Mycamine 50 mg powder for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mycamine 50 mg powder for concentrate for solution for infusion

Mycamine 100 mg powder for concentrate for solution for infusion

micafungin

Read the entire 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 questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Mycamine is and what it is used for

2. What you need to know before using Mycamine

3. How to use Mycamine

4. Possible side effects

5. How to store Mycamine

6. Contents of the pack and other information

1. What Mycamine is and what it is used for

Mycamine contains the active substance micafungin. Mycamine is an antifungal medicine, as it is used to treat infections caused by fungal cells.

Mycamine is used to treat fungal infections caused by fungal cells or yeasts called Candida. Mycamine is effective in treating systemic infections (those that have spread throughout the body). It interferes with the production of a component of the fungal cell wall. Fungi require an intact cell wall to survive and grow. Mycamine causes defects in the fungal cell wall, thereby preventing the fungus from growing and surviving.

When no other antifungal treatment is available, your doctor may prescribe Mycamine under the following circumstances (see section 2):

• To treat a serious fungal infection in adults, adolescents, and children, including neonates, called invasive candidiasis (an infection that has spread into the body).
• To treat adults and adolescents ≥ 16 years of age with a fungal infection of the esophagus when intravenous treatment is appropriate.

To prevent Candida infection in patients undergoing bone marrow transplantation or in patients expected to have neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or longer.

2. What you need to know before using Mycamine

Do not use Mycamine

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Mycamine

• if you are allergic to any medicine.

• if you have hemolytic anemia (anemia caused by the breakdown of red blood cells) or hemolysis (breakdown of red blood cells).

• if you have kidney problems (renal failure or abnormal kidney function tests). In this case, your doctor may decide to monitor your kidney function more closely.

Micafungin may also cause severe skin inflammation/rash and mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other medicines and Mycamine

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that you inform your doctor if you are taking amphotericin B deoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressant), or nifedipine (a calcium channel blocker used to treat high blood pressure). Your doctor may decide to adjust the dose of these medicines.

Use of Mycamine with food and drinks

Since Mycamine is administered intravenously (into the vein), there are no restrictions regarding food or drinks.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Mycamine should not be used during pregnancy unless clearly necessary. If you are taking Mycamine, you should not breastfeed.

Driving and using machines

Micafungin is unlikely to affect your ability to drive or use machines. However, some people may feel dizzy when taking this medicine, and if this happens to you, you should not drive or operate any machinery or tools. Please inform your doctor if you experience any effect that could impair your ability to drive or use machinery.

Mycamine contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially “sodium-free”.

3. How to use Mycamine

Mycamine must be prepared and administered by a doctor or other healthcare professional. Mycamine should be given by slow intravenous infusion (into the vein) once daily. Your doctor will determine the dose of Mycamine you will receive each day.

Use in adults, adolescents ≥ 16 years of age, and elderly patients

• The usual dose for treating invasive Candida infection is 100 mg daily for patients weighing 40 kg or more, and 2 mg/kg daily for patients weighing 40 kg or less.

• The dose for treating esophageal Candida infection is 150 mg daily for patients weighing more than 40 kg, and 3 mg/kg daily for patients weighing 40 kg or less.

• The usual dose for preventing invasive Candida infections is 50 mg daily for patients weighing more than 40 kg, and 1 mg/kg daily for patients weighing 40 kg or less.

Use in children > 4 months of age and adolescents < 16 years of age

• The usual dose for treating invasive Candida infection is 100 mg daily for patients weighing 40 kg or more, and 2 mg/kg daily for patients weighing 40 kg or less.

• The usual dose for preventing invasive Candida infections is 50 mg daily for patients weighing more than 40 kg, and 1 mg/kg daily for patients weighing 40 kg or less.

Use in children and newborns < 4 months of age

• The usual dose for treating invasive Candida infection is 4–10 mg/kg per day.
• The usual dose for preventing invasive Candida infections is 2 mg/kg per day.

If you receive more Mycamine than you should

Your doctor will monitor your response and disease status to determine the appropriate Mycamine dose. However, if you are concerned that you have received too much Mycamine, contact your doctor or another healthcare professional immediately.

If you miss your dose of Mycamine

Your doctor will monitor your response and disease status to determine the appropriate treatment with Mycamine. However, if you are concerned that you have missed a dose of Mycamine, contact your doctor or another healthcare professional immediately.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you suffer an allergic reaction or a severe skin reaction (e.g., blistering of the skin and skin peeling), you must inform your doctor or nurse immediately.

