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Package leaflet: Information for the user

FEIBA 500 U and 1000 U
Powder and Solvent for
Solution for Infusion


Active substance: Factor VIII Inhibitor Bypassing Activity

Read all of this leaflet carefully before you are
given this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
nurse 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 you get any side effects, talk to your doctor,
nurse or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
Throughout this leaflet FEIBA 500 U and 1000 U
Powder and Solvent for Solution for Infusion will be
called FEIBA.
In this leaflet:
1. What FEIBA is and what it is used for
2. What you need to know before you use FEIBA
3. How to use FEIBA
4. Possible side effects
5. How to store FEIBA
6. Contents of the pack and other information
1. What FEIBA is and what it is used for
FEIBA is a concentrate of blood factors normally
present in your blood that help it to clot. It is used to
help clotting in patients who have developed inhibitors
(antibodies) to factor VIII (factor 8). Haemophilia A
patients have lower Factor VIII levels than normal. So,
if anything stops the factor from working your blood will
not clot properly. FEIBA makes sure that your blood
clots properly.
FEIBA is used:
• To treat spontaneous bleeding episodes in
haemophilia A patients with inhibitors (haemophilia is
when your blood does not clot properly)
• In haemophilia A patients with inhibitors if they need
• In haemophilia A patients with inhibitors to prevent
frequent bleeding
• To treat non-haemophiliacs who have developed
antibodies in their blood that prevent factor VIII from
2. What you need to know before you use FEIBA
Do not use FEIBA if:
• You are allergic (hypersensitive) to the active
ingredients or any of the other ingredients (listed
in section 6). The signs of an allergic reaction are
shortness of breath, wheezing, rash, itching or
swelling of your face and lips.
• You have a condition that affects blood clotting called
‘Disseminated Intravascular Coagulation’ or DIC.
This can cause blood clots, bleeding and sudden
bruising. DIC occurs after a serious disease, injury,
or after a major operation. It will be found by your
doctor using laboratory tests.
Do not use FEIBA if any of the above apply to you. If
you are not sure talk to your doctor, nurse or pharmacist
before using FEIBA.

Warnings and precautions
Talk to your doctor, nurse or pharmacist before using
• You have liver problems
• You have suffered a heart attack
• You have a blood clot (thrombosis or embolism)
• Your immune system isn’t working properly
• You are on a low sodium diet.
Your doctor may re-use FEIBA in patients who are, or
who may be allergic (hypersensitive) to the product or
any of its ingredients. They will only do this after careful
weighing of the expected benefits and the risks of using
the product.
Some people have experienced the following side
effects while using FEIBA. Your risk of getting these
side effects is increased if you use high doses of FEIBA:
• Disseminated intravascular coagulation (DIC) (shown
in tests)
• Blood clots in the veins or lungs
• Heart attack
• Stroke.
Tell your doctor, nurse or pharmacist straight away if
you notice any of these side effects.
Other medicines and FEIBA
Tell your doctor, nurse or pharmacist if you are taking
or have recently taken any other medicines, including
medicines you have bought yourself.
Patients who are at risk of bleeding are sometimes
given drugs to help make blood clots more stable and
last longer – these are known as anti-fibrinolytics. No
adequate and well-controlled studies of the combined
or sequential use of FEIBA and anti-fibrinolytics or
recombinant Factor VIIa have been conducted. These
drugs may affect the way FEIBA works. Examples of
these are epsilon-aminocaproic acid, or tranexamic
acid. If your doctor tells you that you need to take
these drugs as well as FEIBA, a gap of at least six
hours should be left between them. The possibility of
thromboembolic events should be considered when
systemic anti-fibrinolytics are used during treatment
with FEIBA. In cases of concomitant rFVIIa use a
potential drug interaction cannot be excluded according
to available in vitro data and clinical observations,
potentially resulting in a thromboembolic event.
After administration of high doses of FEIBA, the
transitory rise of passively transferred Hepatitis B
surface antibodies may result in misleading interpretation of positive results in serological testing.
Fertility, pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you might be
pregnant or are trying to become pregnant.
• FEIBA will only be used if no alternative treatment is
available, because there is an increased risk of your
blood clotting during pregnancy.
• You will be monitored very carefully by your doctor if
you do need to have FEIBA during pregnancy.
Do not breast-feed while being treated with FEIBA.
Driving and using machines
No effects of FEIBA on the ability to drive and use
machines have been observed.
Tests you may have with FEIBA
You will have your blood tested regularly to see how
your treatment is working. If FEIBA doesn’t seem to be
working as well as expected, your doctor may carry out

