Caspofungin Mylan

Package leaflet: Information for the user

Caspofungin Mylan 50 mg powder for concentrate for solution for infusion

caspofungin
Generic medicine
Please read this leaflet carefully before this medicine is administered to you or your child, as 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 experience any side effects, including those not listed in this leaflet, contact your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet

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

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

What Caspofungin Mylan is
Caspofungin Mylan belongs to a group of medicines called antifungals.
What Caspofungin Mylan is used for
Caspofungin Mylan is used to treat the following infections in children, adolescents, and adults:

• severe fungal infections in tissues and organs (called 'invasive candidiasis'). This infection is caused by fungal cells (yeasts) called Candida. People who may develop 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 unwanted effects. This infection is caused by a mould called Aspergillus. People who may develop this type of infection include those undergoing chemotherapy, those who have undergone organ 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 Mylan works
Caspofungin Mylan makes fungal cells fragile and prevents the fungus from growing properly.
This stops the spread of the infection and allows the body's natural defences the chance to
completely eliminate the infection.

2. What you should know before being given Caspofungin Mylan

Do not use Caspofungin Mylan

• if you are allergic to caspofungin or to any of the other ingredients of this medicine

(listed in section 6).
If you are unsure, consult your doctor, nurse, or pharmacist before receiving
this medicine.
Warnings and precautions
Talk to your doctor, nurse, or pharmacist before being given Caspofungin
Mylan if:

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

If any of the above conditions apply to you (or if you are unsure), consult your doctor,
nurse, or pharmacist before being given Caspofungin Mylan.
Caspofungin Mylan may also cause serious skin adverse reactions such as Stevens-Johnson
syndrome (SJS) and toxic epidermal necrolysis (TEN).
Other medicines and Caspofungin Mylan
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 medicines. This is because Caspofungin Mylan
may interfere with the way some other medicines work. Some other medicines may
also interfere with the way Caspofungin Mylan 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 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 above conditions apply to you (or if you are unsure), consult your doctor,
nurse, or pharmacist before being given Caspofungin Mylan.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, or suspect you may be pregnant,
ask your doctor for advice before taking any medicine.

• Caspofungin Mylan 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 Mylan must not breastfeed.

Driving and using machines
There are no data indicating that Caspofungin Mylan has an effect on
the ability to drive or use machines.
Caspofungin Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is essentially
“sodium-free”.

3. How to use Caspofungin Mylan

Caspofungin Mylan must always be prepared and administered by a healthcare professional.
Caspofungin Mylan will be given to you:

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

Your doctor will determine the duration of treatment and the amount of Caspofungin Mylan 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.
Children and adolescents
The dose for children and adolescents may differ from that for adults.
If you have been given more Caspofungin Mylan than you should have
Your doctor will decide the daily amount of Caspofungin Mylan you need and the duration of treatment. If you are concerned that you have been given too much Caspofungin Mylan, 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 everybody gets them.
Contact your doctor or nurse immediately if you notice any of the following side effects – you may need urgent medical treatment:

• Rash, itching, feeling of warmth, swelling of the face, lips or throat, or difficulty breathing – you may be experiencing a histamine reaction to the medicine.
• Breathing difficulties with wheezing or a rash that worsens – 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.
• Rash, skin peeling, mucosal sores, hives, extensive areas of skin peeling.

