INFORMATION FOR PATIENTS

Haemophilia

INFORMATION FOR PATIENTS ON REFACTO AF

Your doctor has prescribed ReFacto AF to treat your haemophilia. This is a recombinant factor eight [VIII] product used to treat Haemophilia A.

This booklet has been designed to help you to understand the medication you have been prescribed. It is not a replacement for the detailed Patient Information Leaflet provided within the medicine carton which you should also read.

If you have any further questions, you should ask the healthcare professional responsible for your treatment at your haemophilia centre.

This booklet explains the following:

what ReFacto AF is and what it is used for

what you need to be aware of before you use ReFacto AF

how to make up and give ReFacto AF

how to take ReFacto AF

what the possible side effects are

how you should store ReFacto AF

WHAT IS REFACTO AF?

ReFacto AF is a recombinant coagulation factor VIII product. Recombinant products are manufactured in a laboratory using DNA technology, rather than produced from donated blood plasma (plasma-derived factor VIII).

HOW DOES IT WORK?

It works by increasing factor VIII in haemophilia A patients to enable their blood to clot.

WHAT IS IT USED FOR?

ReFacto AF is used for the treatment and prevention of bleeding (prophylaxis) in patients with haemophilia A.

ReFacto AF can be used for adults and children of all ages, including newborns.

WHAT DOES IT LOOK LIKE?

ReFacto AF is packaged in five different coloured boxes. This leaflet focuses on the four packages shown below (ReFacto AF 250IU, 500IU, 1000IU and 2000IU). If you have been prescribed ReFacto AF IU in the FuseNGo device, please consult the information leaflet that has been developed specifically for this device, as its pack contains different items and the infusion is made up in a different way.The colours correspond to the vial strength, and the colouring will help you identify the right one. If you need to combine two different vial sizes, the colours act as an easy guide.On each box you will see tamper-proof seals to prevent anyone interfering with your medicine. If a seal is damaged or broken do not use. You should then inform the doctor or nurse at your haemophilia centre.

Vial Colour

250IU Yellow

500IU Blue

1000IU Green

2000IU Red

WHAT DOES YOUR REFACTO AF PACK CONTAIN?

Each pack contains the following: a vial of ReFacto AF powder syringe containing clear liquid (sodium chloride solution) for reconstituting

your product vial adapter to allow you to combine the powder with the solution sterile infusion set, alcohol swabs, a plaster and a gauze pad

The Rapid Reconstitution (R2) Kit

Prefilled syringe

Vial adapter

Vial

WHAT DO YOU NEED TO KNOW BEFORE USING REFACTO AF?

You should not take this product if:

you are allergic to hamster proteins

you are allergic to any of the ingredients in ReFacto AF. You can find this information in section 6 of the patient information leaflet

You should talk to a doctor if:

you are taking any other tablets or medicines

you are on a controlled sodium diet

you are pregnant or breast-feeding

WHAT DO YOU NEED TO LOOK OUT FOR WHEN USING REFACTO AF?

You should stop the infusion immediately and contact a doctor or seek immediate emergency care if any of these signs occur:

you have any sort of allergic reaction. Some of the signs of allergic reaction are difficulty in breathing, shortness of breath, swelling, hives, itching, tightness of chest, wheezing and low blood pressure. Anaphylaxis is a severe allergic reaction that can cause difficulty in swallowing and/or breathing, red or swollen face and/or hands. Please see ‘Possible side effects’ section for further possible symptoms of an allergic reaction

You should contact a doctor or seek immediate emergency care if:

your bleeding doesn’t stop as expected

You should talk to the doctor or nurse at your haemophilia centre immediately if:

your bleeding isn’t controlled with your usual dose

If you are concerned about any side effects (including any not listed above) please talk to a doctor or nurse at your haemophilia centre.

HOW TO TAKE REFACTO AF

Always use your product in the way the doctor or nurse at your haemophilia centre has told you – this will usually mean using it in one of two ways

prophylaxis

on demand

Your doctor will decide the dose you will receive. The dosage and duration of treatment will depend on the severity of your factor VIII deficiency and on your clinical condition. Higher doses or appropriate specific treatment may be required e.g. if you develop inhibitors to the treatment.

The amount of product you use will depend on your needs. A doctor or nurse at your haemophilia centre will have worked out the dosage based on factors such as:

your weight

the level of FVIII in your blood

your response to treatment

During your treatment, a doctor may decide to change the dose of ReFacto AF you receive.

RECORD KEEPING It is recommended that every time you use ReFacto AF, you record the name and batch number of the product. You can use one of the peel-off labels found on the vial to document the batch number in your diary or for reporting any side effects.

TRAVELLING

You should consult with your haemophilia centre before you travel. You should take enough ReFacto AF with you for all anticipated treatment when travelling.

