Caspofungin Zentiva

Patient Information Leaflet: User Information

Caspofungin Zentiva, 70 mg

Powder for concentrate for solution for infusion
Caspofungin

Read the 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 the active substance 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 after recent surgery or with 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 after recent surgery or with 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 eliminate it completely.

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).

If in doubt, consult a doctor, pharmacist, or nurse before administering the medicine.

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), consult a doctor, pharmacist, or nurse before using Caspofungin Zentiva.
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), consult a doctor, nurse, or pharmacist before using Caspofungin Zentiva.

Pregnancy and breastfeeding

If pregnant or breastfeeding, or think you may be pregnant, consult a 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;
• over a period of about 1 hour.

The duration of treatment and the daily dose of Caspofungin Zentiva will be determined by the treating doctor. The doctor 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 more than the recommended dose of Caspofungin Zentiva

The treating doctor 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 much Caspofungin Zentiva, consult the treating doctor 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, Caspofungin Zentiva can cause side effects, although not everybody gets them.
Some of these side effects may be serious.

If you experience 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 problems - in adult patients with invasive aspergillosis, severe breathing problems may occur, which may 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 may 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 tests (including increased values of some liver tests);
• itching, rash, redness of the skin, or excessive 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 tests (including blood clotting, platelet count, red blood cell count, 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), tremor, drowsiness, change in taste, feeling of numbness or tingling;
• blurred vision, increased tearing, swelling of the eyelids, yellowing of the whites of the eyes;
• feeling of rapid or irregular heartbeat, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure;
• redness of the face, flushing, 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, chemical or drug-induced liver damage, liver function disorders;
• abnormal skin changes, generalized itching, hives, rash, abnormal skin appearance, presence of red, often itchy patches on the hands and feet, and sometimes on the face and rest of the body;
• back pain, pain in the 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, discharge from the catheter into the tissues), phlebitis at the injection site;

Rare(may affect up to 1 in 1000 people):

• increased blood pressure and changes in the results of some blood tests (including those related to kidney function, electrolytes, and blood clotting), increased levels of immunosuppressive medicines;
• feeling of discomfort in the chest, chest pain, feeling of temperature change, 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 of the face, low blood pressure;
• changes in the results of some blood tests (increased values of some liver tests);
• itching, rash;
• pain at the injection site;
• chills;
• changes in the results of some blood 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.

• The marketing authorization holder is Zentiva, k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

5. How to store Caspofungin Zentiva

Keep this 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 "EXP". The expiry date refers to the last day of the month.
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 for reconstitution. From a microbiological point of view, the product 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 responsibility for the storage conditions and time before use lies with the healthcare professional.
Stability tests 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 sodium chloride 9 mg/ml (0.9%) solution for injection, 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 not used immediately, the storage conditions before use are the responsibility of the healthcare professional, and the storage time should not exceed 24 hours at a temperature between 2°C and 8°C, unless the reconstitution and dilution are performed in validated, controlled aseptic conditions.
The medicine should only be prepared by trained medical personnel who have read 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 no longer required. These measures 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 70 mg of caspofungin (as caspofungin acetate). After reconstitution with 10.5 ml of water for injections, 1 ml of the concentrate contains 7.2 mg of caspofungin.
• The other ingredients are: sucrose, mannitol, glacial acetic acid, sodium hydroxide (for pH adjustment).

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.
The marketing authorization holder is 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

For more detailed information on this medicine and its authorized names in the European Economic Area, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o., ul. 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 solutions. DO NOT MIX OR ADMINISTER IN THE SAME INFUSION WITH OTHER MEDICINES, as there are no data on the co-administration of Caspofungin Zentiva with other intravenous substances, excipients, or other medicinal products. The infusion solution should be inspected for particulate matter and discoloration.

Caspofungin Zentiva, 70 mg, powder for concentrate for solution for infusion

INSTRUCTIONS FOR USE 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 concentrate has a concentration of 7.2 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 can be stored for up to 24 hours at a temperature not exceeding 25°C or at a temperature between 2°C and 8°C.

Step 2 Addition of 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 particulate matter.

PREPARATION OF THE INFUSION SOLUTION FOR ADULT PATIENTS

* To reconstitute the contents of each vial, 10.5 ml of water for injections should be used.
** If a 70 mg vial is not available, a dose of 70 mg can be obtained from two 50 mg vials.

INSTRUCTIONS FOR USE IN CHILDREN AND ADOLESCENTS

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