Anidulafungin Sandoz

Package Leaflet: Information for the Patient

Anidulafungin Sandoz, 100 mg, Powder for Concentrate for Solution for Infusion

Anidulafungin

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Anidulafungin Sandoz and What is it Used For
• 2. Important Information Before Using Anidulafungin Sandoz
• 3. How to Use Anidulafungin Sandoz
• 4. Possible Side Effects
• 5. How to Store Anidulafungin Sandoz
• 6. Contents of the Package and Other Information

1. What is Anidulafungin Sandoz and What is it Used For

Anidulafungin Sandoz contains the active substance anidulafungin and is prescribed to adults and children and adolescents from 1 month to less than 18 years of age to treat fungal infections of the blood or internal organs, known as invasive candidiasis. This infection is caused by fungal cells (yeast) called Candida. Anidulafungin Sandoz belongs to a group of medicines called echinocandins. Medicines in this group are used to treat severe fungal infections. Anidulafungin Sandoz works by preventing the normal production of the fungal cell wall. In the presence of this medicine, the fungal cell walls are incomplete or damaged, making them fragile or unable to grow.

2. Important Information Before Using Anidulafungin Sandoz

When Not to Use Anidulafungin Sandoz

if you are allergic to anidulafungin, other echinocandins (e.g., caspofungin acetate), or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Before starting treatment with Anidulafungin Sandoz, discuss this with your doctor, pharmacist, or nurse. Your doctor may decide to monitor: liver function, especially in patients who have had liver function disorders during treatment; symptoms of an allergic reaction (such as itching, wheezing, rash) in patients who are receiving anesthesia during treatment with Anidulafungin Sandoz; symptoms of infusion-related reactions, such as rash, urticaria, itching, flushing; shortness of breath/difficulty breathing, dizziness, or fainting.

Children and Adolescents

Anidulafungin Sandoz should not be used in patients under 1 month of age.

Anidulafungin Sandoz and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those for children.

Pregnancy and Breastfeeding

The effect of Anidulafungin Sandoz in pregnant women is not known. Therefore, it is not recommended during pregnancy. Women of childbearing age should use effective contraception. If you become pregnant while using Anidulafungin Sandoz, contact your doctor immediately. The effect of Anidulafungin Sandoz in breastfeeding women is not known. Before using Anidulafungin Sandoz during breastfeeding, consult your doctor or pharmacist. Before using any medicine, consult your doctor or pharmacist.

Anidulafungin Sandoz Contains Fruktose and Sodium

Anidulafungin Sandoz contains 100 mg of fructose in each vial. If you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder, you should not use this medicine. In patients with hereditary fructose intolerance, the body does not break down the fructose contained in this medicine, which can cause severe side effects. Inform your doctor before taking this medicine if you have hereditary fructose intolerance or should not consume sweet foods or drinks due to nausea, vomiting, or unpleasant side effects, such as bloating, stomach cramps, or diarrhea. This medicine contains less than 1 mmol (23 mg) of sodium per vial, which means it is considered "sodium-free".

3. How to Use Anidulafungin Sandoz

Anidulafungin Sandoz is always prepared and administered by a doctor or other medical staff (more information on how to prepare the medicine can be found at the end of the package leaflet, in the section intended only for healthcare professionals). In adults, treatment starts with a dose of 200 mg on the first day (loading dose). Then, a daily dose of 100 mg (maintenance dose) is administered. In children and adolescents (from 1 month to less than 18 years of age), treatment starts with a dose of 3.0 mg/kg body weight (not exceeding 200 mg) on the first day (loading dose). Then, a daily dose of 1.5 mg/kg body weight (not exceeding 100 mg) (maintenance dose) is administered. The administered dose depends on the patient's body weight. Anidulafungin Sandoz should be administered once daily by slow intravenous infusion (drip). In adults, the maintenance dose is administered over at least 1.5 hours, and the loading dose over 3 hours. In children and adolescents, the infusion time may be shorter, depending on the patient's body weight. Your doctor will determine the duration of treatment and the dose of the medicine to be administered each day and will monitor the patient's response to treatment and their condition. In general, treatment lasts at least 14 days after the last day on which Candidayeast was detected in the patient's blood.

Receiving More Than the Recommended Dose of Anidulafungin Sandoz

If you are unsure whether you have received too much Anidulafungin Sandoz, contact your doctor or other medical staff immediately.

Missing a Dose of Anidulafungin Sandoz

The medicine is administered to the patient under strict medical supervision, so missing a dose is unlikely. However, if you have any doubts about whether you received a dose of the medicine, tell your doctor or pharmacist. Your doctor should not administer a double dose of the medicine.

Stopping Treatment with Anidulafungin Sandoz

Stopping treatment with Anidulafungin Sandoz by your doctor should not cause any symptoms in you. After stopping treatment with Anidulafungin Sandoz, your doctor may prescribe another medicine to continue treating the fungal infection or to prevent its recurrence. If the original symptoms recur, inform your doctor or medical staff immediately. If you have any further questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, Anidulafungin Sandoz can cause side effects, although not everybody gets them. Some of these side effects will be detected by your doctor while monitoring your response to treatment and your condition. During treatment with anidulafungin, rare cases of life-threatening allergic reactions have been reported, such as difficulty breathing with wheezing or exacerbation of existing rash.

