Caspofungin Teva Italia

Package leaflet: Information for the user

Caspofungin Teva Italia 50 mg powder for concentrate for solution for infusion, 70 mg powder for concentrate for solution for infusion

Generic medicine
Please read all of this leaflet carefully before this medicine is administered to you or your child because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Caspofungin Teva Italia is and what it is used for
2. What you need to know before being given Caspofungin Teva Italia
3. How to take Caspofungin Teva Italia
4. Possible side effects
5. How to store Caspofungin Teva Italia
6. Contents of the pack and other information

1. What Caspofungin Teva Italia is and what it is used for

What Caspofungin Teva Italia is
Caspofungin Teva Italia contains a medicine called caspofungin. This belongs to a group of medicines called antifungals.

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

• serious fungal infections in tissues or organs (called "invasive candidiasis"). This infection is caused by fungal cells (yeasts) called Candida. People who may get this type of infection include those who have recently undergone surgery or those with a weakened immune system. Fever and chills that do not respond to antibiotics are the most common signs of this type of infection.
• fungal infections of the nose, sinuses, or lungs (called "invasive aspergillosis") when other antifungal treatments have not worked or have caused undesirable effects. This infection is caused by a mould called Aspergillus. People who may get this type of infection include those receiving chemotherapy, those who have undergone transplantation, and those with a weakened immune system.
• suspected fungal infections, if you have fever and a low white blood cell count without improvement after antibiotic therapy. People at risk of developing a fungal infection include those who have recently undergone surgery or those with a weakened immune system.

How Caspofungin Teva Italia works
Caspofungin Teva Italia makes fungal cells fragile and prevents the fungus from growing properly. This stops the spread of the infection and allows the body's natural defenses the opportunity to eliminate the infection completely.

2. What you should know before being given Caspofungin Teva Italia

Do not receive Caspofungin Teva Italia

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

If you have any doubts, consult your doctor, nurse, or pharmacist before receiving this medicine.
Warnings and precautions
Talk to your doctor, nurse, or pharmacist before receiving Caspofungin Teva Italia:

• if you are allergic to any other medicine;
• if you have had liver problems – you may require a different dose of this medicine;
• if you are already taking cyclosporine (used to help prevent organ transplant rejection or to suppress the immune system), as your doctor may need to carry out additional blood tests during treatment;
• if you have any other medical conditions.

If any of the conditions listed above apply to you (or if you have any doubts), consult your doctor, nurse, or pharmacist before receiving Caspofungin Teva Italia.
Caspofungin Teva Italia may also cause serious skin reactions, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Other medicines and Caspofungin Teva Italia
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription, including herbal products.
This is because Caspofungin Teva Italia may interfere with the way some other medicines work.
In addition, some other medicines may affect how Caspofungin Teva Italia works.
Inform your doctor, nurse, or pharmacist if you are taking any of the following medicines:

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

If any of the conditions listed above apply to you (or if you have any doubts), consult your doctor, nurse, or pharmacist before receiving Caspofungin Teva Italia.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor, nurse, or pharmacist for advice before using this medicine.

• Caspofungin Teva Italia has not been studied in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Women receiving Caspofungin Teva Italia must not breastfeed.

Driving and using machines
There are no data suggesting that Caspofungin Teva Italia impairs your ability to drive vehicles or operate machinery.
Caspofungin Teva Italia contains sodium:
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially “sodium-free”.

