Mycamine

HOS-094592 · has-adverse-reaction-information · PDF-Seite 6

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. System Organ Common Uncommon Rare Not known Class ≥ 1/100 to < 1/10 ≥ 1/1,000 to < 1/100 ≥ 1/10,000 to (frequency < 1/1,000 cannot be estimated from available data) Blood and leukopenia, pancytopenia, haemolytic disseminated lymphatic system neutropenia, anaemia thrombocytopenia, anaemia, intravascular disorders eosinophilia, haemolysis coagulation hypoalbuminaemia (see section 4.4) Immune system anaphylactic / anaphylactic disorders anaphylactoid and reaction (see section anaphylactoid 4.4), hypersensitivity shock (see section 4.4) 6 System Organ Common Uncommon Rare Not known Class ≥ 1/100 to < 1/10 ≥ 1/1,000 to < 1/100 ≥ 1/10,000 to (frequency < 1/1,000

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HOS-094588 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance, to other echinocandins or to any of the excipients listed in section 6.1.

HOS-094587 · has-indication-information · PDF-Seite 2

Mycamine is indicated for: Adults, adolescents ≥ 16 years of age and elderly: - Treatment of invasive candidiasis. - Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate. - Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells / µl) for 10 or more days. Children (including neonates) and adolescents < 16 years of age: - Treatment of invasive candidiasis. - Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells / µl) for 10 or more days. The decision to use Mycamine should take into account a potential risk for the development of liver tumours (see section 4.4). Mycamine should therefore only be used if other antifungals are not appropriate. Consideration should be given to official/national guidance on the appropriate use of antifungal agents.

HOS-094590 · has-interaction-information · PDF-Seite 5

Micafungin has a low potential for interactions with medicines metabolised via CYP3A mediated pathways. Drug interaction studies in healthy human subjects were conducted to evaluate the potential for interaction between micafungin and mycophenolate mofetil, ciclosporin, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, ritonavir, rifampicin, itraconazole, voriconazole and amphotericin B. In these studies, no evidence of altered pharmacokinetics of micafungin was observed. No micafungin dose adjustments are necessary when these medicines are administered concomitantly. Exposure (AUC) of itraconazole, sirolimus and nifedipine was slightly increased in the presence of micafungin (22%, 21% and 18% respectively). Co-administration of micafungin and amphotericin B desoxycholate was associated with a 30% increase in amphotericin B desoxycholate exposure. Since this may be of clinical significance this co- administration should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see section 4.4). Patients receiving sirolimus, nifedipine or itraconazole in combination with micafungin should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary (see section 4.4). 5

HOS-094591 · has-pregnancy-information · PDF-Seite 6

Pregnancy There are no data from the use of micafungin in pregnant women. In animal studies micafungin crossed the placental barrier and reproductive toxicity was seen (see section 5.3). The potential risk for humans is unknown. Mycamine should not be used during pregnancy unless clearly necessary. Breast-feeding It is not known whether micafungin is excreted in human breast milk. Animal studies have shown excretion of micafungin in breast milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Mycamine should be made taking into account the benefit of breast-feeding to the child and the benefit of Mycamine therapy to the mother. Fertility Testicular toxicity was observed in animal studies (see section 5.3). Micafungin may have the potential to affect male fertility in humans.

HOS-094589 · has-warning-information · PDF-Seite 4

Hepatic effects: The development of foci of altered hepatocytes (FAH) and hepatocellular tumours after a treatment period of 3 months or longer were observed in rats. The assumed threshold for tumour development in rats is approximately in the range of clinical exposure. The clinical relevance of this finding is not known. Liver function should be carefully monitored during micafungin treatment. To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/AST is recommended. Micafungin treatment should be conducted on a careful risk/benefit basis, particularly in patients having severe liver function impairment or chronic liver diseases known to represent preneoplastic conditions, such as advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects, or receiving a concomitant therapy including hepatotoxic and/or genotoxic properties. Micafungin treatment was associated with significant impairment of liver function (increase of ALT, AST or total bilirubin > 3 times ULN) in both healthy volunteers and patients. In some patients more severe hepatic dysfunction, hepatitis, or hepatic failure including fatal cases have been reported. Paediatric patients < 1 year of age might be more prone to liver injury (see section 4.8). Anaphylactic reactions During administration of micafungin, anaphylactic/anaphylactoid reactions, including shock, may occur. If these reactions occur, micafungin infusion should be discontinued and appropriate treatment administered. Skin reactions Exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. If patients develop a rash they should be monitored closely and micafungin discontinued if lesions progress. 4 Haemolysis Rare cases of haemolysis, including acute intravascular haemolysis or haemolytic anaemia, have been reported in patients treated with micafungin. Patients who develop clinical or laboratory evidence of haemolysis during micafungin therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing micafungin therapy. Renal effects Micafungin may cause kidney problems, renal failure, and abnormal renal function test. Patients should be closely monitored for worsening

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