a test on your blood to count your platelets. Platelets
help your blood to clot and the number affects how well
FEIBA works.
Important information about some of the ingredients
FEIBA is made from human blood or plasma. This
means blood from donors is used to make FEIBA. The
following measures are used to make sure this does not
transmit infections:
• Donors are carefully screened and selected
• When FEIBA is made steps are taken to remove and
destroy the AIDS HIV virus and certain others that
cause liver problems (such as hepatitis A, hepatitis B
and hepatitis C viruses). These steps may be of
limited value against a virus called parvovirus B19
As with any medicine made from human blood or
plasma, the risk of transmission of infectious diseases
cannot be totally ruled out.
FEIBA contains approx. 80mg sodium (calculated) per
vial. This must be taken into account for patients on a
low sodium diet.
Vaccines you may have with FEIBA
Your doctor may recommend that you have vaccinations
against hepatitis A and B if you regularly need products
that are made using blood or blood components.
3. How to use FEIBA
The usual dose
• Your doctor will decide how much you will need, how
often and at what intervals you need to have it. The
solution should be given as an injection into your
• As a guide, 70 to 100 units (U) per kg (kilogram) of
body weight is recommended.
• The maximum single dose should not be more than
100 units per kg.
• The maximum dose in a day should not be more than
200 units per kg.
How to dissolve and inject FEIBA
• Aseptic conditions (meaning clean and germ free)
are required during preparation of the FEIBA
solution and administration
• The BAXJECT II Hi-Flow is used to mix the powder
with the Water for Injections. The BAXJECT II Hi-Flow
will be referred to as ‘the device’ for the rest of the
• When you have mixed the powder with sterile water
(Water for Injections), use it immediately.
In order to ensure a tight connection between the
syringe and BAXJECT II Hi-Flow, the use of a luer
lock syringe is highly recommended (turn the syringe
in a clockwise direction until the stop position when
• Any unused solution must be disposed of
• This medicine must not be mixed with other
medicines or solvents.
• Inject FEIBA solution in the way that you have been
Dissolving the dried substance
When you have mixed the powder with sterile water
use it immediately. Please see the diagrams below.
1. Warm the powder and sterile water vials to room
temperature (15°C – 25°C) if necessary.
2. Remove the protective caps from the powder and
sterile water vials and cleanse the rubber stoppers
of both with alcohol wipes. Place the vials on a flat
3. Open the device package by peeling away the paper
lid without touching the inside (Fig. i). Do not remove
the device from the package.
4. Do not use if the device, its sterile barrier system or
its packaging has been previously opened, damaged
or shows any sign of deterioration. Turn the package

over and insert the clear plastic spike through the
sterile water stopper (Fig. ii). Grip the package at its
edge and pull the package off the device (Fig. iii). Do
not remove the blue cap from the device.
5. With the device attached to the sterile water vial,
invert the system so that the sterile water vial is
on top of the device. Insert the purple plastic spike
through the powder vial stopper. The vacuum will
draw the sterile water into the powder vial (Fig. iv)
6. Swirl, but do not shake, the entire system gently until
all material is dissolved. Ensure that the powder is
completely dissolved, otherwise active material will
not pass through the device filter.
Fig. i

Fig. ii

Fig. iii

Fig. iv

Do not use solutions that are cloudy or contain bits
Injecting the dissolved product
In order to ensure a tight connection between the
syringe and BAXJECT II Hi-Flow, the use of a luer lock
syringe is highly recommended.
1. Remove the blue cap from the device. Take the
syringe and connect it to the device (DO NOT DRAW
2. Invert the system (with product vial on top). Draw the
FEIBA solution into the syringe by pulling the plunger
back slowly (Fig. vi).
3. Disconnect the syringe.
4. If foaming of the product in the syringe occurs, wait
until the foam has collapsed.
Slowly administer the solution intravenously with a
winged set for injection (or a disposable needle).
Fig. v