3. How to use Caspofungin Teva Italia

Caspofungin Teva Italia must always be prepared and administered by a healthcare professional.
You will be given Caspofungin Teva Italia:

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

Your doctor will determine how long your treatment will last and the amount of Caspofungin Teva Italia you will receive each day. Your doctor will monitor the effect of the medicine on you. If your body weight is over 80 kg, you may require a different dose.
Use in children and adolescents
The dose for children and adolescents may differ from that for adults.
If you have been given more Caspofungin Teva Italia than you should have
Your doctor will determine the daily amount of Caspofungin Teva Italia you need and the duration of treatment. If you think you have been given too much Caspofungin Teva Italia, inform your doctor or nurse immediately.
If you have any doubts about how to use this medicine, consult your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Immediately inform your doctor or nurse if you notice any of the following side effects – you may
need urgent medical treatment:

• skin rash, itching, feeling of warmth, swelling of the face, lips or throat, or difficulty breathing – you may be experiencing a histamine-type reaction to the medicine;
• breathing difficulty with wheezing or a worsening skin rash – you may be experiencing an allergic reaction to the medicine;
• cough, severe breathing difficulties – if you are an adult with invasive aspergillosis, you may be experiencing a serious respiratory problem that could lead to respiratory failure;
• skin rash, skin peeling, mucosal sores, hives, large areas of skin peeling.

As with any other prescription medicine, some side effects may be serious. For further information, please consult your doctor.
Other side effects in adults include:
Common (may affect up to 1 in 10 people):

• decrease in haemoglobin (reduction in the substance in the blood that carries oxygen), decrease in white blood cells;
• decrease in blood albumin (a type of protein) in the blood, decrease in potassium or low blood potassium levels;
• headache;
• inflammation of veins;
• shortness of breath;
• diarrhoea, nausea or vomiting;
• changes in certain blood test values (including increased values of certain liver parameters);
• itching, skin rash, skin redness or excessive sweating;
• joint pain;
• chills, fever;
• itching at the injection site.

Uncommon (may affect up to 1 in 100 people):

• changes in certain blood test values (including blood coagulation disorders, platelets, red blood cells and white blood cells);
• loss of appetite, increased body fluid, imbalance of salts in the body, high blood sugar levels, low blood calcium levels, increased blood calcium levels, low blood magnesium levels, increased blood acid levels;
• disorientation, feeling nervous, inability to sleep, dizziness, decreased sensation or sensitivity (especially of the skin), tremor, drowsiness, altered taste, tingling or numbness;
• blurred vision, increased tearing, swollen eyelid, yellowing of the whites of the eyes;
• sensation of rapid or irregular heartbeat, fast heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure;
• redness, hot flushes, high blood pressure, low blood pressure, redness along a vein that is extremely painful to pressure;
• narrowing of the muscular bands in the airways causing wheezing or coughing, rapid breathing, shortness of breath causing waking up, reduced oxygen in the blood, abnormal breathing sounds, crackling sounds in the lungs, wheezing, nasal congestion, cough, sore throat;
• abdominal pain, upper abdominal pain, abdominal distension, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, swelling due to fluid accumulation in the abdomen;
• decreased bile flow, enlarged liver, yellowing of the skin and/or whites of the eyes, liver damage caused by a medicine or chemical substance, liver disorder;
• abnormal skin tissue, generalized itching, hives, various types of skin rash, abnormal skin, red spots often itchy on arms and legs and sometimes on the face and other parts of the body;
• back pain, pain in arms or legs, bone pain, muscle pain, muscle weakness;
• loss of kidney function, sudden loss of kidney function;
• pain at the catheter site, discomfort at the injection site (redness, small hard lump, pain, swelling, irritation, rash, hives, leakage of fluid from the catheter into the tissue), inflammation of the vein at the injection site;
• increased blood pressure and changes in certain blood test values (including renal electrolytes and coagulation parameters), increased levels of medicines you are taking that weaken the immune system;
• chest discomfort, chest pain, sensation of body temperature change, general malaise, general pain, facial swelling, swelling of 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;
• redness, low blood pressure;
• changes in certain blood test values (increased values of certain liver parameters);
• itching, skin rash;
• pain at the catheter site;
• chills;
• changes in certain blood test values.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, nurse or pharmacist.
You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Caspofungin Teva Italia