Mycamine may cause the following adverse effects:

Frequent (may affect up to 1 in 10 people)

• abnormal blood test results (reduction in white blood cell count [leucopenia; neutropenia]); reduction in red blood cells (anaemia)

• low potassium levels in blood (hypokalaemia); low magnesium levels in blood (hypomagnesaemia); low calcium levels in blood (hypocalcaemia)

• headache

• inflammation of the vein wall (at the injection site)

• nausea (feeling unwell); vomiting; diarrhoea; abdominal pain

• abnormal liver function tests (increase in alkaline phosphatase; increase in aspartate aminotransferase; increase in alanine aminotransferase)

• increased bilirubin pigment in blood (hyperbilirubinaemia)

• rash

• fever

• chills

Uncommon (may affect up to 1 in 100 people)

• abnormal blood test results (reduction in blood cells [pancytopenia]); reduction in platelet count (thrombocytopenia); increase in a specific type of white blood cells called eosinophils; reduction in albumin in blood (hypoalbuminaemia)

• hypersensitivity

• increased sweating

• low sodium levels in blood (hyponatraemia); high potassium levels in blood (hyperkalaemia); low phosphate levels in blood (hypophosphataemia); anorexia (eating disorder)

• insomnia (difficulty sleeping); anxiety; confusion

• drowsiness; tremors; dizziness; altered sense of taste

• increased heart rate; stronger heartbeat; irregular heartbeat

• high or low blood pressure; flushing

• shortness of breath

• indigestion; constipation

• liver failure; increased liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the skin or whites of the eyes due to liver or blood problems); reduced bile flow to the intestine (cholestasis); enlarged liver; liver inflammation

• itchy rash (urticaria); pruritus; flushing (erythema)

• abnormal kidney function tests (increased creatinine in blood; increased urea in blood); worsening of renal failure

• increased levels of an enzyme called lactate dehydrogenase

• blood clot formation at injection site; inflammation at injection site; pain at injection site; fluid accumulation in the body

Rare (may affect up to 1 in 1,000 people)

• anaemia caused by breakdown of red blood cells (haemolytic anaemia); breakdown of red blood cells (haemolysis)

Not known (frequency cannot be estimated from available data)

• disorders related to blood coagulation

• shock (allergic)

• liver cell injury including death

• kidney disorders; acute renal failure

Other adverse effects in children and adolescents

The following reactions have been reported more frequently in paediatric patients than in adults:

Frequent (may affect up to 1 in 10 people)

• reduction in platelets in blood (thrombocytopenia)

• increased heart rate (tachycardia)

• high or low blood pressure

• increased bilirubin pigment in blood (hyperbilirubinaemia); enlarged liver

• acute renal failure; increased blood urea

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mycamine

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

Do not use Mycamine after the expiry date stated on the vial and packaging. The expiry date refers to the last day of the month indicated.

The intact vial (unopened) does not require any special storage conditions.

The reconstituted concentrate and the diluted solution for infusion must be used immediately, as they contain no preservatives to prevent bacterial contamination. Only trained healthcare professionals who have fully read and correctly understood the instructions should prepare this medicine for use.

Do not use the diluted solution for infusion if it appears cloudy or if a precipitate has formed.

To protect from light, the bottle/bag containing the diluted solution for infusion must be placed inside an opaque sealed bag.

The vial is for single use only. Therefore, any unused reconstituted concentrate must be immediately discarded.

6. Contents of the container and other information

Composition of Mycamine

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

One vial contains 50 mg or 100 mg of micafungin (as sodium salt).

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

Appearance of the product and contents of the container

Mycamine 50 mg or 100 mg powder for concentrate for solution for infusion is a dry, compact, white lyophilized powder. Mycamine is supplied in a carton containing 1 vial.

Marketing Authorization Holder

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57

1000 Ljubljana

Slovenia

Manufacturer

Astellas Ireland Co., Ltd.

Killorglin, County Kerry

Ireland

Haupt Pharma Wolfratshausen GmbH

Pfaffenrieder Straße 5

82515 Wolfratshausen

Germany

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this summary: {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Mycamine must not be mixed or co-infused with other medicinal products except those mentioned below. Mycamine is reconstituted and diluted using aseptic techniques at room temperature as follows:

1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.

2. Slowly and aseptically inject 5 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) into each vial, directing the stream against the inner wall of the vial. Although foaming will occur, care should be taken to minimize the amount of foam generated. Reconstitute a sufficient number of Mycamine vials to achieve the required dose in mg (see table below).

3. Gently rotate the vial. DO NOT SHAKE. The powder will dissolve completely. The concentrate should be used immediately. The vial is for single use only. Therefore, any unused reconstituted concentrate must be discarded immediately.

4. Withdraw all of the reconstituted concentrate from each vial and return it to the infusion bottle/bag from which the diluent was originally taken. The diluted solution for infusion should be used immediately. Chemical and physical stability has been demonstrated for up to 96 hours when stored at 25°C, provided it is protected from light and the dilution has been performed as described above.

5. Carefully invert the infusion bottle/bag to disperse the diluted solution, but DO NOT SHAKE, to avoid foam formation. The solution must not be used if it is cloudy or if a precipitate has formed.

6. The bottle/bag containing the diluted solution for infusion should be placed in an opaque, sealed bag to protect it from light.

Preparation of the solution for infusion