Caspofungin adamed

Package leaflet: Information for the user

Caspofungin Adamed, 70 mg, powder for solution for infusion concentrate
Caspofunginum
Please read this leaflet carefully before this medicine is given to an adult or child,
as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

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

What Caspofungin Adamed is
Caspofungin Adamed contains an active substance called caspofungin. It belongs to a group of medicines known as antifungal agents.

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

• Severe fungal infections of tissues or organs (called invasive candidiasis). This infection is caused by fungal (yeast) cells called Candida. This type of infection may occur in people who have recently undergone surgery or in individuals with weakened immune systems. The most common symptoms of this type of infection are fever and chills that do not resolve with antibiotic treatment;
• Fungal infections of the nose, sinuses, or lungs (called invasive aspergillosis), when other antifungal treatments have been ineffective or caused adverse reactions. This infection is caused by mould fungi called Aspergillus. This type of infection may occur in people undergoing chemotherapy, those who have had an organ transplant, or individuals with weakened immune systems;
• Suspected fungal infections when fever and low white blood cell count are present, and the patient's condition has not improved with antibiotic treatment. People at risk of fungal infection include those who have recently undergone surgery or those with weakened immune systems.

How Caspofungin Adamed works
Caspofungin Adamed makes fungal cells susceptible to damage and inhibits normal fungal growth. This stops the spread of infection and allows the body's immune system to completely eliminate the infection.

2. Important information before administering Caspofungin Adamed

When not to use Caspofungin Adamed

• if the patient is allergic to caspofungin or any of the other ingredients of this medicine (listed in section 6). If in doubt, discuss this with the doctor, pharmacist, or nurse before starting treatment with this medicine.

Warnings and precautions
Before starting treatment with Caspofungin Adamed, discuss the following with the doctor, pharmacist, or nurse:

• if the patient is allergic to any other medicines,
• if the patient has ever had liver problems – a different dose of this medicine may be required,
• if the patient is currently taking cyclosporine (used to help prevent organ transplant rejection or to suppress immune system reactions) – during treatment, the doctor may order additional blood tests,
• if the patient has ever had any other medical conditions.

If any of the above situations apply to the patient (or if the patient is unsure), inform the doctor, pharmacist, or nurse before starting treatment with Caspofungin Adamed.
Caspofungin Adamed may also cause severe skin-related adverse reactions, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

Caspofungin Adamed and other medicines
Inform the doctor, pharmacist, or nurse about all medicines currently used or recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription, including herbal medicines. This is important because Caspofungin Adamed may affect how some other medicines work. Likewise, some other medicines may affect how Caspofungin Adamed works.
Inform the doctor, pharmacist, or nurse if the patient is taking any of the following medicines:

• cyclosporine or tacrolimus (used to help prevent organ transplant rejection or to suppress immune system reactions), as the doctor may order additional blood tests during treatment;
• certain antiviral medicines for 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 situations apply to the patient (or if the patient is unsure), inform the doctor, pharmacist, or nurse before starting treatment with Caspofungin Adamed.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.

• Caspofungin Adamed has not been studied in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn child.
• Women receiving Caspofungin Adamed should not breastfeed.

Driving and operating machinery
There is no information indicating an effect of Caspofungin Adamed on the ability to drive or operate machinery.

Caspofungin Adamed contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per vial; therefore, the medicine is considered "sodium-free".

3. How to use Caspofungin Adamed

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

• once daily,
• by slow intravenous injection (intravenous infusion),
• over approximately 1 hour. The doctor will determine the duration of treatment and the amount of Caspofungin Adamed to be given each day. The doctor will monitor the patient's response to the treatment. Patients with a body weight over 80 kg may require a different dose.

Use in children and adolescents
The dose used in children and adolescents may differ from that used in adults.
If more Caspofungin Adamed than recommended has been administered
The doctor will determine the required amount of Caspofungin Adamed and the duration of daily administration. If there is any concern that too much Caspofungin Adamed has been given, contact a doctor or nurse immediately.
If there are any further questions about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following undesirable symptoms occur, you must 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 – a histamine reaction to the medicine may have occurred;
• worsening difficulty in breathing accompanied by wheezing or rash – an allergic reaction to the medicine may have occurred;
• cough, severe breathing difficulties – in adults with invasive aspergillosis, serious respiratory problems may occur, leading to respiratory failure;
• rash, skin peeling, mucosal ulceration, urticaria, extensive skin desquamation.

As with any prescription medicine, some adverse reactions may be serious.
Consult your doctor for additional information.

