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adverse reactions
ADVERSE REACTIONS Liver Transplantation The principal adverse reactions of Prograf are tremor, headache, diarrhea, hypertension, nausea, and abnormal renal function. These occur with oral and IV administration of Prograf and may respond to a reduction in dosing. Diarrhea was sometimes associated with other gastrointestinal complaints such as nausea and vomiting. Hyperkalemia and hypomagnesemia have occurred in patients receiving Prograf therapy. Hyperglycemia has been noted in many patients; some may require insulin therapy (see WARNINGS ). The incidence of adverse events was determined in two randomized comparative liver transplant trials among 514 patients receiving tacrolimus and steroids and 515 patients receiving a cyclosporine-based regimen (CBIR). The proportion of patients reporting more than one adverse event was 99.8% in the tacrolimus group and 99.6% in the CBIR group. Precautions must be taken when comparing the incidence of adverse events in the U.S. study to that in the European study. The 12-month posttransplant information from the U.S. study and from the European study is presented below. The two studies also included different patient populations and patients were treated with immunosuppressive regimens of differing intensities. Adverse events reported in ≥ 15% in tacrolimus patients (combined study results) are presented below for the two controlled trials in liver transplantation: LIVER TRANSPLANTATION: ADVERSE EVENTS OCCURRING IN ≥ 15% OF PROGRAF-TREATED PATIENTS U.S. STUDY EUROPEAN STUDY Prograf (N=250) CBIR (N=250) Prograf (N=264) CBIR (N=265) Nervous System Headache (see WARNINGS ) Tremor (see WARNINGS ) Insomnia Paresthesia 64% 56% 64% 40% 60% 46% 68% 30% 37% 48% 32% 17% 26% 32% 23% 17% Gastrointestinal Diarrhea Nausea Constipation LFT Abnormal Anorexia Vomiting 72% 46% 24% 36% 34% 27% 47% 37% 27% 30% 24% 15% 37% 32% 23% 6% 7% 14% 27% 27% 21% 5% 5% 11% Cardiovascular Hypertension (see PRECAUTIONS ) 47% 56% 38% 43% Urogenital Kidney Function Abnormal (see WARNINGS ) Creatinine Increased (see WARNINGS ) BUN Increased (see WARNINGS ) Urinary Tract Infection Oliguria 40% 39% 30% 16% 18% 27% 25% 22% 18% 15% 36% 24% 12% 21% 19% 23% 19% 9% 19% 12% Metabolic and Nutritional Hyperkalemia (see WARNINGS ) Hypokalemia Hyperglycemia (see WARNINGS ) Hypomagnesemia 45% 29% 47% 48% 26% 34% 38% 45% 13% 13% 33% 16% 9% 16% 22% 9% Hemic and Lymphatic Anemia Leukocytosis Thrombocytopenia 47% 32% 24% 38% 26% 20% 5% 8% 14% 1% 8% 19% Miscellaneous Abdominal Pain Pain Fever Asthenia Back Pain Ascites Peripheral Edema 59% 63% 48% 52% 30% 27% 26% 54% 57% 56% 48% 29% 22% 26% 29% 24% 19% 11% 17% 7% 12% 22% 22% 22% 7% 17% 8% 14% Respiratory System Pleural Effusion Atelectasis Dyspnea 30% 28% 29% 32% 30% 23% 36% 5% 5% 35% 4% 4% Skin and Appendages Pruritus Rash 36% 24% 20% 19% 15% 10% 7% 4% Less frequently observed adverse reactions in both liver transplantation and kidney transplantation patients are described under the subsection Less Frequently Reported Adverse Reactions below. Kidney Transplantation The most common adverse reactions reported were infection, tremor, hypertension, abnormal renal function, constipation, diarrhea, headache, abdominal pain and insomnia. Adverse events that occurred in ≥ 15% of kidney transplant patients treated with Prograf in conjunction with azathioprine are presented below: KIDNEY TRANSPLANTATION: ADVERSE EVENTS OCCURRING IN ≥ 15% OF PATIENTS TREATED WITH PROGRAF IN CONJUNCTION WITH AZATHIOPRINE Prograf (N=205) CBIR (N=207) Nervous System Tremor (see WARNINGS ) Headache (see WARNINGS ) Insomnia Paresthesia Dizziness 54% 44% 32% 23% 19% 34% 38% 30% 16% 16% Gastrointestinal