Micafungin Accord 50 mg powder for concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Micafungin Accord 50 mg powder for concentrate for solution for infusion EFG

micafungin

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Micafungin Accord is and what it is used for
2. What you need to know before using Micafungin Accord
3. How to use Micafungin Accord
4. Possible adverse effects
5. How to store Micafungin Accord
6. Contents of the pack and other information

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

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

Micafungin is used to treat fungal infections caused by fungi or yeasts called Candida. Micafungin is effective in the treatment of 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. Micafungin causes defects to form in the fungal cell wall, thereby preventing the fungus from growing and surviving.

When no other antifungal treatment is available, your doctor may prescribe Micafungin in 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 Micafungin Accord

Do not use Micafungin Accord

• if you are allergic to micafungin, to other echinocandins (anidulafungin or caspofungin), or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using micafungin

• 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 and mucosal inflammation/rash (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other medicines and Micafungin Accord

Tell 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 tell 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 Micafungin Accord with food and drink

Since micafungin 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Micafungin should not be used during pregnancy unless clearly necessary. If you are using micafungin, you must 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 side effect that could impair your ability to drive or use machinery.

Micafungin Accord contains sodium

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

3. How to use Micafungin Accord

Micafungin must be prepared and administered by a doctor or other healthcare professional.

Micafungin must be given by slow intravenous infusion (into a vein) once daily. Your doctor will determine the dose of micafungin you will receive each day.

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

• The usual dose for the treatment of invasive Candida infection is 100 mg daily for patients weighing over 40 kg, and 2 mg/kg daily for patients weighing 40 kg or less.
• The dose for the treatment of esophageal Candida infection is 150 mg daily for patients weighing over 40 kg, and 3 mg/kg daily for patients weighing 40 kg or less.
• The usual dose for prevention of invasive Candida infections is 50 mg daily for patients weighing over 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 the treatment of invasive Candida infection is 100 mg daily for patients weighing over 40 kg, and 2 mg/kg daily for patients weighing 40 kg or less.
• The usual dose for prevention of invasive Candida infections is 50 mg daily for patients weighing over 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 the treatment of 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 Micafungin Accord than you should

Your doctor will monitor your response and your medical condition to determine the appropriate dose of micafungin. However, if you are concerned that you have received too much micafungin, contact your doctor or another healthcare professional immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount received.

If you miss your dose of Micafungin Accord

Your doctor will monitor your response and your medical condition to determine the appropriate treatment with micafungin. However, if you are concerned that you have missed a dose of micafungin, 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 of the skin and skin peeling), you must inform your doctor or nurse immediately.

Micafungin may cause the following other adverse effects:

Common (may affect up to 1 in 10 people)

• abnormal blood test results (reduction in the number of white blood cells [leucopenia; neutropenia]); reduction in the number of red blood cells (anaemia)
• reduction of potassium in blood (hypokalaemia); reduction of magnesium in blood (hypomagnesaemia); reduction of calcium 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)
• increase in bile pigment in the blood (hyperbilirubinaemia)
• rash
• fever
• chills

Uncommon (may affect up to 1 in 100 people)

• abnormal blood test results (reduction in the number of blood cells [pancytopenia]); reduction in the number of platelets (thrombocytopenia); increase in the number of a specific type of white blood cells called eosinophils; reduction of albumin in blood (hypoalbuminaemia)
• hypersensitivity
• increased sweating
• reduction of sodium in blood (hyponatraemia); increase of potassium in blood (hyperkalaemia); reduction of phosphates in blood (hypophosphataemia); anorexia (eating disorder)
• insomnia (difficulty sleeping); anxiety; confusion
• drowsiness (somnolence); 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; increase in liver enzymes (gamma-glutamyl transferase); jaundice (yellowing of the skin or the whites of the eyes due to liver or blood problems); reduction in the amount of bile reaching the intestine (cholestasis); enlarged liver; liver inflammation
• itchy rash (urticaria); pruritus; redness (erythema)
• abnormal kidney function tests (increase in creatinine in blood; increase in blood urea); worsening of renal failure
• increase in an enzyme called lactate dehydrogenase
• blood clots 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 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:

Common (may affect up to 1 in 10 people)

• reduction in platelets in blood (thrombocytopenia)
• increased heart rate (tachycardia)
• high or low blood pressure
• increase in bile pigment in blood (hyperbilirubinaemia); enlarged liver
• acute kidney failure; increased blood urea

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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Micafungin Accord

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

Do not use this medicine after the expiry date stated on the vial and 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 contain no preservatives to prevent bacterial contamination. Only a trained healthcare professional who has fully read and 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 discarded immediately.

6. Contents of the container and other information

Composition of Micafungin Accord

• The active substance is micafungin (as the sodium salt). One vial contains 50 mg of micafungin (as the sodium salt).
• The other components are lactose monohydrate, citric acid, and sodium hydroxide.

Appearance of the product and contents of the container

Micafungin Accord 50 mg powder for concentrate for solution for infusion is a compact white or almost white powder.

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n.

Edifici Est 6th floor 08039 - Barcelona

Spain

Manufacturer

PharmIdea SIA

Rupnicu Street 4, Olaine 2114,

Latvia

Or

Lyocontract GmbH

Pulverwiese 1, 38871 Ilsenburg,

Germany

Or

Accord Healthcare Polska Sp. Z.o.o.

Ul. Tasmowa 7, Entrance B, 6th floor

Marynarska Business Park, Warsaw,

Poland

Date of the most recent revision of this leaflet: March 2024

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This information is intended for healthcare professionals only:

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

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 micafungin 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