Micafungin Accord

Leaflet accompanying 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
Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 pack 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, preventing further development and growth of fungi.
Your 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 and older 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 days or more.

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 unknown; 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.

Liver function will be closely monitored during treatment.

Before using Micafungin Accord, you should discuss it with your doctor or pharmacist

• 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 disease (e.g., kidney failure and abnormal kidney function test results). In this case, your doctor may order closer monitoring of kidney function.

Micafungin may cause severe skin and mucous membrane inflammation/allergic reactions [Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)].

Micafungin Accord and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take.
It is especially important to tell your doctor about the use of amphotericin B, itraconazole (antifungal antibiotics), sirolimus (an immunosuppressive drug), or nifedipine (a calcium antagonist used to treat high blood pressure). Your 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 using the medicine with food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Micafungin Accord should not be used during pregnancy unless your doctor considers it absolutely necessary. While using Micafungin Accord, do not breastfeed.

Driving and using machines

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

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 your doctor.

Use in adults, adolescents aged 16 years and older, 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 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 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 per day for patients with a body weight of 40 kg or less.

Use in children over 4 months and adolescents under 16 years of age

• 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 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 per day for patients with a body weight of 40 kg or less.

Use in children and newborns under 4 months of age

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

Use of a higher than recommended dose of Micafungin Accord

Your doctor will determine the correct dose of Micafungin Accord based on your response to treatment and your health condition. If you are unsure whether you have used too high a dose of Micafungin Accord, contact your doctor or other medical personnel immediately.

Missing a dose of Micafungin Accord

Your doctor will decide whether you need to be treated with Micafungin Accord based on your response to treatment and your health condition. If you are unsure whether you have missed a dose of Micafungin Accord, contact your doctor or other medical personnel immediately.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Micafungin Accord can cause side effects, although not everybody gets them.

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

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 (vomiting); 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 disturbance
• 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; 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; injection site inflammation; injection site pain; fluid retention

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 those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

Keep the medicine out of the 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 that month.
The unopened vial does not require any special storage 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 a precipitate.
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 pack and other information

What Micafungin Accord contains

• The active substance is micafungin (as micafungin sodium). One vial contains 50 mg or 100 mg of micafungin (as micafungin sodium).
• The other ingredients are lactose monohydrate, citric acid, and sodium hydroxide.

What Micafungin Accord looks like and contents of the pack

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 supplied 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 the same infusion as 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 the 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 a precipitate.
• 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