Caspofungin fresenius kabi

Package leaflet: Information for the user

Caspofungin Fresenius Kabi, 70 mg, powder for solution for infusion concentrate
Caspofunginum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

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

Contents of the leaflet

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

1. What Caspofungin Fresenius Kabi is and what it is used for

Caspofungin Fresenius Kabi contains an active substance called caspofungin, which belongs to a group of medicines known as antifungal agents.

What Caspofungin Fresenius Kabi is used for
Caspofungin Fresenius Kabi is used to treat the following fungal infections in children, adolescents and adults:

• Severe fungal infections of tissues and organs (called invasive candidiasis). This infection is caused by fungal (yeast) cells called Candida. Patients who may develop this type of infection include those who have recently undergone surgery 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), when other antifungal medicines have not worked or have caused side effects. These infections are caused by a mould called Aspergillus. Patients who may develop such infections include those undergoing chemotherapy, organ transplant recipients, and individuals with weakened immune systems;
• Suspected fungal infection in patients with fever and low white blood cell count whose condition has not improved after antibiotic treatment. Patients at risk of developing fungal infections include those who have recently undergone surgery or have a weakened immune system.

How Caspofungin Fresenius Kabi works
Caspofungin Fresenius Kabi weakens fungal cells and inhibits their normal growth. This helps prevent the spread of infection and allows the body's natural defence mechanisms to eliminate the infection completely.

2. Important information before using Caspofungin Fresenius Kabi

When not to use Caspofungin Fresenius Kabi

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

If in doubt about administering the medicine, consult a doctor, pharmacist, or nurse.
Warnings and precautions
Before starting treatment with Caspofungin Fresenius Kabi, discuss this with a 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 required;
• if the patient is taking cyclosporine (a medicine used to prevent organ 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 apply to the patient (or if there is suspicion),
consult a doctor, pharmacist, or nurse before using Caspofungin Fresenius Kabi.
Caspofungin Fresenius Kabi may also cause severe skin reactions, such as
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Caspofungin Fresenius Kabi and other medicines
Inform the doctor, nurse, or pharmacist about all medicines currently used or recently used,
as well as any medicines the patient plans to use, including over-the-counter medicines and herbal
preparations, because Caspofungin Fresenius Kabi may affect how other medicines work. Likewise,
some other medicines may affect how Caspofungin Fresenius Kabi works.
If the patient is taking any of the following medicines, inform the doctor,
nurse, or pharmacist:

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

If any of the above apply to the patient (or if there is suspicion), inform the doctor, nurse, or
pharmacist before using Caspofungin Fresenius Kabi.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a
child, she should consult her doctor before using this medicine.

• Studies on the use of Caspofungin Fresenius Kabi in pregnant women have not been conducted. The medicine should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn child.
• Women receiving Caspofungin Fresenius Kabi should not breastfeed.

Driving and operating machinery
There is no information indicating that Caspofungin Fresenius Kabi may affect the ability
to drive or operate machinery.
Caspofungin Fresenius Kabi contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free".

3. How to use Caspofungin Fresenius Kabi

Caspofungin Fresenius Kabi is always prepared and administered by a healthcare professional.
Caspofungin Fresenius Kabi will be given:

• once daily;
• by slow injection into a vein (intravenous infusion);
• over approximately 1 hour.

The duration of treatment and the daily dose of Caspofungin Fresenius Kabi will be determined by the physician.
The physician will monitor the effectiveness of the treatment in the patient. In patients weighing over 80 kg,
a different dose may be required.
Use in children and adolescents
The dose intended for children and adolescents may differ from that used in adult patients.
Administration of a higher than recommended dose of Caspofungin Fresenius Kabi
The physician will decide which daily dose of Caspofungin Fresenius Kabi the patient requires and how long
the treatment should last. However, if there is any concern that the patient may have received too
high a dose of Caspofungin Fresenius Kabi, medical advice should be sought immediately from the physician
or nurse.
If there are any further doubts regarding the use of this medicine, consult the physician, nurse, or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, you should
immediately inform your doctor or nurse, as immediate medical assistance may be required:

• Rash, itching, feeling of warmth, swelling of the face, lips or throat, or difficulty breathing – possible occurrence of a histamine reaction to the medicine;
• Difficulty breathing, wheezing, or worsening rash – possible occurrence of an allergic reaction to the medicine;
• Cough, severe breathing problems – in adults with invasive aspergillosis, severe breathing problems may occur, which could progress to respiratory failure;
• Rash, skin peeling, mucosal ulceration, urticaria, extensive skin peeling.

