ANIDULAFUNGINA REIG JOFRE 100 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

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

Do not use Anidulafungina Reig Jofre

• if you or your child is allergic to anidulafungin, 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 to use Anidulafungina Reig Jofre.

Your doctor may decide to monitor:

• your liver function closely if you develop any liver problems during treatment.
• if you or your child are given anesthetics during treatment with anidulafungin.
• the appearance of signs of an allergic reaction such as itching, wheezing, 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 or difficulty breathing, dizziness, or fainting.

Children and adolescents

Anidulafungina should not be given to patients under 1 month of age.

Using Anidulafungina Reig Jofre with other medicines

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

Pregnancy and breastfeeding

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

The effect of anidulafungin on breastfeeding women is not known. Talk to your doctor or pharmacist before taking this medicine while breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Anidulafungina Reig Jofre contains Fructose

This medicine contains 102.5 mg of fructose in each vial. The additive effect of medicines containing fructose (or sorbitol) administered concomitantly and the intake of fructose (or sorbitol) in the diet should be taken into account.

If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you should not receive this medicine. Patients with HFI cannot break down the fructose in this medicine, which may cause serious side effects. Consult your doctor before receiving this medicine if you (or your child) have HFI or cannot take sweet foods or drinks because they cause nausea, vomiting, or unpleasant effects such as bloating, stomach cramps, or diarrhea.

Anidulafungina Reig Jofre contains Sodium

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

3. How to use Anidulafungina Reig Jofre

This medicine will always be prepared and administered 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 adults, treatment starts 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 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.

Anidulafungina Reig Jofre should be administered once a day, by slow 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 Anidulafungina Reig Jofre 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 Reig Jofre than you should

If you think you or your child may have been given too much Anidulafungina, talk to your doctor or another healthcare professional immediately.

If you miss a dose of Anidulafungina Reig Jofre

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

Your doctor should not give you a double dose.

If you stop treatment with Anidulafungina Reig Jofre

You or your child should not notice any of the effects of anidulafungin when your doctor stops your treatment with this medicine.

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

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

If you have any other questions about the use of this medicine, ask 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 taken into account by your doctor when monitoring your response and condition.

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

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

• Seizures (fits).
• Redness or flushing.
• Rash, itching (pruritus).
• Flushing.
• Hives.
• Sudden contraction of the respiratory muscles resulting in wheezing or coughing.
• Difficulty breathing.

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 (fits).
• Headache.
• Vomiting.
• Alteration of blood test values indicating liver function.
• Rash, itching (pruritus).
• Alteration of blood test values indicating kidney function.
• 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 that line the airways producing wheezing and coughing.
• Difficulty breathing.

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, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Anidulafungina Reig Jofre

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. The expiry date refers to the last day of the month shown.

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

The reconstituted solution can be stored at a temperature of 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 or stored frozen for at least 72 hours and must be administered at 25°C (room temperature) within the first 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 before use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C, unless the reconstitution/dilution has taken place in 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 Anidulafungina Reig Jofre

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

Appearance of the product and pack contents

Anidulafungina Reig Jofre is presented in a box containing 1 or 5 vials of 100 mg powder for concentrate for solution for infusion.

Not all pack sizes may be marketed.

The powder is white or almost white.

Marketing Authorisation Holder and Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

This medicine is authorized in the EEA member states with the following names:

Denmark: Anidulafungin Reig Jofre

Finland: Anidulafungin Reig Jofre

Norway: Anidulafungin Reig Jofre

Portugal: Anidulafungina Reig Jofre 100 mg pó para concentrado para solução para perfusão

Spain: Anidulafungina Reig Jofre 100 mg polvo para concentrado para solución para perfusión EFG

Sweden: Anidulafungin Reig Jofre

Date of last revision of this leaflet:May 2023

Other sources of information

Detailed 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 only for doctors or healthcare professionals and applies only to the presentation of Anidulafungina Reig Jofre 100 mg powder for concentrate for solution for infusion that contains a single vial:

The contents of the vial must be reconstituted with water for injection and subsequently 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 Anidulafungina Reig Jofre solution with intravenous substances, additives, 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

Each vial should be reconstituted in aseptic conditions with 30 ml of water for injection 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 a temperature of up to 25°C for a period of up to 24 hours before subsequent dilution.

Dilution and infusion

Parenteral medicines should be inspected visually for particulate matter or color change before administration, whenever the solution and container permit.

Discard the solution if solid particles or a color change are identified.

Adult patients

The contents of the reconstituted vial(s) should be transferred aseptically 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 achieve a final concentration of anidulafungin of 0.77 mg/ml for the infusion solution. The infusion instructions for each dose are as follows. The required volumes for each dose are presented in the following table.

Dilution requirements for the administration of Anidulafungina Reig Jofre

A or 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution 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 less than 18 years, the volume of infusion solution required to administer the dose will vary depending on the patient's weight. The reconstituted solution should be further diluted to a concentration of 0.77 mg/ml for the final infusion solution. A programmable syringe or infusion 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.
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 [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 medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.