drug, taking into account the importance of the drug to the mother.
Geriatric Use
Of the total number (n = 220) of CKD Stages 3 and 4 patients in clinical studies of Zemplar 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 Zemplar Capsules, 28% were age 65 and over, while 6% were age 75 and over. No overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Pediatric Use
Safety and efficacy of Zemplar Capsules in pediatric patients have not been established.
ADVERSE REACTIONS
CKD Stages 3 and 4
The safety of Zemplar Capsules has been eva luated in three 24-week (approximately six-month), double-blind, placebo-controlled, multicenter clinical studies involving 220 CKD Stage 3 and 4 patients. Six percent (6%) of Zemplar Capsules treated patients and 4% of placebo treated patients discontinued from clinical studies due to an adverse event. All reported adverse events occurring in at least 2% in either treatment group are presented in Table 3.
Table 3. Treatment-Emergent Adverse Events by Body System Occurring in ≥ 2% of Subjects in the Zemplar-Treated Group of Three, Double-Blind, Placebo-Controlled, Phase 3, CKD Stage 3 and 4 Studies; All Treated Patients Number (%) of Subjects
Body Systema
COSTART V Term Zemplar Capsules
(n = 107) Placebo
(n = 113)
a. Includes all patients with events in that body system.
Overall 88 (82%) 86 (76%)
Body as a Whole 49 (46%) 40 (35%)
Accidental Injury 10 (9%) 8 (7%)
Pain 8 (7%) 7 (6%)
Viral Infection 8 (7%) 8 (7%)
Allergic Reaction 6 (6%) 2 (2%)
Headache 5 (5%) 5 (4%)
Abdominal Pain 4 (4%) 2 (2%)
Back Pain 4 (4%) 1 (1%)
Infection 4 (4%) 4 (4%)
Asthena 3 (3%) 2 (2%)
Chest Pain 3 (3%) 1 (1%)
Fever 3 (3%) 1 (1%)
Infection Fungal 3 (3%) 0 (0%)
Cyst 2 (2%) 0 (0%)
Flu Syndrome 2 (2%) 1 (1%)
Infection Bacterial 2 (2%) 1 (1%)
Cardiovascular 27 (25%) 19 (17%)
Hypertension 7 (7%) 4 (4%)
Hypotension 5 (5%) 3 (3%)
Syncope 3 (3%) 1 (1%)
Cardiomyopathy 2 (2%) 0 (0%)
Congestive Heart Failure 2 (2%) 5 (4%)
Myocardial Infarct 2 (2%) 0 (0%)
Postural Hypotension 2 (2%) 0 (0%)
Digestive 29 (27%) 31 (27%)
Diarrhea 7 (7%) 5 (4%)
Nausea 6 (6%) 4 (4%)
Vomiting 6 (6%) 5 (4%)
Constipation 4 (4%) 4 (4%)
Gastroenteritis 3 (3%) 3 (3%)
Dyspepsia 2 (2%) 2 (2%)
Gastritis 2 (2%) 4 (4%)
Rectal Disorder 2 (2%) 0 (0%)
Hemic and Lymphatic System 4 (4%) 10 (9%)
Hypervolemia 2 (2%) 4 (4%)
Ecchymosis 2 (2%) 4 (4%)
Metabolic and Nutritional Disorders 24 (22%) 34 (30%)
Edema 7 (7%) 5 (4%)
&nbs |
