FEIBA Patient Information Booklet - Haemophilia Care

Baxter Healthcare Ltd, Wallingford Road, Compton,
Newbury, Berks RG20 7QW.
Tel: 01635 206000. Fax: 01635 206373
Baxter and FEIBA are registered trademarks of
Baxter International Inc., its subsidiaries and affiliates
www.baxterhealthcare.co.uk
www.haemophiliacare.co.uk
About FEIBA and Inhibitors
Date of preparation: September 2009. ADV09/2617B

FEIBA and inhibitors
If you or someone you care for has been told they have an inhibitor,
you may understandably have some questions and concerns about
how this will affect you and your family.
Thankfully, treatment has come a long way in recent years and today
inhibitor patients and their families can generally manage treatment
themselves and continue with daily activities.
FEIBA has been used for inhibitor treatment for over three decades,
which means that there is a long history of clinical data to support its use.
This booklet has been designed for patients who have been prescribed
FEIBA. It will provide you with comprehensive information about FEIBA
treatment and inhibitors. However, if you have any further questions,
please make a note of them to discuss with your Doctor or Nurse at
your next appointment.
Contents
Introduction to inhibitors 4
From hospital to home: the evolution of inhibitor treatment 5
What is FEIBA? 6
How does FEIBA work? 6
Who can use FEIBA? 7
What dose of FEIBA should I take? 8
Why is it important that I keep taking FEIBA? 9
What are the potential side-effects? 9
Using FEIBA safely 10
What should I do if I take too much FEIBA? 10
What should I do if I miss a dose of FEIBA? 10
What’s inside a FEIBA pack? 11
Preparing FEIBA for use 12
How should I store FEIBA? 16
How should I dispose of unused solution and waste material? 17
Protecting patients: the Baxter plasma safety programme 18
Further information 23
3

Introduction to inhibitors
Patients with haemophilia generally receive treatment (known as
‘factor replacement therapy’) to help their blood to clot.
Some patients develop antibodies to their haemophilia treatment.
Antibodies are produced by the immune system to destroy substances
the body perceives as foreign.
The antibodies to haemophilia treatment are known as ‘inhibitors’.
The inhibitor neutralises the haemophilia treatment and prevents it
from doing its job.
Inhibitors stop haemophilia treatment
from doing its work
From hospital to home:
the evolution of inhibitor treatment
The good news is that today there are many things that
can be done to help people who develop inhibitors.
Immune Tolerance Induction (ITI)
When an inhibitor is first detected, ITI may be tried in order to eliminate it.
The idea behind this is to infuse haemophilia treatment in high doses on
a regular basis (sometimes as often as twice a day) so that the body will get
used to the treatment and stop producing antibodies.
Next Steps
If ITI is unsuccessful, the patient will receive a treatment such as FEIBA.
Treatment can either be given as a regular infusion (‘prophylaxis’) in order
to try and prevent the bleed from occurring or be given to control the
bleed when it occurs (‘on- demand’ treatment).
A treatment such as FEIBA can also be used to treat breakthrough bleeds
during ITI.
Treatment At Home
Patients on FEIBA treatment may be able to manage their treatment at home.
This has been a truly life-changing advance. Being able to treat the bleed at
the time it starts means that the bleed can be controlled faster. It also means
that you may not need to go to your Haemophilia Centre for every treatment.
Guidance of how to treat a bleeding episode will be given by your care team
at the centre. Treating within the home environment will help to free up time
and means much less disruption to schooling or work and, perhaps most
importantly, gives you more time to get on with the things you want to do.
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5

