Micafungin pharmline

Package leaflet: Information for the patient

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

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Micafungin PHARMLINE is and what it is 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 pack and other information

1. What Micafungin PHARMLINE is and what it is 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 yeasts called Candida. Micafungin PHARMLINE is effective in treating systemic infections (those that have spread into the body). It interferes 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 PHARMLINE damages the fungal cell wall, thereby preventing further development and growth of fungi.
Your doctor may prescribe Micafungin PHARMLINE 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) 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 levels 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 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 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 PHARMLINE. 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 closely monitored during treatment. Before starting Micafungin PHARMLINE, discuss this with your doctor or pharmacist.

• if the patient is allergic to any medicine;
• if the patient has haemolytic anaemia (anaemia caused by breakdown of red blood cells) or haemolysis (breakdown of red blood cells);
• if the patient has kidney disorders (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 a severe inflammatory condition/skin rash and mucosal lesions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Micafungin PHARMLINE 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 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.

Micafungin PHARMLINE with food and drink
Since Micafungin PHARMLINE is administered intravenously (into a vein), 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 baby, she should consult her doctor or pharmacist before using this medicine.
Micafungin PHARMLINE must not be used during pregnancy unless absolutely necessary. Breastfeeding must not be continued during treatment with Micafungin PHARMLINE.

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 cause difficulties in driving or operating machinery.

Micafungin PHARMLINE contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. this medicine is considered "sodium-free".

3. How to use Micafungin PHARMLINE

Micafungin PHARMLINE must be prepared and administered by a physician or other healthcare professional.
Micafungin PHARMLINE should be given once daily as a slow intravenous infusion. The daily dose of Micafungin PHARMLINE 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 weighing more than 40 kg and 2 mg/kg body weight once daily in patients weighing 40 kg or less.
• 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 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 neonates under 4 months of age

• For the treatment of invasive Candida infection, the usual dose ranges from 4 mg/kg body weight 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 PHARMLINE
The physician will determine the appropriate dose of Micafungin PHARMLINE based on the patient's response to treatment and clinical condition. However, if there is any doubt whether too high a dose of Micafungin PHARMLINE has been administered, contact a physician or other healthcare professional immediately.

Missed dose of Micafungin PHARMLINE
The physician will decide on the need for continued treatment with Micafungin PHARMLINE based on the patient's response to therapy and clinical condition. However, if there is any doubt whether a dose of Micafungin PHARMLINE has been missed, contact a physician or other healthcare professional immediately.

If you have any further questions about the use of this medicine, consult your physician 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 PHARMLINE may cause the following other adverse reactions:

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

• abnormal blood test results (reduced white blood cell count [leukopenia; neutropenia]); reduced red blood cell count (anaemia),
• decreased blood potassium levels (hypokalaemia); decreased blood magnesium levels (hypomagnesaemia); decreased blood calcium levels (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 blood bilirubin levels (hyperbilirubinaemia),
• rash,
• fever,
• chills (shivering).

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

• abnormal blood test results (reduced blood cell count [pancytopenia]); reduced platelet count (thrombocytopenia); increased count of a certain type of white blood cells (eosinophils); decreased blood albumin levels (hypoalbuminaemia),
• hypersensitivity,
• increased sweating,
• decreased blood sodium levels (hyponatraemia); increased blood potassium levels (hyperkalaemia); decreased blood phosphate levels (hypophosphataemia); anorexia (loss of appetite),
• insomnia (difficulty sleeping); anxiety; confusion,
• drowsiness (sleepiness); 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 retention before release into the intestine (cholestasis); enlarged liver; liver inflammation,
• itchy rash (urticaria); itching; skin redness (erythema),
• abnormal kidney function test results (increased blood creatinine levels; increased blood urea levels); worsening of kidney failure,
• increased activity of an enzyme called lactate dehydrogenase,
• phlebitis 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).

Frequency 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 occur in up to 1 in 10 patients)

• reduced platelet count (thrombocytopenia),
• increased heart rate (tachycardia),
• high or low blood pressure,
• increased blood bilirubin levels (hyperbilirubinaemia); enlarged liver,
• acute kidney failure; increased blood urea levels.

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
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 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 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 outer packaging. The expiry date refers to the last day of the specified month.
Unopened vial
Store below 25°C.
The reconstituted 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 contains a precipitate.
To protect from light, the bottle (or bag) containing the diluted solution should be placed inside a closed cover.
The vial is for single use only. Any unused reconstituted concentrate should be discarded immediately.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to properly dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Micafungin Pharmline contains

• The active substance is micafungin (as sodium salt). One vial contains 100 mg of micafungin (as sodium salt).
• The other components are: monohydrate lactose, citric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

What Micafungin Pharmline looks like and contents of the pack
Micafungin Pharmline 100 mg, powder for concentrate for infusion solution, is a white or
nearly white mass or powder. Micafungin Pharmline is available in packs containing 1 vial.
Marketing Authorisation 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 medicinal product is authorised 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

Information intended exclusively for healthcare professionals:

The medicinal product Micafungin PHARMLINE 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, the Micafungin PHARMLINE medicinal product 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 either sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 50 mg/mL (5%) 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 achieve the appropriate dose in mg, prepare the concentrate using the required number of Micafungin PHARMLINE vials (see 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 intended 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 immediately. The diluted solution remains chemically and physically stable for 96 hours at 25°C when protected from light and diluted with sodium chloride 9 mg/mL (0.9%) solution for infusion, and for 48 hours at 25°C when protected from light and diluted with glucose 50 mg/mL (5%) solution for infusion.
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. The infusion bag (bottle) containing the diluted solution should be placed in a closed, light-protective packaging.

Preparation of the infusion solution

*To obtain the required dose in mg, vials with the appropriate concentration of the active substance should be used for reconstitution.
After reconstitution and dilution, the solution should be administered by slow intravenous infusion over approximately 1 hour.
Any unused portions of the medicinal product or waste materials should be disposed of in accordance with local regulations.