Caspofungin Neupharm

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Caspofungin Neupharm(Caspofungin/Anfarm) , 50 mg
powder for concentrate for solution for infusion
Caspofunginum
Caspofungin Neupharm and Caspofungin/Anfarm are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

What is Caspofungin Neupharm

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

What is Caspofungin Neupharm used for

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

• severe fungal infections of tissues and organs (called invasive candidiasis). This is an infection caused by fungi (yeast) called Candida. People who may develop this type of infection include patients 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), 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 undergone surgery or have a weakened immune system.

How Caspofungin Neupharm works

Caspofungin Neupharm 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 Neupharm

When not to use Caspofungin Neupharm

• 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, you should consult a doctor, pharmacist, or nurse.

Warnings and precautions

Before starting treatment with Caspofungin Neupharm, you should discuss it with your doctor, nurse, or pharmacist:

• if the patient is allergic to any medicines;
• if the patient has ever had liver function disorders - a different dose of the medicine may be necessary;
• if the patient is taking cyclosporin (a medicine used to prevent organ 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 disorders.

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

Caspofungin Neupharm and other medicines

You should tell your doctor, nurse, or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines, including herbal preparations, as Caspofungin Neupharm may affect the way other medicines work. Also, some other medicines may affect the way Caspofungin Neupharm works.
If the patient is taking any of the following medicines, they should tell their doctor, nurse, or pharmacist:

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

If any of the above statements apply to the patient (or are suspected), before using Caspofungin Neupharm, they should tell their doctor, nurse, or pharmacist.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if pregnancy is suspected, before using any medicine, you should consult a doctor.

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

Driving and using machines

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

Caspofungin Neupharm contains sodium

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

3. How to use Caspofungin Neupharm

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

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

The duration of treatment and the daily dose of Caspofungin Neupharm will be determined by the doctor. They 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 Neupharm than recommended

The doctor will decide what daily dose of Caspofungin Neupharm 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 Neupharm, they should immediately consult their doctor or nurse.
In case of any further doubts about the use of this medicine, you should consult a 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, you should immediately consult a doctor or nurse, as medical attention may be necessary:

• 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. You should 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 laboratory 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 laboratory blood 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 or numbness (especially of the skin), tremors, drowsiness, change 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;
• redness of the face, 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 that wakes you up 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, multiforme 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 the arms or legs, bone pain, muscle pain, muscle weakness;
• worsening of kidney function, sudden worsening of kidney function;
• pain at the catheter site, changes at the injection site (redness, hard swelling, 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 laboratory 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 changed body temperature, general malaise, generalized pain, swelling of the face, swelling of the 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 laboratory blood tests (increased values of some liver tests);
• itching, rash;
• pain at the catheter site;
• chills;
• changes in the results of some laboratory blood tests.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Caspofungin Neupharm

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the vial and the outer packaging, after: "Expiry date (EXP)". The expiry date refers to the last day of the month.
Sealed vials: store in a refrigerator (2°C - 8°C).
Chemical and physical tests have shown the stability of the product for up to 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 was used to reconstitute the powder. From a microbiological point of view, the medicine should be used immediately, unless the method of opening/reconstitution/dilution precludes the risk of microbiological 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 time.
Stability tests have shown that the product can be used within 48 hours if stored at a temperature between 2°C and 8°C or at room temperature (25°C), if a sodium chloride solution 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 was 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 a temperature between 2°C and 8°C, unless the reconstitution and dilution took place in validated, controlled aseptic conditions.
The medicine should be prepared only by trained medical personnel who have read all the instructions (see below "Instructions for reconstitution and dilution of the medicinal product Caspofungin Neupharm").
Medicines should not be disposed of via wastewater or household waste. You should 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 Neupharm contains

• The active substance of the medicine 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 the pH).

