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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

anidulafungin

Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you or your child experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Anidulafungin Teva contains the active substance anidulafungin and is prescribed in adults and pediatric patients from 1 month to less than 18 years of age for the treatment of 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.

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 Teva

Do not use Anidulafungin Teva:

• if you are allergic to anidulafungin, to other echinocandins (for example, caspofungin, micafungin), 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 Teva.

Your doctor may decide to monitor:

• your liver function carefully if you develop any liver problems during treatment.
• if you are administered anaesthetics during treatment with this medicine.
• any signs of an allergic reaction, such as itching, wheezing, blotchy skin.
• any signs of an infusion-related reaction which may include rash, hives, itching, redness,
• shortness of breath/difficulty breathing, dizziness or lightheadedness.

Children and adolescents

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

Using Anidulafungin Teva with other medicines

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

Pregnancy and breastfeeding

It is not known whether this medicine affects pregnant women. Therefore, the use of Anidulafungin Teva 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 this medicine.

It is unknown whether this medicine affects breastfeeding women. Consult your doctor or pharmacist before taking Anidulafungin Teva while breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Anidulafungin Teva contains sodium

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

Anidulafungin Teva contains polysorbate

This medicine contains 250 mg of polysorbate 80 in each vial, equivalent to 3.6 mg/kg in adults (for example, 70 kg body weight). Polysorbates may cause allergic reactions. Inform your doctor if you or your child have any known allergies.

Polysorbates may have an effect on the heart and blood circulation (abnormal or irregular heartbeat or decreased blood pressure).

3. How to use Anidulafungin Teva

Anidulafungin Teva will always be prepared and administered to you or your child by a doctor or other healthcare professional (for further information on the preparation method, see the section intended for medical or healthcare professionals at the end of the 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 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.

This medicine must be given once daily by 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 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 Teva than you should

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

If you forget to use Anidulafungin Teva

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 Teva

You should not notice any effects of this medicine once your doctor stops your treatment with Anidulafungin Teva.

Your doctor may prescribe another medicine after treatment with Anidulafungin Teva 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 adverse effects

Like all medicines, Anidulafungin Teva 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 clinical condition.

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

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

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

Other adverse effects

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.
• 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 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, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 Teva

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 a temperature of up to 25 °C for up to 24 hours. 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 the first 48 hours.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Package contents and other information

Composition of Anidulafungin Teva

• The active substance is anidulafungin. Each vial of powder contains 100 mg of anidulafungin.
• The other ingredients are: sucrose, polysorbate 80 (E 433), tartaric acid, sodium hydroxide (E 524) (to adjust pH), hydrochloric acid (E 507) (to adjust pH).

Appearance of the product and contents of the pack

Anidulafungin Teva is available as a powder for concentrate for solution for infusion in a carton containing 1 vial.

The powder is white to off-white, with no visible evidence of contamination.

Marketing Authorization Holder and Manufacturer

Teva B.V.

Swensweg, 5

2031GA Haarlem, The Netherlands

Local representative:

Teva Pharma S.L.U.

C/Anabel Segura 11,

Edificio Albatros B 1st floor

28108 Alcobendas

Spain

Manufacturer

Teva Operations Poland Sp. z.o.o

Ul. Mogilska 80

Krakow 31-546 Poland

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25

Zagreb

10000 Croatia

or

S.C. SINDAN-PHARMA S.R.L.

11th Ion Mihalache Boulevard

Bucharest 011171 Romania

or

Merckle GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Date of the most recent revision of this summary: November 2021

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only and applies exclusively to the Anidulafungin Teva 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 50 mg/ml (5%) glucose solution for infusion. Compatibility of the reconstituted Anidulafungin Teva 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. The infusion solution must not be frozen.

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 appearance after reconstitution is a clear, colorless to yellow solution.

The reconstituted solution may be stored at a temperature 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 by slowly adding the solution to 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, with constant gentle agitation, to achieve the appropriate anidulafungin concentration.

The following table provides dilution instructions to achieve a final infusion solution concentration of 0.77 mg/ml and the corresponding infusion instructions for each dose.

Dilution requirements for administration of Anidulafungin Teva

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

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 concentration of 0.77 mg/ml for the final 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). (see sections 4.2 and 4.4)

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

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 solution for infusion or 50 mg/ml (5%) glucose solution 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 anidulafungin and 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion into the required 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.