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CASPOFUNGIN 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CASPOFUNGIN ACETATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Caspofungin 50 mg powder for concentrate for solution
for infusion
caspofungin

Read all of this leaflet carefully before you are given this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Caspofungin is and what it is used for
2. What you need to know before you are given Caspofungin
3. How to use Caspofungin
4. Possible side effects
5. How to store Caspofungin
6. Contents of the pack and other information

1. What Caspofungin is and what it is used for
What Caspofungin is
Caspofungin contains a medicine called caspofungin. This belongs to a group
of medicines called antifungals.
What Caspofungin is used for
Caspofungin is used to treat the following infections in children, adolescents
and adults:
• serious fungal infections in your tissues or organs (called ‘invasive
candidiasis’). This infection is caused by fungal (yeast) cells called Candida.
• People who might get this type of infection include those who have just had
an operation or those whose immune systems are weak. Fever and chills
that do not respond to an antibiotic are the most common signs of this type
of infection.
• fungal infections in your nose, nasal sinuses or lungs (called ‘invasive
aspergillosis’) if other anti-fungal treatments have not worked or have
caused side effects. This infection is caused by a mould called Aspergillus.
• People who might get this type of infection include those having chemotherapy,
those who have had a transplant and those whose immune systems are weak.
• suspected fungal infections if you have a fever and a low white cell count that
have not improved on treatment with an antibiotic. People who are at risk of
getting a fungal infection include those who have just had an operation or
those whose immune systems are weak.
How Caspofungin works
Caspofungin makes fungal cells fragile and stops the fungus from growing
properly. This stops the infection from spreading and gives the body’s natural
defences a chance to completely get rid of the infection.

2. What you need to know before you are given Caspofungin
Do not use Caspofungin
• if you are allergic to caspofungin or any of the other ingredients of this
medicine (listed in section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before you are
given your medicine.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before you are given Caspofungin if:
• you are allergic to any other medicines
• you have ever had liver problems – you might need a different dose of this
medicine
• you are already taking cyclosporin (used to help prevent organ transplant
rejection or to suppress your immune system) – as your doctor may need to
run extra blood tests during your treatment
• if you have ever had any other medical problem.
If any of the above applies to you (or you are not sure), talk to your doctor,
nurse or pharmacist before you are given Caspofungin.
Other medicines and Caspofungin
Please tell 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 can affect the way some other medicines work. Also some other
medicines can affect the way caspofungin works.
Tell your doctor, nurse or pharmacist if you are taking any of the following
medicines:
• cyclosporin or tacrolimus (used to help prevent organ transplant rejection or
to suppress your immune system) as your doctor may need to run extra
blood tests during your treatment
• some HIV medicines such as efavirenz or nevirapine
• phenytoin or carbamazepine (used for the treatment of seizures)
• dexamethasone (a steroid)
• rifampicin (an antibiotic).
If any of the above apply to you (or you are not sure), talk to your doctor, nurse
or pharmacist before you are given Caspofungin.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
• Caspofungin has not been studied in pregnant women. It should be used in
pregnancy only if the potential benefit justifies the potential risk to the unborn
baby.
• Women given caspofungin should not breast-feed.
Driving and using machines
There is no information to suggest that Caspofungin affects your ability to drive
or operate machinery.

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Your doctor will determine the duration of your
treatment and how much caspofungin you will be given each day.
Your doctor will monitor how well the medicine works for you. If you weigh more
than 80 kg, you may need a different dose.

