Ezokamine contains the active substance micafungin.
Ezokamine is called an antifungal medicine because it is used
to treat infections caused by fungal cells.
Ezokamine is used to treat fungal infections caused by fungal
or yeast cells called Candida. Ezokamine is effective in treating
systemic infections (those that have penetrated within the
body). It interferes with the production of a part of the fungal
cell wall. An intact cell wall is necessary for the fungus to
continue living and growing. Ezokamine causes defects in the
fungal cell wall, making the fungus unable to live and grow.
Your doctor has prescribed Ezokamine for you in the following
circumstances when there are no other suitable antifungal
treatments available (see section 2):
• To treat adults, adolescents and children including neonates
who have a serious fungal infection called invasive candidiasis
(infection that has penetrated the body).
• To treat adults and adolescents ≥ 16 years of age who have
a fungal infection in the gullet (oesophagus) where treatment
into a vein (intravenous) is appropriate.
• To prevent infection with Candida in patients who are having
a bone-marrow transplant or who are expected to have a
neutropenia (low levels of neutrophils, a type of white blood
cell) for 10 days or more.
 

Do not use Ezokamine
- if you are allergic to Micafungin, other echinocandins (Ecalta
or Cancidas) or any of the other ingredients of this medicine
(listed in section 6).

Talk to your doctor or pharmacist before using Ezokamine
- if you are allergic to any medicine
- if you have haemolytic anaemia (anaemia due to breakdown
of red blood cells) or haemolysis (breakdown of red blood cells).
- if you have kidney problems (e.g. kidney failure and abnormal
kidney function test). If this happens, your doctor may decide
to monitor your kidney function more closely.
Micafungin may also cause severe inflammation/eruption of
the skin and mucous membranes (Stevens-Johnson syndrome,
toxic epidermal necrolysis).
Other medicines and Ezokamine
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
It is especially important to inform your doctor if you are using
amphotericin B desoxycholate or itraconazole (antifungal
antibiotics), sirolimus (an immunosuppressant) or nifedipine
(calcium channel blocker used to treat high blood pressure).
Your doctor may decide to adjust the dose of these medicines.
Ezokamine with food and drink
As Ezokamine is given intravenously (into a vein), no restrictions
on food or drink are required.
Pregnancy and breast-feeding
If you are pregnant of breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Ezokamine should not be used during pregnancy unless clearly
necessary. If you use Ezokamine you should not breast-feed.
Driving and using machines
Micafungin is unlikely to have an effect on driving or using
machines. However some people may feel dizzy when taking
this medicine and if this happens to you, do not drive or use any
tools or machines. Please inform your doctor if you experience
any effects that may cause you to have problems with driving
or using other machinery.
Ezokamine contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per
dose, that is to say essentially ‘sodium-free’.
 

Ezokamine must be prepared and given to you by a doctor
or another healthcare professional. Ezokamine should be
administered once daily by slow intravenous (into a vein)
infusion. Your doctor will determine how much Ezokamine you
will receive each day.
Use in adults, adolescents ≥ 16 years of age and elderly
- The usual dose to treat an invasive Candida infection is 100
mg per day for patients weighing 40 kg or more and 2 mg/kg
per day for patients weighing 40 kg or less.
- The dose to treat a Candida infection of the oesophagus is
150 mg for patients weighing more than 40 kg and 3 mg/kg per
day for patients weighing 40 kg or less.
- The usual dose to prevent invasive Candida infections is 50
mg per day for patients weighing more than 40 kg and 1 mg/kg
per day for patients weighing 40 kg or less.
Use in children > 4 months of age and adolescents < 16
years of age
- The usual dose to treat an invasive Candida infection is 100
mg per day for patients weighing 40 kg or more and 2 mg/kg
per day for patients weighing 40 kg or less.
- The usual dose to prevent invasive Candida infections is 50
mg per day for patients weighing more than 40 kg and 1 mg/kg
per day for patients weighing 40 kg or less.
Use in children and newborns < 4 months of age
- The usual dose to treat an invasive Candida infection is 4-10
mg/kg per day.
- The usual dose to prevent invasive Candida infections is 2 mg/
kg per day.
If you receive more Ezokamine than you should
Your doctor monitors your response and condition to determine
what dose of Ezokamine is needed. However, if you are
concerned that you may have been given too much Ezokamine,
speak to your doctor or another healthcare professional
immediately.
If you miss a dose of Ezokamine
Your doctor monitors your response and condition to determine
what Ezokamine treatment is needed. However, if you are
concerned that you may have missed a dose, speak to your
doctor or another healthcare professional immediately.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
 