As with all prescription medicines, some of the adverse reactions may be serious. Please consult your doctor for additional information.
Other adverse reactions observed in adults
Common: may occur in no more than 1 in 10 people:

• Decreased haemoglobin concentration (reduced concentration in the blood of the substance transporting oxygen), decreased white blood cell count;
• Decreased albumin (a type of protein) concentration in the blood, decreased potassium concentration or low blood potassium levels;
• Headache;
• Phlebitis (vein inflammation);
• Dyspnoea (shortness of breath);
• Diarrhoea, nausea, or vomiting;
• Changes in results of certain blood laboratory tests (including increased values of certain liver function tests);
• Itching, rash, skin redness, or excessive sweating;
• Joint pain;
• Chills, fever;
• Itching at the injection site.

Uncommon: may occur in no more than 1 in 100 people:

• Changes in results of certain blood laboratory tests (including blood coagulation, platelet count, red blood cells, and white blood cells);
• Loss of appetite, increased body fluid volume, electrolyte imbalance, high blood sugar, low blood calcium, high blood calcium, low blood magnesium, increased blood acidity;
• Disorientation, feeling of nervousness, inability to sleep;
• Dizziness, reduced sensation or sensitivity (especially of the skin), tremor, drowsiness, altered taste, tingling or numbness;
• Blurred vision, increased tear production, eyelid swelling, yellowing of the sclera (whites of the eyes);
• Feeling of rapid or irregular heartbeat, fast heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure;
• Facial flushing, hot flushes, high blood pressure, low blood pressure, redness along the vein, skin unusually sensitive to touch;
• Bronchospasm causing wheezing or cough, rapid breathing, dyspnoea waking from sleep, low blood oxygen levels, abnormal breath sounds, crackles in the lungs, wheezing, nasal congestion, cough, sore throat;
• Abdominal pain, upper abdominal pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, flatulence, stomach discomfort, swelling due to fluid accumulation in the abdominal cavity;
• Reduced bile flow, enlarged liver, yellowing of the skin and (or) sclera (whites of the eyes), chemical or drug-induced liver damage, liver function disturbances;
• Abnormal skin changes, generalized itching, urticaria, erythematous rash, abnormal skin appearance, presence of red, often itchy spots on hands and legs, and sometimes on the face and other parts of the body;
• Back pain, pain in hands or feet, bone pain, muscle pain, muscle weakness;
• Worsening kidney function, sudden worsening of kidney function;
• Pain at the catheter site, injection site reactions (redness, hardening, pain, swelling, irritation, rash, urticaria, leakage of fluid from catheter into tissues), phlebitis at the injection site;
• Increased blood pressure and changes in results of certain blood laboratory tests (including tests assessing kidney function, electrolytes, and blood coagulation), increased concentrations of immunosuppressive drugs;
• Feeling of discomfort in the chest, chest pain, sensation of temperature change in the body, general malaise, generalized pain, facial swelling, swelling of ankles, hands or feet, oedema, tenderness, feeling of fatigue.

Adverse reactions in children and adolescents
Very common: may occur in more than 1 in 10 people:

• Fever.

Common: may occur in no more than 1 in 10 people:

• Headache;
• Rapid heartbeat;
• Sudden facial flushing, low blood pressure;
• Changes in results of certain blood laboratory tests (increased values of certain liver function tests);
• Itching, rash;
• Pain at the catheter site;
• Chills;
• Changes in results of certain blood laboratory tests.

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, you should inform your doctor, nurse, or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Caspofungin Fresenius Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial following EXP.
The expiry date refers to the last day of the specified month.
Store in a refrigerator (2°C to 8°C).
After reconstitution, Caspofungin Fresenius Kabi should be used immediately, as it does not contain any antimicrobial preservatives. The medicinal product should be reconstituted only by trained medical personnel who have read and understood all instructions (see below "Instructions for reconstitution and dilution of Caspofungin Fresenius Kabi").

