Caspofungin Zentiva

Patient Information Leaflet: User Information

Caspofungin Zentiva, 50 mg

Powder for concentrate for solution for infusion
Caspofungin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

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

Table of Contents of the Leaflet

• 1. What is Caspofungin Zentiva and what is it used for
• 2. Important information before using Caspofungin Zentiva
• 3. How to use Caspofungin Zentiva
• 4. Possible side effects
• 5. How to store Caspofungin Zentiva
• 6. Contents of the pack and other information

1. What is Caspofungin Zentiva and what is it used for

What is Caspofungin Zentiva

Caspofungin Zentiva contains a medicine called caspofungin, which belongs to a group of antifungal medicines.

What is Caspofungin Zentiva used for

Caspofungin Zentiva is used to treat the following infections in children, adolescents, and adults:

• severe fungal infections of tissues and organs (called invasive candidiasis). This infection is caused by a fungus called Candida. People who may develop this type of infection include patients who have recently had an operation or have a weakened immune system. The most common symptoms of this infection are fever and chills that do not respond to antibiotic treatment;
• fungal infections of the nose, sinuses, or lungs (called invasive aspergillosis), if other antifungal medicines have not worked or have caused side effects. These infections are caused by a mold called Aspergillus; People who may develop this type of infection include patients undergoing chemotherapy, after organ transplantation, and with a weakened immune system;
• suspected fungal infection in patients with fever and low white blood cell count, whose condition has not improved after antibiotic treatment. People who are at risk of developing a fungal infection include patients who have recently had an operation or have a weakened immune system.

How Caspofungin Zentiva works

Caspofungin Zentiva weakens the fungal cells and inhibits their normal growth. This prevents the spread of the infection and allows the body's natural defense mechanisms to completely eliminate it.

2. Important information before using Caspofungin Zentiva

When not to use Caspofungin Zentiva

• if the patient is allergic to caspofungin or any of the other ingredients of this medicine (listed in section 6).

In case of doubt, before administering the medicine, consult a doctor, pharmacist, or nurse.

Warnings and precautions

Before starting treatment with Caspofungin Zentiva, discuss with your doctor, nurse, or pharmacist:

• if the patient is allergic to any medicines;
• if the patient has ever had liver problems - a different dose of the medicine may be necessary;
• if the patient is taking cyclosporin (a medicine used to prevent transplant rejection or to suppress the immune system), as the doctor may order additional blood tests during treatment;
• if the patient has ever had any other health problems.

If any of the above statements apply to the patient (or are suspected), before using Caspofungin Zentiva, consult a doctor, pharmacist, or nurse.
Caspofungin Zentiva may also cause serious skin reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

Caspofungin Zentiva and other medicines

Tell your doctor, nurse, or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those obtained without a prescription, including herbal preparations, as Caspofungin Zentiva may affect the way other medicines work. Also, some other medicines may affect the way Caspofungin Zentiva works.
If the patient is taking any of the following medicines, tell your doctor, nurse, or pharmacist:

• cyclosporin or tacrolimus (medicines used to prevent transplant rejection or to suppress the immune system), as the doctor may order additional blood tests during treatment;
• some medicines used to treat HIV, such as efavirenz or nevirapine;
• phenytoin or carbamazepine (used to treat seizures);
• dexamethasone (a steroid medicine);
• rifampicin (an antibiotic).

If any of the above statements apply to the patient (or are suspected), before using Caspofungin Zentiva, tell your doctor, nurse, or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using any medicine.

• No studies have been conducted on the use of Caspofungin Zentiva in pregnant women. During pregnancy, the medicine should only be used if the potential benefits of treatment outweigh the potential risk to the unborn child.
• Women taking Caspofungin Zentiva should not breastfeed.

Driving and using machines

There is no information to suggest that Caspofungin Zentiva may affect the ability to drive or use machines.

Caspofungin Zentiva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial, which is essentially 'sodium-free'.

3. How to use Caspofungin Zentiva

Caspofungin Zentiva will always be prepared and administered by medical personnel.
Caspofungin Zentiva will be administered:

• once a day;
• as a slow intravenous infusion (intravenous infusion);
• over a period of about 1 hour.

