DAUNOXOME INJECTION 2MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance: DAUNORUBICIN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR
THE USER

DaunoXome
Injection 2mg/ml concentrate for
solution for infusion
Daunorubicin
Read all of this leaflet carefully before you
start using this medicine.
Keep this leaflet. You may need to
read it again.
If you have any further questions, ask
your doctor.
This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor. See section 4.

1. What DaunoXome is
and what it is used for
What DaunoXome is
DaunoXome is an anti-cancer
medicine (a cytotoxic agent) which
reduces tumour cell growth. The
active substance of DaunoXome is
daunorubicin. DaunoXome is a special
formulation of daunorubicin (in
liposome form), which is used to treat
a type of cancer known as Kaposi’s
sarcoma. Kaposi’s sarcoma is a form of
cancer that mainly affects the skin, but
which can also affect the lungs and
intestines.

What DaunoXome is used for
DaunoXome is used for the treatment
of a severe form of Kaposi’s sarcoma in
patients with AIDS.

In this leaflet:

1. What DaunoXome is
and what it is used for
2. Before you use
DaunoXome
3. How DaunoXome is
used
4. Possible side effects
5. How to store
DaunoXome
6. Further information

2. Before you use
DaunoXome
DaunoXome is not to be used:
if you are allergic (hypersensitive)
to daunorubicin or any of the other
ingredients of DaunoXome, or
any other medicines belonging to
the same group (these are called
anthracyclines or anthracenediones).
if you are pregnant or breastfeeding.
If any of these applies to you, you
must not be given DaunoXome.
If in doubt, ask your doctor or
pharmacist for advice.

Take special care with
DaunoXome
This medicine can cause heart
problems (cardiac failure) because
of its effects on heart muscle. Rarely,
these heart problems can be fatal.
Heart problems can develop suddenly
and may occur weeks or months
after the end of treatment. Damage
to the heart may be irreversible. As
a precaution, your doctor will carry

out tests to monitor your heart’s
performance, before and during the
treatment.
Make sure your doctor knows
about any heart problems you have
had
Tell your doctor if you have been
treated before with any medicines
in the same class as DaunoXome
(anthracyclines or anthracenediones).
The risk of heart problems is higher in
some situations:
if you have existing heart problems
if you are over 65 years old
if you have been given high doses
of DaunoXome, or high total
doses of other anthracycline/
anthracenedione medicines as
well as DaunoXome
if you have been treated with other
medicines that may damage the
heart
if you have received radiation
therapy to the chest.
DaunoXome can suppress bone
marrow activity, which can cause
fever; infections, including infection in
the blood (sepsis); bleeding problems
and reduced red blood cells (anaemia).
Your doctor will carry out regular
blood monitoring. The risk of bone
marrow problems with DaunoXome is
higher if you already have a weakened
immune system.
Daunoxome may also cause tissue
damage such as redness, swelling
or pain at the site of infusion if the
product leaks from the vein. This
damage usually resolves within 6
months.
Tell your doctor if you notice a
stinging pain, redness or leakage of
fluid in the area of the infusion site.
Tell your doctor before treatment
with DaunoXome if you have received,
are receiving or are due to receive
radiation therapy.
If you have impaired kidney or liver
function, your doctor may reduce your
dose of DaunoXome.
DaunoXome is not usually
recommended for children or older
people. Its safety and efficacy has not
yet been studied in these two groups.

Other medicines and
DaunoXome
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.
Daunorubicin can cause inflammation
of the lining of the mouth and
gastrointestinal tract which may affect
the absorption of other medicines
taken orally (by mouth).
Other medicines that affect the
heart or bone marrow
Your doctor will be especially careful if
DaunoXome is given at the same time
as any medicine which reduces the
function of the heart or of the bone
marrow, and with medicines that
suppress the immune system. This
includes medicines in the same class
as DaunoXome (anthracyclines or
anthracenediones).
Other anti-cancer medicines
If you are being treated with other
cytotoxics (anti-cancer medicines) at
the same time as DaunoXome, you
are likely to be at an increased risk of
gastrointestinal side effects.
Anti-viral medicines for HIV
There is a possibility that DaunoXome
may interact with two groups of
anti-HIV medicines, protease inhibitors
(PIs) and non-nucleoside reverse
transcriptase inhibitors (NNRTIs).
Antiplatelet medicines to prevent
blood clots
You should tell your doctor if you are
taking an antiplatelet medicine to
prevent blood clots. Some examples
of antiplatelet medicines are aspirin
(acetylsalicylic acid), clopidogrel,
dipyridamole, eptifibatide; there are
other antiplatelet medicines also
available, so you should check with
your doctor if you are not sure.
Medicines that affect the liver
Some medicines may have an effect
on how your liver works and may,
therefore, have an effect on
DaunoXome. Please tell your doctor
about all other medicines that you are
taking or that you have taken recently.

Vaccinations
Tell your doctor or nurse that you are
taking DaunoXome if you are due to
receive any vaccination, as some
vaccines cannot be given to patients
being treated with DaunoXome.
Tell your doctor if you are taking
or have recently taken any of these.

Pregnancy, breast-feeding
and fertility
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice
before taking this medicine.
DaunoXome can cause serious birth
defects if it is used during pregnancy.
Therefore, DaunoXome must not be
used during pregnancy, unless your
doctor considers it to be vital.
In this case, your doctor should discuss
the possible risks for your unborn child
with you. If you become pregnant
during treatment, you should seek
genetic advice.
DaunoXome should not be used in
mothers who are breast-feeding.
Treatment with DaunoXome may
affect your fertility (female and male).
You should speak to your doctor about
the possible effects on fertility before
your treatment starts.
Men who are treated with
daunorubicin should have counselling
about sperm cryopreservation
before the start of treatment. It is
recommended that men who are
treated with daunorubicin should
not father a child during treatment
or for 6 months afterwards.
Women of childbearing potential have
to use effective contraception during
treatment with daunorubicin and for 6
months after treatment. For women
who want to become pregnant after
treatment with daunorubicin, genetic
counselling is also recommended.

