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Kepivance (palifermin) – Package leaflet - V03AF08

Updated on site: 08-Oct-2017

Medication nameKepivance
ATC CodeV03AF08
Substancepalifermin
ManufacturerSwedish Orphan Biovitrum AB (publ)

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 because it contains

-Keep this leaflet. You may need to read it again.authorised

-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 s de effects not listed in this leaflet. See section 4.What is in this leaflet:1. What Kepivance is and what it is used for2. What you need to know before you use Kepivance3. How to use Kepivance4. Possible side effects5. How to store Kepivance6. Contents of the pack and other informationimportant information for you.

Kepivance contains the active substance palifermin whichlongeris 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 kerati ocyte gr wth factor (KGF) which is made naturally by your body in small amounts.

1. What Kepivance is and what it is used for

no Kepivance is used to producttreat 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 y u may be receiving chemotherapy, radiotherapy and autologous hematopoietic stem cell t ansplantation (cells from your own body that produce blood cells). One of the side effects of these t eatments is oral mucositis. Kepivance is used to reduce the frequency, duration and severity of oral mucositis symptoms.

Medicinal2. What you need to know before you use Kepivance

Kepivance shou d on y be used in adults over the age of 18 years.

Do not use Kepivance:

-if you are allergic to palifermin, Escherichia coli derived proteins or any other ingredients of this medicine (listed in section 6).

Children

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

Other medicines and Kepivance

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.

Ask your doctor or pharmacist for advice before taking this medicine.

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 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.

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3. How to use Kepivance

Kepivance will be given to you by a doctor or nurse with experience in cancer trea ment.

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).

When you will be given Kepivance

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 andradi therapy, must be given at

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 givenlongerat least 7 days after the most recent

Kepivance administration.

 

For information on preparation and adminis ra ion of Kepivance, please see information for

 

 

 

no

healthcare professionals at the end of this leaflet.

4.

Possible side effects

 

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

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

 

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skin r sh, itching and redness (pruritus and erythaema);

an i

cre se in the thickness in the mouth or tongue;

cha

ge 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

Medicinaltreatment 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):

Reporting of side effects

authorised

 

If you get any side effects, talk to your doctor or pharmacist. This includes ny possible side effects

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.

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.

5.

How to store Kepivance

 

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

 

 

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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 hat mo th.

 

 

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Store in a refrigerator (2 °C – 8 °C).

 

Do not freeze.

Store in the original ca t n, in rder to protect from light.

6.

Contents of productthe pack and other information

What Kepiv ce 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.

Medicinal

What Kepivance looks like and contents of the pack

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

Marketing Authorisation Holder and Manufacturer

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm

Sweden

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

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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 solu ion 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 temperatu e for a maximum of 1 hour but

 

 

 

 

authorised

should be protected from light. Kepivance left at room temperature for mo than 1 hour should be

discarded.

 

 

 

 

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

 

 

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