PARICALCITOL (Page 6 of 6)

14.2 Chronic Kidney Disease Stage 5

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 iPTH was 701 pg/mL (range: 216-1933 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 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
9c86c7f2-figure-03
(click image for full-size original)

16 HOW SUPPLIED/STORAGE AND HANDLING

Paricalcitol Capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules.

The 1 mcg capsule is an oval-shaped, gray, soft capsule imprinted with the “1” in black ink, and is available in the following package size:

Bottles of 30 (NDC 47781-476-30)

The 2 mcg capsule is an oval-shaped, orange-brown, soft capsule imprinted with the “2” in black ink, and is available in the following package size:

Bottles of 30 (NDC 47781-477-30)

The 4 mcg capsule is an oval-shaped, gold soft capsule imprinted with the “3” in black ink, and is available in the following package size:

Bottles of 30 (NDC 47781-478-30)

Storage

Store Paricalcitol Capsules at 25°C (77°F). Excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].

17 INFORMATION FOR PATIENTS

Patients should be advised:

  • of the most common adverse reactions with use of Paricalcitol Capsules, which include diarrhea, hypertension, dizziness and vomiting.
  • to adhere to instructions regarding diet and phosphorus restriction.
  • to 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).
  • to 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.
  • to 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 be advised to inform their physicians prescribing a new medication that they are taking Paricalcitol Capsules.

Manufactured by

Lotus Pharmaceutical Co., Ltd. Nantou Plant

No. 30 Chenggong 1st Rd., Sinsing Village,

Nantou City, Nantou County 54066 Taiwan

Revision date: 03/2016

PRINCIPAL DISPLAY PANEL

NDC47781-476-30

Paricalcitol Capsules

1 mcg

9c86c7f2-figure-04
(click image for full-size original)

NDC47781-477-30

Paricalcitol Capsules

2 mcg

9c86c7f2-figure-05
(click image for full-size original)

NDC47781-478-30

Paricalcitol Capsules

4 mcg

9c86c7f2-figure-06
(click image for full-size original)
PARICALCITOL
paricalcitol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-476
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
MEDIUM-CHAIN TRIGLYCERIDES
BUTYLATED HYDROXYTOLUENE
ALCOHOL
GELATIN
GLYCERIN
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
WATER
SHELLAC
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
Product Characteristics
Color GRAY Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code 1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47781-476-30 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206710 03/01/2016
PARICALCITOL
paricalcitol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-477
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
MEDIUM-CHAIN TRIGLYCERIDES
BUTYLATED HYDROXYTOLUENE
ALCOHOL
GELATIN
GLYCERIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
SHELLAC
ISOPROPYL ALCOHOL
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
WATER
Product Characteristics
Color ORANGE, BROWN Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code 2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47781-477-30 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206710 03/01/2016
PARICALCITOL
paricalcitol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47781-478
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
MEDIUM-CHAIN TRIGLYCERIDES
BUTYLATED HYDROXYTOLUENE
ALCOHOL
GELATIN
GLYCERIN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
ISOPROPYL ALCOHOL
SHELLAC
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
WATER
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code 3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47781-478-30 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206710 03/01/2016
Labeler — ALVOGEN, INC. (008057330)
Registrant — Lotus Pharmaceutical Co., Ltd. Nantou Plant (658828103)
Establishment
Name Address ID/FEI Operations
Lotus Pharmaceutical Co., Ltd. Nantou Plant 658828103 MANUFACTURE (47781-476), MANUFACTURE (47781-477), MANUFACTURE (47781-478), ANALYSIS (47781-476), ANALYSIS (47781-477), ANALYSIS (47781-478)

Revised: 03/2016 ALVOGEN, INC.

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