Micafungin Teva

Leaflet attached to the packaging: information for the user

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

Micafungin Teva, 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.
• In case of any doubts, consult a 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 Teva and what is it used for
• 2. Important information before using Micafungin Teva
• 3. How to use Micafungin Teva
• 4. Possible side effects
• 5. How to store Micafungin Teva
• 6. Contents of the packaging and other information

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

Micafungin Teva contains the active substance micafungin. It is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungin Teva is used to treat fungal infections caused by fungal cells or yeast called Candida. Micafungin Teva 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. The medicine damages the cell wall, which prevents further development and growth of the fungus.
The doctor will prescribe Micafungin Teva 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 infection called invasive candidiasis (an infection that penetrates into the body);
• treatment of adults and adolescents over 16 years of age with fungal infection of the esophagus, where it is intended to administer the medicine intravenously (intravenous administration);
• prevention of Candida infections in patients undergoing allogeneic (i.e., from another person) hematopoietic stem cell transplants or in patients who are expected to develop neutropenia (decreased number of neutrophils; a type of white blood cell) lasting 10 or more days.

2. Important information before using Micafungin Teva

When not to use Micafungin Teva:

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

Warnings and precautions

Long-term administration of 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 Teva. 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 Teva, the patient should discuss the following with their 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 closer monitoring of kidney function.

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

Micafungin Teva 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 deoxycholate amphotericin B 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 Teva with food and drink

Since Micafungin Teva 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 Teva should not be used during pregnancy unless it is absolutely necessary.
The patient should not breastfeed while using Micafungin Teva.

Driving and using machines

It is unlikely that micafungin will affect the ability to drive vehicles or operate machines. However, some patients may experience dizziness while taking the medicine, and in such cases, the patient should not drive or operate tools or machines. The patient should inform their doctor if they experience any effects that may cause difficulties in driving or operating other devices.

Micafungin Teva contains sodium

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

3. How to use Micafungin Teva

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

Use in adults, adolescents over 16 years of age, 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 over 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 over 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 over 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 of age 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 over 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 over 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 Teva

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

Missing a dose of Micafungin Teva

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

4. Possible side effects

Like all medicines, Micafungin Teva 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 Teva may cause the following other side effects:

Common (may affect up to 1 in 10 people)

• abnormal blood test results [decreased white blood cell count (leukopenia; neutropenia)]; decreased red blood cell count (anemia)
• decreased potassium levels in the blood (hypokalemia); decreased magnesium levels in the blood (hypomagnesemia); decreased 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)
• increased bilirubin levels in the blood (hyperbilirubinemia)
• rash
• fever
• chills

Uncommon (may affect up to 1 in 100 people)

• abnormal blood test results [decreased blood cell count (pancytopenia)]; decreased platelet count (thrombocytopenia); increased white blood cell count (eosinophilia); decreased 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
• rapid heartbeat; stronger heartbeat; irregular heartbeat
• high or low blood pressure; flushing
• 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 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 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 available data)

• coagulation disorders
• anaphylactic 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:

Common (may affect up to 1 in 10 people)

• decreased 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 the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Micafungin Teva

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton. The expiry date refers to the last day of the month.
The closed vial does not need to be stored in special conditions.
Prepared concentrate in the vial
The prepared concentrate remains chemically and physically stable for 48 hours at 25°C, if the preparation used sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Diluted infusion solution
The prepared solution remains chemically and physically stable for 96 hours at 25°C, if protected from light and diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
From a microbiological point of view, the prepared and diluted solutions should be administered immediately. If not used immediately, the storage time and conditions are the responsibility of the user. The storage time should not exceed 24 hours at a temperature between 2°C and 8°C, unless the dissolution and dilution took place in controlled and validated aseptic conditions.
This medicine may 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 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.
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 Teva contains

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

What Micafungin Teva looks like and contents of the pack

Micafungin Teva 50 mg or 100 mg, powder for concentrate for solution for infusion is a white or almost white powder.
Micafungin Teva is available in a pack containing 1 vial.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
To obtain more detailed information on the medicine, the patient should contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53, 00-113 Warsaw
Tel.: (22) 345 93 00

Manufacturer

S.C. Sindan-Pharma S.R.L.
11, Ion Mihalache Ave., the 1st district
011171 Bucharest
Romania
Merckle GmbH
Graf-Arco-Str. 3,
89079 Ulm
Germany
Date of last revision of the leaflet:August 2024
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Information intended for healthcare professionals only:
Micafungin Teva should not be mixed or administered in infusion with other medicinal products, except for those listed below. In aseptic conditions and at room temperature, Micafungin Teva should be prepared as follows:

• 1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
• 2. In 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 of the medicine in mg, the concentrate should be prepared using the appropriate number of vials (see the table below).
• 3. Gently rotate the vial. 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. Transfer the entire contents of the prepared concentrate from the vials to the infusion bottle (bag) from which the infusion solution was initially taken. The diluted infusion solution should be administered immediately. The prepared solution remains chemically and physically stable for 96 hours at 25°C, if protected from light and diluted as instructed above.

After reconstitution and dilution, the solution should be administered in a slow intravenous infusion lasting approximately 1 hour.