MICAFUNGIN XELLIA 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

Package leaflet: Information for the user

Read all of this leaflet carefully before you start using this medicine because it

contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Micafungin is and what it is used for

• 2. What you need to know before you use Micafungin

• 3. How to use Micafungin

• 4. Possible side effects

• 5. How to store Micafungin

• 6. Contents of the pack and other information

1. what micafungin is and what it is used for

Micafungin contains the active substance micafungin. Micafungin is called an antifungal medicine because it is used to treat infections caused by fungal cells.

Micafungin is used to treat fungal infections caused by fungal or yeast cells called Candida. Micafungin 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. Micafungin causes defects in the fungal cell wall, making the fungus unable to live and grow.

Your doctor has prescribed Micafungin 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.

2. what you need to know before you use micafungin

Do not use Micafungin

• – if you are allergic to micafungin, other echinocandins (Ecalta or Cancidas) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

In rats, long-term treatment with micafungin led to liver damage and subsequent liver tumours. The potential risk of developing liver tumors in humans is not known, and your doctor will assess the benefits and risks of Micafungin treatment before starting your medicine. Please tell your doctor if you have severe liver problems (e.g. liver failure or hepatitis) or have had abnormal liver function tests. During treatment your liver functions will be monitored more closely.

Talk to your doctor or pharmacist before using Micafungin

• – 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 Micafungin

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.

Micafungin with food and drink

As Micafungin 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. Micafungin should not be used during pregnancy unless clearly necessary. If you use Micafungin 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.

Micafungin contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‚sodium free‘.

3. how to use micafungin

Micafungin must be prepared and given to you by a doctor or another healthcare professional. Micafungin should be administered once daily by slow intravenous (into a vein) infusion. Your doctor will determine how much Micafungin 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 Micafungin than you should

Your doctor monitors your response and condition to determine what dose of Micafungin is needed. However, if you are concerned that you may have been given too much Micafungin, speak to your doctor or another healthcare professional immediately.

If you miss a dose of Micafungin

Your doctor monitors your response and condition to determine what Micafungin 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.

4. possible side effects

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

Micafungin 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 (gamma-glutamyltransfe­rase); 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 injection-site; 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)

5. how to store micafungin

Keep this medicine out of the sight and reach of children.

Do not use Micafungin 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.

The unopened vial does not require any special storage conditions.

The reconstituted concentrate and the diluted infusion solution should be used immediately, because it does not contain any preservatives to prevent bacterial contamination. Only a trained healthcare professional who has read the complete directions properly can prepare this medicine for use.

Do not use the diluted infusion solution if it is cloudy or precipitated.

In order to protect the infusion bottle / bag containing the diluted infusion solution from light it should be inserted into a closable opaque bag.

The vial is for single use only. Therefore, please discard unused reconstituted concentrate immediately.

6. contents of the pack and other information

What Micafungin contains

• – The active substance is micafungin (as sodium).

• 1 vial contains 50 mg micafungin (as sodium).

• – The other ingredients are lactose monohydrate, citric acid anhydrous and sodium hydroxide.

What Micafungin looks like and contents of the pack

Micafungin 50 mg powder for concentrate for solution for infusion is a white compact freeze- dried powder. Micafungin is supplied in a box containing 1 vial.

Marketing Authorisation Holder and Manufacturer

Xellia Pharmaceuticals ApS

Dalslandsgade 11

2300 Copenhagen S

Denmark

Distributor

Ranbaxy (UK) Limited

5th floor, Hyde Park, Hayes 3

• 11 Millington Road, Hayes, UB3 4AZ

United Kingdom

Not known (frequency cannot be estimated from the available data)

• – disorder of blood clotting system

• – 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