Micafungin viatris

Package leaflet: Information for the user

Micafungin Viatris 50 mg powder for solution for infusion
Micafungin Viatris 100 mg powder for solution for infusion
Micafunginum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please 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.

Contents of the leaflet

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

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

Micafungin Viatris contains the active substance micafungin. Micafungin Viatris is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungin Viatris is used to treat fungal infections caused by fungi or yeast-like organisms called Candida. Micafungin Viatris is effective in treating systemic infections (those that have spread inside the body). It acts on 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. Micafungin Viatris damages the fungal cell wall, thereby preventing further development and growth of fungi.
Your doctor may prescribe Micafungin Viatris 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 penetrates into body tissues)
• Treatment of adults and adolescents aged ≥ 16 years with fungal infection of the oesophagus (oesophagitis), when intravenous treatment (treatment given into a vein) is appropriate
• Prevention of Candida-related 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 or more days.

2. Important information before using Micafungin Viatris

When not to use Micafungin Viatris

• 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 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. 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 monitored more closely during treatment.
Before starting treatment with Micafungin Viatris, 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 order closer monitoring of kidney function.

Micafungin may cause a severe inflammatory condition/skin rash affecting the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis [Lyell's syndrome]).
Micafungin Viatris 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 you are taking amphotericin B deoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressive medicine), or nifedipine (a calcium channel blocker used to treat high blood pressure). Your doctor may decide to adjust the dosage of these medicinal products.
Micafungin Viatris with food and drink
Since Micafungin Viatris 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 Viatris must not be used during pregnancy unless absolutely necessary, as determined by the doctor. Breastfeeding must not be undertaken during treatment with Micafungin Viatris.
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 adverse effects occur that may impair the ability to drive or operate machinery.
Micafungin Viatris contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Micafungin Viatris

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

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

• For the treatment of invasive Candida infections, 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 oesophagitis, 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 infections, 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 newborns under 4 months of age

• For the treatment of invasive Candida infections, 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 Viatris
The doctor will determine the appropriate dose of Micafungin Viatris based on the patient's response to treatment and overall health condition. If there is any doubt whether too high a dose of Micafungin Viatris has been administered, contact a doctor or other medical personnel immediately.

Missed dose of Micafungin Viatris
The doctor will decide on the need for continued treatment with Micafungin Viatris based on the patient's response to treatment and health status. If there is any doubt whether a dose of Micafungin Viatris has been missed, contact a 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 everyone will experience them.
If an allergic reaction or a severe skin reaction (e.g. blistering and peeling of the skin) occurs,
inform your doctor or nurse immediately.
Micafungin Viatris may cause the following adverse reactions other than those listed above:

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)
• Reduced potassium levels in the blood (hypokalaemia); reduced magnesium levels in the blood (hypomagnesaemia); reduced 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 (reduced blood cell count [pancytopenia]); reduced platelet count (thrombocytopenia); increased number of a certain type of white blood cells (eosinophils); reduced albumin levels in the blood (hypoalbuminaemia)
• Hypersensitivity
• Increased sweating
• Reduced sodium levels in the blood (hyponatraemia); increased potassium levels in the blood (hyperkalaemia); reduced 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 retention before it leaves the liver (cholestasis); enlarged liver; liver inflammation
• 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
• 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 less than 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 clotting disorders
• Shock (anaphylactic)
• Liver cell damage, including cases resulting in death
• Kidney problems; acute kidney failure

Additional adverse reactions occurring in children and adolescents
The following adverse reactions occur more frequently in children and adolescents 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 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 in adult or paediatric patients, 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
Faks: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Micafungin Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and outer packaging after EXP.
The expiry date refers to the last day of the specified month. The batch number is indicated on the packaging after Lot.
Store in the original packaging to protect from light. The product may withstand direct exposure to light for up to 60 days (2 months).
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 qualified healthcare professional who has read and understood the entire instruction.
Do not use the diluted solution if it becomes cloudy or if a precipitate appears.
To protect from light, the bottle/bag containing the diluted solution should be placed inside a closed, opaque cover.
The vial is intended for single use only. Any unused, prepared concentrate should be discarded immediately.

6. Contents of the packaging and other information

What Micafungin Viatris contains

• The active substance is micafungin (in the form of micafungin sodium). Each vial contains 50 mg or 100 mg of micafungin (as micafungin sodium).
• Other ingredients are: lactose monohydrate, citric acid (for pH adjustment), and sodium hydroxide (for pH adjustment) (see section 2).

What Micafungin Viatris looks like and contents of the pack
Micafungin Viatris 50 mg or 100 mg powder for concentrate for solution for infusion is a white or almost white lyophilized powder.
Micafungin Viatris is supplied in packs containing 1 vial with a capacity of 10 ml made of colourless type I glass, with an isobutyl-isoprene rubber stopper and an aluminium seal with a blue flip-off cap for Micafungin Viatris 50 mg and a red flip-off cap for Micafungin Viatris 100 mg. The vial is wrapped in a protective foil to shield it from UV radiation.

Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer
Galenicum Health, S.L.U
Sant Gabriel, 50
Esplugues de Llobregat, 08950, Barcelona (Spain)
BAG Health Care GmbH
Amtsgerichtsstrasse 1 – 5
35423 Lich, Hessen (Germany)
SAG MANUFACTURING, S.L.U.
Ctra. N-I, km 36
28750 San Agustín del Guadalix
Madrid – Spain

For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00

Information intended exclusively for medical professionals or healthcare personnel:
Instructions for use (see also section 3 How to use Micafungin Viatris).
Micafungin Viatris 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%) 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 obtain the correct dose in mg, prepare the concentrate using the appropriate number of 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 vial(s) into the bottle/bag containing the infusion solution from which the diluent was originally withdrawn. The diluted solution for infusion 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 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 bottle/bag containing the diluted solution should be placed in a closed, opaque container to protect it from light.

Preparation of the infusion solution