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warnings and cautions
5 WARNINGS AND PRECAUTIONS Excessive administration of vitamin D compounds, including paricalcitol capsules, can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. Hypercalcemia: Excessive administration of paricalcitol capsules can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. Prescription-based doses of vitamin D and its derivatives should be withheld during paricalcitol treatment ( 5.1 ). Digitalis toxicity: Potentiated by hypercalcemia of any cause. Use caution when paricalcitol capsules are prescribed concomitantly with digitalis compounds ( 5.2 ). Laboratory tests: Monitor serum calcium, serum phosphorus, and serum or plasma iPTH during initial dosing or following any dose adjustment. Paricalcitol capsules may increase serum creatinine and therefore decrease the estimated GFR (eGFR) ( 5.3 ). Aluminum overload and toxicity: Avoid excessive use of aluminum containing compounds ( 5.4 ). 5.1 Hypercalcemia Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention [see Overdosage (10) ]. Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis. Chronic hypercalcemia can lead to generalized vascular calcification and other soft-tissue calcification. Concomitant administration of high does of calcium-containing preparations or thiazide diuretics with paricalcitol may increase the risk of hypercalcemia. High intake of calcium and phosphate concomitant with vitamin D compounds may lead to serum abnormalities requiring more frequent patient monitoring and individualized dose titration. Patients also should be informed about the symptoms of elevated calcium, which include feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss. Prescription-based doses of vitamin D and its derivatives should be withheld during paricalcitol treatment to avoid hypercalcemia. 5.2 Digitalis Toxicity Digitalis toxicity is potentiated by hypercalcemia of any cause. Use caution when paricalcitol capsules are prescribed concomitantly with digitalis compounds. 5.3 Laboratory Tests During the initial dosing or following any dose adjustment 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. In pre-dialysis patients, paricalcitol capsules may increase serum creatinine and therefore decrease the estimated GFR (eGFR). Similar effects have also been seen with calcitriol.In pre-dialysis patients, paricalcitol capsules may increase serum creatinine and therefore decrease the estimated GFR (eGFR). Similar effects have also been seen with calcitriol. 5.4 Aluminum Overload and Toxicity Aluminum-containing preparations (e.g. antacids, phosphate binders) should not be administered chronically with paricalcitol, as increased blood levels of aluminum and aluminum bone toxicity may occur.
6 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. The most common adverse reactions (>5% and more frequent than placebo) include diarrhea, hypertension, dizziness and vomiting ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Banner Life Sciences LLC. 1-800-526-6993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ( 6 ) . 6.1 Clinical Trials Experience CKD Stages 3 and 4 The safety of paricalcitol 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 paricalcitol capsules treated patients and 4% of placebo treated patients discontinued from clinical studies due to an adverse event. Adverse events occurring in the paricalcitol 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 Paricalcitol-Treated Group of Three, Double-Blind, Placebo-Controlled, Phase 3, CKD Stages 3 and 4 Studies; All Treated Patients Number (%) of Subjects Adverse Event Includes only events more common in the paricalcitol treatment group. Paricalcitol 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 Administrative 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%) The following adverse reactions, with a causal relationship to paricalcitol, occurred in <2% of the paricalcitol 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 paricalcitol 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 paricalcitol capsules and 27 patients received placebo. The proportion of patients who terminated prematurely from the study due to adverse events was 7% for paricalcitol capsules treated patients and 7% for placebo patients. Adverse events occurring in the paricalcitol 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 Paricalcitol-Treated Group, Double-Blind, Placebo-Controlled, Phase 3, CKD Stage 5 Study; All Treated Patients Number (%) of Subjects Adverse Events Includes only events more common in the paricalcitol treatment group. Paricalcitol 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%) The following adverse reactions, with a causal relationship to paricalcitol, occurred in <2% of the paricalcitol 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 6.2 Postmarketing Experience The following additional adverse reactions have been reported during post-approval use and post-approval clinical trials with the active ingredient in paricalcitol capsules: Immune System Disorders : Angioedema (including laryngeal edema) Metabolism and Nutrition Disorders : Hypercalcemia Investigations : Blood creatinine increased