Mycamine 100 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, as 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 starting to use Mycamine

Do not use Mycamine

• if you are allergic to micafungin, to other echinocandins (Ecalta or Cancidas), or to any of the other components 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 mucosal membranes (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 drink

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 take Mycamine, you should not breastfeed.

Driving and using machines

It is unlikely that micafungin will 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 must 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 per day for patients weighing 40 kg or more, and 2 mg/kg per day for patients weighing 40 kg or less.

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

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

If you receive more Mycamine than you should

Your doctor will monitor your response and the status of your condition to determine the appropriate dose of Mycamine. 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 the status of your condition to determine the appropriate Mycamine treatment. 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 gets them.

If you experience an allergic reaction or a severe skin reaction (e.g. blistering and peeling of the skin), 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 cells [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 (increased alkaline phosphatase; increased aspartate aminotransferase; increased alanine aminotransferase)

• increased bilirubin 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 platelets (thrombocytopenia); increase in a specific type of white blood cells called eosinophils; low albumin levels 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; tremor; 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-glutamyl transferase); 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)

• blood coagulation disorders

• shock (allergic)

• liver cell injury including death

• kidney abnormalities; 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 in blood (hyperbilirubinaemia); enlarged liver

• acute kidney failure; increased urea in blood

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed 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 on the outer packaging. The expiry date refers to the last day of the month indicated.

The unopened vial does not require special storage conditions.

The reconstituted concentrate and the diluted solution for infusion must be used immediately, as they do not contain preservatives to prevent bacterial contamination. Only trained healthcare professionals who have fully read and correctly followed the instructions should prepare this medicine for administration.

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 should be placed inside a sealed opaque bag.

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

6. Contents of the container and other information

Composition of Mycamine

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

1 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 pack

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 box containing 1 vial.

Marketing Authorization Holder

Sandoz Pharmaceuticals d.d.

Verovškova ulica 57

1000 Ljubljana

Slovenia

Manufacturer responsible

Astellas Ireland Co., Ltd.

Killorglin, County Kerry

Ireland

Haupt Pharma Wolfratshausen GmbH

Pfaffenrieder Straße 5

82515 Wolfratshausen

Germany

For further information about this medicinal product, please contact 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 doctors or healthcare professionals only:

Mycamine must not be mixed or infused simultaneously 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 along the inner wall. Although foaming may occur, care should be taken to minimize the amount of foam generated. Reconstitute a sufficient number of Mycamine vials to obtain the required dose in mg (see table below).

3. Gently rotate the vial. DO NOT SHAKE. The powder will dissolve completely. The concentrate must 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 must 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 foaming. Do not use the solution if it is cloudy or if a precipitate has formed.

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

Preparation of the solution for infusion