nt of medication, serum calcium, serum phosphorus, and serum or plasma iPTH should be monitored at least every two weeks for 3 months, then monthly for 3 months, and every 3 months thereafter.
Aluminum Overload and Toxicity
Aluminum-containing preparations (e.g., antacids, phosphate binders) should not be administered chronically with Zemplar, as increased blood levels of aluminum and aluminum bone toxicity may occur.
Adverse Reactions
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.
Clinical Trials Experience
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 Stages 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. Adverse events occurring in the Zemplar Capsules group at a frequency of 2% or greater and more frequently than in the placebo group are presented in Table 1:
Table 1. 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 Stages 3 and 4 Studies; All Treated Patients Number (%) of Subjects
Adverse Eventa
Zemplar Capsules
(n = 107) Placebo
(n = 113)
Overall 88 (82%) 86 (76%)
Ear and Labyrinth Disorders
Vertigo 5 (4.7%) 0 (0.0%)
Gastrointestinal Disorders
Abdominal Discomfort 4 (3.7%) 1 (0.9%)
Constipation 4 (3.7%) 4 (3.5%)
Diarrhea 7 (6.5%) 5 (4.4%)
Nausea 6 (5.6%) 4 (3.5%)
Vomiting 5 (4.7%) 5 (4.4%)
General Disorders and Administration Site Conditions
Chest Pain 3 (2.8%) 1 (0.9%)
Edema 6 (5.6%) 5 (4.4%)
Pain 4 (3.7%) 4 (3.5%)
Immune System Disorders
Hypersensitivity 6 (5.6%) 2 (1.8%)
Infections and Infestations
Fungal Infection 3 (2.8%) 0 (0.0%)
Gastroenteritis 3 (2.8%) 3 (2.7%)
Infection 3 (2.8%) 3 (2.7%)
Sinusitis 3 (2.8%) 1 (0.9%)
Urinary Tract Infection 3 (2.8%) 1 (0.9%)
Viral Infection 8 (7.5%) 8 (7.1%)
Metabolism and Nutrition Disorders
Dehydration 3 (2.8%) 1 (0.9%)
Musculoskeletal and Connective Tissue Disorders
Arthritis 5 (4.7%) 0 (0.0%)
Back Pain 3 (2.8%) 1 (0.9%)
Muscle Spasms 3 (2.8%) 0 (0.0%)
Nervous System Disorders
Dizziness 5 (4.7%) 5 (4.4%)
