Micafungin Viatris

Leaflet accompanying the packaging: information for the user

Micafungin Viatris 50 mg powder for concentrate for solution for infusion

Micafungin Viatris 100 mg powder for concentrate for solution for infusion

Micafungin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 Viatris and what is it used for
• 2. Important information before using Micafungin Viatris
• 3. How to use Micafungin Viatris
• 4. Possible side effects
• 5. How to store Micafungin Viatris
• 6. Contents of the packaging and other information

1. What is Micafungin Viatris and what is it 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 fungal cells or yeast called Candida. Micafungin Viatris 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. Micafungin Viatris damages the cell wall of the fungal cell, which prevents further development and growth of the fungus. The doctor will prescribe Micafungin Viatris 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 tissues)
• 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 treatment)
• prevention of Candidainfections 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 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

Prolonged treatment with micafungin in rats 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. You should

tell your doctor if you have severe liver disease (e.g., liver failure or hepatitis) or if abnormal liver function test results have been found. During treatment, liver function will be closely monitored.
Before starting Micafungin Viatris, you should discuss this with your doctor or pharmacist
if you are allergic to any medicine

• if you have hemolytic anemia (anemia caused by the breakdown of red blood cells) or hemolysis (breakdown of red blood cells)
• if you have kidney disease (e.g., kidney failure and abnormal kidney function test results). In this case, your doctor may order closer monitoring of kidney function.

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

Micafungin Viatris and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
It is especially important to tell your doctor about the use of amphotericin B, 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 dose of these medicinal products.

Micafungin Viatris with food and drink

Since Micafungin Viatris is administered intravenously (into a vein), there are no restrictions on taking the medicine with food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Micafungin Viatris should not be used during pregnancy unless, in the doctor's opinion, it is absolutely necessary. While using Micafungin Viatris, you should not breastfeed.

Driving and using machines

It is unlikely that micafungin will affect your ability to drive or use machines. However, some patients may experience dizziness while taking the medicine, and in that case, you should not drive or use machines. You should inform your doctor if you experience any side effects that may cause difficulties in driving or using machines.

Micafungin Viatris 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 Viatris

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

Use in adults, adolescents over 16 years of age, and elderly patients

• In the treatment of invasive Candidainfection, a dose of 100 mg per day is usually used for patients with a body weight over 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 Candidaesophageal infection, the daily dose is 150 mg for patients with a body weight over 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 Candidainfections, a dose of 50 mg per day is usually used for patients with a body weight over 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 of age and adolescents under 16 years of age

• In the treatment of invasive Candidainfection, a dose of 100 mg per day is usually used for patients with a body weight over 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 Candidainfections, a dose of 50 mg per day is usually used for patients with a body weight over 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 Candidainfection, 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 Candidainfections, a dose of 2 mg/kg body weight per day is usually used.

Use 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 health status. If you are unsure whether too high a dose of Micafungin Viatris has been used, you should immediately contact your doctor or other medical personnel.

Missing a dose of Micafungin Viatris

The doctor will decide whether treatment with Micafungin Viatris is necessary based on the patient's response to treatment and health status. If you are unsure whether a dose of Micafungin Viatris has been missed, you should immediately contact your doctor or other medical personnel.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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, you should immediately inform your doctor or nurse.
Micafungin Viatris may cause the following other side effects:

• Frequent (may occur in up to 1 in 10 patients)
• abnormal blood test results [decrease in the number of white blood cells (leukopenia; neutropenia)]; decrease in the number of red blood cells (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)
• increase in bilirubin levels in the blood (hyperbilirubinemia)
• rash
• fever
• chills

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

• abnormal blood test results (decrease in the number of blood cells [pancytopenia]); decrease in the number of platelets (thrombocytopenia); increase in the number of a certain type of white blood cells (eosinophils); decrease in albumin levels in the blood (hypoalbuminemia)
• hypersensitivity
• increased sweating
• decrease in sodium levels in the blood (hyponatremia); increase in potassium levels in the blood (hyperkalemia); decrease in phosphate levels in the blood (hypophosphatemia); anorexia (loss of appetite)
• insomnia (sleep problems); 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; 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 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 less than 1 in 1,000 patients)

• 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)

• blood clotting disorders
• anaphylactic shock
• liver cell damage, including fatal cases
• kidney problems; acute kidney failure

Additional side effects occurring in children and adolescents

The following side effects are more common in children and adolescents than in adult patients:

• Frequent (may occur in up to 1 in 10 patients)
• decrease in the number of platelets (thrombocytopenia)
• rapid heartbeat (tachycardia)
• high or low blood pressure
• increase in bilirubin levels in the blood (hyperbilirubinemia); liver enlargement
• acute kidney failure; increase in urea levels in the blood

Reporting side effects

If an adult or child 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 Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: 22 49 21 301
Fax: 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, you can help provide more information on the safety of this medicine.

5. How to store Micafungin Viatris

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 after EXP.
The expiry date refers to the last day of the month stated.
Store in the original packaging to protect from light. The product can withstand direct light for 60 days (2 months).
The prepared 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 qualified healthcare professional after proper instruction.
Do not use the diluted solution if it is cloudy or contains precipitated sediment.
To protect from light, the bottle/bag containing the diluted solution should be placed in a closed, non-transparent cover.
The vial is 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 of the medicine is micafungin (in the form of micafungin sodium). Each vial contains 50 mg or 100 mg of micafungin (in the form of micafungin sodium).
• The other ingredients are: lactose monohydrate, citric acid (to adjust pH), and sodium hydroxide (to adjust pH) (see section 2).

What Micafungin Viatris looks like and what the packaging contains

Micafungin Viatris 50 mg or 100 mg powder for concentrate for solution for infusion is a lyophilized white or almost white powder.
Micafungin Viatris is supplied in packs containing 1 vial of 10 ml capacity made of colorless glass type I, with a cork made of isobutyl-isoprene rubber, an aluminum 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 against UV radiation.

Marketing authorization 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

Pharmadox Healthcare Limited

KW20A Corradino Industrial Estate
Paola, PLA 3000
Malta

To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00

Date of last revision of the leaflet: 04/2024

Information intended only for healthcare professionals or medical staff:

Instructions for use (see also section 3 How to use Micafungin Viatris).
Micafungin Viatris should be prepared as follows:

• 1. The plastic cap should be removed from the vial and the cork disinfected with alcohol.
• 2. Under aseptic conditions, 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) should be slowly injected into each vial, along the inner wall. 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. The vial should be gently rotated. 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. The entire amount of prepared concentrate should be transferred from the vials to the bottle/bag with the solution for infusion from which the solution was initially taken. The diluted solution for infusion should be administered immediately. The prepared solution maintains chemical and physical stability for 96 hours at 25°C, provided it is protected from light and diluted according to the instructions above.
• 5. The bottle/bag with the solution for infusion should be gently turned upside down to ensure thorough mixing of the diluted solution and SHOULD NOT BE SHAKEN to avoid foaming. The solution should not be administered if it is cloudy or contains precipitated sediment.

The solution for infusion should be prepared as follows: