Factor VIII inhibitor bypassing fraction powder for injection with diluent vials (500,
1000, 2500 U/vial)
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before you start using FEIBA NF.
This leaflet answers some common questions about the FEIBA NF. It does not contain
all of the available information. It does not take the place of talking to your doctor
All medicines have risks and benefits. Your doctor has weighed the risks against the
benefits of using FEIBA NF for you.
If you have any concerns about having this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
What FEIBA NF is used for
FEIBA NF is used for the treatment and prevention of bleeding in haemophilia A and
B patients who have developed inhibitors (antibodies) against coagulation factor VIII
(FVIII), and factor IX (FIX) respectively.
It is possible that your doctor may give you FEIBA NF for another reason.
Ask your doctor if you have any questions about why you are being given FEIBA NF.
How does FEIBA NF work
Under normal physiological conditions, FVIII and FIX are essential for blood clotting
and therefore the control of bleeding. Individuals with haemophilia A have decreased
FVIII in their blood circulation, and individuals with haemophilia B have decreased
levels of FIX. These deficiencies may lead to heavy bleeding into joints, muscles
or internal organs, either spontaneously or as a result of accidental or surgical
Some haemophilia A and haemophilia B patients develop antibodies against FVIII and
FIX, respectively, in the course of their treatment, leading to replacement therapy
In patients with acquired haemophilia (non-haemophiliacs), some of these coagulation
factors are not working properly because the patient has developed antibodies to his/her
own coagulation factors.
FVIII and FIX replacement therapy have been successfully used for the treatment of
haemophilia A and haemophilia B as well as non-haemophiliacs. FEIBA NF can bypass
the effects of these antibodies, thus normalising the blood clotting process. FEIBA
NF is a mixture of coagulation factors that converts pro-thrombin to thrombin in the
coagulation pathway without the need for FVIII or FIX. Factor VII is present in FEIBA
NF mainly in the activated form, and factors II, IX, and X are present mainly in the
non-activated form. FEIBA stands for Factor Eight Inhibitor Bypassing Activity.
Before you are given FEIBA NF
FEIBA NF should not be given to you if:
you have a tendency to develop allergic reactions or are hypersensitive to any human
plasma-derived product; (Some of the symptoms of an allergic reaction may include
skin rash, shortness of breath, swelling of the face, lips or tongue, which may cause
you are suffering from a generalised blood clotting disorder (Disseminated Intravascular
Coagulation or DIC) resulting from an excessive activation of the blood clotting system;
(DIC usually occurs in connection with severe disease, injury, or a major operation,
and is diagnosed by a laboratory test.)
you have a history of angina or heart attacks, or currently have a severe clot (thrombosis
the expiry date printed on the pack has passed;
the packaging is torn or show sign of tampering.
You must tell your doctor if you:
have liver problems;
have suffered a heart attack;
have a blood clot;
are on a low sodium diet;
have any other illness causing your immune system not to work properly.
You must tell your doctor if you are pregnant, planning to become pregnant or breast
Although haemophilia is very rare in women, the use of FEIBA NF during pregnancy or
breastfeeding is not recommended, due to insufficient information being available.
It should only be used in these situations if clearly needed.
If you have not told your doctor about any of the above, tell them before you start
using FEIBA NF.
If you are, or may be allergic to FEIBA NF or any of its ingredients, and your doctor
is aware of this, it is possible that your doctor may give you FEIBA NF if no alternative
treatment is available. Your doctor will only do so after careful weighing of the
expected benefits and the risks of using the product.
Taking other medicines
Tell your doctor or pharmacist if you are using any other medicines including any
that you obtained without a prescription from your pharmacy, supermarket or health
Some medicines and FEIBA NF may interfere with each other. These include:
any medicines which help make blood clots more stable and last longer (these are known
as anti-fibrinolytics), for example tranexamic acid, aminocarproic acid, recombinant
emicizumab (which is used to prevent bleeding in haemophilia A patients who have inhibitors
Your doctor may recommend that you have vaccinations against hepatitis A and B if
you regularly need products which are made using blood or blood components, such as
How FEIBA NF is given
How much is given:
Your doctor will decide how much FEIBA NF will be given to you. Each individual will
receive a different amount, which may vary between treatments. The dose you receive
will be based on:
how much, how often and in which sites bleeding occurs (knees, muscle, etc.).