What Caspofungin Neupharm looks like and contents of the pack

Caspofungin Neupharm is a sterile, white or almost white powder.
Caspofungin Neupharm is available in vials of 10 ml, made of colorless glass type I, with a stopper made of bromobutyl rubber and a cap made of plastic, in a cardboard box.
The pack contains 1 vial.
For more detailed information, you should consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

ANFARM HELLAS S.A.
4 Achaias Str. & Trizinias Str.
14 564 Kifissia, Attiki
Greece

Manufacturer:

ANFARM HELLAS S.A.
61st km NAT.RD. ATHENS-LAMIA
32 009 Schimatari Viotias
Greece

Parallel importer:

Neupharm Sp. z o.o.
Chełmska 30/34
00-725 Warsaw

Repackaged by:

LABOR Pharmaceutical-Chemical Company Sp. z o.o.
Długosza 49
51-162 Wrocław
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Greece, the country of export:88202/08-09-2020

Parallel import authorization number: 19/24

Date of leaflet approval: 16.01.2024

[Information about the trademark]

Information intended for healthcare professionals only:

Instructions for reconstitution and dilution of the medicinal product Caspofungin Neupharm:

Reconstitution of Caspofungin Neupharm

DO NOT USE ANY SOLUTIONS CONTAINING GLUCOSE, as Caspofungin Neupharm 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 Caspofungin Neupharm with other intravenously administered active substances, excipients, or other medicinal products. The infusion solution should be inspected for particulate matter and discoloration.

Caspofungin Neupharm, 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, the unopened vial should be brought to room temperature, and then, in a sterile manner, 10.5 ml of water for injections should be added. The resulting concentrate 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. The white or almost white, compact, lyophilized powder should be dissolved by gently mixing to obtain a clear solution. The prepared solution should be inspected for particulate matter and discoloration. The prepared solution may 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 Adding the reconstituted Caspofungin Neupharm to the infusion solution for the patient

To prepare the final infusion solution, the following solutions can be used: sodium chloride injection solution or Ringer's lactate injection solution. 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 with a volume of 250 ml. The daily dose of 50 mg or 35 mg, if indicated, can be administered in a reduced infusion volume of 100 ml. Do not use the solution if it is cloudy or contains sediment.

PREPARATION OF THE INFUSION SOLUTION FOR ADULTS

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

INSTRUCTIONS FOR USE IN CHILDREN AND ADOLESCENTS

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

Before preparing the infusion, the patient's body surface area should be calculated using the following formula: (Mosteller's formula)
BSA (m²) = √height (cm) × body weight (kg)
3600
Preparing an 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 dose calculated for the individual patient.
• 2. Remove the Caspofungin Neupharm, 50 mg vial from the refrigerator and allow it to reach room temperature.
• 3. Aseptically, add 10.5 ml of water for injections. The resulting 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. In this way, a final 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 loading dose (step 1). Aseptically, add this volume (ml) of the reconstituted Caspofungin Neupharm, 50 mg to an infusion bag or bottle containing 250 ml of sodium chloride injection solution with a concentration of 0.9%, 0.45%, or 0.225% or Ringer's lactate injection solution. Alternatively, the specified volume (ml) of the reconstituted Caspofungin Neupharm, 50 mg can be added to a smaller volume of sodium chloride injection solution with a concentration of 0.9%, 0.45%, or 0.225% or Ringer's lactate injection solution, without exceeding a 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 an 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 dose calculated for the individual patient.
• 2. Remove the Caspofungin Neupharm, 50 mg vial from the refrigerator and allow it to reach room temperature.
• 3. Aseptically, add 10.5 ml of water for injections. The resulting 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. In this way, a final 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 maintenance dose (step 1). Aseptically, add this volume (ml) of the reconstituted Caspofungin Neupharm, 50 mg to an infusion bag or bottle containing 250 ml of sodium chloride injection solution with a concentration of 0.9%, 0.45%, or 0.225% or Ringer's lactate injection solution. Alternatively, the specified volume (ml) of the reconstituted Caspofungin Neupharm, 50 mg can be added to a smaller volume of sodium chloride injection solution with a concentration of 0.9%, 0.45%, or 0.225% or Ringer's lactate injection solution, without exceeding a 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. The contents should be gently mixed until a clear solution is obtained.
• b.During dilution and before administration, the prepared solution should be inspected for particulate matter and discoloration. If the solution is cloudy or contains sediment, it should not be administered.
• c.Caspofungin Neupharm is prepared to allow the full dose stated on the vial label (50 mg) to be withdrawn from the vial after the addition of 10 ml of water for injections.