Ecalta 100 mg powder for concentrate for infusion solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ECALTA 100 mg powder for concentrate for solution for infusion

Anidulafungin

Read all of this 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you or your child only and must not be given to other people, even if they have the same symptoms as you or your child, because it may harm them.
• If you or your child experience any side effects, talk to your doctor, pharmacist or nurse, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What ECALTA is and what it is used for.
2. What you need to know before you or your child start using ECALTA.
3. How to use ECALTA.
4. Possible side effects.
5. How to store ECALTA.
6. Contents of the pack and other information.

1. What ECALTA is and what it is used for

ECALTA contains the active substance anidulafungin and is prescribed for adults 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.

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

ECALTA prevents the normal development of the fungal cell wall. In the presence of ECALTA, 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 ECALTA

Do not use ECALTA

• if you are allergic to anidulafungin, to other echinocandins (for example, 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 to use ECALTA. Your doctor may decide to monitor:

• your liver function carefully if you develop any liver problems during treatment.
• if you are given anesthetics during treatment with ECALTA.
• for signs of an allergic reaction such as itching, wheezing, skin rash.
• for signs of an infusion-related reaction such as rash, hives, itching, or redness.
• for symptoms such as shortness of breath, dizziness, or fainting.

Children and adolescents

ECALTA must not be administered to patients under 1 month of age.

Use of ECALTA with other medicines

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 ECALTA has an effect in pregnant women. Therefore, the use of ECALTA during pregnancy is not recommended. Women of childbearing age should use an effective method of contraception. Contact your doctor immediately if you become pregnant during treatment with ECALTA.

It is unknown whether ECALTA affects women who are breastfeeding. Consult your doctor or pharmacist before taking ECALTA if you are breastfeeding.

Talk to your doctor or pharmacist before taking any medicine.

ECALTA contains fructose

This medicine contains 119 mg of fructose (a type of sugar) in each vial. If your doctor has told you that you have an intolerance to certain sugars, consult with your doctor before using this medicine.

If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, this medicine must not be given. Patients with HFI cannot break down the fructose in this medicine, which may cause 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.

ECALTA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; therefore, it is essentially “sodium-free”.

3. How to use ECALTA

ECALTA 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 for doctors or healthcare professionals only, at the end of the leaflet).

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).

For use in children and adolescents (aged 1 month to less than 18 years), treatment is initiated 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 body weight.

ECALTA should be given 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 ECALTA 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 on which Candida was detected in your blood.

If you receive more ECALTA than you should

If you think you may have been given too much ECALTA, consult your doctor or another healthcare professional immediately.

If you forget to use ECALTA

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 using ECALTA

You should not notice any effects from ECALTA when your doctor stops your treatment with ECALTA.

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

If the initial symptoms of infection return, 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, ECALTA 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 overall condition.

Life-threatening allergic reactions have rarely been reported during administration of ECALTA, 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 any 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 levels of potassium in the blood (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 cough.
• Difficulty breathing.

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

• Disorders related to blood clotting.
• 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 type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ECALTA

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

Do not use this medicine after the expiry date stated on the container. 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 can be stored at temperatures up to 25°C for a period of up to 24 hours. The infusion solution can be stored at 25°C (room temperature) for 48 hours (do not freeze) and must be administered at 25°C (room temperature) within the first 48 hours.

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

6. Contents of the pack and other information

Composition of ECALTA

• The active substance is anidulafungin. Each vial of powder contains 100 mg of anidulafungin.
• The other ingredients are: fructose (see section 2 “ECALTA contains fructose”), mannitol, polysorbate 80, tartaric acid, sodium hydroxide (to adjust pH) (see section 2 “ECALTA contains sodium”), hydrochloric acid (to adjust pH).

Appearance of the product and contents of the pack

ECALTA is presented in a carton containing 1 vial of 100 mg powder for concentrate for solution for infusion.

The powder is white or almost white.

Marketing Authorization Holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

Manufacturer

Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs-Sint-Amands, Belgium.

For more information about this medicine, contact the local representative of the Marketing Authorization Holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Date of the most recent review of this summary: 06/2023

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.

This information is intended for healthcare professionals only and applies exclusively to the presentation of ECALTA 100 mg powder for concentrate for solution for infusion containing a single vial:

The contents of the vial must be reconstituted with water for injections and subsequently diluted ONLY with 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion. Compatibility of the reconstituted ECALTA solution with other intravenous substances, additives, or medicinal products has not been established, except with 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion.

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 reconstitution, discard the solution if solid particles or discoloration are observed.

The reconstituted solution may be stored at temperatures up to 25°C for up to 24 hours prior to subsequent dilution.

Dilution and infusion

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

Adult patients

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

Dilution requirements for administration of ECALTA

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).

Paediatric patients

For paediatric 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 obtain a concentration of 3.33 mg/ml.

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

? Volume of anidulafungin (ml) = Dose of anidulafungin (mg) ÷ 3.33 mg/ml

3. 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) = Dose of anidulafungin (mg) ÷ 0.77 mg/ml

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

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

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

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