Mycamine Adverse Reactions

The safety profile of micafungin is based on 3028 patients treated with micafungin in clinical studies: 2,002 patients with Candida infections (including candidemia, invasive candidiasis and esophageal candidiasis), 375 with invasive aspergillosis (primarily refractory infections) and 651 for prophylaxis of systemic fungal infections.
The patients treated with micafungin in clinical studies represent a critically ill patient population that requires multiple medicinal products including antineoplastic chemotherapy, potent systemic immunosuppressants and broad spectrum antibiotics. These patients had a wide variety of complex underlying conditions such as hematological malignancies and HIV-infection or were transplant recipients and/or treated in intensive care. Patients treated prophylactically with micafungin were those undergoing hematopoietic stem cell transplantation (HSCT) who were at high risk for fungal infections.
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%). No clinically significant differences were seen when the safety data were analysed by gender or race.
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 7.)

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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.
Pediatric patients: The incidence of some adverse reactions (listed as follows) was higher in pediatric patients than in adult patients. Additionally, pediatric patients <1 year of age experienced about two times more often an increase in ALT, AST and AP than older pediatric patients (see Precautions). The most likely reason for these differences were different underlying conditions compared with adults or older pediatric patients observed in clinical studies. At the time of entering the study, the proportion of pediatric 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: Hyperbilirubinemia, hepatomegaly.
Renal and urinary disorders: Common: Acute renal failure, blood urea increased.