ANIDULAFUNGINA ACCORD 100 mg POWDER FOR CONCENTRATE FOR INFUSION SOLUTION

1. What Anidulafungina Accord is and what it is used for

Anidulafungina Accord contains the active substance anidulafungina and is prescribed for adult patients and pediatric patients from 1 month to less than 18 years to treat a type of fungal infection of the blood or other internal organs called invasive candidiasis. The infection is caused by fungal cells (yeast) known as Candida.

This medicine belongs to a group of medicines called echinocandins. These medicines are used to treat serious fungal infections.

Anidulafungina prevents the normal development of the fungal cell wall. In the presence of Anidulafungina, the fungal cell wall is incomplete or defective, making it fragile or unable to grow.

2. What you need to know before you or your child start using Anidulafungina Accord

Do not use Anidulafungina Accord

• if you are allergic to anidulafungina, to other echinocandins (e.g., caspofungin acetate), or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting treatment with Anidulafungina Accord.

Your doctor may decide to monitor:

• your liver function closely if you develop any liver problems during treatment.
• if you are given anesthetics during treatment with Anidulafungina Accord.
• the appearance of signs of an allergic reaction such as itching, wheezing (whistling sound when breathing), skin rash.
• the appearance of signs of a reaction related to the infusion such as rash, hives, itching, or redness.
• the appearance of shortness of breath/breathing difficulties, dizziness, or fainting.

Children and adolescents

Anidulafungina Accord should not be given to patients under 1 month.

Other medicines and Anidulafungina Accord

Tell your doctor or pharmacist if you or your child are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

The effect of Anidulafungina Accord on pregnant women is not known. Therefore, Anidulafungina Accord is not recommended during pregnancy. Women of childbearing age should use effective contraception. Contact your doctor immediately if you become pregnant during treatment with this medicine.

The effect of Anidulafungina Accord on breastfeeding women is not known. Talk to your doctor or pharmacist before taking Anidulafungina Accord while breastfeeding.

Talk to your doctor or pharmacist before taking any medicine.

Anidulafungina Accord contains fructose

This medicine contains 102.5 mg of fructose (a type of sugar) per vial. If your doctor has told you that you have an intolerance to some sugars, consult them before using this medicine.

If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder,

you must not receive this medicine. Patients with HFI cannot break down the fructose in this medicine, which can cause serious side effects.

Talk to your doctor before receiving this medicine if you (or your child) have HFI or cannot take sweet foods or drinks because they make you feel sick, vomit, or have unpleasant effects such as bloating, stomach cramps, or diarrhea.

Anidulafungina Accord contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per vial; this is essentially "sodium-free".

3. How to use Anidulafungina Accord

Anidulafungina Accord will always be prepared and administered to you or your child by a doctor or other healthcare professional (for more information on the preparation method, see the section intended only for doctors or healthcare professionals at the end of the leaflet).

For use in children and adolescents (aged 1 month to less than 18 years), treatment starts with 3.0 mg/kg (not exceeding 200 mg) on the first day (loading dose), followed by a daily dose of 1.5 mg/kg (not exceeding 100 mg) (maintenance dose). The dose administered depends on the patient's weight.

For use in adults, treatment starts with 200 mg on the first day (loading dose), followed by a daily dose of 100 mg (maintenance dose).

This medicine must be administered once a day, by intravenous infusion (drip). For adults, the maintenance dose takes 1.5 hours to administer and the loading dose 3 hours. For children and adolescents, the infusion may take less time depending on the patient's weight.

Your doctor will determine the duration of treatment and the amount of medicine to be administered each day, and will monitor both your response to treatment and your general condition.

In general, your treatment should continue for at least 14 days after the last day that Candidawas detected in your blood.

If you receive more Anidulafungina Accord than you shouldIf you think you have been given too much Anidulafungina Accord, talk to your doctor or other healthcare professional immediately.

If you miss a dose of Anidulafungina Accord

Since this medicine will be administered under strict medical supervision, it is unlikely that a dose will be missed. However, if you think a dose has been missed, talk to your doctor or other healthcare professional immediately.

Your doctor should not give you a double dose.

If you stop treatment with Anidulafungina Accord

You should not notice any of the effects of this medicine when your doctor stops your treatment with Anidulafungina Accord.

Your doctor may prescribe another medicine after treatment with Anidulafungina Accord to continue treating your fungal infection or prevent a relapse.

If the initial symptoms of the infection return, talk to your doctor or other healthcare professional immediately.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Anidulafungina Accord can cause side effects, although not everybody gets them. Some of these side effects will be taken into account by your doctor when monitoring your response and condition.

Rarely, life-threatening allergic reactions have been reported during administration of Anidulafungina Accord, which can include difficulty breathing with wheezing (whistling sound when breathing) or worsening of a pre-existing rash.

Serious side effects – tell your doctor or other healthcare professional immediately if you experience any of the following:

• Seizures (fits).
• Redness or flushing
• Rash, itching (pruritus).
• Flushing.
• Hives.
• Sudden contraction of the muscles that line the airways resulting in wheezing or coughing.
• Breathing difficulties.

Very common side effects (may affect more than 1 in 10 people):

• Low potassium levels in the blood (hypokalaemia).
• Diarrhea.
• Nausea.

