PACKAGE
LEAFLET : INFORMATION FOR THE USER
Kepivance 6.25 mg powder for solution
for injection
palifermin
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 further questions, ask your doctor or
pharmacist.
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, nurse or pharmacist.
In
this leaflet
-
1. What Kepivance is and what it is used for
-
2. Before you use Kepivance
-
3. How to use Kepivance
-
4. Possible side effects
-
5 How to store Kepivance
-
6. Further information
1. WHAT
KEPIVANCE IS AND WHAT IT IS USED FOR
Kepivance
should only be used in adults over the age of 18 years.
Kepivance
contains the active substance palifermin which is a
protein produced by biotechnology in a bacteria called
Escherichia coli.
Palifermin is similar to the protein called keratinocyte
growth factor (KGF) that is naturally made by your body
in small amounts. Palifermin acts in the same way as
naturally occurring KGF by stimulating the growth of
specific cells called epithelial cells that form the
tissue lining of your mouth and digestive tract, as well
as other tissues such as skin.
Kepivance is
used to reduce the frequency, duration and severity of
oral mucositis (soreness, dryness and inflammation of
the mouth) and improve related symptoms in patients with
haematological malignancies (blood cancers) receiving
certain types of chemotherapy and/or radiotherapy
requiring autologous haematopoietic stem cell support
(cells from your own body that produce blood).
2.
BEFORE YOU USE KEPIVANCE
Do
not use Kepivance:
-
if you are allergic (hypersensitive ) to
palifermin‚ any other ingredients of Kepivance,
or to Escherichia coli
derived proteins.
Taking other medicines
Please
inform your doctor or pharmacist if you are taking
or have recently taken any other medicines, even
those not prescribed to you by a doctor.
Pregnancy and breast-feeding
Kepivance has not been tested in pregnant women. It
is important to tell your doctor if you:
-
are pregnant;
-
think you may be pregnant; or
-
plan to get pregnant.
It is
not known whether Kepivance is present in human
milk. Do not use Kepivance if you are
breast-feeding.
Ask your
doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
The
effect of Kepivance on the ability to drive or use
machinery is not known.
3. HOW
TO USE KEPIVANCE
As Kepivance
is a powder it must be mixed with water for injections
before being injected into a vein.
The usual
dose is 60 micrograms of Kepivance per kilogram of
bodyweight per day. This is given as an intravenous
injection (into a vein) for three days in a row before
chemotherapy and/or radiotherapy and three days in a row
after chemotherapy and/or radiotherapy for a total of
six doses.
Before
injection‚ Kepivance may be allowed to reach room
temperature for a maximum of 1 hour but should be
protected from light. Kepivance left at room temperature
for more than 1 hour must be disposed of.
Do not shake
Kepivance.
4.
POSSIBLE SIDE EFFECTS
Like all
medicines, Kepivance can have side effects, although not
everybody gets them.
Very common
(more than 1 in every 10 patients) side effects are skin
rash, itching and redness (pruritus and erythema), an
increase in the thickness in the mouth or tongue, change
in colour of the mouth or tongue, generalised swelling
(oedema), pain, fever, aching joints (arthralgia) and
altered taste.
Some
patients have had an increase in lipase and amylase
levels (digestive enzymes) in their blood, which do not
require treatment and usually return to normal after
stopping treatment with Kepivance.
If any of
the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW
TO STORE KEPIVANCE
Keep out of
the reach and sight of children.
Do not use
Kepivance after the expiry date which is stated on the
carton and vial label, after EXP. The expiry date refers
to the last day of that month.
Store in a
refrigerator (2°C – 8°C).
Do not
freeze.
Store in the
original carton, in order to protect from light.
6.
FURTHER INFORMATION
What
Kepivance contains
The
active substance is palifermin. Each vial contains
6.25 mg of palifermin.
The
other ingredients of Kepivance are mannitol,
sucrose, L-histidine, polysorbate 20 and diluted
hydrochloric acid.
What
Kepivance looks like and contents of the pack
Kepivance is a white powder supplied in vials. Each
pack contains 6 vials.
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