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

• Decreased haemoglobin (reduced substance in the blood carrying oxygen), decreased white blood cells
• Decreased blood albumin (a type of protein), decreased potassium or low blood potassium levels
• Headache
• Inflammation of the vein
• Shortness of breath
• Diarrhoea, nausea, vomiting
• Changes in certain blood test values (including increased values of certain liver parameters)
• Itching, 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 clotting disorders, platelets, red blood cells and white blood cells)
• Loss of appetite, increased body fluid, electrolyte imbalance, high blood sugar, low blood calcium, increased blood calcium, low blood magnesium, increased blood acid levels
• Disorientation, feeling nervous, inability to sleep
• Dizziness, reduced sensation or sensitivity (especially skin-related), tremor, drowsiness, altered taste, tingling or numbness
• Blurred vision, increased tear production, swollen eyelid, yellowing of the whites of the eyes
• Sensation of rapid or irregular heartbeat, fast heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure
• Hot flushes, hot flashes, high blood pressure, low blood pressure, redness of a vein that is extremely painful to pressure
• Constriction of muscle bands in the airways causing shortness of breath or cough, rapid breathing, shortness of breath waking the patient, reduced oxygen in the blood, abnormal breathing sounds, lung friction rub, dyspnoea, 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 agents, 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
• Impaired kidney function, sudden loss of kidney function
• Pain at catheter site, discomfort at injection site (redness, small hard lump, pain, swelling, irritation, rash, hives, leakage of fluid from catheter into tissue), inflammation of the vein at 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 changes, feeling of general malaise, general pain, facial swelling, swelling of ankles, hands or feet, swelling, hypersensitivity, 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
• Fast heartbeat
• Flushing, low blood pressure
• Changes in certain blood test values (increased values of certain liver tests)
• Itching, rash
• Pain at 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 or pharmacist.
You can also report side effects directly via the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Caspofungin Mylan

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 (the first two digits indicate the month, the following four digits the year). The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Once Caspofungin Mylan has been prepared, it should be used immediately. This is because it does not contain ingredients to prevent bacterial growth. Only a trained healthcare professional who has read the complete instructions should prepare this medicine (see below “Instructions for reconstitution and dilution of Caspofungin Mylan”).
If not used immediately, the solution may be used within 24 hours if stored at a temperature equal to or below 25°C, or within 48 hours if the intravenous infusion bag (bottle) is stored refrigerated (2–8°C) and diluted with an intravenous infusion solution of sodium chloride 9 mg/ml (0.9%), 4.5 mg/ml (0.45%), or 2.25 mg/ml (0.225%), or with Ringer's lactate solution. If not used immediately, the storage times during use and storage conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless reconstitution and dilution have taken place under controlled and validated aseptic conditions.
Do not use the solution if discolouration or foreign particles are observed.
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 Mylan contains

• The active substance is caspofungin. Each vial of Caspofungin Mylan contains 50 mg of caspofungin (as acetate).
• The other ingredients are sucrose, mannitol, concentrated hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and carbon dioxide (for pH adjustment).

Description of the appearance of Caspofungin Mylan and contents of the pack
Caspofungin Mylan is a compact, sterile, white to off-white powder. The reconstituted solution is clear. Caspofungin Mylan is available in 10 ml glass vials with a bromobutyl stopper, removable aluminium seal, and red plastic flip-off cap.
Each pack contains one vial of powder.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer
SAG Manufacturing S.L.U
Ctra. N-I, Km 36. San Agustín de Guadalix
28750, Madrid, Spain
Or
Galenicum Health S.L.U
Sant Gabriel, 50, 08950
Esplugues de Llobregat
Barcelona, Spain
Or
Viatris Santé
1 rue de Turin
69007 Lyon
France
Or
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe
Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352
Germany
Or
Hikma Italia S.p.A.
Viale Certosa, 10
27100, Pavia (PV)
Italy
Or
Mylan UK Healthcare Limited
Building 20, Station Close
EN6 1 L, Potters Bar
United Kingdom

The following information is intended exclusively for medical or healthcare professionals

Instructions for reconstituting and diluting Caspofungin Mylan:

Reconstitution of Caspofungin Mylan
Do not use diluents containing glucose, as Caspofungin Mylan is not stable in glucose-containing diluents. Do not mix or administer Caspofungin Mylan through the same intravenous line with any other medicinal product, as compatibility data with other substances, additives, or intravenous drugs are not available. The reconstituted solution is clear. Visually inspect the intravenous infusion solution for the presence of particles or discoloration.

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 solution will be 5.2 mg/ml.
The white to off-white lyophilized powder will dissolve completely. Gently swirl until a clear solution is obtained. Reconstituted solutions should be visually inspected for the presence of particles or color change. This reconstituted solution may be stored for up to 24 hours at temperatures not exceeding 25°C.

