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adverse reactions
ADVERSE REACTIONS The safety data were obtained from 316 patients who received AMMONUL ® as emergency (rescue) or prospective treatment for hyperammonemia as part of an uncontrolled, open-label study. The study population included patients between the ages of 0 to 53 years with a mean (SD) of 6.2 (8.54) years; 51% were male and 49% were female who had the following diagnoses: OTC (46%), ASS (22%), CPS (12%), ASL (2%), ARG ( less than 1%), THN ( less than 1%), and other (18%). Table 2 Adverse Events Occurring in≥ 3% of Patients Treated with AMMONUL ® Patients N=316 No. patients with any adverse event 163 (52%) Blood and lymphatic system disorders 35 (11%) Anemia NOS 12 (4%) Disseminated intravascular coagulation 11 (3%) Cardiac disorders 28 (9%) Gastrointestinal disorders 42 (13%) Diarrhea NOS 10 (3%) Nausea 9 (3%) Vomiting NOS 29 (9%) General disorders and administration-site conditions 45 (14%) Injection-site reaction NOS 11 (3%) Pyrexia 11 (3%) Infections 17 (5%) Urinary tract infection NOS 39 (12%) Injury, poisoning and procedural complications 9 (3%) Investigations 32 (10%) Metabolism and nutrition disorders 67 (21%) Acidosis NOS 8 (3%) Hyperammonemia 17 (5%) Hyperglycemia NOS 22 (7%) Hypocalcemia 8 (3%) Hypokalemia 23 (7%) Metabolic acidosis NOS 13 (4%) Nervous system disorders 71 (22%) Brain edema 17 (5%) Coma 10 (3%) Convulsions NOS 19 (6%) Mental impairment NOS 18 (6%) Psychiatric disorders 16 (5%) Agitation 8 (3%) Renal and urinary disorders 14 (4%) Respiratory, thoracic and mediastinal disorders 47 (15%) Respiratory distress 9 (3%) Skin and subcutaneous tissue disorders 19 (6%) Vascular disorders 19 (6%) Hypotension NOS 14 (4%) Clinically Important Adverse Reactions Adverse events occurred most frequently in the following system organ classes: nervous system disorders (22% of patients), metabolism and nutrition disorders (21% of patients), and respiratory, thoracic and mediastinal disorders (15% of patients). The most frequently reported adverse events were vomiting (9% of patients), hyperglycemia (7% of patients), hypokalemia (7% of patients), convulsions (6% of patients), and mental impairment (6% of patients). Adverse events leading to study drug discontinuation occurred in 4% of patients. Metabolic acidosis and injection-site reactions each led to discontinuation in 2 patients (less than 1%). Adverse events leading to discontinuation in 1 patient included bradycardia, abdominal distension, injection-site extravasation, injection-site hemorrhage, blister, overdose, subdural hematoma, hyperammonemia, hypoglycemia, clonus, coma, increased intercranial pressure, hypercapnia, Kussmaul respiration, respiratory distress, respiratory failure, pruritis, and maculo-papular rash. Subpopulation and Risk Factor Data Adverse events were reported with similar frequency in patients with OTC, ASS, CPS, and diagnoses categorized as "other." Nervous system disorders were more frequent in patients with OTC and CPS, compared with patients with ASS and patients with "other" diagnoses. Convulsions and mental impairment were reported in patients with OTC and CPS. These observations are consistent with literature reports that patients with enzyme deficiencies occurring earlier in the urea cycle (i.e., OTC and CPS) tend to be more severely affected. Adverse event profiles did differ by age group. Patients ≤ 30 days of age had more blood and lymphatic system disorders and vascular disorders (specifically hypotension), while patients > 30 days of age had more gastrointestinal disorders (specifically nausea, vomiting and diarrhea). Other Less Common Adverse Events Occurring in less than 3% of Patients Less common adverse events that could represent drug-induced reactions or are characterized as severe are listed below by body system. BLOOD AND LYMPHATIC SYSTEM DISORDERS: coagulopathy, pancytopenia, thrombocytopenia CARDIAC DISORDERS: atrial rupture, cardiac or cardiopulmonary arrest/failure, cardiogenic shock, cardiomyopathy, pericardial effusion EYE DISORDERS: blindness GASTROINTESTINAL DISORDERS: gastrointestinal hemorrhage GENERAL DISORDERS AND ADMINISTRATION-SITE CONDITIONS: asthenia, brain death, chest pain, multiorgan failure, edema HEPATOBILIARY DISORDERS: cholestasis, hepatic artery stenosis, hepatic failure/ hepatotoxicity, jaundice INFECTIONS AND INFESTATIONS: sepsis/septic shock INJURY, POISONING AND PROCEDURAL COMPLICATIONS: brain herniation, subdural hematoma INVESTIGATIONS: blood carbon dioxide changes, blood glucose changes, blood pH increased, cardiac output decreased, pCO 2 changes, respiratory rate increased METABOLISM AND NUTRITION DISORDERS: alkalosis, dehydration, fluid overload/retention, hyperkalemia, hypernatremia, alkalosis, tetany NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED: hemangioma acquired NERVOUS SYSTEM DISORDERS: areflexia, ataxia, brain infarction, brain hemorrhage, cerebral atrophy, clonus, depressed level of consciousness, encephalopathy, nerve paralysis, intracranial pressure increased, tremor PSYCHIATRIC DISORDERS: acute psychosis, aggression, confusional state, hallucinations RENAL AND URINARY DISORDERS: anuria, renal failure, urinary retention RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS: acute respiratory distress syndrome, dyspnea, hypercapnia, hyperventilation, Kussmaul respiration, pneumonia aspiration, pneumothorax, pulmonary hemorrhage, pulmonary edema, respiratory acidosis or alkalosis, respiratory arrest/failure SKIN AND SUBCUTANEOUS TISSUE DISORDERS: alopecia, pruritis generalized, rash, urticaria VASCULAR DISORDERS: flushing, hemorrhage, hypertension, phlebothrombosis/thrombosis