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CASPOFUNGIN ALTAN 70 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

If you have been given more Caspofungin Altan than you should

Caspofungin Altan 70 mg powder for concentrate for
solution for infusion

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

Read all of this leaflet carefully before you or your child are given this
medicine because it contains important information for you.

If you have any further questions on the use of this medicine, ask your doctor,
nurse or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, nurse or pharmacist.
• f 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 Altan is and what it is used for
2. What you need to know before you are given Caspofungin Altan
3. How to use Caspofungin Altan
4. Possible side effects
5. How to store Caspofungin Altan
6. Contents of the pack and other information
1. What Caspofungin Altan is and what it is used for
What Caspofungin Altan is
Caspofungin Altan 70 contains a medicine called caspofungin. This belongs to a
group of medicines called antifungals.
What Caspofungin Altan is used for
Caspofungin Altan is used to treat the following infections in children,
adolescents and adults:
• serious fungal infections in your tissues or organs (called ‘invasive
candidiasis’). This infectionis 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 otheranti-fungal treatments have not worked or have caused
side effects. This infection is caused by amould 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 Altan works
Caspofungin Altan makes fungal cells fragile and stops the fungus from growing
properly. This stops the infection from spreading and gives the body’s natural
defenses a chance to completely get rid of the infection.
2. What you need to know before you are given Caspofungin Altan
Do not use Caspofungin Altan
if you are allergic to caspofungin or any of the other ingredients of this medicine
(listed insection 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 Altan
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 Altan.
Caspofungin Altan may also cause Serious Cutaneous Adverse Reactions such
as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
Other medicines and Caspofungin Altan
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 Altan can affect the way some other medicines
work. Also some other medicines can affect the way Caspofungin Altan 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 Altan.
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 Altan 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 Altan 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 Altan
Caspofungin Altan will always be prepared and given to you by a healthcare
professional.
You will be given Caspofungin Altan:
• 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 Altan 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.

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 allergicreaction 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.
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 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 Altan

PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS

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.

Volume of
reconstituted
Caspofungin
Altan for
transfer to
intravenous
bag or bottle

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

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

70 mg

10 ml

0,28 mg/ml

Not
Recommended

70 mg (from
two 50 mg
vials)**

14 ml

0,28 mg/ml

Not
Recommended

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

5 ml

0,14 mg/ml

0,34 mg/ml

Store in a refrigerator (2ºC to 8ºC).
Once Caspofungin Altan 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 Altan”).
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 Altan 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.

DOSE*

*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
fron two 50-mg vial.

Do not use this medicine if you notice any signs of deterioration such as cracks
in the vial.

INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS

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.

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).

6. Contents of the pack and other information
What Caspofungin Altan contains
- The active substance is caspofungin. Each vial of Caspofungin Altan contains
70 mg of caspofungin (as acetate). The concentration of the reconstituted
vials is 7.2 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 Altan).
What Caspofungin Altan looks like and contents of the pack
Caspofungin Altan is a sterile, white to off-white compact powder in a glass vial
with a rubber stopper and a yellow aluminium cap.
Each pack contains one vial of powder.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ALTAN Pharma Ltd.
2 Harbour Square, Crofton Road
Dun Laoghaire, Co Dublin
Ireland
Manufacturer
Famar Health Care Services Madrid SAU
Avda Leganes, 62
28923 Alcorcón (Madrid)
Spain
This medicinal product is authorized by the Member States of the EEA
under the following names:
Spain: Caspofungina Altan 70 mg polvo para concentrado para solución para
perfusión
Belgium: Caspofungin Altan 70 mg powder for concentrate for solution for
infusion
Portugal: Caspofungina Altan 70 mg pó para concentrado para solução para
perfusão
This leaflet was last revised in january 2017
The following information is intended for medical or healthcare
professionals only:
Instructions of how to reconstitute and dilute Caspofungin Altan:
Reconstitution of Caspofungin Altan
DO NOT USE ANY DILUENTS CONTAINING GLUCOSE, as Caspofungin Altan
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 Altan 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.

Preparation of the 70 mg/m 2 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 (m 2 ) 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 Altan 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 loading dose
(Step 1) from the vial. Aseptically transfer this volume (ml)c of reconstituted
Caspofungin Altan 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,
c
the volume (ml) of reconstituted Caspofungin Altan 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/m 2 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 (m 2 ) 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 Altan 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
c
maintenance dose. (Step 1) from the vial. Aseptically transfer this volume (ml) of
reconstituted Caspofungin Altan 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 Altan 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.

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 Altan
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 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 Altan is formulated to provide the full labeled vial
dose (70 mg) when 10 ml is withdrawn from the vial.

MEDIDAS: 210x390 mm

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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