As a general guide a dose of 50 to 100 Units per kg (U/kg) body weight is recommended.
The maximum single dose should not be more than 100 U/kg.
The maximum daily dose of 200 U/kg body weight should not be exceeded.
Since the response to treatment may differ from patient to patient the dosage recommendations
are only guidelines.
Method of Administration (use aseptic technique):
FEIBA NF is usually administered in a hospital. Some individuals may be trained to
use FEIBA NF at home.
FEIBA NF is given by a slow injection or infusion directly into your vein.
Do not attempt to inject FEIBA NF by yourself unless you have received proper training
on how to use the product by your doctor or other competent healthcare professional,
e.g. a haemophilia nurse.
If you are unsure about how to use this medicine contact your doctor or competent
healthcare professional to seek advice.
Before injecting FEIBA NF, take the vials out of the refrigerator and let them come
to room temperature.
Do not mix FEIBA NF with any other medicines or solvent other than the water for injections
supplied with the pack.
Always inspect the solution after it is prepared for use and before injection.
The solution should be clear to slightly off white to faint yellow.
Do not inject if the solution is discoloured or cloudy or contains particles.
Use the solution straight away or within 3 hours after it is prepared.
Do not refrigerate the solution after it is prepared.
Use a new syringe and needle for each injection.
Instructions for using FEIBA NF
Always follow the specific instructions given by your healthcare provider.
The steps listed below are general guidelines for using your medicine.
Ask your healthcare provider before using FEIBA NF if you are unsure of the procedures.
FEIBA NF is provided as a powder (in a single-dose vial) and water for injections
(in a diluent vial). The water for injection in the diluent vial is used as a solvent
to dissolve the powder.
Preparing FEIBA NF for injection
1. Warm the vials to room temperature, for example by using a water bath for several
minutes (max. 37°C).
2. Remove the protective caps from the powder vial and diluent vial and clean the rubber
stoppers of both. Place the vials on a flat surface.
3. Open the BAXJECT II Hi-Flow device package by peeling away the paper lid without touching
the inside. Do not remove the device from the package.
4. Turn the package over and insert the clear plastic spike through the diluent stopper.
Grip the package at its edge and pull the package off BAXJECT II Hi-Flow. Do not remove
the blue cap from BAXJECT II Hi-Flow device.
5. With BAXJECT II Hi-Flow attached to the diluent vial; invert the system so that the
diluent vial is on top of the device. Insert the purple plastic spike through the
powder vial stopper. The vacuum will draw the solution into the powder vial at the
6. Swirl gently until all powder is dissolved. Make sure the powder is completely dissolved
or otherwise the undissolved powder will not pass through the device filter.
Injecting a dose
1. Remove the blue cap from BAXJECT II Hi-Flow. Take the syringe and connect it to BAXJECT
II Hi-Flow (DO NOT DRAW AIR INTO THE SYRINGE).
2. Invert the system (with the vial now containing the solution on top). Draw the solution
into the syringe by pulling the plunger back slowly.
3. Disconnect the syringe.
4. Slowly inject the solution into your vein with a winged set for injection (or a disposable
If you use too much (overdose)
Overdosage of FEIBA NF may increase the risk of adverse reactions, such as blood clots,
or a heart attack. In such cases administration of the product should be stopped immediately.
As the product will most likely be given to you in a hospital setting by a trained
healthcare professional, the chances of you receiving an overdose are remote.
Immediately telephone your doctor or the Poisons Information Centre (telephone 131
126), or go to accident and emergency at your nearest hospital, if you think that
you or anyone else may have been given too much FEIBA NF.
Do this even if there are no signs of discomfort or poisoning.
While you are using FEIBA NF
Things you must do
Monitor your bleeding and tell your doctor or nurse if your bleeding gets worse.
You will have your blood tested regularly to see how your treatment is working. If
FEIBA NF does not 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 of platelets affects how well FEIBA NF works.
If you are about to have any blood test for red cell antibodies or hepatitis, tell
your doctor that you are using FEIBA NF.
FEIBA NF may interfere with some of these blood tests leading to inaccurate results.
Talk to your doctor before travelling, and make sure you have enough FEIBA NF with
you to cover the time of travelling.
