Label: information for the user

Anidulafungina Reig Jofre 100 mg powder for concentrate for solution for infusionEFG

anidulafungina

Read this label carefully before starting to use this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you or your child experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

This medication contains the active ingredient anidulafungina and is prescribed for adults and pediatric patients 1 month to less than 18 years old 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 asCandida.

Anidulafungina belongs to a group of medications called echinocandins. These medications are used for the treatment of severe fungal infections.

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

No use Anidulafungina Reig Jofre

• If you or your child is allergic to anidulafungina, other echinocandins (for example, caspofungin acetate), or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult 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 administered anesthetics during treatment with anidulafungina.
• The appearance of signs of an allergic reaction such as itching, wheezing, skin rashes.
• The appearance of signs of a perfusion-related reaction such as rash, urticaria, itching, or redness.
• The appearance of shortness of breath/difficulty breathing, dizziness, or vertigo.

Children and Adolescents

Anidulafungina should not be administered to patients under 1 month.

Use of Anidulafungina Reig Jofre with Other Medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and Lactation

The effect of anidulafungina on pregnant women is unknown. Therefore, the use of anidulafungina during pregnancy is not recommended. Women of childbearing age should use an effective contraceptive method. Contact your doctor immediately if you become pregnant during treatment with anidulafungina.

The effect of anidulafungina on women in lactation is unknown. Consult your doctor or pharmacist before taking this medication while breastfeeding.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Anidulafungina Reig Jofre Contains Fructose

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

If you (or your child) suffer from hereditary fructose intolerance (HFI), a rare genetic disease, you should not receive this medication. Patients with HFI cannot break down the fructose in this medication, which can cause severe adverse effects.
Consult with your doctor before receiving this medication if you (or your child) suffer from 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 medication contains less than 1 mmol of sodium (23 mg) per vial; it is essentially "sodium-free".

This medication 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 prospectus).

For use in adults, treatment begins 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 (1 month to less than 18 years old), treatment begins 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 must be administered once a day, via 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 overall condition.

Generally, 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 Anidulafungina Reig Jofre than you should

If you think you or your child may have been given too much Anidulafungina, consult your doctor or other healthcare professional immediately.

If you forgot to use Anidulafungina Reig Jofre

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

Your doctor should not administer a double dose.

If you interrupt treatment with Anidulafungina Reig Jofre

You or your child should not notice any effects of anidulafungina when your doctor suspends treatment with this medication.

Your doctor may prescribe another medication after treatment with anidulafungina to continue treating your fungal infection or prevent a relapse.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 anidulafungin administration, which may include difficulty breathing with wheezing (a high-pitched sound when breathing) or worsening of an existing rash.

Severe side effects – immediately inform your doctor or any other healthcare professional if any of the following side effects occur:

• Seizures (convulsions).
• Redness or flushing.
• Rash, pruritus (itching).
• Angioedema.
• Urticaria.
• 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 levels of potassium in the blood (hypokalemia).
• Diarrhea.
• Nausea.

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

• Seizures (convulsions).
• Headache.
• Vomiting.
• Abnormal results in blood tests indicating liver function.
• Rash, pruritus (itching).
• Abnormal results in blood tests indicating kidney function.
• Abnormal bile flow from the gallbladder into the intestine (cholestasis).
• High levels of sugar in the blood.
• High blood pressure.
• Low blood pressure.
• Sudden contraction of the muscles covering the airways producing stridor and coughing.
• Difficulty breathing.

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

• Bleeding disorders.
• Redness or flushing.
• Angioedema.
• Abdominal pain.
• Urticaria.
• Pain at the injection site.

Unknown frequency (cannot be estimated from available data):

• Life-threatening allergic reactions.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Store in 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 must be used immediately. If not used immediately, storage times in use and conditions before use are the responsibility of the user and normally should not exceed more than 24 hours at 2 – 8°C, unless reconstitution / dilution has taken place in controlled and validated aseptic conditions

Medicines should not be disposed of through drains or in the trash.

Composition of Anidulafungin Reig Jofre

• The active ingredient is anidulafungin. Each vial of powder contains 100 mg of anidulafungin.
• The rest of the ingredients are: fructose, mannitol, polisorbate 80, tartaric acid, sodium hydroxide (to adjust the pH) and/or hydrochloric acid (to adjust the pH).

Appearance of the product and contents of the package

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

Not all package sizes may be marketed.

The powder is white or off-white.

Holder of the Marketing Authorization and Responsible for Manufacturing

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 for concentrate for solution for infusion

Spain:Anidulafungina Reig Jofre 100 mg powder for concentrate for solution for infusion EFG

Sweden:Anidulafungin Reig Jofre

Date of the last review of this leaflet:May 2023.

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)

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This information is intended solely for doctors or healthcare professionals and is applicable 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%) for infusion or with glucose 50 mg/ml (5%) for infusion. The compatibility of the reconstituted solution of Anidulafungina Reig Jofre with intravenous substances, additives, or other medications, except for sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) for infusion, has not been established.

Reconstitution

Each vial must 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 must be discarded if solid particles or a change in coloration 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 medications must be visually inspected to check for the presence of solid particles or a change in coloration prior to administration, whenever the solution and packaging permit.

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

Adult patients

The contents of the reconstituted vial(s) must be transferred aseptically to an intravenous administration bag (or flask) containing sodium chloride 9 mg/ml (0.9%) for infusion or glucose 50 mg/ml (5%) for infusion to achieve a final concentration of anidulafungin of 0.77 mg/ml and the infusion instructions for each dose. The following table presents the required volumes for each dose.

Requirements for dilution for the administration of Anidulafungina Reig Jofre

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

BThe 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 once reconstitution and subsequent dilution have been completed, according to the instructions described).

Pediatric patients

For pediatric patients from 1 month to <18>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 the instructions).

1. Calculate the dose for the patient and reconstitute the (the) vial(s) as required 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 the 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%) 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)

1. 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 aseptically to an infusion syringe or an intravenous infusion bag (or flask) necessary for administration.

For single use. The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.