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CASPOFUNGIN 70 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CASPOFUNGIN ACETATE

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Package Leaflet: Information for the user
Caspofungin 70mg powder for concentrate for
solution for infusion
Caspofungin
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your
doctor, nurse or pharmacist.
- If you get any side effects, talk to your doctor, nurse or
pharmacist. 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 will Caspofungin be given to you
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
This medicine 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 this medicine works
This medicine 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
• 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 this medicine.

Other medicines and Caspofungin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines
including medicines obtained without a prescription.
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 applies to you (or you are not sure),
talk to your doctor, nurse or pharmacist before you are
given this medicine.
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.
• This medicine 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 who received this medicine should not breastfeed.
Driving and using machines
There is no information to suggest that this medicine
affects your ability to drive or operate machinery.
3. How will Caspofungin be given to you
This medicine will always be prepared and given to you
by a healthcare professional.
You will be given this medicine:
• once each day
• by slow injection into a vein (intravenous infusion)
• over about 1 hour.
Your doctor will determine the duration of your
treatment and how much of this medicine 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.
Use in children and adolescents
The dose for children and adolescents may differ from
the adult dose.
If you are given more Caspofungin than you should
Your doctor will decide how much of this medicine you
need and for how long each day. If you are worried that
you may have been given too much of this medicine,
tell your doctor or nurse straight away.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
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

The following information is intended for 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.
Preparation of the diluted solution before infusion
Caspofungin can be administered in the following
infusion solutions:
• Sodium Chloride 0.9 %
• Sodium Chloride 0.45 %
• Sodium Chloride 0.225 %
• Lactated Ringer’s
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 7.2 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.
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

70 mg

10 mL

0.28
mg/mL

Not
recommended

70 mg
(from two
50 mg
vial)**

14 mL

0.28
mg/mL

Not
recommended

35 mg for 5 mL
0.14
0.34
moderamg/mL
mg/mL
te
hepatic
impairment
(from one
70 mg
vial)
* 10.5 mL should be used for reconstitution of all vials
** If 70 mg vial is not available, the 70 mg dose can be
prepared from two 50-mg vials

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
• Sensation of fast or irregular heartbeats, rapid
heartbeat, irregular heartbeat, 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
resulting in wheezing or coughing (bronchospasm),
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 (jaundice), 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 heartbeat
• 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.





Other side effects reported since this medicine has
been on the market
Not known: frequency cannot be estimated:
• Liver problems
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: (Mosteller1 Formula)

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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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