Overall MYCAMINE Safety Experience in Clinical Trials: The overall safety of MYCAMINE was assessed in 3083 patients and 501 volunteers in 41 clinical studies, including the invasive candidiasis, esophageal candidiasis and prophylaxis studies, who received single or multiple doses of MYCAMINE, ranging from 12.5 mg to ≥150 mg/day. Treatment emergent adverse events which occurred in ≥ 5% of all patients who received MYCAMINE in these trials are shown in Table 7.
Overall, 2810 of 3083 (91.1%) patients who received MYCAMINE experienced an adverse event.
Clinically significant adverse events regardless of causality or incidence which occurred in these trials are listed as follows: Blood and lymphatic system disorders: coagulopathy, febrile neutropenia, haemolysis, haemolytic anemia, pancytopenia, thrombotic thrombocytopenic purpura.
Cardiac disorders: arrhythmia, atrial fibrillation, cardiac arrest, cyanosis, hypotension, myocardial infarction, tachycardia.
Gastrointestinal disorders: abdominal pain upper, dyspepsia.
General disorders and administration site conditions: injection site thrombosis.
Hepatobiliary disorders: hepatocellular damage, hepatomegaly, jaundice, hepatic failure.
Infections and infestations: infection, pneumonia, sepsis.
Metabolism and nutrition disorders: acidosis, anorexia, hyponatraemia.
Musculoskeletal, connective tissue and bone disorders: arthralgia.
Nervous system disorders: convulsions, encephalopathy, intracranial haemorrhage.
Psychiatric disorders: delirium.
Renal and urinary disorders: anuria, haemoglobinuria, oliguria, renal failure acute, renal tubular necrosis.
Respiratory, thoracic and mediastinal disorders: apnoea, dyspnoea, hypoxia, pulmonary embolism.
Skin and subcutaneous tissue disorders: erythema multiforme, skin necrosis, urticaria.
Vascular disorders: deep venous thrombosis, hypertension. (See Table 7.)
Click on icon to see table/diagram/image
Postmarketing Adverse Reactions: The following adverse reactions have been identified during the post-approval use of micafungin (as sodium) powder for injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency. A causal relationship to micafungin (as sodium) powder for injection could not be excluded for these adverse reactions, which included: Blood and lymphatic system disorders: white blood cell count decreased, haemolytic anaemia, disseminated intravascular coagulation.
Hepatobiliary disorders: hyperbilirubinaemia, hepatic function abnormal, hepatic disorder, hepatocellular damage.
Immune system disorders: anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, anaphylactoid shock.
Renal and urinary disorders: acute renal failure and renal impairment.
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis.
Vascular disorders: shock.
Paediatric patients: The incidence of some adverse events (AEs) in the clinical study database (thrombocytopenia, tachycardia, hypertension, hypotension, hyperbilirubinaemia, hepatomegaly, renal failure acute, blood urea increased) was higher in paediatric patients than adult patients. Additionally, paediatric patients < 1 year of age experienced about two times more often an increase in ALT, AST and AP than older paediatric patients.
No clinically meaningful differences in the safety profile could be discerned by paediatric age strata of < 4 weeks, 4 weeks to < 1 year, 1 to 4 years, 5 to 8 years, 9 to 12 years and 13 to < 16 years.