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CASPOFUNGIN DR. REDDYS 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 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
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
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.
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
• 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.
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.
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.
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 (2ºC to 8ºC).
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”).
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.
Chemical and physical stability has been demonstrated up to
24 hours when the vial is stored at 25°C or less and
reconstituted with water.
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 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.

Caspofungin contains no preservatives. Chemical and physical
in-use stability has been demonstrated for 24 hours at 25°C before
its use. 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.
Do not use this medicine if you notice any signs of deterioration
such as cracks in the vial.
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 vials is 5.2 mg/ml.
- The other ingredients are sucrose, mannitol, glacial acetic acid
and sodium hydroxide (please see section 2. What you need to
know before you are given Caspofungin).
What Caspofungin looks like and contents of the pack
Caspofungin is a sterile, white to off-white compact powder in a
glass vial with a rubber stopper and a red aluminium cap.
Each pack contains one vial of powder.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Dr. Reddy´s Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire
HU17 0LD
United Kingdom

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 powder for concentrate for solution for infusion 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.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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
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

Manufacturer
Famar Health Care Services Madrid SAU
Avda Leganes, 62
28923 Alcorcón (Madrid)
Spain

50 mg

10 ml

0.20 mg/ml

-

50 mg at reduced volume

10 ml

-

0.47 mg/ml

This leaflet was last revised in 11/2016

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

-

0.34 mg/ml

*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).
Height
(cm) x Weight (kg)
_____________________
BSA (m²) =
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 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 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.
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 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 25ºC or within 48 hours if stored refrigerated at 2 to 8ºC.

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 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 labelled vial dose (50 mg) when 10 ml is withdrawn from the vial.

+ Expand Transcript

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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