Anidulafungin Accord 100 mg powder for concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Anidulafungine Accord 100 mg powder for concentrate for solution for infusion EFG

Read this entire leaflet carefully before you or your child start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you or your child experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Anidulafungin Accord is and what it is used for.
2. What you need to know before using Anidulafungin Accord.
3. How to use Anidulafungin Accord.
4. Possible adverse effects.
5. How to store Anidulafungin Accord.

Pack contents and additional information.

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

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

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

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

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

Do not use Anidulafungin Accord

• if you are allergic to anidulafungin, to other echinocandins (for example, caspofungin acetate), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Anidulafungin Accord.

Your doctor may decide to monitor:

• your liver function carefully if you develop any liver problems during treatment.
• whether you are administered anesthetics during treatment with Anidulafungin Accord.
• the appearance of signs of an allergic reaction such as itching, wheezing, skin rash.
• the appearance of signs of an infusion-related reaction such as rash, hives, itching, or redness.
• the appearance of shortness of breath/difficulty breathing, dizziness, or fainting.

Children and adolescents

Anidulafungin Accord must not be given to patients under 1 month of age.

Other medicines and Anidulafungin Accord

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

Pregnancy and breastfeeding

It is not known whether Anidulafungin Accord has an effect in pregnant women. Therefore, the use of Anidulafungin Accord during pregnancy is not recommended. Women of childbearing age should use an effective method of contraception. Contact your doctor immediately if you become pregnant while being treated with this medicine.

It is not known whether Anidulafungin Accord affects breastfeeding women. Consult your doctor or pharmacist before taking Anidulafungin Accord if you are breastfeeding.

Talk to your doctor or pharmacist before taking any medicine.

Anidulafungin Accord contains fructose

This medicine contains 102.5 mg of fructose (a type of sugar) in each vial. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before using this medicine.

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

this medicine must not be administered. Patients with HFI cannot metabolize the fructose in this

medicine, which may lead to serious adverse effects.

Consult your doctor before receiving this medicine if you (or your child) have HFI or

cannot consume sweet foods or drinks because they cause dizziness, vomiting, or unpleasant effects

such as bloating, stomach cramps, or diarrhea.

Anidulafungin 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 Anidulafungin Accord

Anidulafungin 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 exclusively for doctors or healthcare professionals at the end of this leaflet).

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

For use in adults, treatment is initiated 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 daily by intravenous infusion (by drip). In adults, the maintenance dose takes 1.5 hours to administer and the loading dose takes 3 hours. In children and adolescents, the infusion may take less time depending on the patient's body 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 overall condition.

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

If you receive more Anidulafungin Accord than you should
If you think you may have been given too much Anidulafungin Accord, consult your doctor or another healthcare professional immediately.

If you forget to use Anidulafungin 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 may have been missed, consult your doctor or another healthcare professional immediately.

Your doctor must not administer a double dose.

If you stop treatment with Anidulafungin Accord
You should not notice any effects of this medicine when your doctor stops your treatment with Anidulafungin Accord.

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

If the initial symptoms of infection reappear, consult your doctor or another healthcare professional immediately.

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

4. Possible adverse effects

Like all medicines, Anidulafungin Accord may cause adverse effects, although not everyone experiences them. Some of these adverse effects will be monitored by your doctor when assessing your response and condition.

Life-threatening allergic reactions have rarely been reported during administration of Anidulafungin Accord, which may include difficulty breathing with wheezing (a whistling sound when breathing) or worsening of a pre-existing rash.

Serious adverse effects – contact your doctor or other healthcare professional immediately if any of the following occur:

• Seizures (fits).
• Redness or flushing.
• Rash, pruritus (itching).
• Hot flushes.
• Urticaria.
• Sudden contraction of the respiratory muscles resulting in gasping or coughing.
• Difficulty breathing.

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

• Low blood potassium levels (hypokalaemia).
• Diarrhoea.
• Nausea.

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

• Seizures (fits).
• Headache.
• Vomiting.
• Abnormal blood test results indicating liver function abnormalities.
• Rash, pruritus (itching).
• Abnormal blood test results indicating kidney function abnormalities.
• Abnormal flow of bile from the gallbladder into the intestine (cholestasis).
• High blood sugar levels.
• High blood pressure.
• Low blood pressure.
• Sudden contraction of the muscles lining the airways causing whistling sounds and coughing.
• Difficulty breathing.

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

• Disorders related to blood coagulation.
• Redness or flushing.
• Hot flushes.
• Stomach pain.
• Urticaria.
• Pain at the injection site.

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

• Life-threatening allergic reactions.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anidulafungin Accord

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

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

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

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

From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C, unless reconstitution/dilution has taken place 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

Composition of Anidulafungin Accord

• The active substance 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 “Anidulafungin Accord contains fructose”), mannitol, polysorbate 80, lactic acid, sodium hydroxide (to adjust pH) (see section 2 “Anidulafungin Accord contains sodium”), hydrochloric acid (to adjust pH).

Appearance of the product and contents of the pack

Anidulafungin Accord is supplied as a carton containing 1 vial of 100 mg powder for concentrate for solution for infusion.

The powder is white or almost white.

Pack 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 most recent review of this summary: May 2022

Detailed and up-to-date information on this medicine 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 physicians or healthcare professionals and applies only to the Anidulafungin Accord 100 mg powder for concentrate for solution for infusion presentation containing a single vial:

The contents of the vial must be reconstituted with water for injections and subsequently diluted ONLY with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion. Compatibility of the reconstituted Anidulafungin Accord solution with intravenous substances, additives, or other medicines 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 must not be frozen.

Reconstitution

Each vial must be reconstituted under aseptic conditions with 30 ml of water for injections to achieve a concentration of 3.33 mg/ml. Reconstitution may take up to 5 minutes. After dilution, the solution must be discarded if solid particles or discoloration are observed.

The reconstituted solution may be stored at up to 25 °C for up to 24 hours prior to further dilution. From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for the duration and conditions of in-use storage prior to use.

Dilution and infusion

Parenteral medicines should be inspected visually for solid particles and discoloration prior to administration, whenever the solution and container permit. If solid particles or discoloration are observed, discard the solution.

Adult patients

The contents of the reconstituted vial(s) should be transferred aseptically into 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 obtain the appropriate anidulafungin concentration. The following table provides dilution instructions to achieve a final infusion solution concentration of 0.77 mg/ml and infusion instructions for each dose.

Dilution requirements for administration of Anidulafungin 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 must not exceed 1.1 mg/min (equivalent to 1.4 ml/min or 84 ml/hour after reconstitution and subsequent dilution as described in the instructions).

Pediatric patients

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

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

2. 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 [9 mg/ml (0.9%) sodium chloride for infusion or 50 mg/ml (5%) glucose for infusion] required to prepare the dosing solution:

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

1. Aseptically transfer the required volumes (ml) of reconstituted anidulafungin and 9 mg/ml (0.9%) sodium chloride for infusion or 50 mg/ml (5%) glucose for infusion into an infusion syringe or intravenous infusion bag as needed for administration.

For single use only. Any unused medicine and all materials that have come into contact with it must be disposed of in accordance with local regulations.