Anidulafungin Fresenius Kabi

Leaflet accompanying the packaging: information for the user

Anidulafungin Fresenius Kabi, 100 mg,

powder for concentrate for solution for infusion
Anidulafungin

You should carefully read the contents of the leaflet before administering the medicine to adult patients or children and adolescents, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• If adult patients or children and adolescents experience any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What Anidulafungin Fresenius Kabi is and what it is used for
• 2. Important information before taking Anidulafungin Fresenius Kabi in adult patients or children and adolescents
• 3. How to take Anidulafungin Fresenius Kabi
• 4. Possible side effects
• 5. How to store Anidulafungin Fresenius Kabi
• 6. Contents of the packaging and other information

1. What Anidulafungin Fresenius Kabi is and what it is used for

Anidulafungin Fresenius Kabi contains the active substance anidulafungin and is prescribed to adult patients and children and adolescents from 1 month to 18 years of age for the treatment of a fungal infection of the blood or internal organs, called invasive candidiasis. This infection is caused by fungal cells (yeast) called Candida.
Anidulafungin Fresenius Kabi belongs to a group of medicines called echinocandins. Medicines in this group are used to treat serious fungal infections.
Anidulafungin Fresenius Kabi inhibits the process of producing a proper fungal cell wall.
Fungal cells exposed to Anidulafungin Fresenius Kabi have incomplete or damaged cell walls, making them vulnerable to damage or preventing them from growing.

2. Important information before taking Anidulafungin Fresenius Kabi in adult patients or children and adolescents

patients or children and adolescents

When not to use Anidulafungin Fresenius Kabi

Warnings and precautions

Before starting treatment with Anidulafungin Fresenius Kabi, you should discuss it with your doctor, pharmacist, or nurse.
The doctor may decide to monitor:

• liver function, more closely if the patient has liver function disorders during treatment;
• the occurrence of symptoms of an allergic reaction, such as itching, wheezing, skin rashes;
• the occurrence of symptoms related to infusion, which may include rash, hives, itching, redness;
• the occurrence of shortness of breath or difficulty breathing, dizziness, or a feeling of emptiness in the head.

Children and adolescents

Anidulafungin Fresenius Kabi should not be used in patients under 1 month of age.

Anidulafungin Fresenius Kabi and other medicines

You should tell your doctor or pharmacist about all medicines currently being taken or recently taken by adult patients or children and adolescents, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine.
The effect of Anidulafungin Fresenius Kabi in pregnant women is not known. Therefore, the use of Anidulafungin Fresenius Kabi during pregnancy is not recommended. Women of childbearing age should use effective contraception methods.
If the patient becomes pregnant while taking Anidulafungin Fresenius Kabi, she should immediately inform her doctor.
The effect of Anidulafungin Fresenius Kabi in breastfeeding women is not known.

Anidulafungin Fresenius Kabi contains sodium and fructose

The medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e., the medicine is considered "sodium-free".
The medicine contains 100 mg of fructose in each vial.
If hereditary fructose intolerance (HFI) has been previously diagnosed in adult patients (or children and adolescents), a rare genetic disease, adult patients (or children and adolescents) should not take this medicine. In patients with hereditary fructose intolerance, the body does not break down the fructose contained in this medicine, which may cause severe adverse reactions. Before taking this medicine, you should tell your doctor if you have HFI or if you cannot consume sweet foods or drinks due to symptoms such as nausea, vomiting, or symptoms such as bloating, stomach cramps, or diarrhea.

3. How to take Anidulafungin Fresenius Kabi

Anidulafungin Fresenius Kabi will always be prepared and administered by a doctor or other medical staff (more information on how to prepare the medicine can be found at the end of the leaflet, in the section intended only for medical staff).
In adult patients, treatment starts with a dose of 200 mg administered on the first day (loading dose). Then, a daily dose of 100 mg (maintenance dose) is administered.
In children and adolescents (from 1 month to 18 years of age), treatment starts with a dose of 3.0 mg/kg body weight (dose not exceeding 200 mg) on the first day (loading dose). Then, a daily dose of 1.5 mg/kg body weight (dose not exceeding 100 mg) (maintenance dose) is administered. The administered dose depends on the patient's body weight.
Anidulafungin Fresenius Kabi should be administered once a day, in a slow intravenous infusion (drip).
In adult patients, the infusion should last at least 1.5 hours for the maintenance dose and 3 hours for the loading dose. In children and adolescents, the infusion may last shorter, depending on the patient's body weight.
The doctor will determine the duration of treatment and the dose of Anidulafungin Fresenius Kabi administered each day and will monitor the patient's response to treatment and condition.
Generally, treatment lasts at least 14 days after the last day on which the presence of Candidayeast was detected in the patient's blood.

Using a higher dose of Anidulafungin Fresenius Kabi than recommended

In case of suspected overdose of Anidulafungin Fresenius Kabi, you should immediately inform your doctor or other medical staff.

Missing a dose of Anidulafungin Fresenius Kabi

Since the medicine is administered under close medical supervision, it is unlikely that a dose will be missed. However, if a dose is missed, you should inform your doctor or nurse.
You should not take a double dose to make up for a missed dose.

Stopping treatment with Anidulafungin Fresenius Kabi

In case of stopping treatment with Anidulafungin Fresenius Kabi by the doctor, no symptoms should occur.
After treatment with Anidulafungin Fresenius Kabi, the doctor may prescribe another medicine to continue treatment of the fungal infection or to prevent recurrence of fungal infections.
If the initial symptoms return, you should immediately inform your doctor or other medical staff.
If you have any further doubts about taking this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these side effects will be observed by the doctor during monitoring of the patient's response to treatment and condition.
During administration of Anidulafungin Fresenius Kabi, life-threatening allergic reactions have been rarely reported, such as difficulty breathing, wheezing, or worsening of existing rash.

