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Zemplar Capsules

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Zemplar Capsules

SIDE EFFECTS

CKD Stages 3 and 4

The safety of Zemplar Capsules (paricalcitol) has been evaluated 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 (paricalcitol) 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 4.

Table 4 : 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

Body Systema
COSTART V Term
Number (%) of Subjects
Zemplar Capsules
(n = 107)
Placebo
(n = 113)
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%)
  Uremia 7 (7%) 9 (8%)
  Gout 4 (4%) 6 (5%)
  Dehydration 3 (3%) 1 (1%)
  Acidosis 2 (2%) 1 (1%)
  Hyperkalemia 2 (2%) 3 (3%)
  Hyperphosphatemia 2 (2%) 4 (4%)
  Hypoglycemia 2 (2%) 4 (4%)
  Hypokalemia 2 (2%) 1 (1%)
Musculoskeletal 12 (11%) 9 (8%)
  Arthritis 5 (5%) 1 (1%)
  Leg Cramps 3 (3%) 0 (0%)
  Myalgia 2 (2%) 5 (4%)
Nervous 18 (17%) 12 (11%)
  Dizziness 5 (5%) 5 (4%)
  Vertigo 5 (5%) 0 (0%)
  Depression 3 (3%) 0 (0%)
  Insomnia 2 (2%) 2 (2%)
  Neuropathy 2 (2%) 1 (1%)
Respiratory 26 (24%) 25 (22%)
  Pharyngitis 11 (10%) 12 (11%)
  Rhinitis 5 (5%) 4 (4%)
  Bronchitis 3 (3%) 1 (1%)
  Cough Increased 3 (3%) 2 (2%)
  Sinusitis 3 (3%) 1 (1%)
  Epistaxis 2 (2%) 1 (1%)
  Pneumonia 2 (2%) 0 (0%)
Skin and Appendages 17 (16%) 10 (9%)
  Rash 6 (6%) 3 (3%)
  Pruritus 3 (3%) 3 (3%)
  Skin Ulcer 3 (3%) 0 (0%)
  Skin Hypertrophy 2 (2%) 0 (0%)
  Vesiculobullous Rash 2 (2%) 1 (1%)
Special Senses 9 (8%) 11 (10%)
  Amblyopia 2 (2%) 0 (0%)
  Retinal Disorder 2 (2%) 0 (0%)
Urogenital System 10 (9%) 10 (9%)
  Urinary Tract Infection 3 (3%) 1 (1%)
  Kidney Function Abnormal 2 (2%) 1 (1%)
a Includes all patients with events in that body system.

CKD Stage 5

The safety of Zemplar Capsules (paricalcitol) has been evaluated in one 12-week, double-blind, placebo-controlled, multicenter clinical study involving 88 CKD Stage 5 patients. Sixty-one patients received Zemplar Capsules (paricalcitol) and 27 patients received placebo.

The proportion of patients who terminated prematurely from the study due to adverse events was 7% for Zemplar Capsules (paricalcitol) treated patients and 7% for placebo patients.

Adverse events occurring in the Zemplar Capsules (paricalcitol) group at a frequency of 2% or greater and more frequently than in the placebo group are as follows:

Table 5 : Treatment-Emergent Adverse Events by Body System Occurring in ≥ 2% of Subjects in the Zemplar-Treated Group , Double-Blind, Placebo-Controlled, Phase 3, CKD Stage 5 Study; All Treated Patients

Body Systema
COSTART V Term
Number (%) of Subjects
Zemplar Capsules
(n = 61)
Placebo
(n = 27)
Overall 43 (70%) 19 (70%)
Body as a Whole 27 (44%) 8 (30%)
  Infection 9 (15%) 3 (11%)
  Asthenia 3 (5%) 0 (0%)
  Peritonitis 3 (5%) 0 (0%)
  Accidental Injury 2 (3%) 0 (0%)
  Headache 2 (3%) 0 (0%)
Digestive 18 (30%) 4 (15%)
  Diarrhea 7 (11%) 3 (11%)
  Constipation 3 (5%) 0 (0%)
  Nausea and Vomiting 3 (5%) 0 (0%)
  Dyspepsia 2 (3%) 0 (0%)
Hemic and Lymphatic System 6 (10%) 0 (0%)
  Hypervolemia 3 (5%) 0 (0%)
  Ecchymosis 2 (3%) 0 (0%)
Metabolic and Nutritional Disorders 7 (11%) 0 (0%)
  Hypoglycemia 2 (3%) 0 (0%)
  Peripheral Edema 2 (3%) 0 (0%)
  Uremia 2 (3%) 0 (0%)
Nervous 12 (20%) 2 (7%)
  Dizziness 4 (7%) 0 (0%)
  Insomnia 3 (5%) 0 (0%)
  Anxiety 2 (3%) 0 (0%)
Respiratory 8 (13%) 4 (15%)
  Sinusitis 2 (3%) 0 (0%)
Urogenital System 6 (10%) 4 (15%)
  Urinary Tract Infection 2 (3%) 0 (0%)

Read the Zemplar Capsules (paricalcitol) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Paricalcitol is not expected to inhibit the clearance of drugs metabolized by cytochrome P450 enzymes CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A nor induce the clearance of drugs metabolized by CYP2B6, CYP2C9 or CYP3A.

A multiple dose drug-drug interaction study demonstrated that ketoconazole approximately doubled paricalcitol AUC0-∞ (see CLINICAL PHARMACOLOGY). Since paricalcitol is partially metabolized by CYP3A and ketoconazole is known to be a strong inhibitor of cytochrome P450 3A enzyme, care should be taken while dosing paricalcitol with ketoconazole and other strong P450 3A inhibitors including atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole. Dose adjustment of Zemplar Capsules (paricalcitol) may be required, and iPTH and serum calcium concentrations should be closely monitored if a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor such as ketoconazole.

Drugs that impair intestinal absorption of fat-soluble vitamins, such as cholestyramine, may interfere with the absorption of Zemplar Capsules.

Read the Zemplar Capsules Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 7/20/2009
This monograph has been modified to include the generic and brand name in many instances.

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