The duration of treatment and the daily dose of Caspofungin Zentiva will be determined by the attending physician. He will monitor the effectiveness of the medicine in the patient. In patients with a body weight over 80 kg, a different dose may be necessary.

Children and adolescents

The dose for children and adolescents may be different from the dose used in adults.

Using a higher dose of Caspofungin Zentiva than recommended

The attending physician will decide what daily dose of Caspofungin Zentiva the patient needs and how long the treatment should last. However, if there is a concern that the patient has received too high a dose of Caspofungin Zentiva, consult the attending physician or nurse immediately.
If you have any further questions about the use of this medicine, ask your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these side effects may be serious.

If you notice any of the following side effects, tell your doctor or nurse immediately, as you may need urgent medical attention:

• rash, itching, feeling of warmth, swelling of the face, lips, or throat, or difficulty breathing - possible histamine reaction to the medicine;
• difficulty breathing with wheezing or worsening rash - possible allergic reaction to the medicine;
• cough, severe breathing difficulties - in adult patients with invasive aspergillosis, severe breathing difficulties may occur, which can lead to respiratory failure;
• rash, peeling of the skin, ulcers of the mucous membranes, hives, peeling of large areas of skin.

As with all prescription medicines, some side effects may be serious. Consult your doctor for further information.
Other side effects that occur in adults include:
Common (may affect up to 1 in 10 people):

• decreased hemoglobin level (decreased level of the substance that carries oxygen in the blood), decreased white blood cell count;
• decreased albumin level (a type of protein) in the blood, decreased potassium level or low potassium level in the blood;
• headache;
• phlebitis;
• shortness of breath;
• diarrhea, nausea, or vomiting;
• changes in the results of some blood laboratory tests (including increased values of some liver tests);
• itching, rash, redness of the skin, or increased sweating;
• joint pain;
• chills, fever;
• itching at the injection site.

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

• changes in the results of some blood laboratory tests (including blood clotting, platelet count, red and white blood cell count);
• loss of appetite, increased fluid in the body, imbalance of salt levels in the body, high blood sugar level, low calcium level in the blood, low magnesium level in the blood, increased acidity of the blood;
• disorientation, feeling of agitation, insomnia;
• dizziness, weakness, numbness or tingling (especially of the skin), tremors, drowsiness, changes in taste, feeling of numbness or tingling;
• blurred vision, increased tearing, swelling of the eyelids, yellowing of the whites of the eyes (sclera);
• feeling of rapid or irregular heartbeat, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure;
• flushing, hot flashes, high blood pressure, low blood pressure, redness of the skin along the vein, extremely sensitive to touch;
• bronchospasm causing wheezing or cough, rapid breathing, shortness of breath waking from sleep, low oxygen level in the blood, abnormal breathing sounds, crackling in the lungs, wheezing, stuffy nose, cough, sore throat;
• abdominal pain, pain in the upper abdomen, bloating, constipation, difficulty swallowing, dry mouth, nausea, gas, stomach upset, swelling due to fluid accumulation in the abdominal cavity;
• decreased bile flow, enlarged liver, yellowing of the skin and/or whites of the eyes (jaundice), chemical or drug-induced liver damage, liver function disorders;
• abnormal skin changes, generalized itching, hives, polymorphic rash, abnormal skin appearance, presence of red, often itchy spots on the hands and feet, and sometimes on the face and rest of the body;
• back pain, pain in arms or legs, bone pain, muscle pain, muscle weakness;
• worsening of kidney function, sudden worsening of kidney function;
• pain at the injection site, changes at the injection site (redness, hardening, pain, swelling, irritation, rash, hives, fluid leakage from the catheter into the tissues), phlebitis at the injection site;

increased blood pressure and changes in the results of some blood laboratory tests (including those evaluating kidney function, electrolytes, and blood clotting), increased levels of immunosuppressive medicines;

• feeling of discomfort in the chest, chest pain, feeling of changes in body temperature, general malaise, generalized pain, swelling of the face, ankles, hands, or feet, swelling, tenderness, feeling of fatigue.

Side effects in children and adolescents

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

• fever.