Reconstituted concentrate: Should be used immediately. Stability studies have shown that the concentrate for infusion solution may be stored for up to 24 hours if vials are kept at temperatures up to 25°C and the diluent used for reconstitution was water for injections. Chemical and physical stability has been demonstrated for up to 24 hours when vials are stored at temperatures up to 25°C and water was used for reconstitution.

Diluted solution: Should be used immediately. Stability studies have shown that the product may be used within 24 hours if stored at temperatures up to 25°C, or within 48 hours if the infusion bag (bottle) is stored refrigerated (from 2°C to 8°C), when the infusion solution was prepared using sodium chloride solution 9 mg/ml (0.9%), 4.5 mg/ml (0.45%), 2.25 mg/ml (0.225%), or lactated Ringer's solution.
Caspofungin Fresenius Kabi does not contain any preservatives. Chemical and physical stability has been demonstrated for up to 24 hours at temperatures up to 25°C prior to administration. From a microbiological standpoint, the product should be used immediately. If not used immediately, responsibility for storage conditions and duration lies with the user. Storage time should not exceed 24 hours at 2°C to 8°C, provided reconstitution and dilution were performed under controlled, validated aseptic conditions.

Do not use this medicine if the vial shows visible signs of damage.
Medicines must 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 Fresenius Kabi contains

• The active substance is caspofungin. Each vial of Caspofungin Fresenius Kabi contains 70 mg of caspofungin (as caspofungin acetate). The concentration of the resulting concentrate will be 7.2 mg/ml.
• Other ingredients are: sucrose, mannitol, glacial acetic acid, sodium hydroxide (to adjust pH) (see section 2 “Important information before using Caspofungin Fresenius Kabi”).

What Caspofungin Fresenius Kabi looks like and contents of the pack
Caspofungin Fresenius Kabi is a sterile, white or almost white, hygroscopic powder in a glass vial with a grey bromobutyl rubber stopper and a yellow aluminium flip-off cap, packed in a cardboard box.
The pack contains 1 vial with powder.

Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

Manufacturer
Famar Health Care Services Madrid S.A.U.
Avda. Leganés, 62, Alcorcón
28923 Madrid
Spain

For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134, 02-305 Warsaw
Tel.: +48 22 345 67 89

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria: Caspofungin Fresenius Kabi 50 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Germany: Caspofungin Fresenius Kabi 50 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
France: Caspofungine Fresenius Kabi 50 mg poudre pour solution à diluer pour perfusion
Italy: Caspofungin Fresenius Kabi
Ireland: Caspofungin Fresenius Kabi 70 mg Powder for concentrate for solution for infusion
Poland: Caspofungin Fresenius Kabi
Spain: Caspofungina Fresenius Kabi 50 mg polvo para concentrado para solución para perfusión

Information intended exclusively for healthcare professionals:

Instructions for reconstitution and dilution of the medicinal product Caspofungin Fresenius Kabi:
Reconstitution of the medicinal product Caspofungin Fresenius Kabi
DO NOT USE ANY SOLUTIONS CONTAINING DEXTROSE, as the medicinal product Caspofungin Fresenius Kabi is not stable in solutions containing dextrose. DO NOT MIX OR ADMINISTER SIMULTANEOUSLY IN THE SAME INFUSION WITH OTHER MEDICINAL PRODUCTS, as there are no data available on the co-administration of Caspofungin Fresenius Kabi with other intravenously administered active substances, excipients, or medicinal products. The infusion solution should be inspected visually for particulate matter and discoloration.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
INSTRUCTIONS FOR ADMINISTRATION OF THE MEDICINAL PRODUCT IN ADULT PATIENTS
Step 1: Reconstitution of the vial contents
To reconstitute the powder, allow the vial to reach room temperature and then aseptically add 10.5 mL of Water for Injections. The resulting concentration of the concentrate will be 7.2 mg/mL.
The white or almost white, amorphous, lyophilized powder will dissolve completely. Mix gently until a clear solution is obtained. The prepared solution should be inspected visually for particulate matter and discoloration. The prepared solution may be stored for 24 hours at a temperature not exceeding 25°C.
Step 2: Adding the reconstituted medicinal product Caspofungin Fresenius Kabi to the patient's infusion solution
The following solutions may be used to prepare the final infusion solution: Sodium Chloride 0.9% Injection or Ringer's Lactate Solution. The infusion solution should be prepared by aseptically adding the appropriate volume of the prepared concentrate (as shown in the table below) to a 250 mL infusion bag or bottle. A daily dose of 50 mg or 35 mg, if indicated, may be administered in an infusion volume reduced to 100 mL.
Do not use the solution if cloudiness or precipitation occurs.
PREPARATION OF INFUSION SOLUTION FOR ADULT PATIENTS