What is FEIBA?
FEIBA is derived from human plasma and permits blood clotting in haemophilia
patients with inhibitors. FEIBA has over 30-years history of effectively
controlling bleeding in haemophilia patients with inhibitors, an established
safety profile and a convenient dosing schedule (see page 8).
How does FEIBA work?
Inhibitors neutralise the infused haemophilia treatment and prevent blood
from clotting. FEIBA is able to bypass the inhibitors and enable the blood
to form a stable clot and stop bleeding at the site of injury.
Who can use FEIBA?
• FEIBA is prescribed for the control of spontaneous bleeding episodes
or to cover surgical interventions in patients with congenital haemophilia A
with inhibitors
• FEIBA may also be given to help prevent bleeding episodes (prophylaxis)
in patients with haemophilia A and inhibitors who suffer from frequent
joint bleeding
• FEIBA is also prescribed for treatment of spontaneous bleeding and
cover of surgical interventions in patients with acquired haemophilia A
• FEIBA may be used to treat bleeds that can occur during ITI treatment
(ITI is a treatment aimed at eradicating the inhibitor)
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Why is it important that I keep
taking FEIBA?
When medication has been prescribed, it is important to continue taking
it regularly as recommended by your Haemophilia Centre, as this will reduce
the risk of ‘spontaneous’ bleeds. Prophylactic treatment enables patients to
get on with their lives more easily.
For those with haemophilia, prophylaxis can prevent bleeds and joint damage,
which can be painful and debilitating. By protecting joints the likelihood of
requiring orthopaedic surgery later in life can also be reduced.
What dose of FEIBA should I take?
Your haemophilia Doctor or Nurse will give you clear guidance as to the dose
you need and how often you should infuse.
For regular infusions (prophylaxis) the recommended dose is 50–100 units per
kilogram of body weight from daily to three times a week. When administered
during ITI, a daily dose of 50 U/kg body weight may be sufficient.
For prophylactic treatment, FEIBA can be infused as regularly as daily or as
little as three times a week. Patients will be treated individually to assess their
needs. Regular appointments to track progress and assess symptoms will
enable your haemophilia care team to ensure you are using the optimum dose.
What are the potential
side-effects?
As with all injected products, allergic reactions are possible. As a result
the most frequently reported side-effects of FEIBA include allergic and
hypersensitivity reactions such as shortness of breath, hives, rash
and flushing.
Rarely, other more serious side-effects may occur. Please read the
leaflet inside your FEIBA packaging carefully and seek medical attention
immediately if you become concerned about any potential reactions
to FEIBA.
To treat a spontaneous bleed (on-demand treatment), you will be given clear
guidance by your haemophilia care team, as the dose and dosing interval will
depend on the nature and severity of the bleed. Depending on the nature
of the bleed and how confident you feel about home infusion, you may need
to go to your Haemophilia Centre to deal with a spontaneous bleed.
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9

Using FEIBA safely
• Generally, an infusion of FEIBA should not exceed 100 units per kg of
body weight for a single dose, or a total dose of 200 units per kg of body
weight per day. Please see page 8 for recommended FEIBA doses for
prophylactic treatment and treatment during ITI
• FEIBA should not be given to people with a normal blood
clotting mechanism
What should I do if I take too
much FEIBA?
Heart and circulation problems have been observed with overdoses of
FEIBA. If you have any concerns please contact your doctor immediately.
What’s inside a FEIBA pack?
If you receive your FEIBA treatment in the Haemophilia Care Centre
they have access to all the ancillaries needed for infusion.
If FEIBA is delivered to your home with the Baxter Factor Direct Home
Delivery Service, you can ask for the ancillaries needed for infusion
(free of charge) to be delivered at the same time as your FEIBA.
It is recommended that a Iuer lock syringe is used (this is not included
in the FEIBA pack)
15-25 0 C
What should I do if I miss my
dose of FEIBA?
Do not take double your dose. Take the next dose immediately and
continue future doses at the regular intervals your doctor has advised.
Wash hands.
Bring the vials to room temperature.
Remove caps from vials.
Wipe vial tops with alcohol swabs and let dry.
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11

5
10
15
20
ml
Preparing FEIBA for use
As easy as 1, 2, 3
A guide to reconstituting FEIBA therapy
1
Connecting
1a
2
water vial
Do not remove
device from
packaging.
2a
Connecting
FEIBA vial
Turn device over
and connect
purple side of
device to FEIBA
vial. Press down
until purple spike
pierces
vial stopper.
1b
On a flat surface,
connect clear
side of device
to water vial.
Press down
until clear
spike pierces
vial stopper.
2b
Swirl gently to
dissolve FEIBA.
1c
Grip packaging
at edge and lift it
off, leaving device
connected to
water vial.
2c
Latex-free
Remove blue cap
from device and
attach syringe.
Do not inject air.
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13

5
5
10
10
15
15
20
ml
20
ml
Preparing FEIBA for use
As easy as 1, 2, 3
A guide to reconstituting FEIBA therapy
3
3a
Latex-free
Withdrawing
dissolved FEIBA
solution
Turn device over
so empty water
vial is at the bottom.
Slowly pull back
on syringe plunger
to withdraw FEIBA
solution.
3b
Remove syringe
with FEIBA
solution.
Latex-free
Disconnect the BAXTECT II Hi-Flow from the syringe and attach a winged
infusion set. Hold the needle above the syringe and get rid of any excess
air from the line before infusing the FEIBA solution. Slowly inject the
solution intravenously.
DO NOT EXCEED AN INJECTION/INFUSION RATE OF 2 UNITS OF FEIBA
PER KG OF BODY WEIGHT PER MINUTE
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15

How should I store FEIBA?
FEIBA should be stored in a refrigerator between 2° and 8°C. It should not
be frozen.
Within the indicated shelf life, you can also store FEIBA at room temperature
(up to 25°C) for a period of 6 months or up to 2 years if it is in the
refrigerator. When storing FEIBA at room temperature it is important that
you write the new expiry date on the box. At the end of this period the
product must be used, discarded or returned to the Haemophilia Centre.
You must not return it to the fridge following storage at room temperature.
Keep the vials in the box in order to protect them from light.
Mix the FEIBA just before you are going to use it. The solution should be
used immediately. You must only use solutions that are clear and not cloudy
or containing any particles. If you are unsure, please contact your
Haemophilia Centre for advice.
How should I dispose of unused
solution and waste material?
When a home delivery service is used, they will normally take away unused
solution and waste material. Your haemophilia care team will show you
how to store these materials in the bins provided until it is removed by the
delivery team.
Any unused solution and waste material should be disposed of carefully
to avoid any risk of injury to others. All equipment used for the infusion
and its preparation should be disposed of directly into a sharps bin that can
be sealed when it is three quarters full. Your haemophilia care team will give
guidance on the safe storage and disposal of your infusion materials.
Normally when FEIBA is delivered by a home delivery service, you can
simply order replacement sharps bins from your coordinator and return
your sealed sharps bins by handing them to the delivery driver.
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17

