Anidulafungina Accord

Patient Information Leaflet: User Information

Anidulafungin Accord, 100 mg, Powder for Concentrate for Solution for Infusion

Anidulafungin

Read the Leaflet Carefully Before Using the Medication in an Adult or Child Patient, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• If an adult or child patient experiences any of the side effects or any other side effects not mentioned in the leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Anidulafungin Accord and what is it used for.
• 2. Important information before using Anidulafungin Accord in an adult or child patient.
• 3. How to use Anidulafungin Accord.
• 4. Possible side effects.
• 5. How to store Anidulafungin Accord.
• 6. Contents of the pack and other information.

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

Anidulafungin Accord contains the active substance anidulafungin and is prescribed for adults and children and adolescents from 1 month to 18 years 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 Accord belongs to a group of medicines called echinocandins. Medicines in this group are used to treat severe fungal infections. Anidulafungin Accord inhibits the production of a component of the fungal cell wall. Fungal cells exposed to Anidulafungin Accord have incomplete or damaged cell walls, making them susceptible to damage or preventing their growth.

2. Important information before using Anidulafungin Accord in an adult

or child patient

When not to use Anidulafungin Accord

• If the patient is allergic to anidulafungin, other medicines in the echinocandin group (e.g. caspofungin acetate), or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to take Anidulafungin Accord, 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,
• if the patient is taking anesthetics during treatment with Anidulafungin Accord,
• if the patient has symptoms of an allergic reaction, such as itching, wheezing, skin rash,
• if the patient has symptoms related to infusion, which may include rash, urticaria, itching, redness,
• if the patient has difficulty breathing or dizziness or a feeling of impending fainting.

Children and adolescents

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

Anidulafungin Accord and other medicines

Tell your doctor or pharmacist about all medicines currently or recently taken by an adult or child patient.

Pregnancy and breastfeeding

The effect of Anidulafungin Accord in pregnant women is not known. Therefore, Anidulafungin Accord should not be used during pregnancy. Women of childbearing age should use effective methods of contraception. If pregnancy occurs during treatment with Anidulafungin Accord, the doctor should be informed immediately. The effect of Anidulafungin Accord in breastfeeding women is not known. Before taking Anidulafungin Accord during breastfeeding, consult a doctor or pharmacist. Before taking any medicine, consult a doctor or pharmacist.

Anidulafungin Accord contains fructose

The medicine contains 102.5 mg of fructose (a type of sugar) in one vial. If the patient has previously been diagnosed with intolerance to some sugars, consult a doctor before taking the medicine. If an adult or child patient has a rare genetic disorder, hereditary fructose intolerance (HFI), they should not take this medicine. Patients with HFI are unable to break down the fructose contained in this medicine, which can lead to serious side effects. Before taking this medicine, tell your doctor if an adult or child patient has HFI or if the patient cannot consume sweet foods or drinks due to nausea, vomiting, or symptoms such as bloating, stomach cramps, or diarrhea.

Anidulafungin Accord contains sodium

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

3. How to use Anidulafungin Accord

Anidulafungin Accord 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 children and adolescents (from 1 month to 18 years), 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 dose of 1.5 mg/kg body weight/day (dose not exceeding 100 mg) (maintenance dose) is administered. The administered dose depends on the patient's body weight. In adults, 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. Anidulafungin Accord should be administered once a day, in a slow intravenous infusion (drip). In adults, 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 Accord administered each day and will monitor the patient's response to treatment and their condition. Generally, treatment lasts at least 14 days after the last day on which yeast (Candida) was detected in the patient's blood.

Using a higher than recommended dose of Anidulafungin Accord

If it is suspected that the dose of Anidulafungin Accord was too high, the doctor or other medical staff should be informed immediately.

Missing a dose of Anidulafungin Accord

Since the medicine will be administered under close medical supervision, it is unlikely that a dose will be missed. However, if it is suspected that a dose has been missed, the doctor or pharmacist should be informed. The doctor should not administer a double dose of the medicine.

Stopping treatment with Anidulafungin Accord

If treatment with Anidulafungin Accord is discontinued by the doctor, no symptoms should occur. After treatment with Anidulafungin Accord, the doctor may prescribe another medicine to continue treatment of the fungal infection or to prevent recurrence of fungal infections. If the original symptoms return, the doctor or other medical staff should be informed immediately. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Severe side effects - if you experience any of the following side effects, tell your doctor or healthcare professional immediately:

• Seizures (epileptic fits);
• Sudden redness of the skin, especially the face;
• Rash, itching (pruritus);
• Flushing;
• Urticaria;
• Sudden constriction of the airways causing wheezing and coughing;
• Breathing difficulties.

Other side effects

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

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

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

• 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 (bile stasis);
• High blood sugar levels;
• High blood pressure;
• Low blood pressure;
• Sudden constriction of the airways causing wheezing and coughing;
• Breathing difficulties.