Severe side effects - if you notice any of the following side effects, you should immediately inform your doctor or healthcare professional:

• seizures (epileptic fits);
• sudden redness of the face;
• rash, itching (pruritus);
• flushing;
• hives;
• sudden constriction of the airways causing wheezing and cough;
• difficulty breathing.

Other side effects

Very common (may affect more than 1 in 10 patients):

• low potassium levels in the blood (hypokalemia);
• diarrhea;
• nausea.

Common (may affect up to 1 in 10 patients):

• seizures (epileptic fits);
• headache;
• vomiting;
• abnormal liver function test results;
• rash, itching (pruritus);
• abnormal kidney function test results;
• impaired bile flow from the gallbladder to the intestines (cholestasis);
• high blood sugar levels;
• high blood pressure;
• low blood pressure;
• sudden constriction of the airways causing wheezing and cough;
• difficulty breathing.

Uncommon (may affect up to 1 in 100 patients):

• blood clotting disorders;
• sudden redness of the face;
• flushing;
• abdominal pain;
• hives;
• pain at the injection site.

Frequency not known (cannot be estimated from the available data):

• life-threatening allergic reactions.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. 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
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov
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 Anidulafungin Fresenius Kabi

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month stated.
Store in a refrigerator (2°C – 8°C).
After reconstitution, the solution can be stored at a temperature up to 25°C for no more than 24 hours before dilution of the solution. The infusion solution can be stored at 25°C for 48 hours.
Do not freeze.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Anidulafungin Fresenius Kabi contains

• The active substance of the medicine is anidulafungin. Each vial of powder contains 100 mg of anidulafungin.
• The other ingredients are: fructose, mannitol, polysorbate 80, acetic acid, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).

What Anidulafungin Fresenius Kabi looks like and what the pack contains

Anidulafungin Fresenius Kabi is available in a pack containing 1 vial of 100 mg powder for concentrate for solution for infusion.
The powder is white or almost white.

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Laboratori FUNDACIO DAU
C/ De la letra C, 12-14
Polígono Industrial de la Zona Franca
08040 Barcelona
Spain
To obtain more detailed information, you should contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet:20.10.2023
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Information intended for healthcare professionals only and relates to a single vial of Anidulafungin Fresenius Kabi, 100 mg, powder for concentrate for solution for infusion:

The contents of the vial should be dissolved in water for injections, and then diluted EXCLUSIVELYwith sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 50 mg/mL (5%) solution for infusion. The compatibility of the dissolved Anidulafungin Fresenius Kabi with substances administered intravenously, excipients, or other medicines has not been established, except for sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 50 mg/mL (5%) solution for infusion.
Reconstitution
With aseptic precautions, the contents of each vial should be dissolved in 30 mL of water for injections to obtain a concentrate with a concentration of 3.33 mg/mL. The dissolution time may take up to 2 minutes. If solid particles or a color change are visible after dissolution, the solution should be discarded. The solution after reconstitution should be clear, colorless to light yellow.
After reconstitution, the solution can be stored at a temperature up to 25°C for no more than 24 hours before dilution of the solution.
Dilution and infusion

Medicines for parenteral use should be inspected visually for particulate matter and color change prior to administration, whenever the solution and container permit.

If solid particles or a color change are detected, the solution should be discarded.
Adult patients
With aseptic precautions, the contents of the dissolved vial(s) of the medicine should be transferred to an intravenous infusion bag (or bottle) containing sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 50 mg/mL (5%) solution for infusion to obtain the appropriate concentration of anidulafungin. The following table shows the dilution to a concentration of 0.77 mg/mL for the final infusion solution and the infusion instructions for each dose.

Requirements for diluting Anidulafungin Fresenius Kabi before administration

sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 50 mg/mL (5%) solution for infusion
the concentration of the infusion solution is 0.77 mg/mL
The infusion rate should not exceed 1.1 mg/min (which corresponds to 1.4 mL/min or 84 mL/h, if the medicine is dissolved and diluted according to the instructions).
Children and adolescents
In the case of children and adolescents from 1 month to 18 years of age, the volume of the infusion solution required to administer the appropriate dose will vary depending on the patient's body weight.
The solution after reconstitution should be further diluted to a concentration of 0.77 mg/mL to obtain the final infusion solution. The use of a programmable syringe or infusion pump is recommended.

The infusion rate should not exceed 1.1 mg/min (which corresponds to 1.4 mL/min or 84 mL/h, if the medicine is dissolved and diluted according to the instructions)

• 1. Calculate the dose for the patient and subject the required vial(s) to reconstitution according to the reconstitution instructions to obtain a concentration of 3.33 mg/mL.
• 2. Calculate the required volume (mL) of anidulafungin after reconstitution:
• volume of anidulafungin (mL) = dose of anidulafungin (mg) ÷ 3.33 mg/mL
• 3. Calculate the total volume (mL) of the dosing solution required to obtain a final concentration of 0.77 mg/mL:
• total volume of the solution for administration (mL) = dose of anidulafungin (mg) ÷ 0.77 mg/mL
• 4. Calculate the volume of the diluent (glucose 50 mg/mL (5%) solution for infusion or sodium chloride 9 mg/mL (0.9%) solution for infusion) required to prepare the solution for administration:
• volume of the diluent (mL) = total volume of the solution for administration (mL) - volume of anidulafungin (mL)
• 5. With aseptic precautions, transfer the required volumes (mL) of anidulafungin and glucose 50 mg/mL (5%) solution for infusion or sodium chloride 9 mg/mL (0.9%) solution for infusion to the infusion syringe or bag required for administration of the medicine.

For single use only. Dispose of waste according to local regulations.