Step 2: Adding reconstituted Caspofungin Mylan to the intravenous infusion solution for the patient
The diluents for the final intravenous infusion solution are: sodium chloride solution for injection or Ringer's lactate solution. The intravenous infusion solution is prepared by aseptically adding the appropriate volume of the reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle. If medically necessary, reduced infusion volumes down to 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 INTRAVENOUS INFUSION SOLUTION IN ADULTS

*10.5 ml must be used to reconstitute all vials
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)

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

1. Determine the appropriate loading dose to be used in pediatric patients 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 Mylan vial to reach room temperature.
3. Aseptically add 10.5 ml of water for injections. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C. This will provide a final caspofungin concentration 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 Mylan into an intravenous infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% sodium chloride for injection, or lactated Ringer’s for injection. Alternatively, the volume (ml) of reconstituted Caspofungin Mylan may be added to a reduced volume of 0.9%, 0.45%, or 0.225% sodium chloride for injection, or lactated Ringer’s for injection, provided that the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if refrigerated at 2–8°C.

Preparation of the 50 mg/m 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 Mylan vial to reach room temperature.
3. Aseptically add 10.5 ml of water for injections. This reconstituted solution may be stored for up to 24 hours at a temperature not exceeding 25°C. This will provide a final caspofungin concentration 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 Mylan into an intravenous infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% sodium chloride for injection, or lactated Ringer’s for injection. Alternatively, the volume (ml) of reconstituted Caspofungin Mylan may be added to a reduced volume of 0.9%, 0.45%, or 0.225% sodium chloride for injection, or lactated Ringer’s for injection, provided that the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if refrigerated at 2–8°C.

Preparation Notes:
a. The white to off-white powder will dissolve completely. Gently swirl until the solution becomes clear.
b. Visually inspect the reconstituted solution for particulate matter or discoloration during reconstitution and before infusion. Do not use if the solution is not clear or contains precipitates.
c. Caspofungin Mylan is formulated to deliver the full labeled dose (50 mg) when 10 ml are withdrawn from the vial.

Package leaflet: information for the user

Caspofungin Mylan 70 mg powder for concentrate for solution for infusion

caspofungin
Generic medicine
Please read this leaflet carefully before this medicine is administered to you or your child, as 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 experience any side effects, including those not listed in this leaflet, inform your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet

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

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

What Caspofungin Mylan is
Caspofungin Mylan belongs to a group of medicines called antifungals.
What Caspofungin Mylan is used for
Caspofungin Mylan is used to treat the following infections in children, adolescents, and adults:

• serious fungal infections in tissues and 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 whose immune system is weakened. 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 unwanted side 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 whose immune system is weakened.
• 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 whose immune system is weakened.

How Caspofungin Mylan works
Caspofungin Mylan makes fungal cells fragile and prevents the fungus from growing properly.
This stops the spread of the infection and gives the body's natural defences the chance to
completely eliminate the infection.

2. What you should know before being given Caspofungin Mylan

Do not use Caspofungin Mylan

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

If you are unsure, consult your doctor, nurse, or pharmacist before being given this medicine.
Warnings and precautions
Talk to your doctor, nurse, or pharmacist before being given Caspofungin Mylan if:

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

If any of the conditions listed above apply to you (or if you are unsure), consult your doctor, nurse, or pharmacist before being given Caspofungin Mylan.
Caspofungin Mylan may also cause serious skin reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
Other medicines and Caspofungin Mylan
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 medicines. This is because Caspofungin Mylan may interfere with the way some other medicines work. Likewise, some other medicines may interfere with the way Caspofungin Mylan works.
Inform your doctor, nurse, or pharmacist if you are taking any of the following medicines:

• cyclosporine or tacrolimus (used to help prevent rejection of a transplanted organ or to suppress the immune system), as your doctor may need 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 are unsure), consult your doctor, nurse, or pharmacist before being given Caspofungin Mylan.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, or suspect you may be pregnant, ask your doctor for advice before taking any medicine.