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 after
EXP. The expiry date refers to the last day of that month.
Closed vial: Store in a refrigerator (2 °C – 8 °C).
Chemical and physical in-use stability has been demonstrated for up to 24 hours at a temperature equal to or below 25°C and at 5 ± 3°C, when reconstituted with water for injection. From a microbiological point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbiological contamination, the medicine should be used immediately.
This is because it does not contain ingredients to inhibit bacterial growth.
If not used immediately, the storage times and conditions during use are the responsibility of the user.
Chemical and physical in-use stability of the diluted infusion solution for the patient has been demonstrated for 48 hours at 2–8°C and at room temperature (25°C), when diluted in sodium chloride 9 mg/ml (0.9%), 4.5 mg/ml (0.45%) or 2.25 mg/ml (0.225%) infusion solution or in Ringer's lactate solution.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally do not exceed 24 hours at 2–8°C, unless the solution has been reconstituted/diluted under controlled, aseptic, and validated conditions.
Only a qualified healthcare professional who has read the complete instructions should prepare the medicine (please see below “Instructions for reconstitution and dilution of Caspofungin Teva Italia”).
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the Pack and Other Information

What Caspofungin Teva Italia Contains

• The active substance is caspofungin.
• Each 50 mg vial contains 50 mg of caspofungin (as acetate).
• Each 70 mg vial contains 70 mg of caspofungin (as acetate).
• After reconstitution with 10.5 ml of water for injections, 1 ml of concentrate contains 5.2 mg or 7.2 mg of caspofungin.
• The other components are sucrose, mannitol, glacial acetic acid and sodium hydroxide.

Description of the Appearance of Caspofungin Teva Italia and Contents of the Pack
Caspofungin Teva Italia is a sterile, white to off-white lyophilized powder.
Each pack contains one vial (10 ml) of powder.

Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Manufacturer:
Pharmathen S.A.
Dervenakion str., 6
153 51 - Pallini, Attiki
Greece
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Park
PLA 3000 - Paola
Malta
Merckle GmbH
Ludwig-Merckle-Strasse, 3 - Blaubeuren
89143 - Baden-Wuerttemberg
Germany
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:
Austria Caspofungin ratiopharm GmbH 50 mg Powder for a Concentrate for Solution for Infusion
Caspofungin ratiopharm GmbH 70 mg Powder for a Concentrate for Solution for Infusion
Belgium Caspofungin Teva Generics 50 mg powder for concentrate for solution for infusion / poudre pour solution à diluer pour perfusion / Pulver für Konzentrat zur Herstellung einer Infusionslösung
Caspofungin Teva Generics 70 mg powder for concentrate for solution for infusion / poudre pour solution à diluer pour perfusion / Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Croatia Kaspofungin Pliva 50 mg prašak za koncentrat za otopinu za infuziju
Kaspofungin Pliva 70 mg prašak za koncentrat za otopinu za infuziju
Denmark Caspofungin Teva B.V.
Estonia Caspofungin Teva Generics
France Caspofungine Teva Sante 50 mg poudre pour solution à diluer pour perfusion
Caspofungine Teva Sante 70 mg poudre pour solution à diluer pour perfusion
Germany Caspofungin-ratiopharm 50 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Caspofungin-ratiopharm 70 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Greece Caspofungin/Teva 50 mg κόνις για πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση
Caspofungin/Teva 70 mg κόνις για πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση
Hungary Caspofungin ratiopharm 50 mg por oldatos infúzióhoz való koncentrátumhoz
Caspofungin ratiopharm 70 mg por oldatos infúzióhoz való koncentrátumhoz
Italy Caspofungin Teva Italia
Lithuania Caspofungin Teva Generics 50 mg milteliai infuzinio tirpalo koncentratui
Caspofungin Teva Generics 70 mg milteliai infuzinio tirpalo koncentratui
Netherlands Caspofungine 50 mg Teva, poeder voor concentraat voor oplossing voor infusie
Caspofungine 70 mg Teva, poeder voor concentraat voor oplossing voor infusie
Poland Caspofungin Teva Pharmaceuticals
Portugal Caspofungina Teva
Slovenia Kaspofungin Teva 50 mg mg prašek za koncentrat za raztopino za infundiranje
Kaspofungin Teva 70 mg mg prašek za koncentrat za raztopino za infundiranje
Slovak Republic Caspofungin Teva B.V. 50 mg
Caspofungin Teva B.V. 70 mg
Spain Caspofungina Tevagen 50 & 70 mg polvo para concentrado para solución para perfusión EFG
United Kingdom Caspofungin Teva 50 mg & 70 mg Powder For Concentrate For Solution For Infusion
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The following information is intended exclusively for healthcare professionals:

