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1. Feiba 500 U Powder And Solvent For Solution For Infusion
2. Feiba 500 U Powder And Solvent For Solution For Infusion

Active substance: Factor VIII Inhibitor Bypassing Activity

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 surgery

•    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 working

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 FEIBA if:

•    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 of FEIBA

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 vein.

•    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 leaflet.

•    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 mounting).

• Any unused solution must be disposed of appropriately.

• This medicine must not be mixed with other medicines or solvents.

•    Inject FEIBA solution in the way that you have been trained.

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 surface.

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 (deposits).

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 AIR INTO THE SYRINGE) (Fig. v).

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 frequencies are used to evaluate side effects:

Very common: may affect more than 1 in 10 people Common:    may    affect    up to    1    in 10 people

Uncommon:    may    affect    up to    1    in 100 people

Rare:    may    affect    up to    1    in 1,000 people

Very rare:    may    affect    up to    1    in 10,000 people

Not known: frequency cannot be estimated from the available data

In clinical trials the following side effects were reported as common:

Hypersensitivity

Headache

Dizziness

Hypotension

Rash

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 data.

•    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.

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.

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 leaflet.

You can also report side effects directly via the national reporting system listed below.

United Kingdom

The Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal By reporting side effects you can help provide more information on the safety of this medicine.

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 light.

•    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 solution.

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 Austria

Tel. +44 (0) 1635 798 777 Send all enquiries to this address.

FEIBA is made at:

Baxter AG

Vienna

Austria

This leaflet was last revised in 09/2015

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Telephone +44 (0) 1635 798 777 for an audiotape, large print leaflet or other formats.

Baxalta and FEIBA are trademarks of Baxalta Incorporated.

Baxter is a registered trademark of Baxter International Inc.

BaxJect II Hi-Flow Device

The device is sterilized by gamma irradiation. It is for single use only.

The device is latex free.

Do not use if package is damaged

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