Micafungin Dai Zero

Leaflet accompanying the packaging: information for the user

Micafungin Day Zero, 50 mg, powder for solution for infusion

Micafungin Day Zero, 100 mg, powder 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Micafungin Day Zero and what is it used for
• 2. Important information before using Micafungin Day Zero
• 3. How to use Micafungin Day Zero
• 4. Possible side effects
• 5. How to store Micafungin Day Zero
• 6. Contents of the packaging and other information

1. What is Micafungin Day Zero and what is it used for

Micafungin Day Zero contains the active substance micafungin. Micafungin Day Zero is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungin Day Zero is used to treat fungal infections caused by fungal cells or yeast called Candida. Micafungin Day Zero 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 Day Zero damages the cell wall, preventing further development and growth of fungi.
The doctor will prescribe Micafungin Day Zero 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 infections called invasive candidiasis (infection that penetrates 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 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 Day Zero

When not to use Micafungin Day Zero

• if the patient is allergic to micafungin, other echinocandins (Ecaltaor 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, consequently, 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 Day Zero. You should tell your doctor if you have severe liver disease (e.g., liver failure or hepatitis) or if you have abnormal liver function test results. During treatment, liver function will be closely monitored.

Before using Micafungin Day Zero, you should discuss it 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 also cause severe inflammation and (or) skin and mucous membrane rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Micafungin Day Zero and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
It is especially important to tell your doctor about the use of amphotericin B desoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressive medicine), or nifedipine (a calcium antagonist used to treat high blood pressure). Your doctor may decide to adjust the dose of these medicines.

Micafungin Day Zero with food and drink

Since Micafungin Day Zero 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 Day Zero should not be used during pregnancy, unless your doctor considers it absolutely necessary.
While using Micafungin Day Zero, 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 this medicine, and in that case, you should not drive or use machines.
You should inform your doctor if you experience any effects that may cause difficulties in driving or using machines.

Micafungin Day Zero contains sodium

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

3. How to use Micafungin Day Zero

Micafungin Day Zero must be prepared and administered by a doctor or other medical personnel. Micafungin Day Zero 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 Candidainfection, 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 Candidaesophageal infection, 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 Candidainfections, 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 Candidainfection, 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 Candidainfections, 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 Candidainfection, a dose of 4 mg/kg per day to 10 mg/kg per day is usually used.
• In the prevention of invasive Candidainfections, a dose of 2 mg/kg per day is usually used.

Use of a higher than recommended dose of Micafungin Day Zero

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

Missing a dose of Micafungin Day Zero

The doctor will decide on the need for treatment with Micafungin Day Zero based on the patient's response to treatment and health status. If there is any doubt as to whether a dose of Micafungin Day Zero has been missed, you should immediately contact a 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, Micafungin Day Zero 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 Day Zero may cause the following other side effects:

Common (may affect up to 1 in 10 people)

• 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 (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 (shivering).

Uncommon (may affect up to 1 in 100 people)

• 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 called 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 (eating disorders);
• insomnia (sleep problems); anxiety; disorientation;
• drowsiness (drowsiness); tremors; dizziness; taste disorders;
• rapid heartbeat; stronger heartbeat; irregular heartbeat;
• high or low blood pressure; flushing of the skin;
• 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); decreased bile excretion into the intestine (cholestasis); liver enlargement; liver inflammation;
• itchy rash (hives); itching; skin redness (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 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 the available data)

• coagulation disorders;
• anaphylactic shock (allergic shock);
• liver cell damage, which can also lead to death;
• kidney problems; acute kidney failure.

Additional side effects occurring in children and adolescents

The following reactions were observed more frequently in children and adolescents than in adult patients:

Common (may affect up to 1 in 10 people)

• decrease in the number of platelets (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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Micafungin Day Zero

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the given month.
Closed vials do not require special storage conditions.
The prepared concentrate in the vial:

The prepared concentrate remains chemically and physically stable for 48 hours at 25°C, if the preparation used a sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
The diluted infusion solution:

The prepared solution remains chemically and physically stable for 96 hours at 25°C, if protected from light and diluted with a 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 used 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 has precipitated.
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.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Day Zero contains

• The active substance of the medicine is micafungin (in the form of sodium salt). One vial contains sodium micafungin equivalent to 50 mg or 100 mg of micafungin.
• The other ingredients are: sucrose, citric acid, and sodium hydroxide.

What Micafungin Day Zero looks like and what the pack contains

Micafungin Day Zero in doses of 50 mg or 100 mg is a white or off-white powder for solution for infusion.
Micafungin Day Zero is supplied in packs containing 1 vial.

Marketing authorization holder and manufacturer

Marketing authorization holder

Day Zero ehf,
Reykjavíkurvegi 62
220 Hafnarfjordur
Iceland

Manufacturer

Actavis Italy S.p.A- Nerviano Plant
Via Pasteur 10
20014 Nerviano (Milan),
Italy
S.C. Sindan-Pharma S.R.L.
11 Ion Mihalache Ave.,
the 1st district Bucharest 011171,
Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Micafungin Day Zero 50 mg Pulver zur Herstellung einer
Infusionslösung
Micafungin Day Zero 100 mg
Pulver zur Herstellung einer
Infusionslösung
Poland
Micafungin Day Zero

Date of last revision of the leaflet: ---------------------------------------------------------------------------

Information intended for healthcare professionals only:

Micafungin Day Zero should not be mixed or administered in infusion with other medicinal products, except for those listed below. Under aseptic conditions and at room temperature, Micafungin Day Zero should be prepared as follows:

• 1. The plastic cap should be removed from the vial and the stopper 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 Micafungin Day Zero in mg, the concentrate should be prepared using the appropriate number of vials (see table below).
• 3. The vial should be gently rotated along its longer 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, unused concentrate should be discarded immediately.
• 4. The entire amount of prepared concentrate should be transferred from the vials to the infusion solution bottle (bag) from which the 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 according to the instructions above.
• 5. The infusion solution bottle (bag) should be gently turned over to ensure thorough mixing of the diluted solution and NOT SHAKEN, to avoid foaming. After dilution, the solution is clear and colorless, without visible particles. Only a clear and colorless solution, without visible particles, should be used. The solution should not be administered if it is cloudy or contains precipitated sediment.
• 6. The bottle (bag) containing the diluted solution should be placed in a closed, non-transparent bag to protect it from light.

Preparation of the infusion solution

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