Children and adolescents
The dose for children and adolescents may differ from the adult dose.
If you have been given more Caspofungin than you should
Your doctor will decide how much Caspofungin you need and for how
long each day. If you are worried that you may have been given too much
caspofungin, tell your doctor or nurse straight away.
If you have any further questions on the use of this medicine, ask your doctor,
nurse or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Tell your doctor or nurse straight away if you notice any of the following
side effects – you may need urgent medical treatment:
• rash, itching, feeling warm, swelling of your face, lips or throat or difficulty
breathing – you may be having a histamine reaction to the medicine
• difficulty breathing with wheezing or a rash that gets worse – you may be
having an allergic reaction to the medicine
• cough, serious breathing difficulties – if you are an adult and have invasive
aspergillosis you may be experiencing a serious respiratory problem that
could result in respiratory failure.
As with any prescription medicine, some side effects may be serious. Ask your
doctor for more information.
Other side effects in adults include
Common: may affect up to 1 in 10 people:
• Decreased haemoglobin (decreased oxygen carrying substance in the
blood), decreased white blood cells
• Decreased blood albumin (a type of protein) in your blood, decreased
potassium or low potassium levels in the blood
• Headache
• Inflammation of the vein
• Shortness of breath
• Diarrhoea, nausea or vomiting
• Changes in some laboratory blood tests (including increased values of some
liver tests)
• Itching, rash, skin redness or sweating more than usual
• Joint pain
• Chills, fever
• Itching at the injection site.
Uncommon: may affect up to 1 in 100 people:
• Changes in some laboratory blood tests (including disease of blood clotting,
platelets, red blood cells and white blood cells)
• Loss of appetite, increase in amount of body fluid, imbalance of salt in
the body, high sugar level in the blood, low calcium level in the blood, low
magnesium level in the blood, increase in acid level in the blood
• Disorientation, feeling nervous, being unable to sleep
• Feeling dizzy, decreased feeling or sensitivity (especially in the skin),
shaking, feeling sleepy, change in the way things taste, tingling or numbness
• Blurred vision, increase in tears, swollen eyelid, yellowing of the whites of
the eyes (jaundice)
• Sensation of fast or irregular heart beats, rapid heart beat, irregular heart
beat, abnormal heart rhythm, heart failure
• Flushing, hot flush, high blood pressure, low blood pressure, redness along
a vein which is extremely tender when touched
• Tightening of the bands of muscle around the airways (bronchospasm)
resulting in wheezing or coughing, fast breathing rate, shortness of breath
that wakes you up, shortage of oxygen in the blood, abnormal breath sounds,
crackling sounds in the lungs, wheezing, nasal congestion, cough, throat pain
• Belly pain, upper belly pain, bloating, constipation, difficulty swallowing, dry
mouth, indigestion, passing gas, stomach discomfort, swelling due to
build-up of fluid around the belly
• Decreased flow of bile, enlarged liver, yellowing of the skin and/or whites of
the eyes, liver injury caused by a drug or chemical, liver disorder
• Abnormal skin tissue, generalised itching, hives, rash of varying appearance,
abnormal skin, red often itchy spots on your arms and legs and sometimes
on the face and the rest of the body
• Back pain, pain in an arm or leg, bone pain, muscle pain, muscle weakness
• Loss of kidney function, sudden loss of kidney function
• Catheter site pain, injection site complaints (redness, hard lump, pain,
swelling, irritation, rash, hives, leaking of fluid from the catheter into the
tissue), inflammation of vein at injection site
• Increased blood pressure and alterations in some laboratory blood tests
(including kidney electrolyte and clotting tests), increased levels of the
medicines you are taking that weaken the immune system
• Chest discomfort, chest pain, feeling of body temperature change, generally
feeling unwell, general pain, swelling of the face, swelling of the ankles,
hands or feet, swelling, tenderness, feeling tired.
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 heart beat
• Flushing, low blood pressure
• Changes in some laboratory blood tests (increased values of some liver tests)
• Itching, rash
• Catheter site pain
• Chills
• Changes in some laboratory blood tests.

3. How to use Caspofungin

Other side effects reported since this medicine has been on the market

Caspofungin will always be prepared and given to you by a healthcare
professional.
You will be given Caspofungin :
• once each day
• by slow injection into a vein (intravenous infusion)
• over about 1 hour

Not known: frequency cannot be estimated:
• Liver problems
• Swelling of the ankles, hands or feet
• Increased calcium levels in the blood have been reported.
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Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/
yellowcard). By reporting side effects you can help provide more information
on the safety of this medicine.

PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS

DOSE*

Volume of
reconstituted
Caspofungin
for transfer to
intravenous
bag or bottle

Standard
preparation
(reconstituted
Caspofungin
added to
250 ml) final
concentration

Reduced volume
infusion
(reconstituted
Caspofungin
added to 100 ml)
final concentration

50 mg

10 ml

0.20 mg/ml

-

50 mg at
reduced
volume

10 ml

-

0.47 mg/ml

35 mg for
moderate
hepatic
impairment
(from one
50 mg vial)

7 ml

0.14 mg/ml

-

35 mg for
moderate
hepatic
impairment
(from one
50 mg vial)
at reduced
volume

7 ml

-

0.34mg/ml

5. How to store Caspofungin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton
and the vial as EXP.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C).
Reconstituted concentrate: should be used immediately. Stability data have
shown that the concentrate for solution for infusion can be stored for up to 24
hours when the vial is stored at 25°C or less and reconstituted with water for
injection.
Diluted patient infusion solution: should be used immediately. Stability data
have shown that the product can be used within 24 hours when stored at 25°C
or less, or within 48 hours when the intravenous infusion bag (bottle) is stored
refrigerated (2 to 8°C) and diluted with compatible infusion solution..
From a microbiological point of view, the product should be used immediately.
If not used immediately, in use storage times and conditions prior to use are
the responsibility of the user and would normally not be longer than 24 hours
at 2 to 8°C, unless reconstitution and dilution have taken place in controlled
validated aseptic conditions.
Once Caspofungin has been prepared, it should be used straight away. This
is because it does not contain any ingredients to stop the growth of bacteria.
Only a trained healthcare professional who has read the complete directions
should prepare the medicine (please see below “Instructions of how to
reconstitute and dilute Caspofungin”).
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help to protect the environment.

