Kepivance 6.25 mg powder for solution for injection

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.

For the treatment of your blood cancer you are receiving chemotherapy in combination with radiotherapy followed by autologous hematopoietic stem cell transplantation (cells from your own body that produce blood cells). One of the side effects of this treatment is mucositis (soreness, dryness and inflammation of the mouth). Kepivance is used to reduce the frequency, duration and severity of oral mucositis and improve related symptoms.

Kepivance should only be used in adults over the age of 18 years.

Do not use Kepivance:

• if you are allergic (hypersensitive) to palifermin, any other ingredients of Kepivance, or to Escherichia coli derived proteins.

Use in Children

Kepivance is not recommended in children (0 to 18 years).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Kepivance might interact with a medicine called heparin. Please inform your doctor if you are receiving or have recently received heparin.

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.

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 any medicine.

.
A doctor with experience in cancer treatment should supervise your Kepivance treatment.

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. The last of the three doses given before chemotherapy/radiotherapy, must be given at least 24 to 48 hours before the chemotherapy/radiotherapy. The first of the three doses given after the chemotherapy/radiotherapy must be given more than four 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 Kepivance can cause side effects, although not everybody gets them.

Very common (affects more than 1 user in 10) side effects are:

• 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).

Common (affects 1 to 10 users in 100) side effects are:

• tingling of the mouth;
• darkening of an area of skin (hyperpigmentation);
• eyelid swelling;
• lip swelling.

Not known (frequency cannot be estimated from available data):

• 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 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.

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 the month.

Store in a refrigerator (2°C ? 8°C).

Do not freeze.

Store in the original carton, in order to protect from light.

What Kepivance contains

• 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.

What Kepivance looks like and contents of the pack

Kepivance is a white powder supplied in vials. Each pack contains 6 vials.

Marketing Authorisation Holder and Manufacturer

Biovitrum AB (publ)
SE-112 76 Stockholm
Sweden

This leaflet was last approved in

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for medical or 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.

Any unused product or waste material should be disposed of in accordance with local requirements.