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AMBISOME 50 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): AMPHOTERICIN B / AMPHOTERICIN B / AMPHOTERICIN B

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Package leaflet: Information for the user

AmBisome®
50 mg Powder for solution for infusion
Liposomal amphotericin B
Read all of this leaflet carefully before you are
given 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.
If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this leaflet.
See section 4.

1. What AmBisome is and what it is
used for
AmBisome is an antifungal antibiotic. The active
ingredient in AmBisome is amphotericin B.
AmBisome is given as an infusion into a vein (a drip) in
hospital by a doctor or nurse.

■■

1. What AmBisome is and what it is
used for

■■

4. Possible side effects

6. Content of the pack and other
information

■■

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.

■■

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.

2. What you need to know before
you are given AmBisome

5. How to store AmBisome

Your doctor will take special care with AmBisome
■■ If you have a severe allergic (anaphylactic)
reaction. If this happens your doctor will stop the
infusion.

AmBisome is used to treat serious infections caused by
fungi:
■■ Fungal infections of one or more deep organs of
the body.

What is in this leaflet

3. How to use AmBisome

Warnings and precautions

Visceral leishmaniasis, a disease caused by a
parasite.

2. What you need to know before
you are given AmBisome
Before your first treatment

■■

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Your doctor will not give you AmBisome
■■

■■

If you are allergic (hypersensitive) to
Amphotericin B or any of the other ingredients of
AmBisome. However, if your condition is lifethreatening 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.

■■

■■

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.

Medicines that may lower your potassium levels:
■■ Corticosteroids, anti-inflammation medicines that
work by reducing the response of your immune
system.
■■

■■

■■

■■

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.

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.
■■

■■

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.

Pregnancy and breast-feeding

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

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine.

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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➥➥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.

If you have had kidney failure and are having
dialysis. Your doctor may start AmBisome
treatment after the procedure has ended.

Other medicines and AmBisome

■■

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

Certain antibiotics called aminoglycosides
(including gentamicin, neomycin and
streptomycin) and polymixins.

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.

3. How AmBisome is given
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 medicinal products 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.

Use in adults
Your dose of AmBisome will depend on your body
weight.
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 of body weight.
For mucormycosis the starting dose is normally
5 mg per kg of body weight per day. The duration of
therapy will be determined on an individual basis by your
Doctor.
Suspected fungal infections in patients with a raised
temperature and neutropenia: The recommended daily
dose is 3 mg per kg of 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 of 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.

Use in children and adolescents
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.
AmBisome is not recommended in babies under 1 month
old.

Use in elderly patients

Driving and using machines

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

Do not drive or operate machinery

Use in patients with kidney problems

Some of the possible side effects of AmBisome could
affect your ability to drive or use machines safely,
See Section 4, Possible side effects.

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.

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

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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.

■■

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).

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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.
If you receive a higher dose of AmBisome than
you should
You should tell your doctor immediately if you think you
received too much AmBisome.
If you have any further questions on the use of this
product, ask your doctor.

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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Headache

Do not use AmBisome after the date which is stated on
the label after {EXP}. The expiry date refers to the last day
of the month.

■■

A faster heart rate than normal

Do not store above 25°C.

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

Do not store partially used vials for future patient use.

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Diarrhoea

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Stomach (abdominal) pain

Side effects during the infusion

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Rash

You may get side effects during the infusion:
■■ Very common (These can affect more than 1 in
every 10 people): fever, chills, and shivering.

■■

Chest pain

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Back pain

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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).

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

Feeling sick or being sick

■■

Fever, chills or shivering.

■■

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

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

■■

Fits or seizures (convulsions)

■■

Difficulty breathing, possibly with wheezing.

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

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 AmBisome contains
The active ingredient is amphotericin B. Each vial
contains 50 mg of amphotericin B enclosed inside
liposomes (small fat particles).

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Gilead Sciences International Ltd
Granta Park
Abington
Cambridge CB21 6GT
United Kingdom
Manufacturer
Gilead Sciences Ireland UC,
IDA Business & Technology Park,
Carrigtohill,
County Cork,
Ireland
For any information about this medicine, please contact
the local representative of the Marketing Authorisation
Holder:
United Kingdom
Gilead Sciences Ltd
Tel: + 44 (0) 8000 113700
This leaflet was last revised in
March 2017

The other ingredients are: hydrogenated
soy phosphatidylcholine, cholesterol,
distearoylphosphatidylglycerol, alpha tocopherol,
sucrose (sugar), disodium succinate hexahydrate, sodium
hydroxide and hydrochloric acid.

What AmBisome looks like and contents
of the pack
AmBisome is a sterile, bright yellow lyophilisate
(freeze-dried powder) for solution for infusion.
It is presented in a 15-ml, 20-ml or 30-ml glass vial.

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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.

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

High blood sugar levels

Breathlessness

Like all medicines, AmBisome can cause side effects,
although not everybody gets them.

AmBisome is stored in the hospital pharmacy.

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4. Possible side effects

5. How to store AmBisome

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

Severe swelling of the skin around the lips, eyes or
tongue.

■■

Breakdown of muscle

■■

Bone pain and joint pain

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.
If your test results show high levels of phosphate,
then further analysis using a different system may be
necessary to confirm the results.
Reporting of side effects
If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the nationnal
reporting system:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

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21/03/2017 11:30

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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