NIKP Micafungin For Injection Adverse Reactions

Summary of the safety profile: Based on clinical trial experience, overall 32.2% of the patients experienced adverse drug reactions. The most frequently reported adverse reactions were nausea (2.8%), blood alkaline phosphatase increased (2.7%), phlebitis (2.5%, primarily in HIV infected patients with peripheral lines), vomiting (2.5%), and aspartate aminotransferase increased (2.3%).
Tabulated list of adverse reactions: In the following table adverse reactions are listed by system organ class and MedDRA preferred term. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 6.)

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Description of selected adverse reactions: Possible allergic-like symptoms: Symptoms such as rash and rigors have been reported in clinical studies. The majority were of mild to moderate intensity and not treatment limiting. Serious reactions (e.g. anaphylactoid reaction 0.2%, 6/3028) were uncommonly reported during therapy with micafungin and only in patients with serious underlying conditions (e.g. advanced AIDS, malignancies) requiring multiple co-medications.
Hepatic adverse reactions: The overall incidence of hepatic adverse reactions in the patients treated with micafungin in clinical studies was 8.6% (260/3028). The majority of hepatic adverse reactions were mild and moderate. Most frequent reactions were increase in AP (2.7%), AST (2.3%), ALT (2.0%), blood bilirubin (1.6%) and liver function test abnormal (1.5%). Few patients (1.1%; 0.4% serious) discontinued treatment due to a hepatic event. Cases of serious hepatic dysfunction occurred uncommonly (see Precautions).
Injection-site reactions: None of the injection-site adverse reactions were treatment limiting.
Paediatric population: The incidence of some adverse reactions (listed as follows) was higher in paediatric patients than in 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 (see Precautions). The most likely reason for these differences were different underlying conditions compared with adults or older paediatric patients observed in clinical studies. At the time of entering the study, the proportion of paediatric patients with neutropenia was several-fold higher than in adult patients (40.2% and 7.3% of children and adults, respectively), as well as allogeneic HSCT (29.4% and 13.4%, respectively) and haematological malignancy (29.1% and 8.7%, respectively).
Blood and lymphatic system disorders: Common: thrombocytopenia.
Cardiac disorders: Common: tachycardia.
Vascular disorders: Common: hypertension, hypotension.
Hepatobiliary disorders: Common: hyperbilirubinaemia, hepatomegaly.
Renal and urinary disorders: Common: acute renal failure, blood urea increased.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.