Other adverse reactions in adults
Common: may affect up to 1 in 10 people:

• decreased hemoglobin concentration (reduced amount of oxygen-carrying substance in the blood), decreased number of white blood cells;
• decreased concentration of albumin (a type of protein) in blood, low or decreased potassium levels in blood;
• headache;
• phlebitis (vein inflammation);
• dyspnea (shortness of breath);
• diarrhea, nausea or vomiting;
• altered results of certain blood laboratory tests (including elevated values in certain liver function tests);
• itching, rash, skin redness, or increased sweating more than usual;
• joint pain;
• chills, fever;
• itching at the injection site.

Uncommon: may affect up to 1 in 100 people:

• altered results of certain blood laboratory tests (including blood coagulation, platelet count, red blood cells, and white blood cells);
• loss of appetite, increased body fluids, disturbances in salt concentration in the body, high blood sugar, low blood calcium, increased blood calcium, low blood magnesium, increased blood acidity;
• confusion, restlessness, difficulty sleeping;
• dizziness, reduced sensation or sensitivity (especially of the skin), chills, drowsiness, altered taste perception, tingling or numbness;
• blurred vision, increased lacrimation, eyelid swelling, yellowing of the sclera of the eye;
• sensation of rapid or irregular heartbeat, palpitations, irregular heartbeats, abnormal heart rhythm, heart failure;
• redness, hot flushes, elevated blood pressure, low blood pressure, redness along the vein which is unusually sensitive to touch;
• bronchial muscle contraction causing wheezing or cough, rapid breathing, breathlessness waking from sleep, low blood oxygen levels, unusual breath sounds, crackles in the lungs, wheezing, rhinitis, cough, sore throat;
• lower abdominal pain, upper abdominal pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, gas, stomach discomfort, swelling due to accumulation of excess fluid in the abdominal area;
• reduced bile flow, enlarged liver, jaundice (yellowing of the skin and/or sclera), liver damage caused by a medicine or chemical agent, liver function disorder;
• abnormal skin tissue, generalized itching, urticaria, rash with various appearances, abnormal skin appearance, red and often itchy patches on hands and legs, sometimes also on the face and other body parts;
• back pain, pain in arms and legs, bone pain, muscle pain, muscle weakness;
• impaired kidney function, sudden loss of kidney function;
• pain at the catheter insertion site, injection site reactions (redness, hard spot, pain, swelling, irritation, rash, urticaria, leakage of fluid from the catheter into tissue), phlebitis at the injection site;
• increased blood pressure and altered results of certain blood laboratory tests (including kidney function, electrolytes, and blood coagulation), increased concentration of medicines taken by the patient that suppress the immune system;
• chest discomfort, chest pain, sensation of body temperature change, general malaise, general pain, facial swelling, swelling of ankles, hands or feet, edema, tenderness, feeling of fatigue.

Adverse reactions 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;
• redness, low blood pressure;
• altered results of certain blood laboratory tests (increased values in certain liver function tests);
• itching, rash;
• pain at the catheter site;
• chills;
• altered results of certain blood laboratory tests.

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

5. How to store Caspofungin Adamed

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 stated month.
Unopened vials: store in a refrigerator (2°C - 8°C).
Chemical and physical in-use stability of the reconstituted concentrate for infusion solution, stored at temperatures up to 25°C or 5°C ± 3°C, has been demonstrated for 24 hours when reconstituted with Water for Injections. From a microbiological point of view, if the method of opening/reconstitution/dilution does not exclude the risk of microbial contamination, the product should be used immediately, as it contains no agents to inhibit bacterial growth. If not used immediately, the user is responsible for the storage duration and conditions prior to use.
Chemical and physical in-use stability of the diluted infusion solution for the patient, stored at 2°C - 8°C or at 25°C, has been demonstrated for 48 hours when diluted with Sodium Chloride Injection 9 mg/ml (0.9%), 4.5 mg/ml (0.45%), 2.25 mg/ml (0.225%) or Ringer's solution with lactate.
From a microbiological standpoint, the product should be used immediately. If this is not possible, the user is responsible for the storage duration and conditions prior to use. Under normal circumstances, storage should not exceed 24 hours at 2°C – 8°C, unless reconstitution and dilution were performed under controlled and validated aseptic conditions.
This medicine must be prepared only by trained healthcare personnel, after having read all instructions (see "Instructions for reconstitution and dilution of Caspofungin Adamed" below).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the pack and other information

What Caspofungin Adamed 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 concentrate contains 7.2 mg of caspofungin.
• The other ingredients are: sucrose, mannitol, glacial acetic acid, and sodium hydroxide (for pH adjustment).

