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AMBISOME 50 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): AMPHOTERICIN B

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Package leaflet

AmBisome®

1. What AmBisome is and what it is
used for

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50 mg Powder for solution for infusion
Liposomal amphotericin B

What AmBisome is

Read all of this leaflet carefully before you start your
treatment with this medicine.

AmBisome is an antifungal antibiotic. The active
ingredient in AmBisome is amphotericin B.

Keep this leaflet. You may need to read it again.

AmBisome is given as an infusion into a vein (a drip) in
hospital by a doctor or nurse.

If you have any further questions, ask your doctor.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, tell your doctor.

In this leaflet:

1. What AmBisome is and what it is
used for

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What AmBisome is used for
AmBisome is used to treat serious infections caused by
fungi:
■■ Fungal infections of one or more deep organs of
the body.
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2. Before you are given AmBisome
3. How AmBisome is used

Suspected fungal infections in patients with
a raised temperature and neutropenia.
Neutropenia is a reduced number of white blood
cells called neutrophils. These are important in
fighting infections. Neutropenia can be a side
effect of cancer treatments.

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Before you are given AmBisome your doctor will
check that your fever is not due to bacteria or viruses.
You will probably have had one or more antibiotics
already. A fever which continues despite treatment
may be due to a fungal infection. It’s difficult to
confirm this with current tests, however.

4. Possible side effects
5. How AmBisome is stored
6. Further information

Your doctor will take special care with
AmBisome

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Visceral leishmaniasis, a disease caused by a
parasite.

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2. Before you are given AmBisome
Before your first treatment
Before your first treatment your doctor may give you
a small amount of AmBisome. They will then wait for
approximately 30 minutes to see whether you have an
allergic reaction, before continuing the infusion of the
full dose.

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Your doctor will not give you AmBisome
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If you are allergic (hypersensitive) to amphotericin
B or any of the other ingredients of AmBisome.
However, if your condition is life-threatening you
may be given AmBisome if your doctor believes
that only AmBisome can help you.
If you have previously experienced a severe allergic
reaction (anaphylactic or anaphylactoid) to
AmBisome. Symptoms of such immediate and
life-threatening allergic reactions include: flushing,
itching, sickness, swelling of the face, mouth,
tongue and airways, often enough to
cause difficulty breathing.

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If you get other reactions related to the
infusion. If this happens, your doctor may slow
down the infusion, so you receive AmBisome over
a longer period of time (approximately 2 hours).
Your doctor may also give you medicines to
prevent or treat infusion-related reactions, such as
diphenhydramine (an antihistamine), paracetamol,
pethidine (for pain relief ) and/or hydrocortisone
(an anti-inflammatory medicine that works by
reducing the response of your immune system).
If you are taking other medicines that may
cause kidney damage, see Taking other medicines,
right. AmBisome may cause damage to the kidney.
Your doctor or nurse will take regular blood
samples. This is to test creatinine (a chemical in the
blood that reflects kidney function), and electrolyte
levels (particularly potassium and magnesium)
Both of these can be abnormal if you have kidney
problems. This is particularly important if you are
taking other medicines that may cause damage to
the kidney.
The blood samples will also be tested for changes
in your liver, and your body’s ability to produce
new blood cells and platelets.
If blood tests show a change in kidney function,
or other important changes. If this happens, your
doctor may give you a lower dose of AmBisome or
stop treatment.
If blood tests show that your potassium levels
are low. If this happens, your doctor may prescribe
a potassium supplement for you to take while you
are treated with AmBisome.
If you have a white blood cell transfusion.
Sudden and severe problems in the lungs can
happen if you are given AmBisome infusion during
or shortly after a white blood cell transfusion.
Your doctor will recommend that the infusions are
separated by as long a period as possible. This will
reduce the risk of lung problems, and your lungs
will be monitored.
If you have had kidney failure and are having
dialysis. Your doctor may start AmBisome
treatment after the procedure has ended.
If you have diabetes. AmBisome contains
approximately 900 mg of sucrose (sugar) in each
vial. Tell your doctor if you have diabetes.

Taking other medicines
Tell your doctor if you are taking any other medicines,
or have recently taken any. This includes medicines and
herbal products you bought without a prescription.
Medicines that may cause kidney damage:
■■ Medicines that suppress the immune system
(immunosuppressants), such as ciclosporin and
tacrolimus.
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Certain antibiotics called aminoglycosides
(including gentamicin, neomycin and
streptomycin) and polymixins.

Pentamidine a medicine used to treat pneumonia
in people with AIDS and leishmaniasis.

