Micafungin Accord

Leaflet attached to the packaging: information for the user

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

Micafungin Accord, 100 mg, powder for concentrate for solution for infusion

Micafungin
You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Micafungin Accord and what is it used for
• 2. Important information before using Micafungin Accord
• 3. How to use Micafungin Accord
• 4. Possible side effects
• 5. How to store Micafungin Accord
• 6. Contents of the packaging and other information

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

Micafungin Accord contains the active substance micafungin. Micafungin Accord is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungin Accord is used to treat fungal infections caused by fungal cells or yeast called Candida. Micafungin Accord is effective in treating systemic infections (those that have entered the body). It affects the process of creating a component of the fungal cell wall. An intact cell wall is necessary for the proper development and growth of fungal cells. Micafungin Accord damages the cell wall, which prevents further development and growth of fungi.
The doctor will prescribe Micafungin Accord in the following cases, if no other suitable antifungal treatment is available (see section 2):

• treatment of adults, adolescents, and children, including newborns, with severe fungal infections called invasive candidiasis (infection that penetrates the body);
• treatment of adults and adolescents aged ≥ 16 years with fungal infection of the esophagus, where it is intended to administer the medicine intravenously (intravenous treatment);
• prevention of Candida infections in patients undergoing allogeneic hematopoietic stem cell transplantation or in patients who are expected to develop neutropenia (decrease in the number of neutrophils; a type of white blood cell) lasting 10 or more days.

2. Important information before using Micafungin Accord

When not to use Micafungin Accord

• if the patient is allergic to micafungin, other echinocandins (anidulafungin or caspofungin) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Prolonged treatment with micafungin in rats led to liver damage and subsequently to liver tumors. The potential risk of developing liver tumors in humans is not known; before starting treatment, the doctor will assess the benefits and risks of using Micafungin Accord. You should tell your doctor if you have severe liver disease (e.g., liver failure or hepatitis) or if abnormal liver function test results have been found.

During treatment, liver function will be monitored more closely.

Before starting to use Micafungin Accord, you should discuss it with your doctor or pharmacist

• if the patient is allergic to any medicine;
• if the patient has hemolytic anemia (anemia caused by the breakdown of red blood cells) or hemolysis (breakdown of red blood cells);
• if the patient has kidney disease (e.g., kidney failure and abnormal kidney function test results). In this case, the doctor may order more frequent monitoring of kidney function.

Micafungin may cause a severe inflammatory condition/skin rash and mucous membranes [Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)].

Micafungin Accord and other medicines

You should tell your doctor or pharmacist about all medicines that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take.
It is especially important to tell your doctor about the use of amphotericin B deoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressive medicine), or nifedipine (a calcium antagonist used to treat high blood pressure). The doctor may decide to adjust the dose of these medicinal products.

Micafungin Accord with food and drink

Since Micafungin Accord is administered intravenously (into a vein), there are no restrictions on the use of the medicine with food and drink.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Micafungin Accord should not be used during pregnancy, unless the doctor considers it absolutely necessary. During treatment with Micafungin Accord, breastfeeding should not be performed.

Driving and using machines

It is unlikely that micafungin will affect the ability to drive and use machines. However, some patients may experience dizziness while taking the medicine, and in this case, the patient should not drive or operate machines. You should inform your doctor if you experience any effects that may cause difficulties in driving and using machines.

Micafungin Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, which means that the medicine is considered "sodium-free".

3. How to use Micafungin Accord

Micafungin Accord must be prepared and administered by a doctor or other medical personnel.
Micafungin Accord should be administered once a day in a slow intravenous infusion (into a vein). The daily dose of Micafungin Accord is determined by the doctor.

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

• In the treatment of invasive Candida infection, a dose of 100 mg per day is usually used for patients with a body weight greater than 40 kg and 2 mg/kg body weight per day for patients with a body weight of 40 kg or less.
• In the treatment of Candida esophagitis, the daily dose is 150 mg for patients with a body weight greater than 40 kg and 3 mg/kg body weight per day for patients with a body weight of 40 kg or less.
• In the prevention of invasive Candida infections, a dose of 50 mg per day is usually used for patients with a body weight greater than 40 kg and 1 mg/kg body weight per day for patients with a body weight of 40 kg or less.

Use in children over 4 months and adolescents under 16 years

• In the treatment of invasive Candida infection, a dose of 100 mg per day is usually used for patients with a body weight greater than 40 kg and 2 mg/kg body weight per day for patients with a body weight of 40 kg or less.
• In the prevention of invasive Candida infections, a dose of 50 mg per day is usually used for patients with a body weight greater than 40 kg and 1 mg/kg body weight per day for patients with a body weight of 40 kg or less.

Use in children and newborns under 4 months

• In the treatment of invasive Candida infection, a dose of 4 mg/kg body weight per day to 10 mg/kg body weight per day is usually used.
• In the prevention of invasive Candida infections, a dose of 2 mg/kg body weight per day is usually used.

Use of a higher than recommended dose of Micafungin Accord

The doctor will determine the correct dose of Micafungin Accord based on the patient's response to treatment and health status. If there is any doubt as to whether too high a dose of Micafungin Accord has been used, you should contact a doctor or other medical personnel immediately.

