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Zemplar Capsules

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Zemplar Capsules

Side Effects
Interactions

SIDE EFFECTS

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 evaluated 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

Adverse Eventa Number (%) of Subjects
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%)
  Headache 5 (4.7%) 5 (4.4%)
  Syncope 3 (2.8%) 1 (0.9%)
Psychiatric Disorders
  Depression 3 (2.8%) 0 (0.0%)
Respiratory, Thoracic and Mediastinal Disorders
  Cough 3 (2.8%) 2 (1.8%)
  Oropharyngeal Pain 4 (3.7%) 0 (0.0%)
Skin and Subcutaneous Tissue Disorders
  Pruritus 3 (2.8%) 3 (2.7%)
  Rash 4 (3.7%) 1 (0.9%)
  Skin Ulcer 3 (2.8%) 0 (0.0%)
Vascular Disorders
  Hypertension 7 (6.5%) 4 (3.5%)
  Hypotension 5 (4.7%) 3 (2.7%)
a Includes only events more common in the Zemplar treatment group.

The following adverse reactions, with a causal relationship to Zemplar, occurred in < 2% of the Zemplar treated patients in the above double-blind, placebo-controlled clinical trial data set.

Gastrointestinal Disorders: Dry mouth

Investigations: Hepatic enzyme abnormal

Nervous System Disorders: Dysgeusia

Skin and Subcutaneous Tissue Disorders: Urticaria

CKD Stage 5

The safety of Zemplar Capsules 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 and 27 patients received placebo.

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

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

Table 2: 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

Adverse Eventsa Number (%) of Subjects
Zemplar Capsules
(n=61)
Placebo
(n = 27)
Overall 43 (70%) 19 (70%)
Gastrointestinal Disorders
  Constipation 3 (4.9%) 0 (0.0%)
  Diarrhea 7 (11.5%) 3 (11.1%)
  Vomiting 4 (6.6%) 0 (0.0%)
General Disorders and Administration Site Conditions
  Fatigue 2 (3.3%) 0 (0.0%)
  Edema Peripheral 2 (3.3%) 0 (0.0%)
Infections and Infestations
  Nasopharyngitis 5 (8.2%) 2 (7.4%)
  Peritonitis 3 (4.9%) 0 (0.0%)
  Sinusitis 2 (3.3%) 0 (0.0%)
  Urinary Tract Infection 2 (3.3%) 0 (0.0%)
Metabolism and Nutrition Disorders
  Fluid Overload 3 (4.9%) 0 (0.0%)
  Hypoglycemia 2 (3.3%) 0 (0.0%)
Nervous System Disorders
  Dizziness 4 (6.6%) 0 (0.0%)
  Headache 2 (3.3%) 0 (0.0%)
Psychiatric Disorders
  Anxiety 2 (3.3%) 0 (0.0%)
  Insomnia 3 (4.9%) 0 (0.0%)
Renal and Urinary Disorders
  Renal Failure Chronic 2 (3.3%) 0 (0.0%)
a Includes only events more common in the Zemplar treatment group.

The following adverse reactions, with a causal relationship to Zemplar, occurred in < 2% of the Zemplar treated patients in the above double-blind, placebo-controlled clinical trial data set.

Gastrointestinal Disorders: Gastroesophageal reflux disease

Metabolism and Nutrition Disorders: Decreased appetite, hypercalcemia, hypocalcemia

Reproductive System and Breast Disorders: Breast tenderness

Skin and Subcutaneous Tissue Disorders: Acne

Postmarketing Experience

The following additional adverse reactions have been reported during post-approval use and post-approval clinical trials with the active ingredient in Zemplar capsules:

Immune System Disorders: Angioedema (including laryngeal edema)

Metabolism and Nutrition Disorders: Hypercalcemia

Investigations: Blood creatinine increased

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

DRUG INTERACTIONS

CYP3A Inhibitors

Since paricalcitol is partially metabolized by CYP3A, exposure of paricalcitol will be increased while paricalcitol is co-administered with strong CYP3A inhibitors including the following drugs but not limited to: ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole. Dose adjustment of Zemplar Capsules 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 [see CLINICAL PHARMACOLOGY].

Cholestyramine

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

Mineral Oil

The use of mineral oil or other substances that may affect absorption of fat may influence the absorption of Zemplar Capsules.

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

Last reviewed on RxList: 9/24/2014
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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Zemplar Capsules - User Reviews

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