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adverse reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥10%) include: diarrhea and blood creatinine increased ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Veloxis Pharmaceuticals, Inc. at 1-844-VELOXIS (1-844-835-6947) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience 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. In addition, the clinical studies were not designed to establish comparative differences across study arms with regards to the adverse reactions discussed below. In an open label, randomized, multinational conversion study, stable kidney transplant patients on a tacrolimus immediate-release product and concomitant immunosuppressants were randomized to treatment with ENVARSUS XR (N=162) or to continued treatment on the tacrolimus immediate-release product (N=162) and treated for a duration of 12 months [see Clinical Studies (14) ] . The proportion of patients who discontinued treatment due to adverse reactions was 7.4% and 1.2% in the ENVARSUS XR and tacrolimus immediate-release treatment groups, respectively, through 12 months of treatment. The most common adverse reactions leading to discontinuation of study drug in the ENVARSUS XR treatment group was cardiac arrest (2 events). Infections The overall incidence of infections, serious infections, and infections with identified etiology reported in stable kidney transplant recipients treated with ENVARSUS XR or tacrolimus immediate-release product are shown in Table 1 . Table 1. Percentage of Stable Patients with Infections Through One Year Post- Treatment in the Conversion Study a a The stable kidney transplant study was not designed to support comparative claims of ENVARSUS XR compared to tacrolimus immediate-release product for the adverse reactions reported in this table. b BK virus associated nephropathy (BKVAN) occurred in 1.2% (2/162) and 0.6% (1/162) in the ENVARSUS XR and tacrolimus immediate-release treatment groups, respectively. ENVARSUS XR ± steroids, MMF/MPS or AZA N=162 Tacrolimus immediate-release product ± steroids, MMF/MPS or AZA N=162 All infections 46% 48% Respiratory Infections 26% 28% Urinary Tract Infections 10% 14% Bacterial Infections 7% 5% Fungal Infections 4% 4% Gastrointestinal Infections 4% 5% BK virus b 2% 2% Cytomegalovirus Infections 2% 1% Serious Infections 8% 9% New Onset Diabetes After Transplantation (NODAT) New onset diabetes after transplantation (NODAT) was defined by the composite occurrence of fasting plasma glucose values ≥126 mg/dL, 2-hour postprandial plasma glucose of at least 200 mg/dL (in oral glucose tolerance test) on 2 or more consecutive occasions post baseline, insulin requirement for ≥31 days, an oral hypoglycemic agent use ≥31 days, or HbA 1c ≥6.5% (at least 3 months after randomization) among kidney transplant patients with no medical history of diabetes. The incidence of NODAT for the stable kidney transplant study through one year post-transplant is summarized in Table 2 below [see Warnings and Precautions (5.4) ] . Table 2. Percentage of Stable Patients with NODAT Through 1 Year Post- Treatment in the Conversion Study a a The stable kidney transplant study was not designed to support comparative claims of ENVARSUS XR compared to tacrolimus immediate-release product for the adverse reactions reported in this table. b Analyses restricted to patients at risk for NODAT ENVARSUS XR ± steroids , MMF/MPS or AZA (N=90) Tacrolimus immediate-release product ± steroids, MMF/MPS or AZA (N=95) Composite NODAT b 10% 11% HbA 1c ≥6.5% 3% 7% Fasting Plasma Glucose Values ≥126 mg/dL on 2 consecutive occurrences 8% 6% Oral hypoglycemic use 1% 1% Insulin Use ≥31 days 1% 0% Common Adverse Reactions The incidence of adverse reactions that occurred in ≥5% of ENVARSUS XR-treated patients compared to tacrolimus immediate-release product through one year of treatment in the conversion study is shown by treatment group in Table 3 . Table 3. Adverse Reactions ( ≥ 5%) in Stable Kidney Transplant Patients Through 1 Year Post- Treatment in the Conversion Study a a The stable kidney transplant study was not designed to support comparative claims of ENVARSUS XR compared to tacrolimus immediate-release for the adverse reactions reported in this table. Adverse Reaction ENVARSUS XR N=162 Tacrolimus immediate-release product N=162 Diarrhea 14% 9% Blood Creatinine Increased 12% 9% Urinary Tract Infection 9% 14% Nasopharyngitis 9% 11% Headache 9% 7% Upper Respiratory Tract Infection 7% 9% Peripheral Edema 7% 6% Hypertension 4% 6% 6.2 Postmarketing Experience The following adverse reactions have been reported from marketing experience with tacrolimus in the U.S. and outside the U.S. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and Lymphatic System Disorders: Agranulocytosis, decreased blood fibrinogen, disseminated intravascular coagulation, hemolytic anemia, hemolytic uremic syndrome, pancytopenia, prolonged activated partial thromboplastin time, pure red cell aplasia [see Warnings and Precautions (5.12) ] , thrombocytopenic purpura, thrombotic thrombocytopenic purpura Cardiac Disorders : Atrial fibrillation, atrial flutter, cardiac arrhythmia, cardiac arrest, electrocardiogram T wave abnormal, flushing, myocardial hypertrophy, myocardial infarction, myocardial ischaemia, pericardial effusion, QT prolongation, supraventricular extrasystoles, supraventricular tachycardia, Torsade de Pointes, deep limb venous thrombosis, ventricular fibrillation Ear Disorders : Hearing loss including deafness Eye Disorders : Blindness, photophobia, optic atrophy Gastrointestinal Disorders : Colitis, dysphagia, gastrointestinal perforation, impaired gastric emptying, intestinal obstruction, mouth ulceration, peritonitis, stomach ulcer Hepatobiliary Disorders : Bile duct stenosis, cholangitis, cirrhosis, fatty liver, hepatic cytolysis, hepatic failure, hepatic necrosis, hepatic steatosis, jaundice, hemorrhagic pancreatitis, necrotizing pancreatitis, venoocclusive liver disease Hypersensitivity Reactions : Hypersensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria Immune System Disorders : Graft versus host disease (acute and chronic) Metabolism and Nutrition Disorders : Glycosuria, increased amylase, pancreatitis Musculoskeletal and Connective Tissue Disorders : Myalgia, polyarthritis, rhabdomyolysis Neoplasms : Lymphoma including EBV-associated lymphoproliferative disorder, PTLD [see Warnings and Precautions (5.1) ] ; leukemia Nervous System Disorders : Carpal tunnel syndrome, cerebral infarction, coma, dysarthria, flaccid paralysis, hemiparesis, mental disorder, mutism, nerve compression, posterior reversible encephalopathy syndrome (PRES) [see Warnings and Precautions (5.6) ] , progressive multifocal leukoencephalopathy (PML) sometimes fatal [see Warnings and Precautions (5.2) ] , quadriplegia, speech disorder, status epilepticus, syncope Renal and Urinary Disorder: Acute renal failure, hemorrhagic cystitis, hemolytic uremic syndrome, micturition disorder Respiratory, Thoracic and Mediastinal Disorders : Acute respiratory distress syndrome, interstitial lung disease, lung infiltration, pulmonary hypertension, respiratory distress, respiratory failure Skin and Subcutaneous Tissue Disorders : Hyperpigmentation, photosensitivity