What Caspofungin Adamed looks like and contents of the pack
Caspofungin Adamed is a white or almost white, lyophilized powder.
Each pack contains one vial of powder.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer/Importer:
Pharmathen S.A.
6 Dervenakion str., Pallini, Attiki
153 51 Greece
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park, Paola
PLA 3000 Malta
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
ELPEN PHARMACEUTICAL CO., INC
Marathonos Ave. 95,
Pikermi Attiki,
19009 Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: CASMYG
Poland: Caspofungin Adamed
Greece: CASMYG
France: CASPOFUNGINE STRAGEN® 70 mg powder for solution for infusion

Information intended exclusively for healthcare professionals:

Instructions for reconstitution and dilution of Caspofungin Adamed
Reconstitution of Caspofungin Adamed
DO NOT USE SOLVENTS CONTAINING GLUCOSE, as Caspofungin Adamed is not stable in solutions containing glucose. DO NOT MIX OR ADMINISTER Caspofungin Adamed IN THE SAME INFUSION BAG AS OTHER MEDICINAL PRODUCTS, due to lack of available data on compatibility of Caspofungin Adamed with other substances, additives or intravenous drugs. The infusion solution should be inspected visually for particulate matter and discoloration.
Caspofungin Adamed 70 mg, powder for reconstitution of concentrate for infusion solution
INSTRUCTIONS FOR USE IN ADULT PATIENTS
Step 1 Reconstitution of the vial contents
To dissolve the powder, bring the unopened vial to room temperature and then aseptically add 10.5 mL of Water for Injections. The concentration of the resulting concentrate will be 7.2 mg/mL.
The white or almost white lyophilized powder should dissolve completely. Gently mix until a clear solution is obtained. The prepared solution should be inspected visually for particulate matter and discoloration. The reconstituted solution may be stored for 24 hours at 25°C or lower, or at 5 ± 3°C.
Step 2 Addition of reconstituted Caspofungin Adamed 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. The daily dose of 50 mg or 35 mg, if indicated, may be administered in a reduced infusion volume of up to 100 mL. This infusion solution must be used within 48 hours if stored at 2–8°C or 25°C. Do not use the solution if cloudiness or precipitation occurs.
PREPARATION OF INFUSION SOLUTION FOR ADULTS

* To reconstitute the contents of each vial, use 10.5 ml of diluent.
** If a vial containing 70 mg is not available, a 70 mg dose can be obtained from two vials
of 50 mg.
INSTRUCTIONS FOR USE IN CHILDREN AND ADOLESCENTS
Calculation of body surface area (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/m 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 a given patient.
2. Remove the Caspofungin Adamed vial from the refrigerator and allow it to warm to 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 25°C or lower, or at 5°C ± 3°C. This yields a final caspofungin concentration of 7.2 mg/ml in the vial.
4. Withdraw from the vial the volume corresponding to the calculated loading dose (step 1). Under aseptic conditions, transfer this volume (ml) of diluted Caspofungin Adamed product 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 solution. Alternatively, the specified volume (ml) of diluted Caspofungin Adamed product may be added to a smaller volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer’s solution, provided that the final concentration does not exceed 0.5 mg/ml. The ready-to-use infusion solution should be used within 48 hours if stored at 2°C–8°C or at 25°C.

Preparation of intravenous infusion containing a dose of 50 mg/m 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 a given patient.
2. Remove the Caspofungin Adamed vial from the refrigerator and allow it to warm to 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 25°C or lower, or at 5°C ± 3°C. This yields a final caspofungin concentration of 7.2 mg/ml in the vial.
4. Withdraw from the vial the volume corresponding to the calculated daily maintenance dose (step 1). Under aseptic conditions, transfer this volume (ml) of diluted Caspofungin Adamed product 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 solution. Alternatively, the specified volume (ml) of diluted Caspofungin Adamed product may be added to a smaller volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer’s solution, provided that the final concentration does not exceed 0.5 mg/ml. The ready-to-use infusion solution should be used within 48 hours if stored at 2°C–8°C or at 25°C.

Notes on preparation of the medicinal product:
a. The white or almost white compact substance should dissolve completely. Gently mix the contents until a clear solution is obtained.
b. 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.
c. Caspofungin Adamed is formulated so that withdrawal of 10 ml of solution from the vial provides the full labeled dose (70 mg).