Mycamine is a powder that is dissolved to make a solution for infusion (drip into a vein). It contains the active substance micafungin.
|Table of Contents|
|What is it used for?|
|How is it used?|
|How does it work?|
|How has it been studied?|
|What benefits has it shown during the studies?|
|What is the risk associated?|
|Why has it been approved?|
Mycamine is used in babies, children and adults in the following situations:
- to treat invasive candidiasis (a type of fungal infection caused by a yeast-like fungus called Candida). ?Invasive? means that the fungus has spread into tissue and blood vessels;
- to prevent infection with Candida in patients who are having a bone marrow transplant (to treat bone marrow or blood problems, or certain types of cancer) or who are expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more. Mycamine is also used to treat candidiasis in the oesophagus (gullet) in patients over 16 years of age for whom intravenous treatment is suitable. Doctors should only use Mycamine when using other antifungal medicines is not appropriate. This is because micafungin has been shown to increase the risk of liver tumours developing in rats. The medicine can only be obtained with a prescription.
Treatment with Mycamine should be initiated by a doctor who has experience in the management of fungal infections, and after considering official or national guidance on the use of antifungal medicines.
Mycamine is given once a day as an infusion lasting around one hour. The dose depends on what it is being used for, the patient?s weight, and the response to treatment.
Patients being treated for invasive candidiasis should receive Mycamine for at least two weeks, and for a week after symptoms have resolved and there are no signs of fungus in the blood. Patients being treated for oesophageal candidiasis should continue to receive Mycamine for at least one week after symptoms have resolved.
When Mycamine is used to prevent Candida infection, treatment should continue for one week after white blood cell counts have recovered.
The active substance in Mycamine, micafungin, is an antifungal medicine, which belongs to the group ?echinocandins?. It works by interfering with the production of a component of the fungal cell wall called 1,3-?-D-glucan, which is necessary if the fungus is to continue living and growing. Fungal cells treated with Mycamine have incomplete or defective cell walls, making them fragile and unable to grow. The list of fungi against which Mycamine is active can be found in the Summary of Product Characteristics (also part of the EPAR).
The effects of Mycamine were first tested in experimental models before being studied in humans. The effectiveness of Mycamine has been studied in four main studies, in which it was compared with other antifungal medicines. There were three treatment studies and one prevention study. For the treatment of invasive candidiasis, Mycamine was compared with amphotericin B in one study involving 531 adults and 106 children, including newborns and premature babies.
For the treatment of oesophageal candidiasis, Mycamine was compared with fluconazole in one study involving 518 adults, and with caspofungin in another study involving 452 adults. Most of the patients in these two studies were infected with human immunodeficiency virus (HIV). In all three studies, the main measure of effectiveness was the number of patients in whom treatment was successful, based on an improvement in symptoms and eradication of the fungus at the end of treatment. For the prevention of candidiasis, Mycamine was compared with fluconazole in 889 adults and children undergoing a bone marrow transplant. The main measure of effectiveness was the number of patients who did not develop a fungal infection during treatment or the following four weeks.
Mycamine was as effective as the comparator medicines in the treatment of candidiasis. In the study of invasive candidiasis, around 90% of the adults receiving either Mycamine or amphotericin B were successfully treated. Similar results were seen in children.
In the two studies of oesophageal candidiasis, around 90% of the patients were successfully treated with Mycamine, fluconazole or caspofungin.
Mycamine was more effective than fluconazole in preventing fungal infection in patients undergoing a bone marrow transplant: 80% of the patients (340 out of 425) receiving Mycamine did not develop a fungal infection, compared with 74% of the patients (336 out of 457) receiving fluconazole.
The most common side effects with Mycamine (seen in between 1 and 10 patients in 100) are leucopenia (low levels of leucocytes, a type of white blood cell), neutropenia (low levels of neutrophils, a type of white blood cell), anaemia (low red blood cell counts), hypokalaemia (low blood potassium levels), hypomagnesaemia (low blood magnesium levels), hypocalcaemia (low blood calcium levels), headache, phlebitis (inflammation of a vein), nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain, signs of liver problems in the blood (increased levels of alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase or bilirubin), rash, pyrexia (fever) and rigors (shaking chills).
Additional common side effects in children (seen in between 1 and 10 children in 100) are thrombocytopenia (low blood platelet counts), tachycardia (rapid heart rate), hypertension (high blood pressure), hypotension (low blood pressure), hepatomegaly (enlarged liver), acute renal failure (sudden kidney failure) and increased blood urea levels.
For the full list of all side effects reported with Mycamine, see the Package Leaflet. Mycamine should not be used in people who may be hypersensitive (allergic) to micafungin or any of the other ingredients.
Because liver damage and tumours have been seen in rats receiving Mycamine for long periods, patients should be monitored for liver problems during Mycamine treatment using blood tests. Treatment should be stopped if there are persistent increases in liver enzymes. Mycamine should only be used after careful assessment of its risks and benefits, particularly in patients who have existing liver problems. Mycamine is not recommended for use in patients who have severe problems with their liver, who have long-term liver disease or who are taking other medicines that could harm the liver or the DNA.
The Committee for Medicinal Products for Human Use (CHMP) decided that Mycamine?s benefits are greater than its risks for the treatment of invasive candidiasis and of oesophageal candidiasis, and for the prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or who are expected to have neutropenia for 10 or more days, but that it should only be used if other antifungals are not appropriate. The Committee recommended that Mycamine be given marketing authorisation.