Diarrhea Nausea Constipation Vomiting Dyspepsia 44% 38% 35% 29% 28% 41% 36% 43% 23% 20% Cardiovascular Hypertension (see PRECAUTIONS ) Chest pain 50% 19% 52% 13% Urogenital Creatinine Increased (see WARNINGS ) Urinary Tract Infection 45% 34% 42% 35% Metabolic and Nutritional Hypophosphatemia Hypomagnesemia Hyperlipemia Hyperkalemia (see WARNINGS ) Diabetes Mellitus (see WARNINGS ) Hypokalemia Hyperglycemia (see WARNINGS ) Edema 49% 34% 31% 31% 24% 22% 22% 18% 53% 17% 38% 32% 9% 25% 16% 19% Hemic and Lymphatic Anemia Leukopenia 30% 15% 24% 17% Miscellaneous Infection Peripheral Edema Asthenia Abdominal Pain Pain Fever Back Pain 45% 36% 34% 33% 32% 29% 24% 49% 48% 30% 31% 30% 29% 20% Respiratory System Dyspnea Cough Increased 22% 18% 18% 15% Musculoskeletal Arthralgia 25% 24% Skin Rash Pruritus 17% 15% 12% 7% Adverse events that occurred in ≥ 10% of kidney transplant patients treated with Prograf in conjunction with MMF in Study 1* are presented below: *Study 1 was conducted entirely outside of the United States. Such studies often report a lower incidence of adverse events in comparison to US studies. KIDNEY TRANSPLANTATION: ADVERSE EVENTS OCCURRING IN ≥ 10% OF PROGRAF-TREATED PATIENTS Prograf (Group C) Cyclosporine (Group A) Cyclosporine (Group B) (N=403) (N=384) (N=408) Anemia 17% 19% 17% Leucopenia 13% 10% 10% Diarrhea 25% 16% 13% Edema peripheral 11% 12% 13% Urinary tract infection 24% 28% 24% Hyperlipidemia 10% 15% 13% Hypertension (see PRECAUTIONS ) 13% 14% 12% Adverse events that occurred in ≥15% of kidney transplant patients treated with Prograf in conjunction with MMF in Study 2 are presented below: KIDNEY TRANSPLANTATION: ADVERSE EVENTS OCCURRING IN ≥ 15% OF PROGRAF-TREATED PATIENTS Prograf Cyclosporine (N=212) (N=212) Gastrointestinal Disorders Diarrhea 44% 26% Nausea 39% 47% Constipation 36% 41% Vomiting 26% 25% Dyspepsia 18% 15% Injury, Poisoning, and Procedural Complications Post Procedural Pain 29% 27% Incision Site Complication 28% 23% Graft Dysfunction 24% 18% Metabolism and Nutrition Disorders Hypomagnesemia 28% 22% Hypophosphatemia 28% 21% Hyperkalemia (see WARNINGS ) 26% 19% Hyperglycemia (see WARNINGS ) 21% 15% Hyperlipidemia 18% 25% Hypokalemia 16% 18% Nervous System Disorders Tremor 34% 20% Headache 24% 25% Blood and Lymphatic System Disorders Anemia 30% 28% Leukopenia 16% 12% Miscellaneous Edema Peripheral 35% 46% Hypertension (see PRECAUTIONS ) 32% 35% Insomnia 30% 21% Urinary Tract Infection 26% 22% Blood creatinine increased 23% 23% Less frequently observed adverse reactions in both liver transplantation and kidney transplantation patients are described under the subsection Less Frequently Reported Adverse Reactions shown below. Heart Transplantation The more common adverse reactions in Prograf-treated heart transplant recipients were abnormal renal function , hypertension, diabetes mellitus, CMV infection, tremor, hyperglycemia, leukopenia, infection, and hyperlipemia. Adverse events in heart transplant patients in the European trial are presented below: HEART TRANSPLANTATION: ADVERSE EVENTS OCCURRING IN ≥ 15% OF PROGRAF-TREATED PATIENTS COSTART Body System COSTART Term Prograf+ Azathioprine (n=157) CsA + Azathioprine (n=157) Cardiovascular System Hypertension (See PRECAUTIONS ) 62% 69% Pericardial effusion 15% 14% Body as a Whole CMV infection 32% 30% Infection 24% 21% Metabolic and Nutritional Disorders Hyperlipemia 18% 27% Diabetes Mellitus (See WARNINGS ) 26% 16% Hyperglycemia (See WARNINGS ) 23% 17% Hemic and Lymphatic System Leukopenia 48% 39% Anemia 50% 36% Urogenital System Kidney function abnormal (See WARNINGS ) 56% 57% Urinary tract infection 16% 12% Respiratory System Bronchitis 17% 18% Nervous System Tremor (See WARNINGS ) 15% 6% In the