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CASPOFUNGIN ACTAVIS 70MG 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
Read all of this leaflet carefully before you start using 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, 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.
- The full name of this medicine is Caspofungin 70mg Powder for Concentrate for Solution for Infusion but
within the leaflet it will be referred to as Caspofungin Powder.

• you have ever had liver problems - you might need a different dose of this medicine
• you are already taking ciclosporin (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 Powder.
Other medicines and Caspofungin Powder
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines. This is because Caspofungin Powder can affect the
way some other medicines work. Also some other medicines can affect the way
Caspofungin Powder works.

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

Tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
• ciclosporin 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).

1 What Caspofungin Powder is and what it is used for
What Caspofungin Powder is

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 Powder.

Caspofungin Powder contains a medicine called caspofungin. This belongs to a group of medicines called
anti‑fungals.

Pregnancy and breast-feeding

What Caspofungin Powder is used for

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 using this medicine.
• Caspofungin Powder 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 Powder should not breast-feed.

Caspofungin Powder 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.

Driving and using machines

There is no information to suggest that Caspofungin Powder affects your ability to
drive or operate machinery.

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

How Caspofungin Powder works

Caspofungin Powder 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.

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

2 What you need to know before you use Caspofungin Powder

Use in children and adolescents

Do not use Caspofungin Powder

The dose for children and adolescents may differ from the adult dose.

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

If you have been given more Caspofungin Powder than you should

If you are not sure, talk to your doctor, nurse or pharmacist before you are given your medicine.

Your doctor will decide how much Caspofungin Powder you need and for how long each day. If you are
worried that you may have been given too much Caspofungin Powder, tell your doctor or nurse straight
away.

Warnings and precautions

Talk to your doctor, nurse or pharmacist before you are given Caspofungin Powder if:
• you are allergic to any other medicines
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If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
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Caspofungin 70mg Powder for Concentrate for Solution for Infusion

PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS

The following information is intended for healthcare professionals only:

DOSE*

Instructions of how to reconstitute and dilute Caspofungin Powder:
Reconstitution of Caspofungin Powder
DO NOT USE ANY DILUENTS CONTAINING GLUCOSE as Caspofungin Powder is not stable in diluents
containing glucose. DO NOT MIX OR CO-INFUSE CASPOFUNGIN POWDER WITH ANY OTHER MEDICINES,
as there are no data available on the compatibility of Caspofungin Powder with other intravenous
substances, additives, or medicinal products. Visually inspect the infusion solution for particulate matter or
discolouration.

Volume of
reconstituted
Caspofungin Powder
for transfer to
intravenous bag or
bottle
10ml
14ml

70mg
70mg
(from two 50mg
vials)**
35mg for moderate
hepatic
impairment
5ml
(from one 70mg
vial)

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 10.5ml of water for
injection. The concentrations of the reconstituted vials will be 7.2mg/ml.

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

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

0.28mg/ml
0.28mg/ml

Not Recommended
Not Recommended

0.14mg/ml

0.34mg/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.

* 10.5ml should be used for reconstitution of all vials
** If 70mg vial is not available, the 70mg dose can be prepared from two 50mg vials

Step 2 Addition of reconstituted Caspofungin Powder 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 250ml infusion bag or bottle. Reduced volume infusions in
100ml may be used, when medically necessary, for 50mg or 35mg daily doses. Do not use if the solution is
cloudy or has precipitated.

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

1

BSA (m2) =

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Caspofungin 70mg Powder for Concentrate for Solution for Infusion PIL UK

colours/plates:
1. black

item no:

AAAJ1076

dimensions: 300 x 415

print proof no:

2

pharmacode:

origination date: 14.6.16
approved for print/date

Height (cm) x Weight (kg)
3600

min pt size:

9 pt

2.
3.
4.
5.
6.

originated by:

db

revision date:

15.6.16

Technical Approval

revised by:

db

date sent:

supplier:

IL/Xellia

approved:

14.6.16

Non Printing Colours
1. profile
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

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

4 Possible side effects

Not known: frequency cannot be estimated:
• Liver problems
• Swelling of the ankles, hands or feet
• Increased calcium levels in the blood have been reported.

