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CASPOFUNGIN 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CASPOFUNGIN ACETATE / 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 or your child 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, 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 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
Caspofungin 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.

Caspofungin may also cause Serious Cutaneous Adverse Reactions such as
Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

As with any prescription medicine, some side effects may be serious. Ask your
doctor for more information.

The following information is intended for medical or healthcare
professionals only:

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.

Other side effects in adults include

Instructions of how to reconstitute and dilute CASPOFUNGIN:

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
Ask your doctor for advice before taking any medicine, if you are pregnant or
breast-feeding or think you are pregnant.
• 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.

3. How to use Caspofungin
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.
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.
• rash, skin peeling, mucous membrane sores, hives, large areas of peeling skin.

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, increase 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 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 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.

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.
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
(reconsttuted
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

7 ml

0.14 mg/ml

-

7 ml

-

0.34 mg/ml

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

*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)
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.

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, website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Caspofungin
Keep this medicine out of the sight and reach of children.

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 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.

Do not use this medicine after the expiry date which is stated on the carton and
the vial (the first two numbers are the month; the next four numbers are the year).
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C to 8°C).
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”).
If not used immediately, the solution may be stored for up to 24 hours at 25°C
or less or for 48 hours when the intravenous infusion bag (bottle) is stored
refrigerated (2 to 8°C) and diluted with sodium chloride solution 9 mg/ml (0.9 %),
4.5 mg/ml (0.45 %), or 2.25 mg/ml (0.225 %) for infusion, or lactated Ringer’s
solution. 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.
Do not use the solution if you notice any signs of discolouration or
suspended particles.
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 other ingredients are sucrose, manitol, hydrochloric acid (for pH-adjustment),
sodium hydroxide (for pH-adjustment), carbon dioxide (for pH-adjustment) (please
see section 2. What you need to know before you are given Caspofungin).
What Caspofungin looks like and contents of the pack
Lyophilised sterile white to off-white compact powder.
The reconstituted solution is clear.
10 ml Type I glass vial with a bromobutyl rubber and a plastic cap with a red
aluminum band.
Supplied in packs of 1 vial.
Marketing Authorisation Holder and Manufacturer

Preparation notes:
a) The white to off-white cake will dissolve completely. Mix gently until a clear
solution is obtained.
b) 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.
c) CASPOFUNGIN is formulated to provide the full labeled vial dose (50 mg)
when 10 ml is withdrawn from the vial.

Marketing Authorisation Holder:
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó nº8, 8A, 8B
Fervença, 2705-906 Terrugem SNT, Portugal
Manufacturer:
Pharmadox Healthcare, Ltd
KW20A Kordin Industrial Park, Paola,
PLA 3000, Malta
Distributed by:
Consilient Health (UK) Ltd.
No. 1 Church Road,
Richmond upon Thames, Surrey, TW9 2QE
This leaflet was last revised in December 2016

P0569

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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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