Micafungin accordpharma

Package leaflet: Information for the user

Mykafungina Accordpharma, 50 mg, powder for solution for infusion concentrate
Mykafungina Accordpharma, 100 mg, powder for solution for infusion concentrate
Micafunginum
Please read all of this leaflet carefully before using this medicine, because it contains important
information for the patient.

• Keep this leaflet, as 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Mykafungina Accordpharma is and what it is used for

Mykafungina Accordpharma contains the active substance micafungin. Mykafungina Accordpharma
is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Mykafungina Accordpharma is used to treat fungal infections caused by fungi or yeast-like organisms called Candida. Mykafungina Accordpharma is effective in treating systemic infections (those that have spread into the body). It affects 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. Mykafungina Accordpharma damages the cell wall, thereby preventing further development and growth of fungi.
Your doctor will prescribe Mykafungina Accordpharma in the following cases, if 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 spreads into the body);
• treatment of adults and adolescents aged ≥ 16 years with fungal infection of the oesophagus (oesophageal candidiasis) when intravenous treatment (treatment by infusion) is appropriate;
• prevention of Candida infections in patients undergoing allogeneic haematopoietic stem cell transplantation or in patients expected to have neutropenia (low levels of neutrophils; a type of white blood cell) lasting for 10 or more days.

2. Important information before using Mykafungina Accordpharma

When not to use Mykafungina Accordpharma

• if the patient is allergic to micafungin, other echinocandins (Cancidas or Ecalta), 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, consequently, to liver tumours. The potential risk of liver tumour development in humans is unknown; before starting treatment, the doctor will assess the benefits and risks of using Mykafungina Accordpharma. You should inform 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 closely monitored during treatment.
Before starting treatment with Mykafungina Accordpharma, 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 disease (e.g. kidney failure or abnormal kidney function test results). In such cases, the doctor may recommend closer monitoring of kidney function.

Micafungin may cause severe skin inflammation/rash and mucosal lesions [Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)].
Mykafungina Accordpharma and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
It is especially important to inform your doctor about the use of amphotericin B deoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressive medicine), or nifedipine (a calcium channel blocker used in the treatment of hypertension). The doctor may decide to adjust the dosage of these medicinal products.
Mykafungina Accordpharma with food and drink
Since Mykafungina Accordpharma is administered intravenously (into a vein), there are no restrictions regarding food and drink.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
Mykafungina Accordpharma must not be used during pregnancy unless absolutely necessary. Breastfeeding is not recommended during treatment with Mykafungina Accordpharma.
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. If this applies to the patient, he or she should not drive or operate machinery. Inform your doctor if any side effects occur that may impair the ability to drive or operate machinery.
Mykafungina Accordpharma 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 Mykafungina Accordpharma

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

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

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

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

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

Use in children and newborns under 4 months of age

• For the 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 infections caused by Candida, the usual dose is 2 mg/kg body weight once daily.

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

Missed dose of Mykafungina Accordpharma
The doctor will decide on the need for continued treatment with Mykafungina Accordpharma based on the patient's response to treatment and overall health status. If there is any doubt whether a dose of Mykafungina Accordpharma has been missed, contact a doctor or other medical personnel immediately.

If you have any further questions about the use of this medicine, please 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.
Mykafungina Accordpharma may cause the following other adverse reactions:

Common (may occur in up to 1 in 10 patients)

• abnormal blood test results (decreased white blood cell count [leukopenia; neutropenia]); decreased red blood cell count (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; 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 blood cells [pancytopenia]); decreased platelet count (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; stronger heartbeat; irregular heartbeat
• high or low blood pressure; skin redness
• shortness of breath
• indigestion; constipation
• liver failure; increased liver enzyme activity (gamma-glutamyltransferase); jaundice (yellowing of the skin or whites of the eyes due to liver or blood disorders); bile stagnation before it exits into the intestine (cholestasis); liver enlargement; 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
• venous 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)

Unknown (frequency cannot be estimated from available data)

• blood coagulation disorders
• 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 platelet count (thrombocytopenia)
• increased heart rate (tachycardia)
• high or low blood pressure
• increased bilirubin levels in the blood (hyperbilirubinaemia); liver enlargement
• acute kidney failure; increased urea levels in the blood

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform 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 Mykafungina Accordpharma

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the stated month.
No special temperature storage requirements apply.
Store the vial in its outer packaging to protect it from light.

Concentrate after reconstitution in the vial
The reconstituted concentrate is chemically and physically stable for 48 hours at 2°-8°C and at 20°-25°C if prepared using sodium chloride solution 9 mg/mL (0.9%) for infusion or glucose solution 50 mg/mL (5%) for infusion.

Diluted infusion solution
The prepared diluted solution maintains chemical and physical stability for 96 hours at 2°-8°C and at 20-25°C, provided it is protected from light and diluted with sodium chloride solution 9 mg/mL (0.9%) for infusion or glucose solution 50 mg/mL (5%) for infusion.

Mykafungina Accordpharma does not contain preservatives. From a microbiological standpoint, prepared and diluted solutions should be used immediately. If not used immediately, the responsibility for storage conditions and duration lies with the user. The storage time should not exceed 24 hours at a temperature of 2 to 8°C, unless reconstitution and dilution were carried out under controlled and validated aseptic conditions.
Do not use the diluted solution if it becomes cloudy or if a precipitate forms.
To protect from light, place the infusion bag/bottle containing the diluted solution into a closed, opaque bag.

The vial is intended for single use only. Any unused reconstituted concentrate should be promptly discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This practice helps protect the environment.

6. Contents of the pack and other information

What Mykafungina Accordpharma contains

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

What Mykafungina Accordpharma looks like and contents of the pack
Mykafungina Accordpharma is a white lyophilized powder in a glass vial with a rubber stopper and
an aluminium seal. Each vial contains 50 mg or 100 mg of mykafungin (as sodium mykafungin).
Each medicinal product pack contains 1 vial.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: + 48 22 577 28 00
{logo of the marketing authorisation holder}
Manufacturer/Importer
Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice

This medicinal product is authorized for marketing in the European Economic Area member states under the following names:

Information intended exclusively for medical personnel or healthcare professionals:

Mykafungina Accordpharma 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, Mykafungina Accordpharma 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%) for infusion or glucose 50 mg/mL (5%) for infusion (drawn 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 achieve the correct dose in mg, prepare the concentrate using the appropriate number of Mykafungina Accordpharma vials (see table below).
3. Gently rotate the vial. DO NOT SHAKE! The powder will dissolve completely. The concentrate should be used immediately. The vial is for single use only. Any prepared but unused concentrate must be discarded immediately.
4. Transfer the entire volume of the prepared concentrate from the vials into the infusion bottle (bag) from which the diluent was originally withdrawn. The diluted infusion solution should be administered promptly. The prepared solution remains chemically and physically stable for 96 hours at 20–25°C, provided it is protected from light and has been diluted according to the instructions above.
5. Gently invert the infusion bottle (bag) to ensure thorough mixing of the diluted solution and DO NOT SHAKE to avoid foaming. The solution must not be administered if it is cloudy or contains particulate matter.
6. Place the bag (bottle) containing the diluted solution into a closed container protecting it from light.
7. Only clear solutions, practically free from solid particles, should be used.

Preparation of the infusion solution