Fig. vi

Do not exceed an injection/infusion rate of 2 units
FEIBA per kg of body weight per minute.
If FEIBA is given by infusion, a disposable infusion set
with an adequate filter must be used.
If you are not sure about how to prepare or give the
injection or if you have any other questions about your
treatment, ask your doctor or nurse.
If you have more FEIBA than you should
If you think you have had too much FEIBA, stop the
treatment quickly and speak to your doctor or nurse
immediately. Sometimes if you have too much you
may get the signs of ‘Disseminated Intravascular
Coagulation’ or DIC. See above in Section 2 ‘Do not
take FEIBA if’ for more information.
4. Possible side effects
Like all medicines, FEIBA can cause side effects,
although not everybody gets them.
Tell your doctor, nurse or pharmacist straight away if
you notice any of the following side effects. Sometimes
they can be serious.
The following
Very common:
Very rare:
Not known:

frequencies are used to evaluate side
may affect more than 1 in 10 people
may affect up to 1 in 10 people
may affect up to 1 in 100 people
may affect up to 1 in 1,000 people
may affect up to 1 in 10,000 people
frequency cannot be estimated from the
available data

In clinical trials the following side effects were reported
as common:
Hepatitis B surface antibody positive.
The following side effects have been reported during
post marketing surveillance. The frequency cannot be
estimated (not known) on the basis of the available
• Blood and the lymphatic system:
– Increase of inhibitor titer – shown in tests
– Disseminated intravascular coagulation (DIC) –
shown in tests.
• Immune system:
– Nettle-rash on the entire body
– Anaphylactic reaction (severe allergy).
• Nervous system:
– Stroke
– Feeling sleepy
– Changes in the way things taste
– Feeling of numbness in the arms or legs
– Abnormal or reduced sensation.
• Heart and circulation:
– Flushing
– Palpitation of the heart
– High blood pressure
– Blood clots – signs may include pain in the legs or
other places or difficulty breathing
– Heart attack – the risk is higher if you use high
doses, or are treated for a long time when other
risk factors exist.
• Chest:
– Narrowing of the airways
– Blocked blood vessel in the lung
– Wheezing, Cough, Feeling breathless.
• Stomach and gut:
– Diarrhoea
– Stomach pain
– Feeling sick or being sick
• Skin and tissue:
– Feeling of numbness in the face.
• Injection site:
– Swelling of the face, tongue and lips
– Nettle-rash on the entire body
– Itching
– Pain.

5. How to store FEIBA
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not freeze.
• Keep the vials in the outer carton to protect from
• Do not use FEIBA after the expiry date which is
stated on the label after ‘EXP’. The expiry date refers
to the last day of that month.
• FEIBA must not be used if the vials are damaged.
• Do not use if the device or its packaging are damaged
or show any sign of deterioration.
• The solution should only be used once.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other information
What FEIBA contains
• The active substance is Human Plasma Protein
200 to 600 mg or 400 to 1200 mg with a Factor VIII
Inhibitor Bypassing Activity of 500 units or 1000 units.
• The other ingredients are sodium chloride and
sodium citrate.
• A vial of Water for Injections is also provided.
What FEIBA looks like and contents of the pack
It is supplied as a white to pale green dry substance
together with a vial of Water for Injections to make a
FEIBA is available in sizes of 500 and 1000 units, to
be dissolved in 20ml of sterile water. Each pack also
includes a device for reconstitution.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is:
Baxalta Innovations GmbH
Industriestrasse 67
A-1221 Vienna
Tel. +44 (0) 1635 798 777
Send all enquiries to this address.
FEIBA is made at:
Baxter AG
This leaflet was last revised in 09/2015

Other side effects:
• Rapid intravenous infusion can cause stabbing pain
and a feeling of numbness in the face, arms or legs,
as well as a drop in blood pressure.

Is this leaflet hard to see or read?
Telephone +44 (0) 1635 798 777 for an audiotape, large print leaflet or other formats.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse.
This includes any possible side effects not listed in this
You can also report side effects directly via the national
reporting system listed below.

Baxalta and FEIBA are trademarks of Baxalta
Baxter is a registered trademark of Baxter International

United Kingdom
The Yellow Card Scheme at:

BaxJect II Hi-Flow Device
The device is sterilized by gamma irradiation.
It is for single use only.
The device is latex free.

ADR Reporting
By reporting side effects you can help provide more
information on the safety of this medicine.

Do not use if package is damaged

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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.