Micafungin accord

Package leaflet: Information for the user

Micafungin Accord, 50 mg, powder for solution for infusion
Micafungin Accord, 100 mg, powder for solution for infusion
Micafunginum
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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 side 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

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 fungi or yeast-like organisms called Candida. Micafungin Accord is effective in treating systemic infections (those that have spread into the body). It acts on the process of forming a component of the fungal cell wall. An intact cell wall is essential for the normal development and growth of fungal cells. Micafungin Accord damages the fungal cell wall, thereby preventing further development and growth of fungi.

Your doctor will prescribe Micafungin Accord in the following cases, when no other appropriate antifungal treatment is available (see section 2):

• Treatment of adults, adolescents, and children, including newborns, with a serious fungal infection called invasive candidiasis (an infection that has spread into the body);
• Treatment of adults and adolescents aged ≥ 16 years with fungal infection of the oesophagus (oesophageal candidiasis) where intravenous treatment is appropriate;
• Prevention of Candida infections in patients undergoing allogeneic haematopoietic stem cell transplantation or in patients expected to have neutropenia (low neutrophil count; a type of white blood cell) lasting for 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
Long-term treatment with micafungin in rats has led to liver damage and, as a consequence, to liver tumours. The potential risk of developing liver tumours 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 diseases (e.g. liver failure or hepatitis) or if abnormal liver function test results have been observed.
Liver function will be monitored more closely during treatment.
Before starting Micafungin Accord, discuss this with your doctor or pharmacist

• if the patient is allergic to any medicine;
• if the patient has haemolytic anaemia (anaemia caused by the breakdown of red blood cells) or haemolysis (breakdown of red blood cells);
• if the patient has kidney diseases (e.g. kidney failure or abnormal kidney function test results). In such cases, the doctor may order closer monitoring of kidney function.

Micafungin may cause severe inflammatory reactions/skin rashes and mucosal lesions [Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)].
Micafungin Accord and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is especially important to inform the doctor about concomitant use of amphotericin B deoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressive medicine), or nifedipine (a calcium channel blocker used to treat hypertension). The doctor may decide to adjust the dosage of these medicinal products.
Micafungin Accord with food and drink
Since Micafungin Accord is administered intravenously (into a vein), there are no restrictions regarding food and drink intake.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Micafungin Accord must not be used during pregnancy unless absolutely necessary, as determined by the doctor. Breastfeeding is not recommended while receiving Micafungin Accord.
Driving and operating machinery
It is unlikely that micafungin will affect the ability to drive or operate machinery. However, dizziness may occur in some patients during treatment, and in such cases, the patient should not drive or operate machinery. Inform your doctor if any side effects occur that may impair the ability to drive or operate machinery.
Micafungin Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, meaning the medicine is considered "sodium-free".

3. How to use Micafungin Accord

Micafungin Accord must be prepared and administered by a physician or other medical personnel.
Micafungin Accord should be given once daily as a slow intravenous infusion (into a vein). The daily dose of
Micafungin Accord will be determined by the treating physician.

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

• For treatment of invasive Candida infection, the usual dose is 100 mg once daily in patients weighing more than 40 kg and 2 mg/kg body weight once daily in patients weighing 40 kg or less.
• For treatment of Candida oesophagitis, the daily dose is 150 mg in patients weighing more than 40 kg and 3 mg/kg body weight once daily in patients weighing 40 kg or less.
• For prophylaxis of invasive Candida infections, the usual dose is 50 mg once daily in patients weighing more than 40 kg and 1 mg/kg body weight once daily in patients weighing 40 kg or less.

Use in children aged > 4 months and adolescents aged < 16 years

• For treatment of invasive Candida infection, the usual dose is 100 mg once daily in patients weighing more than 40 kg and 2 mg/kg body weight once daily in patients weighing 40 kg or less.
• For prophylaxis of invasive Candida infections, the usual dose is 50 mg once daily in patients weighing more than 40 kg and 1 mg/kg body weight once daily in patients weighing 40 kg or less.

Use in children and newborns aged < 4 months

• For treatment of invasive Candida infection, the usual dose ranges from 4 mg/kg to 10 mg/kg body weight once daily.
• For prophylaxis of invasive Candida infections, the usual dose is 2 mg/kg body weight once daily.

Use of a higher than recommended dose of Micafungin Accord
The physician will determine the appropriate dose of Micafungin Accord based on the patient's response to treatment and medical condition. If there is any doubt whether too high a dose of Micafungin Accord has been administered, contact the physician or other medical personnel immediately.