27/03/14

Driving and using machines
Do not drive a car, or use any tools
or machines immediately after
treatment with DaunoXome,
because the side effects of this
medicine could stop you doing
this safely. In particular, the
medicine can cause dizziness,
nausea or sickness (see also section
4, Possible side effects).

Tell your doctor at once if you
suspect that you have been given
too much DaunoXome. In the event
of an overdose, the side effects
listed in section 4 may appear more
pronounced.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

4. Possible side effects
3. How DaunoXome is
used
DaunoXome is always given to you by
a doctor or nurse. It is given as an
infusion into a vein (a drip).
DaunoXome must not be given by
any other method.
Before use, DaunoXome will first be
diluted with a solution of glucose (5%),
and it will then be administered as an
infusion into a vein (intravenously).
Normally, DaunoXome should be used
straight after it has been diluted.
However, your doctor or pharmacist
may decide to store the diluted
DaunoXome for a maximum of 24
hours before use, depending on the
solution.
The infusion will usually take 30 to 60
minutes.

Dosage for adults
The dose of DaunoXome is calculated
on the basis of your body surface area
(which is related to your height and
weight). The starting dose is 40
milligrams per m2, given every
two weeks.
During your treatment, your doctor
may also decide to raise or lower the
amount you are given. Normally, he or
she will treat you with DaunoXome for
as long as it has a positive effect.

If you are given too much
DaunoXome
As your infusion is administered by a
doctor or nurse, it is very unusual to be
given too much of this medicine.

Common side effects
(may affect up to 1 in 10 people treated)
dehydration
depression
dizziness
decreased ability of the left chamber
of the heart to pump blood
redness of the skin, pain and swelling
around the infusion site, caused by
leakage from a vein into
surrounding tissue.

Uncommon side effects
Like all medicines, DaunoXome can
cause side effects, although not
everybody gets them.
Tell your doctor at once if you
notice any of these side effects, or
any others not listed in this leaflet.

Very common side effects
(may affect more than 1 in 10 people
treated):
damage to the bone marrow. Signs
include frequent infections and
bleeding, reduced levels of red blood
cells (anaemia)
infusion reactions. Signs include
back pain, flushing, a tight feeling in
the chest and shortness of breath.
These reactions generally occur
within the first 10 minutes of the
infusion and subside when the
infusion is slowed or stopped
allergic reactions. These may include
rash or wheezing
headaches
tiredness
difficulty breathing
chills, fever
nausea, vomiting, diarrhoea, tummy
ache
hair loss
inflammation of the mucous
membranes (such as the lining of
the mouth, throat, nose, rectum
and vagina).

(may affect up to 1 in every 100 people
treated)
an infection in the blood (sepsis)
which can cause fever or chills, rapid
heartbeat or rapid breathing; and/or
septic shock (a life-threatening form
of sepsis) which also causes low
blood pressure.
disease of the heart muscle and
heart failure. Your doctor may order
some special heart function tests,
both before and during your
treatment.

Rare side effects
(may affect up to 1 in every 1,000 people
treated)
anaphylactic reactions (lifethreatening type of allergic reaction).
Signs include flushing, itching,
wheezing, and swelling of the
mouth, tongue or throat that can
prevent breathing.
heart attack; abnormal rhythm of the
heart (atrial fibrillation)
hand-foot syndrome, which is also
known as Palmar-Plantar
Erythrodysaesthesia (PPE). Signs are
swelling, redness, pain, and tingling
of the hands and feet, which may
lead to peeling of the skin.

Side effects of unknown
frequency
(frequency cannot be estimated from the
available data)
shock, which may cause a sudden drop
in blood pressure, faint or collapse
transient/temporary increases in the
blood levels of some liver enzymes
and bilirubin in laboratory tests

hepatitis, or inflammation (swelling)
of the liver which can cause different
symptoms including jaundice
(yellowing of the whites of the eyes
and skin) and lead to hepatic (liver)
failure. Your doctor will be able to tell
you if you are suffering from these
conditions
red discolouration of the urine
amenorrhoea, which is the absence
of a menstrual period in females of
child-bearing potential
azoospermia, which is a reduction in
the sperm count in males.

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
DaunoXome
Keep out of the reach and sight of
children.
Do not use DaunoXome after the
expiry date which is stated on the
label {Expiry Date}. The product
must be used within 24 hours after
dilution with 5% glucose.
Store at 2°C to 8°C (in a refrigerator).
Do not freeze. Keep the vial in the
outer carton. Vials are for single
use only.
Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required.
These measures will help to protect
the environment.

6. Further information
What DaunoXome contains
The active substance is daunorubicin
(as citrate salt) equivalent to 2 mg/mL
(total 50 mg) daunorubicin base,
encapsulated in liposomes.
The other ingredients
in the liposome are
distearoylphosphatidylcholine,
cholesterol, citric acid (E330).
The other ingredients in the buffer
are sucrose, glycine (E640), calcium
chloride (E509), water for injection.

What DaunoXome looks like
and contents of the pack
DaunoXome is a red, clear or slightly
cloudy solution in a 50 ml glass vial
containing 25 ml of concentrate.
Each vial contains daunorubicin
hydrochloride, corresponding to
50 mg of daunorubicin.

Marketing Authorisation
Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK

Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK
DaunoXome is registered under the
number PL 27827/0007.
This leaflet was last updated
in April 2014

PX2159/1

27/03/14

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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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