• Caspofungin Mylan 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 Mylan must not breastfeed.

Driving and using machines
There are no data suggesting that Caspofungin Mylan has an effect on the ability to drive or use machines.
Caspofungin Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is essentially “sodium-free”.

3. How to use Caspofungin Mylan

Caspofungin Mylan must always be prepared and administered by a healthcare professional.
Caspofungin Mylan will be given to you:

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

Your doctor will determine the duration of treatment and the amount of Caspofungin Mylan to be administered daily. Your doctor will monitor the effect of the medicine on you. If you weigh more than 80 kg, you may require a different dose.
Children and adolescents
The dose for children and adolescents may differ from that for adults.
If you have been given more Caspofungin Mylan than you should have
Your doctor will decide the daily amount of Caspofungin Mylan you need and the duration of treatment. If you are concerned that you have been given too much Caspofungin Mylan, 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 gets them.
Contact your doctor or nurse immediately 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 breathing difficulties – you may be experiencing a histamine reaction to the medicine.
• Breathing difficulties 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 and have invasive aspergillosis, you may be experiencing a serious respiratory problem that could lead to respiratory failure.
• Skin rash, skin peeling, sores in the mucous membranes, hives, extensive 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:

• Decreased haemoglobin (reduced substance in the blood that carries oxygen), decreased white blood cells
• Decreased blood albumin (a type of protein) in the blood, decreased potassium or low blood potassium levels
• Headache
• Inflammation of the vein
• Shortness of breath
• Diarrhoea, nausea, 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 clotting disorders, platelets, red blood cells and white blood cells)
• Loss of appetite, increased body fluid, electrolyte imbalance, high blood sugar, low blood calcium, increased blood calcium, low blood magnesium, increased blood acid levels
• Disorientation, feeling nervous, inability to sleep
• Dizziness, decreased sensation or sensitivity (especially at skin level), 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
• Flushing, hot flushes, high blood pressure, low blood pressure, redness of a vein that is extremely painful to pressure
• Constriction of muscle bands in the airways causing breathlessness or cough, rapid breathing, shortness of breath waking the patient, reduced oxygen in the blood, abnormal breathing sounds, rubbing noise in the lungs, dyspnoea, 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 causes, 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 catheter site, discomfort at injection site (redness, small hard lump, pain, swelling, irritation, rash, hives, leakage of fluid from catheter into tissue), inflammation of the vein at 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 change in body temperature, feeling of general malaise, general pain, facial swelling, swelling of ankles, hands or feet, swelling, hypersensitivity, 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
• Fast heartbeat
• Flushing, low blood pressure
• Changes in certain blood test values (increased values in some liver-related tests)
• Itching, skin rash
• Pain at catheter site
• Chills
• Changes in certain blood test values.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Caspofungin Mylan

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 (the first two digits indicate the month, the following four digits the year). The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Once Caspofungin Mylan has been prepared, it should be used immediately. This is because it does not contain ingredients to prevent bacterial growth. Only a trained healthcare professional who has read the complete instructions should prepare this medicine (see below “Instructions for reconstitution and dilution of Caspofungin Mylan”).
If not used immediately, the solution may be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if the intravenous infusion bag (bottle) is stored refrigerated (2–8°C) and diluted with an intravenous infusion solution of sodium chloride 9 mg/ml (0.9%), 4.5 mg/ml (0.45%), or 2.25 mg/ml (0.225%), or with Ringer lactate solution. If not used immediately, the storage times during use and storage conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless reconstitution and dilution have taken place under controlled, validated aseptic conditions.
Do not use the solution if discoloration or foreign particles are observed.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Caspofungin Mylan contains

• The active substance is caspofungin. Each vial of Caspofungin Mylan contains 70 mg of caspofungin (as acetate).
• The other excipients are sucrose, mannitol, concentrated hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and carbon dioxide (for pH adjustment).