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you experience an allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin), you must inform your
doctor or nurse immediately
Ezokamine may cause the following other side effects:
Common (may affect up to 1 in 10 people)
-abnormal blood tests (decreased white blood cells [leucopenia;
neutropenia]); decreased red blood cells (anaemia)
-decreased potassium in the blood (hypokalaemia); decreased
magnesium in the blood (hypomagnesaemia); decreased
calcium in the blood (hypocalcaemia)
- headache
- inflammation of the vein wall (at injection-site)
- nausea (feeling sick); vomiting (being sick); diarrhoea;
abdominal pain
- abnormal liver function tests (increased alkaline phosphatase;
increased aspartate aminotransferase, increased alanine
aminotransferase)
- increased bile pigment in the blood (hyperbilirubinaemia)
- rash
- fever
- rigors (shivering)
Uncommon (may affect up to 1 in 100 people)
- abnormal blood tests (decreased blood cells [pancytopenia]);
decreased blood platelets (thrombocytopenia); increases in a
certain type of white blood cells called eosinophils; decreased
albumin in the blood (hypoalbuminaemia)
- hypersensitivity
- increased sweating
- decreased sodium in the blood (hyponatraemia); increased
potassium in the blood (hyperkalaemia); decreased phosphates
in the blood (hypophosphataemia); anorexia (eating disorder)
- insomnia (difficulty in sleeping); anxiety; confusion
- feeling lethargic (somnolence); trembling; dizziness; disturbed
taste
- increased heart rate; stronger heartbeat; irregular heartbeat
- high or low blood pressure; skin flushing
- shortness of breath
- indigestion; constipation
- liver failure; increased liver enzymes (gammaglutamyltransferase); jaundice (yellowing of the skin or whites
of the eyes caused by liver or blood problems); reduced bile
reaching the intestine (cholestasis); enlarged liver; liver
inflammation
- itchy rash (urticaria); itching; skin flushing (erythema)
- abnormal kidney function tests (increased blood creatinine;
increased urea in the blood); aggravated kidney failure
- increase in an enzyme called lactate dehydrogenase
- clotting in vein at injection-site; inflammation at injectionsite; pain at injection-site; collection of fluid in your body
Rare (may affect up to 1 in 1,000 people)
- anaemia due to breakdown of red blood cells (haemolytic
anaemia), breakdown of red blood cells (haemolysis)
Not known (frequency cannot be estimated from the
available data)
- disorder of blood clotting system
- (allergic) shock
- damage to liver cells including death
- kidney problems; acute kidney failure
Additional side effects in children and adolescents
The following reactions have been reported more often in
paediatric patients than in adult patients:
Common (may affect up to 1 in 10 people)
- decreased blood platelets (thrombocytopenia)
- increased heart rate (tachycardia)
- high or low blood pressure
- increased bile pigment in the blood (hyperbilirubinaemia);
enlarged liver
- acute kidney failure; increased urea in the blood
 

• Do not store above 30° C
• Store the reconstituted product at 25°C
• Store the diluted solution at 25°C and protect from Light.
• Keep this medicine out of the sight and reach of children.
• Do not use Ezokamine after the expiry date which is stated
on the vial and on the carton. The expiry date refers to the last
day of that month.
• Do not use the diluted infusion solution if it is cloudy or
precipitated.
• The vial is for single use only. Therefore, please discard
unused reconstituted product immediately.
• Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer require. These measures will help
protect the environment.