European study, the cyclosporine trough concentrations were above the pre-defined target range (i.e., 100-200 ng/mL) at Day 122 and beyond in 32-68% of the patients in the cyclosporine treatment arm, whereas the tacrolimus trough concentrations were within the pre-defined target range (i.e., 5-15 ng/mL) in 74-86% of the patients in the tacrolimus treatment arm. Only selected targeted treatment-emergent adverse events were collected in the US heart transplantation study. Those events that were reported at a rate of 15% or greater in patients treated with Prograf and mycophenolate mofetil include the following: any target adverse events (99.1%), hypertension (88.8%), hyperglycemia requiring antihyperglycemic therapy (70.1%) (see WARNINGS ), hypertriglyceridemia (65.4%), anemia (hemoglobin <10.0 g/dL) (65.4%), fasting blood glucose >140 mg/dL (on two separate occasions) (60.7%) (see WARNINGS ), hypercholesterolemia (57.0%), hyperlipidemia (33.6%), WBCs <3000 cells/mcL (33.6%), serious bacterial infections (29.9%), magnesium <1.2 mEq/L (24.3%), platelet count <75,000 cells/mcL (18.7%), and other opportunistic infections (15.0%). Other targeted treatment-emergent adverse events in Prograf-treated patients occurred at a rate of less than 15%, and include the following: Cushingoid features, impaired wound healing, hyperkalemia, Candida infection, and CMV infection/syndrome. Less Frequently Reported Adverse Reactions The following adverse events were reported in either liver, kidney, and/or heart transplant recipients who were treated with tacrolimus in clinical trials. Nerv o us System (see WARNINGS ) Abnormal dreams, agitation, amnesia, anxiety, confusion, convulsion, crying, depression, dizziness, elevated mood, emotional lability, encephalopathy, haemorrhagic stroke, hallucinations, headache, hypertonia, incoordination, insomnia, monoparesis, myoclonus, nerve compression, nervousness, neuralgia, neuropathy, paresthesia, paralysis flaccid, psychomotor skills impaired, psychosis, quadriparesis, somnolence, thinking abnormal, vertigo, writing impaired Special Senses Abnormal vision, amblyopia, ear pain, otitis media, tinnitus Gastrointestinal Anorexia, cholangitis, cholestatic jaundice, diarrhea, duodenitis, dyspepsia, dysphagia, esophagitis, flatulence, gastritis, gastroesophagitis, gastrointestinal hemorrhage, GGT increase, GI disorder, GI perforation, hepatitis, hepatitis granulomatous, ileus, increased appetite, jaundice, liver damage, liver function test abnormal, nausea, nausea and vomiting, oesophagitis ulcerative, oral moniliasis, pancreatic pseudocyst, rectal disorder, stomatitis, vomiting Cardiovascular Abnormal ECG, angina pectoris, arrhythmia, atrial fibrillation, atrial flutter, bradycardia, cardiac fibrillation, cardiopulmonary failure, cardiovascular disorder, chest pain, congestive heart failure, deep thrombophlebitis, echocardiogram abnormal, electrocardiogram QRS complex abnormal, electrocardiogram ST segment abnormal, heart failure, heart rate decreased, hemorrhage, hypotension, peripheral vascular disorder, phlebitis, postural hypotension, syncope, tachycardia, thrombosis, vasodilatation Urogenital (see WARNINGS ) Acute kidney failure, albuminuria, BK nephropathy, bladder spasm, cystitis, dysuria, hematuria, hydronephrosis, kidney failure, kidney tubular necrosis, nocturia, oliguria, pyuria, toxic nephropathy, urge incontinence, urinary frequency, urinary incontinence, urinary retention, vaginitis Metabolic/Nutritional Acidosis, alkaline phosphatase increased, alkalosis, ALT (SGPT) increased, AST (SGOT) increased, bicarbonate decreased, bilirubinemia, BUN increased, dehydration, edema, GGT increased, gout, healing