MICAFUNGINA ACCORD 50 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

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

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

Micafungin is used to treat fungal infections caused by fungal cells or yeasts called Candida. Micafungin is effective in treating systemic infections (those that have penetrated the body). It interferes with the production of a part of the fungal cell wall. The fungus needs an intact cell wall to live and grow. Micafungin causes the formation of defects in the fungal cell wall, preventing the fungus from growing and living.

When no other antifungal treatment is available, your doctor prescribes Micafungina in the following circumstances (see section 2):

• To treat a severe fungal infection in adults, adolescents, and children, including newborns, called invasive candidiasis (infection that has penetrated the body).
• To treat adults and adolescents ≥ 16 years with a fungal infection in the esophagus where it is appropriate to apply intravenous treatment.
• To prevent Candida infection in patients undergoing bone marrow transplantation or who are expected to have 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 Micafungina Accord

Do not use Micafungina 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

Consult your doctor or pharmacist before starting to use micafungin

• if you are allergic to any medicine
• if you have hemolytic anemia (anemia produced by the breakdown of red blood cells) or hemolysis (breakdown of red blood cells).
• if you have kidney problems (kidney failure or abnormal kidney function tests). In this case, your doctor may decide to monitor your kidney function more closely.

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

Other medicines and Micafungina Accord

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is especially important that you inform your doctor if you are using amphotericin B desoxycholate 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.

Using Micafungina Accord with food and drinks

Since micafungin is administered intravenously (in the vein), there are no restrictions on 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.

Micafungin should not be used during pregnancy unless clearly necessary. If you use micafungin, 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, do not drive or use any machine or tool. Please inform your doctor if you experience any effect that may cause problems for driving or using machinery.

Micafungina Accord contains sodium

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

3. How to use Micafungina Accord

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

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

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

• The usual dose for treating an invasive Candida infection is 100 mg per day for patients weighing more than 40 kg, and 2 mg/kg per day for patients weighing 40 kg or less.
• The dose for treating a Candida esophagus infection 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 for preventing 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

• The usual dose for treating an invasive Candida infection is 100 mg per day for patients weighing more than 40 kg, and 2 mg/kg per day for patients weighing 40 kg or less.
• The usual dose for preventing 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 infants < 4 months of age

• The usual dose for treating an 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 Micafungina Accord than you should

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

If you miss a dose of Micafungina Accord

Your doctor will monitor your response and the condition of your disease 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 other questions about the use of this medicine, 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 suffer an allergic reaction or a severe skin reaction (e.g., blistering of the skin and peeling of the skin), you should inform your doctor or nurse immediately.

Micafungin can cause these other side effects:

Frequent (may affect up to 1 in 10 people)

• abnormal blood test results (reduction in the number of white blood cells [leukopenia; neutropenia]); reduction in the number of red blood cells (anemia)

reduction of potassium in blood (hypokalemia); reduction of magnesium in blood (hypomagnesemia); reduction of calcium in blood (hypocalcemia)

• headache
• inflammation of the vein wall (at the injection site)
• nausea (discomfort); vomiting; diarrhea; 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 (hyperbilirubinemia)
• 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 certain type of white blood cells called eosinophils; reduction of albumin in blood (hypoalbuminemia)
• hypersensitivity
• increased sweating
• reduction of sodium in blood (hyponatremia); increase of potassium in blood (hyperkalemia); reduction of phosphates in blood (hypophosphatemia); anorexia (eating disorder)
• insomnia (difficulty sleeping); anxiety; confusion
• drowsiness (somnolence); tremors; dizziness
• 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-glutamyltransferase); jaundice (the skin or the white of the eyes turn yellow due to liver or blood problems); reduction of bile that reaches the intestine (cholestasis); increase in liver size; liver inflammation
• rash with itching (urticaria); itching; flushing (erythema)
• abnormal kidney function tests (increase in creatinine in blood; increase in urea in blood); worsening of kidney failure
• increase in an enzyme called lactate dehydrogenase
• formation of clots at the injection site; inflammation at the injection site; pain at the injection site; fluid accumulation in the body

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

• anemia produced by the breakdown of red blood cells (hemolytic anemia), breakdown of red blood cells (hemolysis)

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

• blood coagulation disorders
• shock (allergic)
• liver cell damage including death
• kidney damage; acute kidney failure

Other side effects in children and adolescents

The following reactions have been described more frequently in pediatric patients than in adults:

Frequent (may affect up to 1 in 10 people)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Micafungina Accord

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

Do not use this medicine after the expiry date which is stated on the vial and carton. The expiry date is the last day of the month stated.

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

The reconstituted concentrate and the diluted solution for infusion must be used immediately, as it does not contain preservatives to prevent bacterial contamination. Only a healthcare professional who has been properly trained and has read the instructions completely can prepare this medicine for use.

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

To protect the bottle/bag containing the diluted solution for infusion from light, it should be placed in an opaque bag with a seal.

The vial is for single use. Therefore, the reconstituted concentrate that is not used must be discarded immediately.

6. Contents of the pack and other information

Composition of Micafungina Accord

• The active substance is micafungin (as sodium salt). 1 vial contains 50 mg of micafungin (as sodium salt).
• The other ingredients are lactose monohydrate, citric acid, and sodium hydroxide.

Appearance and pack contents

Micafungina Accord 50 mg powder for concentrate for solution for infusion is a compact white or off-white powder.

Marketing authorisation holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n.

Edifici Est 6ª planta 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

Or

Accord Healthcare B.V.

Winthontlaan 200, Utrecht,

Netherlands

Date of last revision of this leaflet: March 2024

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This information is intended only for healthcare professionals:

Micafungin should not be mixed or infused simultaneously with other medicines except those mentioned below. Micafungin is reconstituted and diluted using aseptic techniques at room temperature, as follows:

1. The plastic cap should be removed from the vial and the stopper should be disinfected with alcohol.
2. 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) should be slowly and aseptically injected into each vial along the inner wall. Although the concentrate will foam, care should be taken to minimize the amount of foam generated. A sufficient number of micafungin vials should be reconstituted to obtain the necessary dose in mg (see the table below).
3. The vial should be gently rotated. IT SHOULD NOT BE SHAKEN. The powder will dissolve completely. The concentrate should be used immediately. The vial is for single use. Therefore, the reconstituted concentrate that is not used should be discarded immediately.
4. All the reconstituted concentrate should be withdrawn from each vial and returned to the infusion bottle/bag from which it was initially taken. The diluted solution for infusion should be used immediately. It has been shown that the chemical and physical stability allows the use of the medicine for 96 hours, when kept at 25°C, provided it is protected from light, and the dilution is performed as described above.
5. The infusion bottle/bag should be carefully inverted to disperse the diluted solution but SHOULD NOT BE SHAKEN, to avoid the formation of foam. The solution should 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 bag with a seal to protect it from light.

Preparation of the infusion solution