Micafungin pharmazac

Patient Information Leaflet

Micafungin Pharmazac, 50 mg, powder for solution for infusion
Micafungin Pharmazac, 100 mg, powder for solution for infusion
Micafunginum
Please read all of this leaflet carefully before this medicine is used, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Leaflet Contents:

1. What Micafungin Pharmazac is and what it is used for
2. What you need to know before using Micafungin Pharmazac
3. How to use Micafungin Pharmazac
4. Possible side effects
5. How to store Micafungin Pharmazac
6. Contents of the pack and other information

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

Micafungin Pharmazac contains the active substance micafungin. Micafungin Pharmazac
is called an antifungal medicine because it is used to treat infections caused by fungi.
Micafungin Pharmazac is used to treat fungal infections caused by fungi or yeasts of the genus Candida.
Micafungin Pharmazac is effective in treating systemic infections (those that have spread throughout the body).
It acts by interfering with the formation of a component of the fungal cell wall. An intact cell wall is essential for the normal development and growth of fungal cells. Micafungin Pharmazac damages the fungal cell wall, thereby preventing further development and growth of the fungi.

Your doctor may prescribe Micafungin Pharmazac in the following situations, when no other appropriate antifungal treatment is available (see section 2):

• Treatment of invasive candidiasis (a serious, systemic fungal infection) in adults, adolescents, and children, including newborns;
• Treatment of oesophageal candidiasis (fungal infection of the oesophagus) in adults and adolescents aged ≥ 16 years, when 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 days or longer.

2. Important information before using Micafungin Pharmazac

When not to use Micafungin Pharmazac

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

Warnings and precautions
Long-term treatment with micafungin in rats has 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 Pharmazac.
Please 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 Micafungin Pharmazac, discuss this with your doctor or pharmacist:

• if the patient is allergic to any medication;
• 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 diseases (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 and mucous membrane inflammation/rash (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Micafungin Pharmazac 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 your doctor if the patient is taking amphotericin B deoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressive medicine), or nifedipine (a calcium channel blocker used to treat high blood pressure). The doctor may decide to adjust the dosage of these medicinal products.

Micafungin Pharmazac with food and drink
Since Micafungin Pharmazac is administered intravenously, there are no restrictions regarding food and drink.

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 Pharmazac must not be used during pregnancy unless absolutely necessary.
Breastfeeding must not be continued during treatment with Micafungin Pharmazac.

Driving and operating machinery
It is unlikely that micafungin will affect the ability to drive motor vehicles or operate mechanical equipment. However, dizziness may occur in some patients while taking this medicine, and in such cases, the patient should not drive or operate machinery. Inform your doctor if any symptoms occur that could impair driving or operating machinery.

Micafungin Pharmazac contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is practically sodium-free.

3. How to use Micafungin Pharmazac

Micafungin Pharmazac must be prepared and administered by a doctor or other medical personnel. Micafungin Pharmazac should be given once daily as a slow intravenous infusion.
The daily dose is 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 weighing 40 kg or more, and 2 mg/kg body weight once daily in patients weighing less than 40 kg.
• For the treatment of Candida esophagitis, 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 under 16 years of age

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

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

Missed dose of Micafungin Pharmazac
The doctor will decide on the need for continued treatment with Micafungin Pharmazac based on the patient's response to therapy and clinical status. If there is any doubt whether a dose of Micafungin Pharmazac has been missed, contact the doctor 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 everybody 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 Pharmazac may cause the following other adverse reactions:

Common (may affect up to 1 in 10 people)

• abnormal blood test results (reduced number of white blood cells [leukopenia; neutropenia]); reduced 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; vomiting; diarrhoea; abdominal pain
• abnormal liver function tests (increased alkaline phosphatase activity, increased aspartate aminotransferase activity, increased alanine aminotransferase activity)
• increased bilirubin levels in the blood (hyperbilirubinaemia)
• rash
• fever
• chills

Uncommon (may affect up to 1 in 100 people)

• abnormal blood test results (reduced number of blood cells [pancytopenia]); reduced 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; stronger 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 reaching the intestine (cholestasis); enlarged liver; hepatitis
• itchy rash (urticaria); itching; skin redness (erythema)
• abnormal kidney function tests (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 affect up to 1 in 1,000 people)

• anaemia caused by destruction of red blood cells (haemolytic anaemia), destruction of red blood cells (haemolysis)

Not known (frequency cannot be estimated from available data)

• blood coagulation disorder
• shock (allergic)
• 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 affect up to 1 in 10 people)

• reduced 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. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
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
Adverse reactions may 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 Pharmazac

Keep this medicine out of the sight and reach of children.
Do not use Micafungin Pharmazac 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 do not contain any 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 leaflet.
Do not use the diluted solution if it becomes cloudy or contains a precipitate.
To protect from light, the bottle (bag) containing the diluted solution should be placed inside a closed protective cover.
The vial is intended for single use only. Any unused, prepared concentrate should be discarded immediately.