abnormal, hypercalcemia, hypercholesterolemia, hyperkalemia, hyperlipemia, hyperphosphatemia, hyperuricemia, hypervolemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, hypoproteinemia, lactic dehydrogenase increase, peripheral edema, weight gain Endocrine (see PRECAUTIONS ) Cushing’s syndrome, diabetes mellitus Hemic/Lymphatic Coagulation disorder, ecchymosis, haematocrit increased, haemoglobin abnormal, hypochromic anemia, leukocytosis, leukopenia, polycythemia, prothrombin decreased, serum iron decreased, thrombocytopenia Miscellaneous Abdomen enlarged, abdominal pain, abscess, accidental injury, allergic reaction, asthenia, back pain, cellulitis, chills, fall, feeling abnormal, fever, flu syndrome, generalized edema, hernia, mobility decreased, pain, peritonitis, photosensitivity reaction, sepsis, temperature intolerance, ulcer Musculoskeletal Arthralgia, cramps, generalized spasm, joint disorder, leg cramps, myalgia, myasthenia, osteoporosis Respiratory Asthma, bronchitis, cough increased, dyspnea, emphysema, hiccups, lung disorder, lung function decreased, pharyngitis, pleural effusion, pneumonia, pneumothorax, pulmonary edema, respiratory disorder, rhinitis, sinusitis, voice alteration Skin Acne, alopecia, exfoliative dermatitis, fungal dermatitis, herpes simplex, herpes zoster, hirsutism, neoplasm skin benign, skin discoloration, skin disorder, skin ulcer, sweating. Post Marketing Post Marketing Adverse Events The following adverse events have been reported from worldwide marketing experience with Prograf. Because these events are reported voluntarily from a population of uncertain size, are associated with concomitant diseases and multiple drug therapies and surgical procedures, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these events in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) frequency of the reporting, or (3) strength of causal connection to the drug. There have been rare spontaneous reports of myocardial hypertrophy associated with clinically manifested ventricular dysfunction in patients receiving Prograf therapy (see PRECAUTIONS- Myocardial Hypertrophy ). Other events include: Cardiovascular Atrial fibrillation, atrial flutter, cardiac arrhythmia, cardiac arrest, electrocardiogram T wave abnormal, flushing, myocardial infarction, myocardial ischaemia, pericardial effusion, QT prolongation, Torsade de Pointes, venous thrombosis deep limb, ventricular extrasystoles, ventricular fibrillation Gastrointestinal Bile duct stenosis, colitis, enterocolitis, gastroenteritis, gastrooesophageal reflux disease, hepatic cytolysis, hepatic necrosis, hepatotoxicity, impaired gastric emptying, liver fatty, mouth ulceration, pancreatitis haemorrhagic, pancreatitis necrotizing, stomach ulcer, venoocclusive liver disease Hemic/Lymphatic Disseminated intravascular coagulation, neutropenia, pancytopenia, thrombocytopenic purpura, thrombotic thrombocytopenic purpura Metabolic/Nutritional Glycosuria, increased amylase including pancreatitis, weight decreased Miscellaneous Feeling hot and cold, feeling jittery, hot flushes, multi-organ failure, primary graft dysfunction Nervous System Carpal tunnel syndrome, cerebral infarction, hemiparesis, leukoencephalopathy, mental disorder, mutism, posterior reversible encephalopathy syndrome (PRES), progressive multifocal leukoencephalopathy (PML), quadriplegia, speech disorder, syncope Respiratory Acute respiratory distress syndrome, interstitial lung disease, lung infiltration, respiratory distress, respiratory failure Skin Stevens-Johnson syndrome, toxic epidermal necrolysis Special Senses Blindness, blindness cortical, hearing loss including deafness, photophobia Urogenital Acute renal failure, cystitis haemorrhagic, hemolytic-uremic syndrome, micturition disorder.