* To reconstitute the contents of each vial, use 10.5 ml of diluent.
** If a 70 mg vial is not available, a 70 mg dose can be obtained from two 50 mg vials.
MEDICINAL PRODUCT INSTRUCTIONS FOR USE IN CHILDREN AND ADOLESCENTS
Calculation of body surface area (BSA) for dose determination in children and adolescents
Before preparing the infusion, calculate the patient's body surface area using the following formula (Mosteller formula):

Preparation of intravenous infusion containing a dose of 70 mg/m² BSA for children and adolescents aged >3 months (using a vial containing 70 mg of product)

1. Determine the actual loading dose for children and adolescents based on body surface area (calculated as described above) using the following equation: BSA (m²) x 70 mg/m² = loading dose. The maximum loading dose administered on day 1 of therapy should not exceed 70 mg, regardless of the calculated dose for the individual patient.
2. Remove the Caspofungin Fresenius Kabi medicinal product vial from the refrigerator and allow it to reach room temperature.
3. Under aseptic conditions, add 10.5 ml of Water for Injections. The resulting solution may be stored for up to 24 hours at a temperature not exceeding 25°C. This will yield a final caspofungin concentration of 7.2 mg/ml in the vial.
4. Withdraw from the vial the volume of medicinal product corresponding to the calculated loading dose (step 1). Under aseptic conditions, transfer this volume (ml) of reconstituted Caspofungin Fresenius Kabi into an intravenous infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer's Injection. Alternatively, the specified volume (ml) of reconstituted Caspofungin Fresenius Kabi medicinal product may be added to a smaller volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer's Injection, provided that the final concentration does not exceed 0.5 mg/ml. The ready-to-use infusion solution should be used within 24 hours if stored at temperatures up to 25°C, or within 48 hours if stored refrigerated at 2–8°C.

Preparation of intravenous infusion containing a dose of 50 mg/m² BSA for children and adolescents aged >3 months (using a vial containing 70 mg of product)

1. Determine the actual daily maintenance dose for children and adolescents based on body surface area (calculated as described above) using the following equation: BSA (m²) x 50 mg/m² = daily maintenance dose.
   The daily maintenance dose should not exceed 70 mg, regardless of the calculated dose for the individual patient.
2. Remove the Caspofungin Fresenius Kabi medicinal product vial from the refrigerator and allow it to reach room temperature.
3. Under aseptic conditions, add 10.5 ml of Water for Injections. The resulting solution may be stored for up to 24 hours at a temperature not exceeding 25°C. This will yield a final caspofungin concentration of 7.2 mg/ml in the vial.
4. Withdraw from the vial the volume of medicinal product corresponding to the calculated daily maintenance dose (step 1). Under aseptic conditions, transfer this volume (ml) of reconstituted Caspofungin Fresenius Kabi into an intravenous infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer's Injection. Alternatively, the specified volume (ml) of reconstituted Caspofungin Fresenius Kabi medicinal product may be added to a smaller volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer's Injection, provided that the final concentration does not exceed 0.5 mg/ml. The ready-to-use infusion solution should be used within 24 hours if stored at temperatures up to 25°C, or within 48 hours if stored refrigerated at 2–8°C.

Notes on preparation of the medicinal product:
The white or almost white lyophilized powder should completely dissolve. Gently swirl the contents until a clear, transparent solution is obtained.
The prepared solution should be inspected visually for particulate matter and discoloration prior to administration. If the solution is cloudy or contains precipitate, it should not be administered.
Caspofungin Fresenius Kabi is formulated so that withdrawal of 10 ml of solution from the vial will provide the full labeled dose (70 mg).