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: 216-1933 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
16 HOW SUPPLIED/STORAGE AND HANDLING
Paricalcitol capsules are available as 1 mcg and 2 mcg capsules.
The 1 mcg capsule is an oval, gray, soft gelatin capsule supplied and imprinted as follows:
Bottles of 30 – NDC 68382-330-06 (imprinted with “ZA”)
Bottles of 30 – NDC 68382-266-06 (imprinted with the “a” logo and “ZA”)
The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule supplied and imprinted as follows:
Bottles of 30 – NDC 68382-331-06 (imprinted with “ZF”)
Bottles of 30 – NDC 68382-267-06 (imprinted with the “a” logo and “ZF”)
Storage
Store paricalcitol capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 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)].
© 2021 Zydus Pharmaceuticals USA Inc.
Manufactured for
AbbVie Inc.
North Chicago, IL 60064, U.S.A.
Distributed by:
Zydus Pharmaceuticals USA Inc.
Pennington, NJ 08534, U.S.A.
20067827 May 2021
NDC 68382-330-06
Paricalcitol Capsules
1 mcg
30 CAPSULES
zydus Rx only
NDC 68382-331-06
Paricalcitol Capsules
2 mcg
30 CAPSULES
zydus Rx only
NDC 68382-266-06
NDC 68382-266-06
NDC 68382-267-06
NDC 68382-267-06
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| Labeler — Zydus Pharmaceuticals USA Inc (156861945) |
Revised: 05/2021 Zydus Pharmaceuticals USA Inc
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