6. Contents of the pack and other information
What Caspofungin contains
• The active substance is caspofungin. Each vial of Caspofungin contains
50 mg of caspofungin (as acetate). The concentration of the reconstituted
vial is 5.2 mg/ml.
• The other ingredients are sucrose, mannitol, succinic acid and sodium
hydroxide.
What Caspofungin looks like and contents of the pack
Caspofungin is a sterile, white to off-white compact powder.
Each pack contains one vial of powder.
Marketing Authorisation Holder
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR,
UK
Manufacturer
Xellia Pharmaceuticals ApS
Dalslandsgade 11
DK-2300 Copenhagen S
Denmark

This leaflet was last revised in: 05/2016
The following information is intended for medical or healthcare
professionals only:
Instructions of how to reconstitute and dilute Caspofungin:
Reconstitution of Caspofungin
DO NOT USE ANY DILUENTS CONTAINING GLUCOSE as Caspofungin
is not stable in diluents containing glucose. DO NOT MIX OR CO-INFUSE
CASPOFUNGIN WITH ANY OTHER MEDICINES, as there are no data
available on the compatibility of Caspofungin with other intravenous
substances, additives, or medicinal products. Visually inspect the infusion
solution for particulate matter or discolouration.
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 concentrations of the reconstituted vials
will be 5.2 mg/ml.
The white to off-white compact lyophilised powder will dissolve completely.
Mix gently until a clear solution is obtained. Reconstituted solutions should be
visually inspected for particulate matter or discolouration. This reconstituted
solution may be stored for up to 24 hours at or below 25°C.
Step 2 Addition of reconstituted Caspofungin to patient infusion solution
Diluents for the final solution for infusion are: sodium chloride solution for
injection, or lactated Ringer’s solution. The solution for infusion 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. Reduced volume
infusions in 100 ml may be used, when medically necessary, for 50 mg or
35 mg daily doses. Do not use if the solution is cloudy or has precipitated.

* 10.5 ml should be used for reconstitution of all vials
INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS
Calculation of Body Surface Area (BSA) for paediatric dosing
Before preparation of infusion, calculate the body surface area (BSA) of the
patient using the following formula: (Mosteller Formula)1

1 Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17): 1098 (letter)

BSA (m2) =

Height (cm) X Weight (kg)
3600

Preparation of the 70 mg/m2 infusion for paediatric patients >3 months of
age (using a 50-mg vial)
1. Determine the actual loading dose to be used in the paediatric patient by
using the patient’s BSA (as calculated above) and the following equation:
BSA (m2) X 70 mg/m2 = Loading Dose
The maximum loading dose on Day 1 should not exceed 70 mg
regardless of the patient’s calculated dose.
2. Equilibrate the refrigerated vial of Caspofungin to room temperature.
3. Aseptically add 10.5 ml water for injection.a This reconstituted solution
may be stored for up to 24 hours at or below 25°C.b This will give a final
Caspofungin concentration in the vial of 5.2 mg/ml.
4. Remove the volume of medicine equal to the calculated loading dose
(Step 1) from the vial. Aseptically transfer this volume (ml)c of
reconstituted Caspofungin to an IV bag (or bottle) containing 250 ml of
0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers
Injection. Alternatively, the volume (ml)c of reconstituted Caspofungin can
be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium
Chloride Injection or Lactated Ringers Injection, not to exceed a final
concentration of 0.5 mg/ml. This infusion solution must be used within
24 hours if stored at or below 25°C or within 48 hours if stored refrigerated
at 2 to 8°C.
Preparation of the 50 mg/m2 infusion for paediatric patients >3 months of
age (using a 50-mg vial)
1. Determine the actual daily maintenance dose to be used in the paediatric
patient by using the patient’s BSA (as calculated above) and the following
equation: BSA (m2) X 50 mg/m2 = Daily Maintenance Dose
The daily maintenance dose should not exceed 70 mg regardless of the
patient’s calculated dose.
2. Equilibrate the refrigerated vial of Caspofungin to room temperature.
3. Aseptically add 10.5 ml of water for injection.a This reconstituted solution
may be stored for up to 24 hours at or below 25°C.b This will give a final
Caspofungin concentration in the vial of 5.2 mg/ml.
4. Remove the volume of medicine equal to the calculated daily maintenance
dose (Step 1) from the vial. Aseptically transfer this volume (ml)c of
reconstituted Caspofungin to an IV bag (or bottle) containing 250 ml of
0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers
Injection. Alternatively, the volume (ml)c of reconstituted Caspofungin can
be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium
Chloride Injection or Lactated Ringers Injection, not to exceed a final
concentration of 0.5 mg/ml. This infusion solution must be used within
24 hours if stored at or below 25°C or within 48 hours if stored refrigerated
at 2 to 8°C.
Preparation notes:
The white to off-white cake will dissolve completely. Mix gently until a
clear solution is obtained.

a

Visually inspect the reconstituted solution for particulate matter or
discoloration during reconstitution and prior to infusion. Do not use if the
solution is cloudy or has precipitated.

b

c
Caspofungin is formulated to provide the full labeled vial dose (50 mg)
when 10 ml is withdrawn from the vial.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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