Missed dose of Micafungin Accord

The doctor will decide whether treatment with Micafungin Accord is necessary based on the patient's response to treatment and health status. If there is any doubt as to whether a dose of Micafungin Accord has been missed, you should contact a doctor or other medical personnel immediately.
In case of any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Micafungin Accord may cause the following other side effects:
Common (may affect up to 1 in 10 people)

• abnormal blood test results (decrease in the number of white blood cells [leukopenia; neutropenia]); decrease in the number of red blood cells (anemia)
• decrease in potassium levels in the blood (hypokalemia); decrease in magnesium levels in the blood (hypomagnesemia); decrease in calcium levels in the blood (hypocalcemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (nausea); vomiting; diarrhea; abdominal pain
• abnormal liver function test results (increased alkaline phosphatase activity, increased aspartate aminotransferase activity, increased alanine aminotransferase activity)
• increase in bilirubin levels in the blood (hyperbilirubinemia)
• rash
• fever
• chills

Uncommon (may affect up to 1 in 100 people)

• abnormal blood test results (decrease in the number of blood cells [pancytopenia]); decrease in the number of platelets (thrombocytopenia); increase in the number of a certain type of white blood cells (eosinophils); decrease in albumin levels in the blood (hypoalbuminemia)
• hypersensitivity
• increased sweating
• decrease in sodium levels in the blood (hyponatremia); increase in potassium levels in the blood (hyperkalemia); decrease in phosphate levels in the blood (hypophosphatemia); anorexia (loss of appetite)
• insomnia (sleep problems); anxiety; confusion
• drowsiness (drowsiness); tremors; dizziness; taste disorders
• rapid heartbeat; stronger heartbeat; irregular heartbeat
• high or low blood pressure; flushing
• shortness of breath
• indigestion; constipation
• liver failure; increased activity of liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the skin or whites of the eyes due to liver or blood disorders); bile duct obstruction; liver enlargement; hepatitis
• itchy rash (hives); itching; skin redness (flushing)
• abnormal kidney function test results (increased creatinine levels in the blood; increased urea levels in the blood); worsening of kidney failure
• increased activity of the enzyme lactate dehydrogenase
• vein thrombosis at the injection site; inflammation at the injection site; pain at the injection site; fluid retention in the body

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

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

Unknown (frequency cannot be estimated from the available data)

• coagulation disorders
• anaphylactic shock
• liver cell damage, which can also lead to death
• kidney problems; acute kidney failure

Additional side effects occurring in children and adolescents

The following reactions were observed more frequently in pediatric patients than in adult patients:
Common (may affect up to 1 in 10 people)

• decrease in the number of platelets (thrombocytopenia)
• rapid heartbeat (tachycardia)
• high or low blood pressure
• increase in bilirubin levels in the blood (hyperbilirubinemia); liver enlargement
• acute kidney failure; increase in urea levels in the blood

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Micafungin Accord

The medicine should be stored out of sight and reach of children.
Do not use Micafungin Accord after the expiry date stated on the vial and carton. The expiry date refers to the last day of the given month.
The closed vial does not need to be stored in special conditions.
The prepared concentrate and diluted solution for infusion should be used immediately, as they do not contain any preservatives to protect against bacterial contamination. This medicine can only be prepared for use by a trained healthcare professional after carefully reading the entire instructions.
Do not use the diluted solution if it is cloudy or contains precipitated sediment.
To protect from light, the bottle (bag) containing the diluted solution should be placed in a closed protective cover.
The vial is for single use only. Any unused, prepared concentrate should be discarded immediately.

6. Contents of the packaging and other information

What Micafungin Accord contains

• The active substance of the medicine is micafungin (in the form of micafungin sodium). 1 vial contains 50 mg or 100 mg of micafungin (in the form of micafungin sodium).
• The other ingredients are: lactose monohydrate, citric acid, and sodium hydroxide.

What Micafungin Accord looks like and what the pack contains

Micafungin Accord 50 mg or 100 mg powder for concentrate for solution for infusion is a white or almost white granular powder or powder.
Micafungin Accord is available in packs containing 1 vial.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer

PharmIdea SIA
Rupnicu Street 4
2114 Olaine
Latvia
Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain:
Micafungina Accord
Poland:
Micafungin Accord
Portugal:
Micafungina Accord

Date of last revision of the leaflet: March 2024

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Information intended for healthcare professionals only:

Micafungin Accord should not be mixed or administered in an infusion with other medicinal products, except for those listed below. In aseptic conditions and at room temperature, Micafungin Accord should be prepared as follows:

• 1. The plastic cap should be removed from the vial and the stopper disinfected with alcohol.
• 2. In aseptic conditions, 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 injected into each vial, along the inner wall. Although the concentrate will foam, every effort should be made to minimize the amount of foam formed. To achieve the correct dose of the medicine in mg, the concentrate should be prepared using the appropriate number of Micafungin Accord vials (see table below).
• 3. The vial should be gently rotated. DO NOT SHAKE! The powder will dissolve completely. The prepared concentrate should be used immediately. The vial is for single use only. Any prepared, unused concentrate should be discarded immediately.
• 4. The entire amount of the prepared concentrate should be transferred from the vials to the infusion solution bottle (bag) from which the solution was initially taken. The diluted solution for infusion should be administered immediately. The prepared solution maintains chemical and physical stability for 96 hours at 25°C, provided it is protected from light and diluted according to the instructions above.
• 5. The infusion solution bottle (bag) should be gently turned upside down to ensure thorough mixing of the diluted solution and SHOULD NOT BE SHAKEN to avoid foaming. The solution should not be administered if it is cloudy or contains precipitated sediment.
• 6. The bottle (bag) containing the diluted solution should be placed in a closed protective cover to protect it from light.

Preparation of the infusion solution