Caspofungin Adamed

Leaflet attached to the packaging: information for the user

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

Caspofungin

Read the contents of the leaflet carefully before administering the medicine to an adult or child, 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, pharmacist, or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

What is Caspofungin Adamed

Caspofungin Adamed contains the active substance caspofungin. It belongs to a group of medicines called antifungal medicines.

What is Caspofungin Adamed 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 cells (yeast) called Candida. This type of infection can occur in people who have recently undergone surgery or have a weakened immune system. The most common symptoms of this type of infection are fever and chills that do not go away after taking antibiotics;
• fungal infections of the nose, sinuses, or lungs (called invasive aspergillosis) when other antifungal treatments have been ineffective or have caused side effects. This infection is caused by mold fungi called Aspergillus. This type of infection can occur in people undergoing chemotherapy, after a transplant, or with a weakened immune system;
• suspected fungal infections, if the patient has a fever and a low white blood cell count, and their condition has not improved with antibiotic treatment. People at risk of fungal infection include those who have recently undergone surgery or have a weakened immune system.

How Caspofungin Adamed works

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

2. Important information before taking Caspofungin Adamed

When not to use Caspofungin Adamed

Warnings and precautions

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

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

Caspofungin Adamed and other medicines

Tell your doctor, pharmacist, or nurse about all medicines the patient is taking, has recently taken, or might take, including those obtained without a prescription, including herbal medicines. This is because Caspofungin Adamed may affect the way some other medicines work. Similarly, some other medicines may affect the way Caspofungin Adamed works.
Tell your doctor, pharmacist, or nurse if the patient is taking any of the following medicines:

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

If any of the above applies to the patient (or is unsure), tell your doctor, pharmacist, or nurse before starting treatment with Caspofungin Adamed.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.

• Caspofungin Adamed has not been studied in pregnant women. It can only be used during pregnancy if the potential benefits outweigh the potential risk to the unborn baby.
• Women taking Caspofungin Adamed should not breastfeed.

Driving and using machines

There is no information to suggest that Caspofungin Adamed affects the ability to drive or use machines.

Caspofungin Adamed contains sodium

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

3. How to take Caspofungin Adamed

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

• once a day,
• by slow injection into a vein (intravenous infusion),
• over a period of about 1 hour. The doctor will determine the duration of treatment and the amount of Caspofungin Adamed to be administered each day. The doctor will monitor the effectiveness of the medicine on the patient. Patients weighing over 80 kg may require a different dose.

Use in children and adolescents

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

Overdose of Caspofungin Adamed

The doctor will determine the necessary amount of Caspofungin Adamed and the duration of administration each day. If there are concerns about administering too much Caspofungin Adamed, consult a doctor or nurse immediately.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Caspofungin Adamed can cause side effects, although not everybody gets them.

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 - a histamine reaction to the medicine may have occurred;
• worsening breathing difficulties with wheezing or rash
• a allergic reaction to the medicine may have occurred;
• cough, severe breathing difficulties - in adults with invasive aspergillosis, severe respiratory problems may occur, leading to respiratory failure;
• rash, peeling skin, ulcers of the mucous membranes, hives, peeling skin over a large area.

As with any prescription medicine, some side effects can be serious. Consult your doctor for more information.
Other side effects in adults
Common: may affect up to 1 in 10 people:

• decreased hemoglobin (decreased amount of substance that carries oxygen in the blood), decreased white blood cell count;
• decreased albumin (a type of protein) in the blood, low potassium levels in the blood;
• headache;
• vein inflammation;
• shortness of breath;
• diarrhea, nausea, or vomiting;
• changed results of some blood tests (including increased values in 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:

• changed results of some blood tests (including blood clotting, platelet count, red and white blood cell count);
• loss of appetite, increased fluid in the body, disturbances in salt levels, high blood sugar, low calcium levels, high calcium levels, low magnesium levels, increased acidity of the blood;
• confusion, irritability, sleep disturbances;
• dizziness, decreased sensation or sensitivity (especially on the skin), chills, drowsiness, change in taste, tingling, or numbness;
• blurred vision, increased tearing, swelling of the eyelids, yellowing of the whites of the eyes;
• feeling of rapid or irregular heartbeat, palpitations, irregular heartbeat, abnormal heart rhythm, heart failure;
• redness, flushing, high blood pressure, low blood pressure, redness along the vein, which is extremely sensitive to touch;
• bronchospasm causing wheezing or cough, rapid breathing, breathing difficulties waking from sleep, lack of oxygen in the blood, abnormal breathing sounds, crackling in the lungs, wheezing, runny nose, cough, sore throat;
• lower abdominal pain, upper abdominal pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, gas, discomfort in the stomach area, swelling caused by excess fluid in the abdominal area;
• decreased bile flow, liver enlargement, yellowing of the skin and/or whites of the eyes, liver damage caused by the medicine or chemical, liver function disorder;
• abnormal skin tissue, generalized itching, hives, rash of various appearance, abnormal skin appearance, red and often itchy patches on the hands and feet, and sometimes on the face and other parts of the body;
• back pain, arm and leg pain, bone pain, muscle pain, muscle weakness;
• kidney function loss, sudden kidney function loss;
• pain at the injection site, reactions at the injection site (redness, hardening, pain, swelling, irritation, rash, hives, leakage of fluid from the catheter into the tissue), vein inflammation at the injection site;
• increased blood pressure and changed results of some blood tests (including kidney, electrolyte, and blood clotting tests), increased levels of medicines taken by the patient that weaken the immune system;
• chest discomfort, chest pain, feeling of temperature change, general malaise, general pain, facial swelling, swelling of the ankles, hands, or feet, puffiness, 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;
• redness, low blood pressure;
• changed results of some blood tests (including increased values in some liver tests);
• itching, rash;
• pain at the injection site;
• chills;
• changed results of some blood tests.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to:
Department for the Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Caspofungin Adamed