If You Experience Any of the Following Serious Side Effects, Tell Your Doctor or Medical Staff Immediately:

• seizures
• sudden redness of the skin, especially the face
• rash, itching
• flushing
• urticaria
• sudden constriction of the muscles surrounding the airways, causing 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
• headache
• vomiting
• changes in blood test results evaluating liver function
• rash, itching
• changes in blood test results evaluating kidney function
• disorders of bile flow from the gallbladder to the intestine (bile stasis)
• high blood sugar levels
• high blood pressure
• low blood pressure
• sudden constriction of the muscles surrounding the airways, causing wheezing or coughing
• difficulty breathing

Uncommon Side Effects (May Affect Up to 1 in 100 People)

• blood clotting disorders
• sudden redness of the skin, especially the face
• flushing
• abdominal pain
• urticaria
• pain at the injection site

Side Effects with Unknown Frequency (Frequency Cannot be Estimated from Available Data)

• life-threatening allergic reactions

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Anidulafungin Sandoz

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month. Store in a refrigerator (2°C - 8°C). The chemical and physical stability of the concentrate for solution for infusion has been demonstrated for 24 hours at 25°C. The solution for infusion may be stored at 25°C (room temperature) for 48 hours (do not freeze) and should be administered within 48 hours. Due to microbiological purity, the medicinal product should be used immediately. Otherwise, the user is responsible for the conditions and duration of storage before administration. The solution may be stored for no more than 24 hours at a temperature between 2°C and 8°C, unless reconstitution and dilution are performed under controlled and validated aseptic conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Package and Other Information

What Anidulafungin Sandoz Contains

• The active substance is anidulafungin. One vial contains 100 mg of anidulafungin. The reconstituted concentrate for solution for infusion contains 3.33 mg/ml of anidulafungin, and the diluted solution for infusion contains 0.77 mg/ml of anidulafungin.
• The other ingredients are: fructose, mannitol, polysorbate 80, (S)-lactic acid, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment).

What Anidulafungin Sandoz Looks Like and Contents of the Package

Anidulafungin Sandoz is a white or off-white cake or powder. The medicine is available in cardboard boxes containing 1 vial of powder for concentrate for solution for infusion. Pack size: 1 vial

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria Manufacturer PHARMIDEA SIA Rūpnīcu iela 4, Olaine, Olaine novads LV-2114, Latvia LYOCONTRACT GmbH Pulverwiese 1 38871 Ilsenburg, Germany Salutas Pharma GmbH Otto-von-Guericke-Allee 1 Sachsen-Anhalt 39179 Barleben, Germany LABORATORIOS ALCALÁ FARMA, S.L. Avenida de Madrid, 82 Alcalá de Henares, 28802 Madrid, Spain

For More Detailed Information on the Medicine and Its Names in the Member States of the European Economic Area, Contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00 Sandoz logo Date of Last Revision of the Package Leaflet: 04/2024 The following information is intended only for healthcare professionals and refers only to a single vial of Anidulafungin Sandoz. Anidulafungin Sandoz should be reconstituted in water for injection, and the resulting concentrate should be diluted EXCLUSIVELY with 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion. The compatibility of the reconstituted Anidulafungin Sandoz with other medicines, excipients, or solutions for intravenous administration has not been established, except for 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion. Reconstitution of the Powder (Reconstitution)The contents of each vial should be reconstituted aseptically with 30 ml of water for injection to obtain a concentrate with a concentration of 3.33 mg/ml. Reconstitution may take up to 5 minutes. The resulting concentrate should be clear, colorless, and practically free of visible particles. If, after reconstitution, visible particles or a color change are observed, the solution should be discarded. The reconstituted concentrate for solution for infusion can be stored before dilution for up to 24 hours at a temperature up to 25°C. Dilution and InfusionTransfer the contents of the vial(s) after reconstitution aseptically to an 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 the final anidulafungin infusion solution with a concentration of 0.77 mg/ml. In children and adolescents, the volume of the solution for infusion needed to administer the required dose will vary depending on the patient's body weight. The following table shows the required volumes for each dose.

Dilutions Required to Administer Anidulafungin Sandoz

Either 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion. The concentration of the solution for infusion is 0.77 mg/ml. The infusion rate should not exceed 1.1 mg/min (which corresponds to 1.4 ml/min if reconstitution and dilution are performed according to the instructions), see sections 4.2, 4.4, and 4.8. Medicines for parenteral use should be inspected visually for particulate matter and color change prior to administration, whenever the solution and container permit. If visible particles or a color change are observed, the solution should be discarded. The medicine is for single use only. Dispose of the medicine waste in accordance with local regulations.