Description of the appearance of Caspofungin Mylan and contents of the pack
Caspofungin Mylan is a compact, sterile, white to off-white powder. The reconstituted solution is clear. Caspofungin Mylan is available in 10 ml glass vials with a bromobutyl stopper and an aluminum seal with an orange plastic flip-off cap.
Each pack contains one vial of powder.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer
SAG Manufacturing S.L.U
Ctra. N-I, Km 36. San Agustín de Guadalix
28750, Madrid, Spain
Or
Galenicum Health S.L.U
Sant Gabriel, 50, 08950
Esplugues de Llobregat
Barcelona, Spain
Or
Viatris Santé
1 rue de Turin
69007 Lyon
France
Or
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe
Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352
Germany
Or
Hikma Italia S.p.A.
Viale Certosa, 10
27100, Pavia (PV)
Italy
Or
Mylan UK Healthcare Limited
Building 20, Station Close
EN6 1 L, Potters Bar
United Kingdom

The following information is intended exclusively for medical professionals or healthcare operators
Instructions for reconstituting and diluting Caspofungin Mylan:

Reconstitution of Caspofungin Mylan
Do not use diluents containing glucose, as Caspofungin Mylan is not stable in diluents containing glucose. Do not mix or administer Caspofungin Mylan in the same intravenous line with any other medicinal product, as compatibility data for Caspofungin Mylan with other substances, additives, or intravenous drugs are not available. The reconstituted solution is clear.
Visually inspect the intravenous infusion solution for the presence of particles or discoloration.

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 solution will be 7.2 mg/ml.
The white to off-white compact lyophilized powder will dissolve completely. Gently swirl until a clear solution is obtained. Reconstituted solutions should be visually inspected for the presence of particles or color changes. The reconstituted solution may be stored for up to 24 hours at temperatures not exceeding 25°C.

Step 2: Adding reconstituted Caspofungin Mylan to the patient’s intravenous infusion solution
The diluents for the final intravenous infusion solution are: sodium chloride solution for injection or lactated Ringer’s solution. The intravenous infusion solution is prepared by aseptically adding the appropriate volume of the reconstituted concentrate (as shown in the following table) to a 250 ml infusion bag or bottle. From a medical standpoint, if 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 INTRAVENOUS INFUSION SOLUTION IN ADULTS

* 10.5 ml must be used to reconstitute all vials
**If the 70 mg vial is not available, the 70 mg dose can be prepared using 2 vials of 50 mg
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)

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

1. Determine the appropriate loading dose to be used in pediatric patients 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 Mylan vial to reach room temperature.
3. Aseptically add 10.5 ml of water for injections. This reconstituted 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 medication corresponding to the calculated loading dose (step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Mylan into an IV infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% sodium chloride for injection, or lactated Ringer’s for injection. Alternatively, the volume (ml) of reconstituted Caspofungin Mylan may be added to a reduced volume of 0.9%, 0.45%, or 0.225% sodium chloride for injection, or lactated Ringer’s for injection, provided the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if refrigerated at 2–8°C.

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

1. Determine the appropriate daily maintenance dose to be used in 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 Mylan vial to reach room temperature.
3. Aseptically add 10.5 ml of water for injections. This reconstituted 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 medication corresponding to the calculated daily maintenance dose (step 1). Aseptically transfer this volume (ml) of reconstituted Caspofungin Mylan into an IV infusion bag (or bottle) containing 250 ml of 0.9%, 0.45%, or 0.225% sodium chloride for injection, or lactated Ringer’s for injection. Alternatively, the volume (ml) of reconstituted Caspofungin Mylan may be added to a reduced volume of 0.9%, 0.45%, or 0.225% sodium chloride for injection, or lactated Ringer’s for injection, provided the final concentration does not exceed 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at a temperature not exceeding 25°C, or within 48 hours if refrigerated at 2–8°C.

Preparation Notes:
a. The white to off-white powder will dissolve completely. Gently swirl until the solution becomes clear.
b. Visually inspect the reconstituted solution for particles or discoloration during reconstitution and before infusion. Do not use if the solution is not clear or contains precipitates.
c. Caspofungin Mylan is formulated to deliver the full labeled dose (70 mg) when 10 ml is withdrawn from the vial.