It is important to obtain a written statement from your doctor, explaining the reasons
why you need to have this medicine and injecting device with you, otherwise you may
not be allowed to bring it into the country of travelling. Make sure you have multiple
copies of the letter if travelling to more than one country.
Things you must not do
Do not give FEIBA NF to anyone else, even if they have the same condition as you.
Do not stop using FEIBA NF, or adjust the dosage, without checking with your doctor.
Tell your doctor or pharmacist as soon as possible if you do not feel well after using
All medicines can have side effects. Sometimes they are serious, most of the time
they are not.
Your risk of getting side effects is increased if you are given high doses of FEIBA
You may need medical attention if you get some of these side effects.
Do not be alarmed by this list of possible side effects, you may not experience any
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor, nurse or pharmacist if you notice any of the following and they
light-headedness (or any other sign of low blood pressure);
The above list includes the common side effects of FEIBA NF.
If any of the following happen, tell your doctor immediately or go to Emergency at
the nearest hospital:
shortness of breath; wheezing; difficulty breathing; chest pain or discomfort;
changes in facial skin colour, puffiness or swelling of your face, lips, tongue, or
other parts of the body, rash or hives.
The above list includes serious side effects of FEIBA NF which may occur if you are
having a severe allergic response to the medicine. If any of the above occurs during
the FEIBA NF injection, stop the injection immediately.
You may need urgent medical attention or hospitalisation.
In the course of treatment with FEIBA NF, blood clots may occur, particularly after
high doses and/or in patients with other risk factors for developing blood clots.
A generalised blood clotting disorder (Disseminated Intravascular Coagulation, DIC)
has been observed in some cases.
In patients who have pre-existing risk factors for developing heart disease, heart
attack (myocardial infarction) has been reported after using high doses and/or being
treated for a long time.
FEIBA NF is manufactured from donated blood. There is a small risk that such products
may transmit infections such as viral infections.
Tell your doctor or pharmacist of any suspected undesirable effect that is not mentioned
in this leaflet.
Other side effects not listed above may occur in some patients.
After using FEIBA NF
All medicines should be kept where children cannot reach them.
Store FEIBA NF below 25°C. Protect from light.
Do not freeze FEIBA NF.
Keep the FEIBA NF in the pack until it is time to use it.
This will protect the vials from light. If the vials are not stored in the pack, the
product may not keep well.
Unopened vials stored in the pack can be kept below 25°C until its expiry date which
is printed on the packaging.
Do not store the solution in the fridge after the powder is mixed with the diluent.
Use the solution straight away, or within 3 hours after it is prepared.
FEIBA NF is for single use in single patient only.
Discard any solution left in the vial at the end of your injection or infusion.
Dispose the used vials and all materials in an appropriate container.
If your doctor tells you to stop using FEIBA NF or the expiry date has passed, ask
your pharmacist or your Haemophilia Treatment Centre what to do with any medicine
that is left over.
Ask your doctor, pharmacist or Haemophilia Treatment Centre if you have any questions
about how to dispose FEIBA NF.
What FEIBA NF looks like
FEIBA NF comes as a white-to-cream-coloured powder in a single-dose glass vial.
Each pack contains:
1 vial of FEIBA NF powder for injection;
1 vial of water for injection (diluent to dissolve the powder for injection);
1 BAXJECT II Hi-Flow reconstitution device; and
a package insert.
FEIBA NF is available in the following strengths:
500 Units (containing 200-600 mg of the active ingredient in each vial);
1000 Units (containing 400-1200 mg of the active ingredient in each vial);
2500 Units (containing 1000-3000 mg of the active ingredient in each vial).
human plasma-derived protein with factor VIII inhibitor bypassing activity expressed.
sodium citrate dihydrate;
water for injections.
FEIBA NF is supplied in Australia by:
Shire Australia Pty Limited
Level 39, 225 George Street
Sydney NSW 2000
Telephone: 1800 012 612
Australian registration numbers
AUST R 104896 (500 U)
AUST R 104911 (1000 U)
AUST R 172236 (2500 U)
Date of preparation
This leaflet was prepared in August 2019.
FEIBA NF is a trademark of Baxalta Incorporated, a wholly-owned indirect subsidiary
of Shire plc.
Shire and the Shire Logo are trademarks of Shire Pharmaceutical Holdings Ireland Limited
or its affiliates, each a Takeda company.