Instructions for reconstituting and diluting Caspofungin Teva Italia:
Reconstitution of Caspofungin Teva Italia
DO NOT USE DILUENTS CONTAINING GLUCOSE as Caspofungin Teva Italia is not stable
in diluents containing glucose. DO NOT MIX OR ADMINISTER Caspofungin Teva Italia
WITH ANY OTHER MEDICINAL PRODUCT, as compatibility data with other additives, substances, or intravenous medicinal products are not available. Visually inspect
the infusion solution for the presence of particles or discoloration.
Caspofungin Teva Italia 50 mg powder for concentrate for solution for infusion
INSTRUCTIONS FOR USE IN ADULT PATIENTS
Step 1 Reconstitution of conventional vials
To reconstitute the powder, bring the vial to room temperature and aseptically add
10.5 ml of water for injections. The concentration of the reconstituted vial will be
5.2 mg/ml.
The compact, white to off-white lyophilized powder must be completely dissolved.
Gently mix until a clear solution is obtained. Reconstituted solutions should
be visually inspected for the presence of particles or discoloration. This
reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C or at 5
± 3°C.
Step 2 Addition of reconstituted Caspofungin Teva Italia to the patient’s infusion solution
The diluents for the final infusion solution are: sodium chloride solution for injection or lactated Ringer’s solution. The infusion solution is prepared by aseptically adding
the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle. If medically necessary, reduced infusion volumes of 100 ml may be used for daily doses of 50 mg or 35 mg. Do not use
if the solution is cloudy or contains precipitates.
PREPARATION OF THE INFUSION SOLUTION IN ADULTS

INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS

Calculation of Body Surface Area (BSA) for Pediatric Dosing
Before preparing the infusion, calculate the patient's body surface area (BSA) using the following formula: (Mosteller Formula)
√[Height(cm) × Weight(kg) / 3600]
BSA(m²) =

Preparation of the 70 mg/m² infusion for pediatric patients aged >3 months (using a 50 mg vial)

1. Determine the appropriate loading dose for the pediatric patient using the patient’s BSA (calculated as above) and the following equation:
   BSA (m²) × 70 mg/m² = Loading dose
   The maximum loading dose on Day 1 must not exceed 70 mg, regardless of the calculated patient dose.
2. Allow the refrigerated Caspofungin Teva Italia vial to reach room temperature.
3. Aseptically add 10.5 ml of Water for Injections. The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C or at 5 ± 3°C. This will result in a final concentration of caspofungin of 5.2 mg/ml in the vial.
4. Withdraw from the vial the volume of medication corresponding to the calculated loading dose (Step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Teva Italia 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 volume (ml) of reconstituted Caspofungin Teva Italia may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer’s Injection, provided the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C).

Preparation of the 50 mg/m² infusion for pediatric patients aged >3 months (using a 50 mg vial)

1. Determine the appropriate daily maintenance dose for the pediatric patient using the patient’s BSA (calculated as above) and the following equation:
   BSA (m²) × 50 mg/m² = Daily maintenance dose
   The daily maintenance dose must not exceed 70 mg, regardless of the calculated patient dose.
2. Allow the refrigerated Caspofungin Teva Italia vial to reach room temperature.
3. Aseptically add 10.5 ml of Water for Injections. The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C or at 5 ± 3°C. This will result in a final concentration of caspofungin of 5.2 mg/ml in the vial.
4. Withdraw from the vial the volume of medication corresponding to the calculated daily maintenance dose (Step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Teva Italia 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 volume (ml) of reconstituted Caspofungin Teva Italia may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer’s Injection, provided the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C).

