Anidulafungin Reig Jofre 100 mg powder for concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Anidulafungin Reig Jofre 100 mg powder for concentrate for solution for infusion EFG

anidulafungin

Read all of this leaflet carefully before you start using this medicine, as 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.
• If you or your child experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Anidulafungin Reig Jofre is and what it is used for

This medicine 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 in the blood or other internal organs called invasive candidiasis. The infection is caused by fungal (yeast) cells known as Candida.

Anidulafungin 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 Reig Jofre

Do not use Anidulafungin Reig Jofre

• if you or your child are allergic to anidulafungin, to other echinocandins (e.g., 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 starting to use Anidulafungin Reig Jofre.

Your doctor may decide to monitor:

• your liver function carefully if you develop any liver problems during treatment.
• whether you or your child are receiving anaesthetics during treatment with anidulafungin.
• for signs of an allergic reaction such as itching, wheezing, or 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

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

Using Anidulafungin Reig Jofre with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

It is unknown whether anidulafungin affects pregnant women. Therefore, the use of anidulafungin 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 anidulafungin.

It is unknown whether anidulafungin affects breastfeeding women. Consult your doctor or pharmacist before taking this medicine if you are 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.

Anidulafungin Reig Jofre contains fructose

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

If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, this medicine must not be given. 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 diarrhoea.

Anidulafungin Reig Jofre contains sodium

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

3. How to use Anidulafungin Reig Jofre

This medicine will always be prepared and administered by a doctor or other healthcare professional (for further information on the preparation method, see the section intended exclusively for doctors or healthcare professionals at the end of this leaflet).

For use in adults, treatment is initiated with a 200 mg dose on the first day (loading dose), followed by a daily maintenance dose of 100 mg.

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.

Anidulafungin Reig Jofre must be administered once daily by slow intravenous infusion (drip infusion). 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 Anidulafungin Reig Jofre to be administered each day, and will monitor 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 are given more Anidulafungin Reig Jofre than you should

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

If you forget to use Anidulafungin Reig Jofre

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 Reig Jofre

You or your child should not experience any effects from anidulafungin once your doctor stops treatment with this medicine.

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

If the initial symptoms of the 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Some of these side effects will be monitored by your doctor when assessing your response and condition.

Rarely, life-threatening allergic reactions have been reported during 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 – immediately inform your doctor or any other healthcare professional if any of the following side effects 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.

Other side effects

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

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

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

• Seizures (fits).
• Headache.
• Vomiting.
• Changes in blood test results indicating liver function.
• Rash, pruritus (itching).
• Changes in blood test results 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 lining the airways causing whistling and coughing.
• Difficulty breathing.

Uncommon side 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 side effects

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

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

5. Storage of Anidulafungin Reig Jofre

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 may be stored at temperatures up to 25°C for a period of up to 24 hours. The infusion solution may be stored at 25°C (room temperature) for 48 hours or frozen for at least 72 hours, and must be administered at 25°C (room temperature) within the first 48 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 and should normally not exceed 24 hours at 2–8°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 container and other information

Composition of Anidulafungin 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 (to adjust pH) and/or hydrochloric acid (to adjust pH).

Appearance of the product and contents of the pack

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 pack sizes may be marketed.

The powder is white or almost white.

Marketing Authorization Holder and Manufacturer

Laboratorio Reig Jofre, S.A.
Gran Capitán, 10
08970 Sant Joan Despí (Barcelona)
Spain

This medicinal product is authorized in EEA member states under the following names:

Denmark: Anidulafungin Reig Jofre
Finland: Anidulafungin Reig Jofre
Norway: Anidulafungin Reig Jofre
Portugal: Anidulafungina Reig Jofre 100 mg powder 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 most recent review of this summary: May 2023

Other sources of information

Detailed information on this medicinal product 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 healthcare professionals and applies only to the Anidulafungin Reig Jofre 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 injection and subsequently diluted ONLY with 9 mg/ml (0.9%) sodium chloride solution for infusion or with 50 mg/ml (5%) glucose solution for infusion. Compatibility of the reconstituted Anidulafungin Reig Jofre solution with intravenous substances, additives, or other 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 injection 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 temperatures up to 25°C for up to 24 hours prior to subsequent dilution.

Dilution and infusion

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

Discard the solution if solid particles or discoloration are observed.

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 obtain a final infusion solution concentration of anidulafungin of 0.77 mg/ml and for infusion instructions for each dose. The required volumes for each dose are shown in the following table.

Dilution requirements for administration of Anidulafungin Reig Jofre

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 concentration of 0.77 mg/ml for the infusion solution. 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 patient's dose 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

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) = Anidulafungin dose (mg) ÷ 0.77 mg/ml

4. 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)

5. Aseptically transfer the required volumes (ml) of anidulafungin and 9 mg/ml (0.9%) sodium chloride for infusion or 50 mg/ml (5%) glucose for infusion to the required intravenous infusion syringe or 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 regulations.