6. Contents of the pack and other information

What Micafungin Pharmazac contains

• The active substance is micafungin (as the sodium salt). One vial contains 50 mg or 100 mg of micafungin (as the sodium salt).
• Other ingredients are: monohydrate lactose, citric acid (E330), and sodium hydroxide.

What Micafungin Pharmazac looks like and contents of the pack
Micafungin Pharmazac, 50 mg or 100 mg powder for preparation of concentrate for infusion solution
is a white or off-white solid substance.
Micafungin Pharmazac 50 mg or 100 mg powder for preparation of concentrate for infusion solution
is packed in a 10R type I amber glass vial closed with a bromobutyl rubber stopper 20 mm in diameter and sealed with a single aluminum cap with a blue or red flip-off plastic cap (capsule).
Micafungin Pharmazac is supplied in packs containing 1 vial.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Pharmazac S.A.
Anastasiou Zaroliagki 1 and Dimitriou Lampros 6, Kerateas Industrial Park,
Veniza, Lavreotiki, Keratea, Attica,
190 01, Greece
Tel.: +30 210 3418890

Manufacturer
S.C. ROMPHARM COMPANY S.R.L.
1A Eroilor Street, Rompharm 1 and Rompharm 2 buildings, 075100 Otopeni, Ilfov County,
Romania

This medicinal product is authorised for sale in the EEA Member States under the following names:
Austria Micafungin Pharmazac 50 mg powder for concentrate for solution for infusion
Micafungin Pharmazac 100 mg powder for concentrate for solution for infusion
Cyprus Micafungin/Pharmazac 50 mg κόνις για πυκνό σκεύασμα για παρασκευή διαλύματος προς έγχυση
Micafungin/Pharmazac 100 mg κόνις για πυκνό σκεύασμα για παρασκευή διαλύματος προς έγχυση
Greece Micafungin/Pharmazac 50 mg κόνις για πυκνό σκεύασμα για παρασκευή διαλύματος προς έγχυση
Micafungin/Pharmazac 100 mg κόνις για πυκνό σκεύασμα για παρασκευή διαλύματος προς έγχυση
Hungary Micafungin Pharmazac 50 mg por oldatos infúzióhoz való koncentrátumhoz
Micafungin Pharmazac 100 mg por oldatos infúzióhoz való koncentrátumhoz
Poland Micafungin Pharmazac 50 mg
Micafungin Pharmazac 100 mg
Romania Micafungin Pharmazac 50 mg pulbere pentru concentrat pentru solutie perfuzabila
Micafungin Pharmazac 100 mg pulbere pentru concentrat pentru solutie perfuzabila
Slovenia Micafungin Pharmazac 50 mg prašek za koncentrat za raztopino za infundiranje
Micafungin Pharmazac 100 mg prašek za koncentrat za raztopino za infundiranje
Netherlands Micafungine Pharmazac 50 mg poeder voor concentraat voor oplossing voor infusie
Micafungine Pharmazac 100 mg poeder voor concentraat voor oplossing voor infusie

Information intended exclusively for medical or healthcare personnel:
Micafungin Pharmazac must not be mixed or administered simultaneously in the same infusion with other medicinal products, except as listed below. Under aseptic conditions and at room temperature, Micafungin Pharmazac should be prepared 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 either 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution 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 obtain the correct dose in mg, prepare the concentrate using the appropriate number of vials (see table below).
3. Gently rotate the vial along its long axis. DO NOT SHAKE! The powder will dissolve completely. The prepared 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 bottle (bag) containing the infusion solution from which the diluent was originally drawn. The diluted infusion solution should be administered immediately. The prepared 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. DO NOT SHAKE, to avoid foam formation. Do not administer the solution if it is cloudy or contains a precipitate.
6. Place the bottle (bag) containing the diluted solution into a closed packaging protecting it from light.

Preparation of the infusion solution

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