drug was maintained, increased or decreased weekly based on the results of the previous week’s calculation of iPTH/60. Paricalcitol capsules were administered three times a week, not more than every other day.

The proportion of patients achieving at least two consecutive weekly ≥ 30% reductions from baseline serum iPTH was 88% of paricalcitol capsules treated patients and 13% of the placebo treated patients. The proportion of patients achieving at least two consecutive weekly ≥ 30% reductions from baseline iPTH was similar for HD and PD patients.

The incidence of hypercalcemia (defined as two consecutive serum calcium values > 10.5 mg/dL) in patients treated with paricalcitol capsules was 6.6% as compared to 0% for patients given placebo. In PD patients the incidence of hypercalcemia in patients treated with paricalcitol capsules was 21% as compared to 0% for patients given placebo. The patterns of change in the mean values for serum iPTH are shown in Figure 2. The rate of hypercalcemia with paricalcitol capsules may be reduced with a lower dosing regimen based on the iPTH/80 formula as shown by computer simulations. The hypercalcemia rate can be further predicted to decrease, if the treatment is initiated in only those with baseline serum calcium ≤ 9.5 mg/dL [see Clinical Pharmacology (12.2) and Dosage and Administration (2.2)].

Figure 2. Mean Values for Serum iPTH Over Time in a Phase 3, Double-Blind, Placebo- Controlled CKD Stage 5 Study

Figure 2
(click image for full-size original)

16 HOW SUPPLIED/STORAGE AND HANDLING

Paricalcitol capsules, 1 mcg, are supplied as oval, gray soft gelatin capsules imprinted with “A8”.
They are available as follows:

Bottles of 30: NDC 65162-822-03
Bottles of 90: NDC 65162-822-09

Paricalcitol capsules, 2 mcg, are supplied as oval, brown soft gelatin capsules imprinted with “A83”.
They are available as follows:

Bottles of 30: NDC 65162-823-03
Bottles of 90: NDC 65162-823-09

Paricalcitol capsules, 4 mcg, are supplied as oval, light yellow soft gelatin capsules imprinted with “A84”.
They are available as follows:

Bottles of 30: NDC 65162-824-03
Bottles of 90: NDC 65162-824-09

Storage

Store paricalcitol capsules at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise patients of the following:

  • The most common adverse reactions with use of paricalcitol capsules include diarrhea, hypertension, nausea, nasopharyngitis, dizziness, and vomiting.
  • Patients should adhere to instructions regarding diet and phosphorus restriction.
  • Patients should contact a health care provider if they 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. More frequent monitoring is necessary during the initiation of therapy, following dose changes or when potentially interacting medications are started or discontinued.
  • Patients should inform their physician of all medications, including prescription and nonprescription drugs, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also inform their physician that they are taking paricalcitol capsules if a new medication is prescribed.
  • Breastfeeding is not recommended during treatment with paricalcitol capsules [see Use in Specific Populations (8.2)].

Distributed by:
Amneal Pharmaceuticals LLC Bridgewater, NJ 08807

Rev. 04-2017-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1mcg label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2mcg label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4mcg label
(click image for full-size original)
PARICALCITOL paricalcitol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-822
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARICALCITOL (PARICALCITOL) PARICALCITOL 1 ug
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
ALCOHOL
MEDIUM-CHAIN TRIGLYCERIDES
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
GELATIN
GLYCERIN
TITANIUM DIOXIDE
WATER
Product Characteristics
Color GRAY Score no score
Shape CAPSULE Size 8mm
Flavor Imprint Code A8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-822-03 30 CAPSULE in 1 BOTTLE None
2 NDC:65162-822-09 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204327 01/15/2016
PARICALCITOL paricalcitol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-823
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARICALCITOL (PARICALCITOL) PARICALCITOL 2 ug
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
ALCOHOL
MEDIUM-CHAIN TRIGLYCERIDES
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
GELATIN
GLYCERIN
TITANIUM DIOXIDE
WATER
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code A38
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-823-03 30 CAPSULE in 1 BOTTLE None
2 NDC:65162-823-09 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204327 01/15/2016
PARICALCITOL paricalcitol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-824
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PARICALCITOL (PARICALCITOL) PARICALCITOL 4 ug
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
ALCOHOL
MEDIUM-CHAIN TRIGLYCERIDES
FERRIC OXIDE YELLOW
GELATIN
GLYCERIN
TITANIUM DIOXIDE
WATER
Product Characteristics
Color YELLOW (light yellow) Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code A84
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-824-03 30 CAPSULE in 1 BOTTLE None
2 NDC:65162-824-09 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204327 01/15/2016
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 123797875 ANALYSIS (65162-822), ANALYSIS (65162-823), ANALYSIS (65162-824), LABEL (65162-822), LABEL (65162-823), LABEL (65162-824), MANUFACTURE (65162-822), MANUFACTURE (65162-823), MANUFACTURE (65162-824), PACK (65162-822), PACK (65162-823), PACK (65162-824)

Revised: 12/2020 Amneal Pharmaceuticals LLC

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