Micafungin Pharmline

Leaflet accompanying the packaging: patient information

Micafungin PHARMLINE, 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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Micafungin Pharmline contains the active substance micafungin. Micafungin Pharmline is called an antifungal medicine because it is used to treat infections caused by fungi. Micafungin Pharmline is used to treat fungal infections caused by fungi or yeast called Candida. Micafungin Pharmline is effective in treating systemic infections (those that have entered the body). It disrupts the formation of a part of the fungal cell wall. An intact cell wall is necessary for the proper development and growth of fungal cells. Micafungin Pharmline damages the cell wall, preventing further development and growth of fungi. The doctor will prescribe Micafungin Pharmline 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 has entered the body);
• treatment of adults and adolescents aged 16 years and older with fungal infection of the esophagus, where intravenous administration of the medicine is justified (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 Pharmline

When not to use Micafungin Pharmline

• 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 led to liver damage and subsequent liver tumors. The potential risk of liver tumor development in humans is unknown; before starting treatment, the doctor will assess the benefits and risks of using Micafungin Pharmline. If the patient has severe liver disease (e.g., liver failure or hepatitis) or abnormal liver function test results, they should inform their doctor. During treatment, liver function will be closely monitored. Before starting Micafungin Pharmline, the patient should discuss this with their doctor or pharmacist:

• if the patient is allergic to any medicine;
• if the patient has hemolytic anemia (anemia caused by red blood cell breakdown) or hemolysis (red blood cell breakdown);
• if the patient has kidney problems (e.g., kidney failure and abnormal kidney function test results). In such cases, the doctor may order closer monitoring of kidney function.

Micafungin may cause severe skin and mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Micafungin Pharmline and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. It is especially important to inform the doctor about the use of amphotericin B, 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 Pharmline with food and drink

Since Micafungin Pharmline is administered intravenously (into a vein), there are no restrictions on taking 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 Pharmline should not be used during pregnancy unless it is absolutely necessary. During treatment with Micafungin Pharmline, the patient should not breastfeed.

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 such cases, the patient should not drive or operate machines. The patient should inform their doctor if they experience any effects that may cause difficulties in driving or operating machines.

Micafungin Pharmline contains sodium

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

3. How to use Micafungin Pharmline

Micafungin Pharmline must be prepared and administered by a doctor or other healthcare professional. Micafungin Pharmline should be administered once a day in a slow intravenous infusion. The daily dose of Micafungin Pharmline will be determined by the 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 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 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 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 of age

• 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 Pharmline

The doctor will determine the correct dose of Micafungin Pharmline based on the patient's response to treatment and health status. However, if there is any doubt that too high a dose of Micafungin Pharmline has been used, the patient should immediately contact their doctor or other healthcare professional.

Missing a dose of Micafungin Pharmline

The doctor will decide whether treatment with Micafungin Pharmline is necessary based on the patient's response to treatment and health status. However, if there is any doubt that a dose of Micafungin Pharmline has been missed, the patient should immediately contact their doctor or other healthcare professional. If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Micafungin Pharmline 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, the patient should immediately inform their doctor or nurse. Micafungin Pharmline may cause other side effects:

• Frequent (may occur in up to 1 in 10 patients): abnormal blood test results (decrease in white blood cell count [leukopenia; neutropenia]); decrease in red blood cell count (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); increased bilirubin levels in the blood (hyperbilirubinemia); rash; fever; chills (shivering).

Infrequent (may occur in up to 1 in 100 patients):

• abnormal blood test results (decrease in blood cell count [pancytopenia]); decrease in platelet count (thrombocytopenia); increase in a certain type of white blood cell (eosinophils); decrease in albumin levels in the blood (hypoalbuminemia); hypersensitivity; increased sweating; decreased sodium levels in the blood (hyponatremia); increased potassium levels in the blood (hyperkalemia); decreased phosphate levels in the blood (hypophosphatemia); anorexia (loss of appetite); insomnia (sleep disorders); 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 (cholestasis); liver enlargement; hepatitis; itchy rash (hives); 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 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 occur in up to 1 in 1,000 patients):

• anemia caused by red blood cell breakdown (hemolytic anemia); red blood cell breakdown (hemolysis).

Frequency not known (frequency cannot be estimated from the available data):

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

Additional side effects in children and adolescents

The following reactions were observed more frequently in pediatric patients than in adult patients:

• Frequent (may occur in up to 1 in 10 patients): decrease in platelet count (thrombocytopenia); rapid heartbeat (tachycardia); high or low blood pressure; increased bilirubin levels in the blood (hyperbilirubinemia); liver enlargement; acute kidney failure; increased urea levels in the blood.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 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, more information can be gathered on the safety of the medicine.

5. How to store Micafungin Pharmline

The medicine should be stored out of sight and reach of children. Do not use Micafungin Pharmline after the expiry date stated on the label and carton. The expiry date refers to the last day of the month. Sealed vial. Store in a temperature below 25°C. The reconstituted 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, reconstituted concentrate should be discarded immediately. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Micafungin Pharmline contains

• The active substance of the medicine is micafungin (as sodium salt). One vial contains 100 mg of micafungin (as sodium salt).
• The other ingredients are lactose monohydrate, citric acid (to adjust pH), and sodium hydroxide (to adjust pH).

What Micafungin Pharmline looks like and contents of the pack

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Pharmline Company Sp. z o.o., ul. Juliana Ursyna Niemcewicza 17/11, 02-306 Warsaw, Poland, tel: +48 780 008 085, e-mail: [email protected]

Manufacturer

S.C. Rompharm Company S.R.L., 1A, Eroilor Street, 075100 Otopeni, Romania

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

Hungary: Mikafungin Rompharm 100 mg por koncentrátum oldatos infúzióhoz, Romania: Micafungin Rompharm 100 mg pulbere pentru concentrat pentru soluție perfuzabilă, Bulgaria: Микафунгин Ромфарм 100 mg прах за концентрат за инфузионен разтвор, Poland: Micafungin PHARMLINE

Date of last revision of the leaflet: ---------------------------------------------------------------------------

Information intended for healthcare professionals only: Micafungin Pharmline should not be mixed or administered in infusion with other medicinal products, except for those listed below. Under aseptic conditions and at room temperature, Micafungin Pharmline should be reconstituted and diluted as follows:

• 1. Remove the plastic cap from the vial and disinfect the rubber 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) into each vial. Although the concentrate will foam, every effort should be made to minimize the amount of foam formed. To obtain the correct dose in mg, use the appropriate number of vials of Micafungin Pharmline (see table below).
• 3. Gently rotate the vial. DO NOT SHAKE! The powder will dissolve completely. The reconstituted concentrate should be used immediately. The vial is for single use only. Any unused, reconstituted concentrate should be discarded immediately.
• 4. Transfer the entire contents of the reconstituted concentrate 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 reconstituted and diluted solution for infusion remains chemically and physically stable for 96 hours at 25°C, protected from light, when diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion, and for 48 hours at 25°C, protected from light, when diluted with glucose 50 mg/mL (5%) solution for infusion.
• 5. Gently rotate the infusion solution bottle (bag) to ensure thorough mixing of the diluted solution and DO NOT SHAKE to avoid foaming.

The solution should not be administered if it is cloudy or contains a precipitate.

• 6. Place the bottle (bag) containing the diluted solution in a closed protective cover to protect it from light.

Preparation of the infusion solution

*To obtain the required dose in mg, use vials with the appropriate concentration of the active substance. After reconstitution and dilution, the solution should be administered in a slow intravenous infusion lasting approximately 1 hour.