➥➥Tell your doctor if you are taking any of these
medicines. AmBisome may make any kidney
damage caused by the medicine worse. If you
are taking any of these medicines, your doctor or
nurse will take regular blood samples to check your
kidneys.
Medicines that may lower your potassium levels:
■■ Corticosteroids, anti-inflammation medicines that
work by reducing the response of your immune
system.
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Corticotropin (ACTH), used to control the amount
of corticosteroid produced by your body. The body
produces corticosteroid in response to stress.
Diuretics, medicines that increase the amount
of urine your body produces. This includes
furosemide.
Digitalis glycosides, medicines produced from
the foxglove plant and used to treat heart failure.
AmBisome may worsen the side effects of digitalis,
such as heart rhythm changes.
Muscle relaxants usually used during surgery,
such as tubocurarine. AmBisome may increase the
muscle relaxant effect.

AmBisome contains sugar
Tell your doctor if you have diabetes. AmBisome contains
approximately 900 mg of sugar (sucrose) in each vial.

3. How AmBisome is used
AmBisome is always given to you by a doctor or nurse.
It is given into a vein (a drip). AmBisome must not be
given by any other method.
To prepare the infusion AmBisome must be dissolved in
sterile water for injection and then diluted with a solution
containing dextrose.
AmBisome must not be mixed with saline (salt) solutions
or with other drugs or electrolytes.
AmBisome is not interchangeable with other
amphotericin products.

Before your first treatment
Before your first treatment your doctor may give you
a small amount of AmBisome. They will then wait for
approximately 30 minutes to see whether you have an
allergic reaction, before continuing the infusion of the
full dose.

Dosage for adults

➥➥Tell your doctor if you are taking any of these
medicines.

Your dose of AmBisome will depend on your body
weight.

Other medicines:
■■ Antifungal medicines, such as flucytosine.
AmBisome may worsen the side effects of
flucytosine. This includes changes in the body’s
ability to produce new blood cells. This may be
seen in blood tests.

Fungal infections of one or more deep organs of the
body:
Treatment is normally started at 1 mg per kg of body
weight, every day over 2 to 4 weeks. Your doctor may
decide to increase the amount you receive to as high as
3 mg per kg body weight.

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Certain cancer medicines, such as methotrexate,
doxorubicin, carmustine and cyclophosphamide.
Taking this type of medicine with AmBisome
may cause kidney damage, wheezing or trouble
breathing and low blood pressure.
White blood cell (leukocyte) transfusions.
Sudden and severe problems in the lungs can
happen if you are given AmBisome infusion during
or shortly after a white blood cell transfusion.
Your doctor will recommend that the infusions are
separated by as long a period as possible. This will
reduce the risk of lung problems and your lungs
will be monitored.

Suspected fungal infections in patients with a raised
temperature and neutropenia: The recommended daily
dose is 3 mg per kg body weight, per day. AmBisome
will be given to you until your temperature is normal for
3 days in a row. However, AmBisome must not be given
for more than 42 days in a row.
Visceral leishmaniasis:
You may be given a total dose of between 21 and 30 mg
per kg body weight, over a period of 10 to 21 days. Your
doctor will decide on the amount of AmBisome you will
receive and over how many days it will be given.

Dosage for children

➥➥Tell your doctor if you are taking any of these
medicines.

AmBisome has been used to treat children The dose of
AmBisome for a child is calculated per kg of body weight
in the same way as for adults.

Pregnancy and breast-feeding

AmBisome is not recommended in babies under
1 month old.

Tell your doctor before you are given AmBisome if
you are pregnant, planning to become pregnant, or if
you are breast-feeding.
Your doctor will only prescribe AmBisome if they think
the benefits of treatment outweigh the risks to you and
your unborn child or your baby.

Do not drive or operate machinery
Some of the possible side effects of AmBisome could
affect your ability to drive or use machines safely,
See Section 4, Possible side effects.

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If you have a severe allergic (anaphylactic)
reaction. If this happens your doctor will stop the
infusion.

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Dosage for elderly patients
No change in dose or frequency of infusion is needed for
elderly patients.

Dosage for patients with kidney
problems
AmBisome has been given to patients with kidney
problems at doses ranging from 1 to 5 mg per kg of
body weight per day. No change in dose or frequency of
infusion is required. Your doctor or nurse will take regular
blood samples to test for changes in kidney function
during AmBisome treatment.

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How long will the infusion take?
Normally the infusion will take 30 to 60 minutes. For
doses greater than 5 mg per kg of body weight per day,
the infusion could take up to 2 hours.