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after EXP.
The expiry date refers to the last day of the month.
Unopened vials: store in a refrigerator (2°C - 8°C).
It has been shown that the chemical and physical stability of the reconstituted concentrate for solution for infusion, stored at a temperature up to 25°C or 5°C ± 3°C, is 24 hours, if water for injections is used for reconstitution. From a microbiological point of view, unless the method of opening/ reconstitution/ dilution precludes the risk of microbial contamination, the product should be used immediately. This is because it does not contain any antimicrobial preservatives. If not used immediately, the user is responsible for the storage conditions prior to use.
It has been shown that the chemical and physical stability of the diluted infusion solution for the patient, stored at a temperature of 2°C - 8°C or 25°C, is 48 hours if diluted with sodium chloride 9 mg/ml (0.9%), 4.5 mg/ml (0.45%), or 2.25 mg/ml (0.225%) solution for injection or with Ringer's solution with lactate. For microbiological reasons, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions prior to use. Normally, storage should not exceed 24 hours at 2°C - 8°C, unless reconstitution and dilution are performed under controlled and validated aseptic conditions.
The medicine can only be prepared by healthcare professionals after reading all the 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. This will help protect the environment.

6. Contents of the pack and other information

What Caspofungin Adamed 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, and sodium hydroxide (to adjust pH).

What Caspofungin Adamed looks like and contents of the pack

Caspofungin Adamed is a white or almost white compact powder.
Each pack contains one vial of powder.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names

Danish: CASMYG
Polish: Caspofungin Adamed
Greek: CASMYG
French: CASPOFUNGINE STRAGEN 50 mg poudre pour solution à diluer pour perfusion

Date of last revision of the leaflet: 10.2022

Information intended for healthcare professionals only:

Instructions for reconstitution and dilution of Caspofungin Adamed

Reconstitution of Caspofungin Adamed

DO NOT USE DILUENTS CONTAINING GLUCOSE, as Caspofungin Adamed is not stable in glucose-containing solutions. DO NOT MIX OR ADMINISTER Caspofungin Adamed IN THE SAME INFUSION LINE WITH OTHER MEDICINES, as there is no available data on the compatibility of Caspofungin Adamed with other substances, additives, or intravenously administered medicines. The infusion solution should be inspected for particulate matter and discoloration.

Caspofungin Adamed 50 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 allow it to 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 lyophilized powder will 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.

Step 2 Addition of the reconstituted Caspofungin Adamed 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. 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 sodium chloride solution for injection or Ringer's solution with lactate. Alternatively, the reconstituted Caspofungin Adamed can be added to a smaller volume of sodium chloride solution for injection or Ringer's solution with lactate, not exceeding a final concentration of 0.5 mg/ml. The prepared infusion solution should be used within 48 hours if stored at 2°C - 8°C or 25°C. Do not use the solution if it is cloudy or contains precipitate.

* To reconstitute the contents of each vial, use 10.5 ml of water for injections.

INSTRUCTIONS FOR USE IN CHILDREN AND ADOLESCENTS

Calculating body surface area (BSA) to determine the dose for children and adolescents
Before preparing the infusion, calculate the patient's body surface area using the following formula: (Mosteller's formula)

Preparation of 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 loading 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 = 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 vial from the refrigerator and allow it to reach room temperature.
• 3. 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 lyophilized powder will dissolve completely. Gently mix the contents until a clear solution is obtained. The reconstituted solution can be stored for up to 24 hours at 25°C or below, or at 5°C ± 3°C.
• 4. From the vial, withdraw the volume of the reconstituted product equivalent to the calculated loading dose (step 1). In a sterile manner, add this volume (ml) of the reconstituted Caspofungin Adamed to an infusion bag or bottle containing 250 ml of sodium chloride solution for injection or Ringer's solution with lactate. Alternatively, the reconstituted Caspofungin Adamed can be added to a smaller volume of sodium chloride solution for injection or Ringer's solution with lactate, not exceeding a final concentration of 0.5 mg/ml. The prepared infusion solution should be used within 48 hours if stored at 2°C - 8°C or 25°C.

Preparation of 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 maintenance 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 maintenance dose The daily maintenance dose should not exceed 70 mg, regardless of the calculated dose for the individual patient.
• 2. Remove the vial from the refrigerator and allow it to reach room temperature.
• 3. 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 lyophilized powder will dissolve completely. Gently mix the contents until a clear solution is obtained. The reconstituted solution can be stored for up to 24 hours at 25°C or below, or at 5°C ± 3°C.
• 4. From the vial, withdraw the volume of the reconstituted product equivalent to the calculated daily maintenance dose (step 1). In a sterile manner, add this volume (ml) of the reconstituted Caspofungin Adamed to an infusion bag or bottle containing 250 ml of sodium chloride solution for injection or Ringer's solution with lactate. Alternatively, the reconstituted Caspofungin Adamed can be added to a smaller volume of sodium chloride solution for injection or Ringer's solution with lactate, not exceeding a final concentration of 0.5 mg/ml. The prepared infusion solution should be used within 48 hours if stored at 2°C - 8°C or 25°C.

Notes on preparation:
a.
The compact white or almost white powder should dissolve completely. Gently mix the contents until a clear solution is obtained.
b.
The reconstituted solution should be inspected for particulate matter and discoloration before administration. If the solution is cloudy or contains precipitate, do not administer.
c.
Caspofungin Adamed is prepared to allow for the administration of the full dose stated on the vial label (50 mg) after withdrawal of 10 ml from the vial.