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

• Blood clotting disorders;
• Sudden redness of the skin, especially the face;
• Flushing;
• Abdominal pain;
• Urticaria;
• 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 those not mentioned in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration 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.pl. Side effects can also be reported to the marketing authorization holder.

5. How to store Anidulafungin Accord

Keep out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of that month. Store in a refrigerator (2-8°C). Do not freeze. The reconstituted solution can be stored at up to 25°C for 24 hours. From a microbiological point of view, the solution should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions and storage time. The infusion solution (diluted) can be stored at up to 25°C (room temperature) for 48 hours or in a refrigerator for 72 hours; the solution should be administered at room temperature (25°C) within 48 hours. From a microbiological point of view, the solution should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions and storage time and this should not exceed 24 hours at 2-8°C, unless reconstitution/dilution was performed under controlled and validated aseptic conditions. Medicines should not be disposed of via wastewater or household waste.

6. Contents of the pack and other information

What Anidulafungin Accord contains

• The active substance is anidulafungin. Each vial 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 "Anidulafungin Accord contains fructose"), mannitol, polysorbate 80, (S)-lactic acid, concentrated hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH) (see section 2 "Anidulafungin Accord contains sodium").

What Anidulafungin Accord looks like and contents of the pack

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o., ul. Taśmowa 7, 02-677 Warsaw

Manufacturer

PHARMIDEA SIA, Rūpnīcu iela 4, Olaine, Olaine novads, LV-2114, Latvia, LYOCONTRACT GmbH, Pulverwiese 1, 38871 Ilsenburg, Germany, LABORATORIOS ALCALÁ FARMA, S.L., 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:

Member State

Marketing authorization holder

Product name

Austria, Anidulafungin Accord 100 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung, Belgium, Anidulafungine Accord Healthcare 100 mg, poeder voor concentraat voor oplossing voor infusie, Croatia, Anidulafungin Accord 100 mg prašak za koncentrat za otopinu za infuziju, Czech Republic, Anidulafungin Accord, Denmark, Anidulafungin Accord, Finland, Anidulafungin Accord 100 mg aine konsentraattiliuosta varten infuusionesteen, Greece, Anidulafungin Accord, Spain, Anidulafungina accord 100 mg polvo para concentrado para solución para perfusión EFG, Netherlands, Anidulafungine Accord 100 mg poeder voor concentraat voor oplossing voor infusie, Ireland, Anidulafungin 100 mg powder for concentrate for solution for infusion, Germany, Anidulafungin Accord 100 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung, Norway, Anidulafungin Accord, Poland, Anidulafungina Accord, Portugal, Anidulafungina Accord, Romania, Anidulafungină Accord 100 mg pulbere pentru concentrat pentru solutie perfuzabila, Slovenia, Anidulafungin Accord 100 mg prašek za koncentrat za raztopino za infundiranje, Sweden, Anidulafungin Accord 100 mg pulver till koncentrat till infusionsvätska, lösning, United Kingdom, Anidulafungin 100 mg powder for concentrate for solution for infusion, Italy, Anidulafungina Accord

Date of last revision of the leaflet: January 2024

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The following information is intended for medical staff only and applies to a single vial of Anidulafungin Accord, 100 mg, powder for concentrate for solution for infusion: The vial contents should be dissolved in water for injection, and then diluted EXCLUSIVELY with a 9 mg/ml (0.9%) sodium chloride solution for infusion or a 50 mg/ml (5%) glucose solution for infusion. The compatibility of reconstituted Anidulafungin Accord with intravenously administered substances, excipients, or other medicines has not been established, except for 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion. Reconstitution. With aseptic precautions, the contents of each vial should be dissolved by adding 30 ml of water for injection to obtain a concentrate with a concentration of 3.33 mg/ml. The dissolution time may take up to 5 minutes. The reconstituted solution should be clear and free of visible particles. If particles or color change are visible after reconstitution, the solution should be discarded. After reconstitution, the solution can be stored at up to 25°C for 24 hours before dilution of the solution. From a microbiological point of view, the solution should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions and storage time. Dilution and infusion. The contents of the reconstituted vial should be transferred aseptically to an infusion bag (or bottle) for intravenous infusion containing a 9 mg/ml (0.9%) sodium chloride solution for infusion or a 50 mg/ml (5%) glucose solution for infusion, obtaining an anidulafungin solution with a concentration of 0.77 mg/ml. The following table shows the volume of solutions for individual doses.

Requirements for dilution of Anidulafungin Accord before administration

The infusion rate should not exceed 1.1 mg/min (which corresponds to 1.4 ml/min if the product is reconstituted and diluted according to the instructions). Medicines for intravenous administration should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. If particulate matter or discoloration is visible, the solution should be discarded. For single use only. Dispose of waste in accordance with local requirements.