Protecting patients: the Baxter
plasma safety programme
In the production of plasma-derived treatments such as FEIBA, patient safety
is of paramount importance.
By adhering to the most stringent plasma safety regulations, Baxter is
exceeding standard industry practices, dedicating efforts to advancing plasma
safety. In fact, Baxter is a world leader in all aspects of plasma-derived
therapeutic safety from initial donor selection to final product formulation.
We source plasma from our own plasmapheresis centres or from centres
that meet Baxter standards. Our plasma screening standards meet or exceed
all industry and regulatory requirements.
As a result, you can be confident that everything possible has been done
to ensure the safety of FEIBA.
Protecting patients: the Baxter
plasma safety programme
Our safety measures include
• One of the first companies to receive QSEAL (Quality, Standards of
Excellence, Assurance, and Leadership) certification which recognises
the company’s commitment to outstanding quality and safety in
plasma sourcing and manufacturing
Strict selection of plasma donors according to the
Qualified Donor Standard
• All donor applicants have to go through two sets of screening interviews
(covering case history, high-risk behaviour inquiry, physical examination)
and laboratory tests before being a qualified donor
• All donations made by donors that do not come back for a second
donation are automatically discarded
60-day inventory hold period of all plasma donations
to ensure safety of donation
• The inventory hold period allows each donation to be virus-tested
(and discarded if positive) before it goes into the manufacturing process
• It also gives sufficient time to receive post-donation information about
donor and to discard any single donations
18
19

PCR and Serology testing of plasma
• PCR testing is performed on sample donations to detect virus genomes
• Small samples are pooled and only those that are PCR-negative are
allowed to enter the production pool. Positive samples are isolated and
destroyed along with any previous samples provided by the donor.
The donor is then rejected from future donations
• Prior to using a plasma production pool for FEIBA production, further PCR
testing is conducted in Baxter’s dedicated Serology laboratories in Vienna
NAT (nucleic acid amplification technology) testing
for assurance
• Allows detection of certain viruses earlier than current serological
screening methods
Vapour Heat treatment for inactivation of viruses
• During the manufacturing process, FEIBA also undergoes a two-step
vapour heat treatment which destroys potential viruses without destroying
the product
Leading the way
in patient protection
Since the early 1990s, our experts have been leading the way in Plasma
Safety, pioneering many key innovations that have increased the quality
and safety of plasma products.
Many other companies have adopted our plasma inventory hold and
Qualified Donor Programme standards.
Plasma Master File
Baxter collaborated with European authorities to develop the concept
of the Plasma Master File, which was officially adopted in 1994.
In 2001 Baxter was one of the first companies to receive the Plasma Protein
Therapeutics Association (PPTA) certification of compliance with the
International Quality of Standards of Excellence, Assurance and Leadership
(QSEAL) Program, which recognizes the company’s commitment to
outstanding quality and safety in plasma sourcing and manufacturing.
Nanofiltration of viruses
• As well as vapour heat treatment, nanofiltration takes place during the
manufacturing process. Nanofiltration means that in the unlikely event that
viruses are still present in the raw material, they will be removed via very
fine filters
Every stage of the manufacturing process for FEIBA,
from donor to patients, is subjected to the most rigorous
quality control and quality assurance standards
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21

Unrivalled commitment
to plasma safety
Production safety in state-of-the-art manufacturing facilities using
processes with validated virus reduction capacity.
Continuing research, development and introduction of improved safety
measures, under the direction of The Baxter Global Pathogen Safety Group.
Further information
For further information on FEIBA please see your package insert or contact
your Haemophilia Centre.
For information on getting your FEIBA delivered to you at home, contact your
Haemophilia Centre for advice.
Further information on haemophilia and related bleeding disorders is
available from The Haemophilia Society at www.haemophilia.org.uk
The Inhibitor Group is run under the umbrella of the Haemophilia Society
in the UK.
The Haemophilia Society provides information, support and advocacy
for people affected by haemophilia and related bleeding disorders.
Freephone helpline: 0800 018 6068 (Monday – Friday, 10am – 4pm)
Email: info@haemophilia.org.uk
Explore www.haemophiliacare.co.uk/feiba to find information about
inhibitors, FEIBA and details regarding the Inhibitor Group.
All data is reviewed by haemophilia specialists.
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