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

• headache;
• rapid heartbeat;
• sudden flushing, low blood pressure;
• changes in the results of some blood laboratory tests (including increased values of some liver tests);
• itching, rash;
• pain at the injection site;
• chills;
• changes in the results of some blood laboratory tests.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Al. Jerozolimskie 181 C

• 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 or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Caspofungin Zentiva

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and carton, after "Expiry Date (EXP)". The expiry date refers to the last day of the month stated.
Unopened vials: store in a refrigerator (2°C - 8°C).
Chemical and physical tests have shown that the product is stable for 24 hours when stored at a temperature up to 25°C or at a temperature between 2°C and 8°C, if water for injections is used to reconstitute. From a microbiological point of view, the medicine should be used immediately, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination .
After preparation, the medicine should be used immediately, as it does not contain any preservatives. If the medicine is not used immediately, the person administering the medicine is responsible for the storage conditions and the storage time should not exceed 24 hours at 2°C to 8°C.

Stability studies have shown that the product can be used for 48 hours if stored at a temperature between 2°C and 8°C or at room temperature (25°C), if a sodium chloride solution for injection with a concentration of 9 mg/ml (0.9%), 4.5 mg/ml (0.45%), or 2.25 mg/ml (0.225%) or Ringer's solution with lactate for injection is used for dilution.
From a microbiological point of view, the product should be used immediately. If the medicine is not used immediately, the person administering the medicine is responsible for the storage conditions before use, and the storage time should not exceed 24 hours at 2°C to 8°C, unless the reconstitution and dilution take place in validated, controlled aseptic conditions.
The medicine should only be prepared by trained medical personnel who have read all the instructions (see below "Instructions for reconstitution and dilution of Caspofungin Zentiva").
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Caspofungin Zentiva contains

• The active substance is caspofungin. Each vial contains 50 mg of caspofungin (as caspofungin acetate). After reconstitution in 10.5 ml of water for injections, 1 ml of the concentrate contains 5.2 mg of caspofungin.
• The other ingredients are: sucrose, mannitol, glacial acetic acid, sodium hydroxide (to adjust pH).

What Caspofungin Zentiva looks like and contents of the pack

Caspofungin Zentiva is a sterile, white or almost white powder.
Each pack contains 1 vial (10 ml) of powder.
Marketing authorization holder
Zentiva, k.s.
U Kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Manufacturer/Importer:
Pharmathen S.A.
6 Dervenakion str.
153 51 Pallini, Athens
Greece
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Elpen Pharmaceutical Co., Inc
Marathonos Ave. 95,
Pikermi Attiki,
19009,
Greece

To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, contact the representative of the marketing authorization holder in Poland:

Zentiva Poland Sp. z o.o.
Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00
Date of last revision of the leaflet:March 2021

Information intended for healthcare professionals only:

Instructions for reconstitution and dilution of Caspofungin Zentiva:

Reconstitution of Caspofungin Zentiva

DO NOT USE ANY SOLUTIONS CONTAINING GLUCOSE, as the Caspofungin Zentiva medicinal product is not stable in glucose-containing solutions. DO NOT MIX OR ADMINISTER IN THE SAME INFUSION WITH OTHER MEDICINES, as there are no data on the co-administration of the Caspofungin Zentiva medicinal product with other intravenously administered active substances, excipients, or other medicinal products. The infusion solution should be inspected for particulate matter and discoloration.

Caspofungin Zentiva, 50 mg, powder for concentrate for solution for infusion

INSTRUCTIONS FOR USE OF THE MEDICINE IN ADULT PATIENTS

Step 1 Reconstitution of the vial contents

To reconstitute the powder, remove the vial from the refrigerator and let it reach room temperature. Then, in a sterile manner, add 10.5 ml of water for injections. The resulting concentration will be: 5.2 mg/ml.
The white or almost white, compact, lyophilized powder should dissolve completely. Gently mix the contents until a clear solution is obtained. The reconstituted solution should be inspected for particulate matter and discoloration. If the solution is cloudy or contains precipitate, do not administer it.

Step 2 Adding the reconstituted Caspofungin Zentiva to the infusion solution for the patient

To prepare the final infusion solution, the following solutions can be used: sodium chloride solution for injection or Ringer's solution with lactate for injection. The infusion solution should be prepared by adding the appropriate volume of the reconstituted concentrate (as shown in the table below) to an infusion bag or bottle containing 250 ml of the solution. The daily dose of 50 mg or 35 mg, if indicated, can be administered in a reduced volume of 100 ml. Do not use the solution if it is cloudy or contains precipitate.

