Kepivance
palifermin
palifermin
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Kepivance is and what it is used for
What you need to know before you use Kepivance
How to use Kepivance
Possible side effects
How to store Kepivance
Contents of the pack and other information
Medicinal product no longer authorised
Kepivance contains the active substance palifermin which is a protein produced by biotechnology in a bacteria called Escherichia coli. Palifermin stimulates 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. Palifermin works in the same way as keratinocyte growth factor (KGF) which is made naturally by your body in small amounts.
Kepivance is used to treat oral mucositis (soreness, dryness and inflammation of the mouth) which has occurred as a side effect of treatments for your blood cancer.
To treat your blood cancer you may be receiving chemotherapy, radiotherapy and autologous hematopoietic stem cell transplantation (cells from your own body that produce blood cells). One of the side effects of these treatments is oral mucositis. Kepivance is used to reduce the frequency, duration and severity of oral mucositis symptoms.
Kepivance should only be used in adults over the age of 18 years.
if you are allergic to palifermin, Escherichia coli derived proteins or any other ingredients of this medicine (listed in section 6).
Kepivance is not recommended in children (0 to 18 years).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Kepivance might interact with a medicine called heparin. Please inform your doctor if you are receiving or have recently received heparin.
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 have a baby.
If you are pregnant you should not use Kepivance unless clearly necessary.
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 this medicine.
Kepivance will be given to you by a doctor or nurse with experience in cancer treatment.
The usual dose of Kepivance is 60 micrograms of Kepivance per kilogram of bodyweight per day. This dose will be given to you as an intravenous injection (into a vein).
You will be given Kepivance for three days in a row before chemotherapy and radiotherapy and for three days in a row after chemotherapy and radiotherapy for a total of six doses.
The last of the three doses given before chemotherapy andradiotherapy, must be given at
Medicinal product no longer authorised
least 24 to 48 hours before the chemotherapy and radiotherapy starts. The first of the three doses given after the chemotherapy and radiotherapy must be given at least 7 days after the most recent Kepivance administration.
For information on preparation and administration of Kepivance, please see information for healthcare professionals at the end of this leaflet.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
skin rash, itching and redness (pruritus and erythaema);
an increase in the thickness in the mouth or tongue;
change in colour of the mouth or tongue;
generalised swelling (oedema);
swelling of hands, ankles or feet;
pain;
fever;
aching joints (arthralgia);
altered taste;
increase in lipase and amylase levels (digestive enzymes) in the blood (which do not require treatment and usually return to normal after stopping treatment with Kepivance).
tingling of the mouth;
darkening of an area of skin (hyperpigmentation);
eyelid swelling;
lip swelling.
redness, bumps or swelling of the tongue;
swelling (oedema) of the face or mouth;
swelling or redness of the vagina;
hand-and-foot skin-reaction (palms of the hands or soles of the feet tingle, become numb, painful, swollen or red);
allergic reactions.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Medicinal product no longer authorised
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 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.
The active substance is palifermin. Each vial contains 6.25 mg of palifermin.
The other ingredients are mannitol, sucrose, L-histidine, polysorbate 20 and diluted hydrochloric acid.
Kepivance is a white powder supplied in vials. Each pack contains 6 vials.
Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm
Sweden
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The following information is intended for healthcare professionals only: Kepivance is a sterile but unpreserved product and is intended for single use only.
Kepivance should be reconstituted with 1.2 ml water for injections. The diluent should be injected slowly into the Kepivance vial. The contents should be swirled gently during dissolution. Do not shake or vigorously agitate the vial.
Generally, dissolution of Kepivance takes less than 5 minutes. Visually inspect the solution for discolouration and particulate matter before administration. Kepivance should not be administered if discolouration or particulates are observed.
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 should be discarded.
Medicinal product no longer authorised
Any unused product or waste material should be disposed of in accordance with local requirements.