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CASPOFUNGIN TEVA 70 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CASPOFUNGIN ACETATE

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TEVA UK Ref:

231-30-90312-A LEA CASPOFUNGIN ACETATE 70MG POWDER INJ VIAL TEVAH Dimensions:
Length:
Width:
Depth:

414 mm
268 mm
-

Version:

7

Colours Used:

PACKAGE LEAFLET: INFORMATION FOR THE USER

CASPOFUNGIN 70 mg POWDER FOR
CONCENTRATE FOR SOLUTION FOR INFUSION

06 May 2016

BLACK
Template

Other medicines and Caspofungin
Please tell your doctor, pharmacist or nurse 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, pharmacist or nurse 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
Read all of this leaflet carefully before you start taking this medicine because it contains
during your treatment
important information for you.
• some HIV medicines such as efavirenz or nevirapine
• Keep this leaflet. You may need to read it again.
• phenytoin or carbamazepine (used for the treatment of seizures)
• If you have any further questions, ask your doctor, pharmacist or nurse.
• dexamethasone (a steroid)
• This medicine has been prescribed for you only. Do not pass it on to others. It may
• rifampicin (an antibiotic).
harm them, even if their signs of illness are the same as yours.
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any nurse before you are given Caspofungin.
possible side effects not listed in this leaflet. See section 4.
Pregnancy and breast-feeding
What is in this leaflet
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have
1. What Caspofungin is and what it is used for
a baby, ask your doctor or pharmacist for advice before taking this medicine.
2. What you need to know before you take Caspofungin
• Caspofungin has not been studied in pregnant women. It should be used in pregnancy
3. How to take Caspofungin
only if the potential benefit justifies the potential risk to the unborn baby
4. Possible side effects
• Women given Caspofungin should not breast-feed.
5. How to store Caspofungin
6. Contents of the pack and other information
Driving and using machines
No studies have been performed with Caspofungin. However, undesirable effects may
occur (e.g. allergic reactions, dizziness, convulsions), which may influence the ability to
1 WHAT CASPOFUNGIN IS AND WHAT IT IS USED FOR
drive and use machines.
What Caspofungin is
Caspofungin contains sodium
Caspofungin contains a medicine called caspofungin. This belongs to a group of medicines This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially
called antifungals.
‘sodium- free’.
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, pharmacist or nurse before you are given your
medicine.
Warnings and precautions
Talk to your doctor, pharmacist or nurse 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 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
• you have ever had any other medical problem.

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.
Use in 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, 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.

If any of the above applies to you (or you are not sure), talk to your doctor, pharmacist or
nurse before you are given Caspofungin.

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.
Chemical and physical in-use stability of the reconstituted concentrate has been
demonstrated for 24 hours at 25°C or less when reconstituted with water for injection.
Chemical and physical in-use stability of the diluted patient infusion solution has been
demonstrated for 24 hours at 25°C and for 48 hours at (2 to 8°C) when 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.
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.
Any unused medicinal product or waste material should be disposed of in accordance with
local requirements.
INSTRUCTIONS FOR USE IN ADULT PATIENTS

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

0.14 mg/ml

0.34 mg/ml

35 mg for moderate 5 ml
hepatic impairment
(from one 70 mg vial)

*10.5 ml should be used for reconstitution of all vials.
Step 1 Reconstitution of conventional vials
To reconstitute the powder bring the vial to room temperature and aseptically add 10.5 ml ** If 70 mg vial is not available, the 70 mg dose can be prepared from two 50-mg vials
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.

TEVA UK Ref:

231-30-90312-A LEA CASPOFUNGIN ACETATE 70MG POWDER INJ VIAL TEVAH Dimensions:
Length:
Width:
Depth:

414 mm
268 mm
-

Version:

7

Colours Used:

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
• 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.

06 May 2016

BLACK
Template

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: 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.
Do not use this medicine after the expiry date which is stated on the carton and the vial
after EXP. 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”).
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 contains
• The active substance is caspofungin. Each vial contains 70 mg of caspofungin. After
reconstitution, each ml of the concentrate contains 7.2 mg of caspofungin.
• The other ingredients are sucrose, mannitol (E421), glacial acetic acid (E260) and
sodium hydroxide (for pH adjustment) (E524) (please see section 2).
What Caspofungin looks like and contents of the pack
Caspofungin is a sterile, white to off-white colour powder.
10 ml colourless clear Type I glass vial with a grey (bromobutyl) rubber stopper with
aluminium band and a orange (polypropylene) plastic flip off cap.
Each pack contains one vial of powder.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg, 89143,
Germany
This leaflet was last revised in 05/2016.

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.
Other side effects reported since this medicine has been on the market:
Not known: frequency cannot be estimated from the available data
• Liver problems
• Swelling of the ankles, hands or feet
• Increased calcium levels in the blood have been reported.

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(m 2 )

Height(cm) X Weight(kg)
3600

Preparation of the 70 mg/m2 infusion for paediatric patients >3 months of age (using a
70-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 of water for injectiona. 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 7.2 mg/ml.
4. Remove the volume of medicinal product 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.

90309-A

3-29146040/A

Preparation of the 50 mg/m2 infusion for paediatric patients >3 months of age (using a
70-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 7.2 mg/ml.
4. Remove the volume of medicinal product 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:
a. The white to off-white colour powder will dissolve completely. Mix gently until a clear
solution is obtained.
b. Visually inspect the reconstituted solution for particulate matter or discolouration
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 (70 mg) when 10 ml is
withdrawn from the vial.

90312-A

3-29146050/A

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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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