PREPARATION OF THE INFUSION SOLUTION FOR ADULT PATIENTS

* To reconstitute the contents of each vial, 10.5 ml of liquid should be used.

INSTRUCTIONS FOR USE OF THE MEDICINE IN CHILDREN AND ADOLESCENTS

Calculating the body surface area (BSA) to determine the dose in children and adolescents

Before preparing the infusion, calculate the patient's body surface area using the following formula: (Mosteller's formula)

Preparing the intravenous infusion containing a dose of 70 mg/m² for children and adolescents over 3 months of age (using a vial containing 50 mg of the product)

• 1. Determine the actual dose to be used in children and adolescents based on the body surface area (calculated as above) using the following equation: BSA (m²) x 70 mg/m² = dose The maximum dose on day 1 of therapy should not exceed 70 mg, regardless of the calculated dose for the individual patient.
• 2. Remove the Caspofungin Zentiva, 50 mg vial from the refrigerator and let it reach room temperature.

• 3. In a sterile manner, add 10.5 ml of water for injections. The resulting solution can be stored for no more than 24 hours at a temperature not exceeding 25°C or at a temperature between 2°C and 8°C. In this way, a concentration of 5.2 mg/ml of caspofungin is obtained in the vial.
• 4. From the vial, withdraw the volume of the product equivalent to the calculated dose (step 1). In a sterile manner, add this volume (ml) of the reconstituted Caspofungin Zentiva, 50 mg, to an infusion bag or bottle containing 250 ml of sodium chloride solution for injection with a concentration of 0.9%, 0.45%, or 0.225% or Ringer's solution with lactate for injection. Alternatively, the specified volume (ml) of the reconstituted Caspofungin Zentiva, 50 mg can be added to a smaller volume of sodium chloride solution for injection with a concentration of 0.9%, 0.45%, or 0.225% or Ringer's solution with lactate for injection, without exceeding the final concentration of 0.5 mg/ml. The prepared infusion solution should be used within 48 hours if stored at a temperature between 2°C and 8°C or at room temperature (25°C). Preparing the intravenous infusion containing a dose of 50 mg/m² for children and adolescents over 3 months of age (using a vial containing 50 mg of the product)
• 1. Determine the actual daily dose to be used in children and adolescents based on the body surface area (calculated as above) using the following equation: BSA (m²) x 50 mg/m² = daily dose The daily dose should not exceed 70 mg, regardless of the calculated dose for the individual patient.
• 2. Remove the Caspofungin Zentiva, 50 mg vial from the refrigerator and let it reach room temperature.
• 3. In a sterile manner, add 10.5 ml of water for injections. The resulting solution can be stored for no more than 24 hours at a temperature not exceeding 25°C or at a temperature between 2°C and 8°C. In this way, a concentration of 5.2 mg/ml of caspofungin is obtained in the vial.
• 4. From the vial, withdraw the volume of the product equivalent to the calculated daily dose (step 1). In a sterile manner, add this volume (ml) of the reconstituted Caspofungin Zentiva, 50 mg, to an infusion bag or bottle containing 250 ml of sodium chloride solution for injection with a concentration of 0.9%, 0.45%, or 0.225% or Ringer's solution with lactate for injection. Alternatively, the specified volume (ml) of the reconstituted Caspofungin Zentiva, 50 mg can be added to a smaller volume of sodium chloride solution for injection with a concentration of 0.9%, 0.45%, or 0.225% or Ringer's solution with lactate for injection, without exceeding the final concentration of 0.5 mg/ml. The prepared infusion solution should be used within 48 hours if stored at a temperature between 2°C and 8°C or at room temperature (25°C).

Notes on preparation:

• a.The white or almost white solid should dissolve completely. Gently mix the contents until a clear solution is obtained.
• b.During reconstitution and before administration, the solution should be inspected for particulate matter and discoloration. If the solution is cloudy or contains precipitate, do not administer it.
• c.The Caspofungin Zentiva medicinal product is prepared to allow the full dose stated on the vial label (50 mg) to be obtained after withdrawal of 10 ml from the vial.