Caspofungin Teva Italia 70 mg powder for concentrate for solution for infusion

INSTRUCTIONS FOR USE IN ADULT PATIENTS

Step 1 Reconstitution of conventional vials
To reconstitute the powder, bring the vial to room temperature and aseptically add
10.5 ml of water for injection. The concentration of the reconstituted vial will be:
7.2 mg/ml.
The compact, white to off-white lyophilized powder must be completely dissolved.
Gently mix until a clear solution is obtained. Reconstituted solutions should
be inspected visually for the presence of particles or discoloration. This
reconstituted solution can be stored for up to 24 hours at a temperature equal to or below 25°C or at 5
± 3°C.
Step 2 Addition of reconstituted Caspofungin Teva Italia to the patient's infusion solution
Diluents for the final infusion solution are: sodium chloride solution for injection or lactated Ringer's solution. The infusion solution is prepared by aseptically adding
the appropriate amount of reconstituted concentrate (as shown in the following table) to
a 250 ml infusion bag or bottle. If medically necessary, reduced infusion volumes of 100 ml may be used for daily doses of 50 mg or 35 mg. Do not use
if the solution is cloudy or contains precipitates.
PREPARATION OF THE INFUSION SOLUTION IN ADULTS

INSTRUCTIONS FOR USE IN PEDIATRIC PATIENTS

Calculation of Body Surface Area (BSA) for Pediatric Dosing
Before preparing the infusion, calculate the patient's body surface area (BSA)
using the following formula: (Mosteller Formula).
$$ \text{BSA (m}^2\text{)} = \sqrt{\frac{\text{Height (cm)} \times \text{Weight (kg)}}{3600}} $$

Preparation of the 70 mg/m Infusion for Pediatric Patients Aged >3 Months (Using a 70 mg Vial)

1. Determine the appropriate loading dose for the pediatric patient using the patient’s BSA (calculated as above) and the following equation:
   BSA (m²) × 70 mg/m² = Loading Dose
   The maximum loading dose on Day 1 must not exceed 70 mg, regardless of the calculated dose.
2. Allow the refrigerated Caspofungin Teva Italia vial to reach room temperature.
3. Aseptically add 10.5 mL of Water for Injections. The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C or at 5 ± 3°C. This will yield a final concentration of caspofungin of 7.2 mg/mL in the vial.
4. Withdraw from the vial the volume of medication corresponding to the calculated loading dose (Step 1). Aseptically transfer this volume (mL) of reconstituted Caspofungin Teva Italia 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 volume (mL) of reconstituted Caspofungin Teva Italia may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer’s Injection, provided the final concentration does not exceed 0.5 mg/mL. This infusion solution must be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C).

Preparation of the 50 mg/m Infusion for Pediatric Patients Aged >3 Months (Using a 70 mg Vial)

1. Determine the appropriate daily maintenance dose for the pediatric patient using the patient’s BSA (calculated as above) and the following equation:
   BSA (m²) × 50 mg/m² = Daily Maintenance Dose
   The daily maintenance dose must not exceed 70 mg, regardless of the calculated dose.
2. Allow the refrigerated Caspofungin Teva Italia vial to reach room temperature.
3. Aseptically add 10.5 mL of Water for Injections. The reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C or at 5 ± 3°C. This will yield a final concentration of caspofungin of 7.2 mg/mL in the vial.
4. Withdraw from the vial the volume of medication corresponding to the calculated daily maintenance dose (Step 1). Aseptically transfer this volume (mL) of reconstituted Caspofungin Teva Italia 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 volume (mL) of reconstituted Caspofungin Teva Italia may be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringer’s Injection, provided the final concentration does not exceed 0.5 mg/mL. This infusion solution must be used within 48 hours if stored refrigerated between 2 and 8°C or at room temperature (25°C).