Common side effects (may affect up to 1 in 10 people):

• Seizures (fits).
• Headache.
• Vomiting.
• Changes in blood test results indicating liver function.
• Rash, itching (pruritus).
• Changes in blood test results indicating kidney function.
• Abnormal flow of bile from the gallbladder to the intestine (cholestasis).
• High blood sugar levels.
• High blood pressure.
• Low blood pressure.
• Sudden contraction of the muscles that line the airways resulting in wheezing or coughing.
• Breathing difficulties.

Uncommon side effects (may affect up to 1 in 100 people):

• Blood clotting disorders.
• Redness or flushing.
• Flushing.
• Stomach pain.
• Hives.
• Pain at the injection site.

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

• Life-threatening allergic reactions.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anidulafungina Accord

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C).

The reconstituted solution can be stored for up to 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

The infusion solution can be stored for 48 hours at 25°C (room temperature) (do not freeze) and should be administered at 25°C (room temperature) within 48 hours.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours at 2-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Medicines should not be disposed of via wastewater or household waste.

6. Container Content and Additional Information

Composition of Anidulafungina Accord

• The active ingredient is anidulafungin. Each vial of powder contains 100 mg of anidulafungin. The reconstituted solution contains 3.33 mg/ml of anidulafungin and the diluted solution contains 0.77 mg/ml of anidulafungin.
• The other ingredients are: fructose (see section 2 "Anidulafungina Accord contains fructose"), mannitol, polysorbate 80, lactic acid, sodium hydroxide (for pH adjustment) (see section 2 "Anidulafungina Accord contains sodium"), hydrochloric acid (for pH adjustment).

Appearance of the Product and Container Content

Anidulafungina Accord is presented in a box containing 1 vial of 100 mg powder for concentrate for solution for infusion.

The powder is white or off-white in color.

Container size: 1 vial

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n.

Edifici Est 6ª planta 08039 - Barcelona

Spain

Manufacturer

PharmIdea SIA

4 Rupnicu Str.

2114 Olaine

Latvia

Or

Lyocontract GmbH

Pulverwiese 1

38871 Ilsenburg

Germany

Or

LABORATORIOS ALCALÁ FARMA, S.L.

Address: Avenida de Madrid, 82,

Alcalá de Henares, 28802

Madrid, Spain

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

Date of the Last Revision of this Leaflet:May 2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals and is applicable only to the presentation of Anidulafungina Accord 100 mg powder for concentrate for solution for infusion, which contains a single vial:

The content of the vial must be reconstituted with water for injectable preparations and then diluted ONLY with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion. The compatibility of the reconstituted solution of Anidulafungina Accord with intravenous substances, additives, or other medicinal products has not been established, except with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion. The infusion solution should not be frozen.

Reconstitution

Each vial should be reconstituted under aseptic conditions with 30 ml of water for injectable preparations to achieve a concentration of 3.33 mg/ml. The reconstitution time may be up to 5 minutes. After dilution, the solution should be discarded if solid particles or a color change are identified.

The reconstituted solution can be stored at up to 25 °C for up to 24 hours before further dilution. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user.

Dilution and Infusion

Parenteral medicinal products should be inspected visually for particulate matter and color change prior to administration, whenever the solution and container permit. If particulate matter or color change is identified, discard the solution.

Adult Patients

The content of the reconstituted vial(s) should be transferred aseptically to an intravenous administration bag (or bottle) containing sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion to achieve the appropriate anidulafungin concentration. The following table provides the dilution to a concentration of 0.77 mg/ml for the final infusion solution and the infusion instructions for each dose.

Dilution Requirements for Administration of Anidulafungina Accord

A 9 mg/ml (0.9%) sodium chloride for infusion or 50 mg/ml (5%) glucose for infusion.

B The concentration of the infusion solution is 0.77 mg/ml.

The infusion rate should not exceed 1.1 mg/min (equivalent to 1.4 ml/min or 84 ml/hour once reconstitution and subsequent dilution are completed, according to the instructions described).

Pediatric Patients

For pediatric patients from 1 month to <18 years, the volume of infusion solution required to administer dose will vary depending on patient's weight. reconstituted should be further diluted a concentration 0.77 mg ml for final solution. programmable syringe or pump is recommended. The infusion rate should not exceed 1.1 mg/minute (equivalent to 1.4 ml/minute or 84 ml/hour when reconstituted and diluted according to the instructions).

1. Calculate the dose for the patient and reconstitute the necessary vial(s) according to the reconstitution instructions to achieve a concentration of 3.33 mg/ml.

1. Calculate the volume (ml) of reconstituted anidulafungin required:

• Volume of anidulafungin (ml) = Anidulafungin dose (mg) ÷ 3.33 mg/ml

1. Calculate the total volume of dosing solution (ml) required to achieve a final concentration of 0.77 mg/ml:

• Total volume of dosing solution (ml) = Anidulafungin dose (mg) ÷ 0.77 mg/ml

1. Calculate the volume of diluent [sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion] required to prepare the dosing solution:

• Volume of diluent (ml) = Total volume of dosing solution (ml) – Volume of anidulafungin (ml)

1. Transfer the required volumes (ml) of anidulafungin and sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion aseptically to an intravenous infusion bag or syringe necessary for administration.

For single use. The disposal of unused medicinal products and all materials that have come into contact with them should be carried out in accordance with local regulations.