4. Possible side effects
Like all medicines, AmBisome can cause side effects,
although not everybody gets them.
Side effects during the infusion
You may get side effects during the infusion:
■■ Very common (These can affect more than 1 in
every 10 people): fever, chills, and shivering.
■■

Less frequent infusion-related side
effects include: chest tightness, chest pain,
breathlessness, difficulty breathing (possibly with
wheezing), flushing, a faster heart rate than normal,
low blood pressure and musculoskeletal pain
(described as joint pain, back pain, or bone pain).

These side effects clear up quickly when the infusion is
stopped. These reactions may not happen with future
infusions of AmBisome or with a slower infusion (over
2 hours). Your doctor may give you other medicines
to prevent infusion-related reactions, or to treat the
symptoms if you do get them. If you have a severe
infusion-related reaction, your doctor will stop the
AmBisome infusion and you should not receive this
treatment in the future.

Uncommon side effects
These can affect up to 1 in every 100 people:
■■ Bleeding into the skin, unusual bruising and
bleeding for a long time after injury
Severe allergic (anaphylactoid) reaction

It is presented in a 15-ml, 20-ml or 30-ml glass vial.

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Fits or seizures (convulsions)

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Difficulty breathing, possibly with wheezing.

Each vial contains 50 mg of the active ingredient
amphotericin B.

Other side effects
It is not known how frequently these side effects occur:
■■ Anaemia (low red blood cell levels), with symptoms
of excessive tiredness, being out of breath after
light activity, and a pale complexion
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Severe allergic (anaphylactic) or sensitivity
reactions
Heart attacks and heart rhythm changes
Kidney failure and kidney problems. Signs include
tiredness and passing less urine
Severe swelling of the skin around the lips, eyes or
tongue.

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Breakdown of muscle

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Bone pain and joint pain

These can affect more than 1 in every 10 people:
■■ Low blood potassium levels, leading to feeling
tired, confused, having muscle weakness or cramps

If your test results show high levels of phosphate,
then further analysis using a different system may be
necessary to confirm the results

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Fever, chills or shivering.

Common side effects
These can affect up to 1 in every 10 people:
■■ Low magnesium, calcium or sodium blood levels,
leading to feeling tired, confused, muscle weakness
or cramps
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High blood sugar levels

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Headache

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A faster heart rate than normal

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Widening of the blood vessels, causing low blood
pressure and flushing

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Breathlessness

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Diarrhoea

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Stomach (abdominal) pain

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Rash

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Chest pain

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Back pain

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Abnormal results for liver or kidney function
showing up in blood tests or urine tests.

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If you notice any side effects that you are worried about,
whether they are listed in this leaflet or not, tell your
doctor.

The closure consists of a rubber stopper and an
aluminium ring seal fitted with a removable plastic cap.
Each carton contains 10 vials and 10 filters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
The product licence holder is:
Gilead Sciences International Ltd
Granta Park
Abington
Cambridge CB21 6GT
United Kingdom
AmBisome is manufactured by:
Gilead Sciences Ireland UC,
IDA Business & Technology Park,
Carrigtohill,
County Cork,
Ireland
This leaflet was last revised in
For any information about this medicine, please contact
the local representative of the Marketing Authorisation
Holder:
United Kingdom
Gilead Sciences Ltd
Tel: + 44 (0) 1223 897555

830444XX

Very common side effects

Feeling sick or being sick

AmBisome is a sterile, bright yellow lyophilisate
(freeze-dried powder) for solution for infusion.

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Interference with Phosphorus blood test results.
False readings showing an increase in the levels of
phosphate in your blood may occur when samples
from patients receiving AmBisome are analyzed
using a specific system called a PHOSm assay.

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What AmBisome looks like and contents
of the pack

5. How AmBisome is stored
AmBisome is stored in the hospital pharmacy.
Keep out of the reach and sight of children.
Do not use AmBisome after the expiry date which is
stated on the label.
Do not store above 25°C.
Do not store partially used vials for future patient use.

6. Further information
What AmBisome contains
The active ingredient of AmBisome is amphotericin B.
Each vial contains 50 mg of amphotericin B enclosed
inside liposomes (small fat particles). The other
ingredients are: hydrogenated soy phosphatidylcholine,
cholesterol, distearoylphosphatidylglycerol, alpha
tocopherol, sucrose (sugar), disodium succinate
hexahydrate, sodium hydroxide and hydrochloric acid.

26/01/2015 14:35

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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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