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

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 Powder
Keep this medicine out of the sight and reach of children.

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
• 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.

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.
Unopened vials: Store in a refrigerator (2°C to 8°C).
Once Caspofungin Powder 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 Powder”).
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 protect the environment.

6 Contents of the pack and other information
What Caspofungin Powder contains
- The active substance is caspofungin. Each vial of Caspofungin Powder contains caspofungin acetate
equivalent to 70mg caspofungin.
- The other ingredients are sucrose, mannitol, succinic acid and sodium hydroxide (please see section 2.
What you need to know before you are given Caspofungin Powder).

What Caspofungin Powder looks like and contents of the pack
Caspofungin Powder is a sterile, white to off-white compact powder.
Each pack contains one vial of powder.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland

Manufacturer

Xellia Pharmaceuticals ApS
Dalslandsgade 11
2300 Copenhagen S
Denmark
This leaflet was last revised in June 2016.

If you would like a
leaflet with larger text,
please contact
01271 385257.

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, including increased values of some liver tests
• Itching, rash
• Catheter site pain
• Chills.

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Actavis, Barnstaple, EX32 8NS, UK



Preparation of the 70mg/m2 infusion for paediatric patients >3 months of age (using a 70mg 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 70mg/m2 = Loading Dose.
The maximum loading dose on Day 1 should not exceed 70mg regardless of the patient’s calculated dose.
2. Equilibrate the refrigerated vial of Caspofungin Powder to room temperature.
3. Aseptically add 10.5ml of water for injection.a b This will give a final caspofungin concentration in the vial of
7.2mg/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 Powder to an IV bag (or bottle)
containing 250ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringers Injection.
Alternatively, the volume (ml)c of reconstituted Caspofungin Powder 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 0.5mg/ml.
Preparation of the 50mg/m2 infusion for paediatric patients >3 months of age (using a 70mg 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 50mg/m2 = Daily Maintenance Dose.
The daily maintenance dose should not exceed 70mg regardless of the patient’s calculated dose.
2. Equilibrate the refrigerated vial of Caspofungin Powder to room temperature.
3. Aseptically add 10.5ml of water for injection.a b This will give a final caspofungin concentration in the vial of
7.2mg/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 Powder to an IV bag (or bottle)
containing 250ml of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringers Injection.
Alternatively, the volume (ml)c of reconstituted Caspofungin Powder 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 0.5mg/ml.

Preparation notes:
a The white to off-white cake will dissolve completely. Mix gently until a clear solution is obtained.
bV
 isually 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.
cC
 aspofungin Powder is formulated to provide the full labelled vial dose (70mg) when 10ml is withdrawn
from the vial.
Storage and shelf-life after reconstitution/dilution
Reconstituted concentrate: Physical and chemical stability has been demonstrated for 24 hours at 25°C.
Diluted solution for infusion: Physical and chemical stability has been demonstrated for 24 hours at 25°C
and for 48 hours at 2 to 8°C when diluted with sodium chloride solution 9mg/ml (0.9%), 4.5mg/ml (0.45%), or
2.25mg/ml (0.225%) for infusion, or lactated Ringer’s solution.
The total in-use period should not exceed 24 hours if stored at 25°C or 48 hours if stored at 2 to 8°C.
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.

Continued top of next column
AAAJ1076

Actavis, Barnstaple, EX32 8NS, UK

Caspofungin 70mg Powder for Concentrate for Solution for Infusion PIL UK

colours/plates:
1. black

item no:

AAAJ1076

dimensions: 300 x 415

print proof no:

2

pharmacode:

origination date: 14.6.16
approved for print/date

min pt size:

9 pt

2.
3.
4.
5.
6.

originated by:

db

revision date:

15.6.16

Technical Approval

revised by:

db

date sent:

supplier:

IL/Xellia

approved:

14.6.16

Non Printing Colours
1. profile
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

Expand view ⇕

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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