Missed dose of Micafungin Accord
The physician will decide on the need for continued treatment with Micafungin Accord based on the patient's response to treatment and medical condition. If there is any doubt whether a dose of Micafungin Accord has been missed, contact the physician or other medical personnel immediately.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If an allergic reaction or severe skin reaction occurs (e.g. blistering and peeling of the skin), inform your doctor or nurse immediately.
Micafungin Accord may cause the following other adverse reactions:
Common (may occur in up to 1 in 10 patients)

• abnormal blood test results (decreased number of white blood cells [leukopenia; neutropenia]); decreased number of red blood cells (anaemia)
• decreased potassium levels in the blood (hypokalaemia); decreased magnesium levels in the blood (hypomagnesaemia); decreased calcium levels in the blood (hypocalcaemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea (feeling sick); vomiting; diarrhoea; abdominal pain
• abnormal liver function test results (increased alkaline phosphatase activity, increased aspartate aminotransferase activity, increased alanine aminotransferase activity)
• increased bilirubin levels in the blood (hyperbilirubinaemia)
• rash
• fever
• chills

Uncommon (may occur in up to 1 in 100 patients)

• abnormal blood test results (decreased number of blood cells [pancytopenia]); decreased number of platelets (thrombocytopenia); increased number of a certain type of white blood cells (eosinophils); decreased albumin levels in the blood (hypoalbuminaemia)
• hypersensitivity
• increased sweating
• decreased sodium levels in the blood (hyponatraemia); increased potassium levels in the blood (hyperkalaemia); decreased phosphate levels in the blood (hypophosphataemia); anorexia (loss of appetite)
• insomnia (sleep problems); anxiety; confusion
• drowsiness (somnolence); tremor; dizziness; taste disturbance
• rapid heartbeat; strong heartbeat; irregular heartbeat
• high or low blood pressure; skin redness
• shortness of breath
• indigestion; constipation
• liver failure; increased liver enzyme activity (gamma-glutamyl transferase); jaundice (yellowing of the skin or whites of the eyes due to liver or blood disorders); bile flow obstruction before bile reaches the intestine (cholestasis); enlarged liver; hepatitis
• itchy rash (urticaria); itching; skin redness (erythema)
• abnormal kidney function test results (increased creatinine levels in the blood; increased urea levels in the blood); worsening of kidney failure
• increased activity of an enzyme called 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 occur in up to 1 in 1,000 patients)

• 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 clotting disorder
• shock (anaphylactic)
• liver cell damage, which may also lead to death
• kidney problems; acute kidney failure

Additional adverse reactions observed in children and adolescents
The following reactions have been observed more frequently in paediatric patients than in adult patients:
Common (may occur in up to 1 in 10 patients)

• decreased number of platelets (thrombocytopenia)
• increased heart rate (tachycardia)
• high or low blood pressure
• increased bilirubin levels in the blood (hyperbilirubinaemia); enlarged liver
• acute kidney failure; increased urea levels in the blood

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Micafungin Accord

Keep this medicine out of the sight and reach of children.
Do not use Micafungin Accord after the expiry date stated on the vial and outer packaging. The expiry date refers to the last day of the specified month.
The unopened vial does not require special storage conditions.
The prepared concentrate and diluted infusion solution should be used immediately, as they contain no preservatives to protect against bacterial contamination. This medicine may be prepared for use only by a trained healthcare professional who has carefully read the entire instruction.
Do not use the diluted solution if it becomes cloudy or if a precipitate appears.
To protect from light, the container (bottle or bag) containing the diluted solution should be placed inside a closed protective covering.
The vial is intended for single use only. Any unused, prepared concentrate should be promptly discarded.

6. Contents of the packaging 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: monohydrate lactose, 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 caked powder or powder.
Micafungin Accord is supplied in packs containing 1 vial.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00
Manufacturer/Importer
PharmIdea SIA
Rupnicu Street 4
2114 Olaine
Latvia
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Spain: Micafungina Accord
Poland: Micafungin Accord
Portugal: Micafungina Accord

Information intended exclusively for medical personnel or healthcare professionals:

Micafungin Accord must not be mixed or administered simultaneously in the same infusion with other medicinal products, except those listed below. Under aseptic conditions and at room temperature, Micafungin Accord should be prepared as follows:

1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
2. Under aseptic conditions, slowly 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) down the inner wall of each vial. Although foaming may occur, every effort should be made to minimize foam formation. To obtain the correct dose of the drug in mg, prepare the concentrate using the appropriate number of Micafungin Accord vials (see table below).
3. Gently rotate the vial. DO NOT SHAKE! The powder will dissolve completely. The prepared concentrate should be clear and colorless. The concentrate should be used immediately. The vial is for single use only. Any unused concentrate must be discarded immediately.
4. Transfer the entire volume of the prepared concentrate from the vials into the bottle (bag) containing the infusion solution from which the diluent was originally withdrawn. The diluted infusion solution should be administered immediately. The solution remains chemically and physically stable for 96 hours at 25°C, provided it is protected from light and has been diluted according to the instructions above.
5. Gently invert the bottle (bag) containing the infusion solution to ensure thorough mixing, and DO NOT SHAKE to avoid foaming. The solution must not be administered if it is cloudy or contains particulate matter.
6. The bag (bottle) containing the diluted solution should be placed in a closed container protecting it from light.

Preparation of infusion solution