If you are travelling within Europe, you may find the www.euhass.org website useful in case of an emergency. There is a facility on there that allows you to locate the nearest haemophilia centre to where you are staying, as well as obtaining their contact details.

HOW TO MAKE UP AND GIVE REFACTO AF

The following procedures are provided as general guidelines on how to make up (reconstitution) and give (administration) ReFacto AF. You should follow the specific reconstitution and administration procedures provided by a doctor or nurse at your haemophilia centre.

ReFacto AF is administered into the vein (intravenous [IV] injection) after reconstitution of the powder with the supplied solution. It should not be mixed with other infusion solutions.

Always wash your hands before performing the following reconstitution and administration procedures. Aseptic technique (meaning clean and germ-free) should be used during the reconstitution procedure.

RECONSTITUTION

The pictures and instructions below provide a guide on how to make up and use the product; your nurse may have taught you a slightly different method to fit with your needs, so please be guided by their recommendations.

Use only the pre-filled syringe provided in the box for reconstitution. Other sterile disposable syringes may be used for administration.

Allow the vial of powder and the pre-filled syringe to reach room temperature.

Wipe the top of the vial with the alcohol swab provided, or use another antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.

Peel back the lid from the clear plastic vial adapter package but do not remove the adapter from the package.

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Remove the plastic flip-top cap from the vial to expose the central portion of the rubber stopper.

Place the vial on a flat surface. While holding the adapter package, place the vial adapter over the vial. Press down firmly on the package until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper.

Attach the plunger rod to the syringe by pushing into the open end and turning firmly.

Break off the plastic tip cap from the syringe by bending the cap up and down to snap the perforation of the cap until the perforation is broken. Do not touch the inside of the cap or the syringe tip. The cap may need to be replaced (if not administering reconstituted ReFacto AF immediately), so set it aside by placing it on its top.

9 Connect the syringe to the vial adapter by inserting the tip into the adapter opening while firmly pushing and turning the syringe clockwise until secured.

10Slowly push the syringe plunger to inject all the solution into the vial.

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Lift the package away from the adapter and discard.6

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With the syringe still connected to the adapter, gently rotate the vial until the powder is dissolved.

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The final solution must be checked for particles before administration. The solution should appear clear to slightly opalescent and colourless.

Note: If you use more than one vial per infusion, each vial should be reconstituted as shown above. The syringe should be removed, leaving the vial adapter in place, and a separate large luer lock syringe may be used to draw back the reconstituted contents of each individual vial.

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Ensuring that the syringe plunger rod is still fully depressed, turn vial upside down. Slowly draw back all the solution through the vial adapter into the syringe.

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Detach the syringe from the vial adapter by gently pulling and turning the syringe anti-clockwise. Discard the vial with the adapter attached.

ReFacto AF must be used within 3 hours of reconstitution.

Note: If the solution is not to be used immediately, the syringe cap should be carefully replaced. Do not touch the syringe tip or the inside of the cap.

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ADMINISTRATION

ReFacto AF should be given using the infusion set provided, with either

the syringe provided, or

a single larger sterile plastic luer lock syringe (if you need to combine vials)

POSSIBLE SIDE EFFECTS

Like all medicines, ReFacto AF can have side effects, although not everybody gets them.

Allergic reactionsIf severe, sudden allergic reactions (anaphylactic) occur, the infusion must be stopped immediately. You must contact a doctor immediately if you have any of the following early symptoms of allergic reactions:

rash, hives, wheals, generalised itching

swelling of lips and tongue

difficulty in breathing, wheezing, tightness in the chest

general feeling of being unwell

dizziness and loss of consciousness

Attach the syringe to the luer end of the infusion set1

Apply a tourniquet and prepare the injection site by wiping the skin well with an alcohol swab provided in the kit.

Insert the needle on the infusion set tubing into the vein as instructed by your doctor, and remove the tourniquet. Remove any air in the infusion set tubing by drawing back on the syringe. The factor should be injected over several minutes. If necessary, your doctor can advise you on how to make the infusion more comfortable.

Please dispose of all unused solution, empty vial(s), used needles and syringes in an appropriate container for medical waste as these may hurt others if not disposed of properly.

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Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment. Severe, sudden allergic (anaphylactic) reactions are uncommon (may affect up to 1 in 100 people)

Other possible side effects include: Very common: inhibitor development for patients who have never been previously treated with factor VIII products, headache, cough, joint pain, fever.Common: inhibitor development for patients who have been previously treated with factor VIII products, bleeding, dizziness, decreased appetite, diarrhoea, vomiting, stomach pain, nausea, hives, rash, itching, muscular pain, chills, catheter site reaction, certain blood tests may show an increase in antibodies to factor VIII.Uncommon: severe allergic reaction, numbness, sleepiness, altered taste, chest pain, rapid heart beat, palpitations, low blood pressure, pain and redness of veins associated with a blood clot, flushing, shortness of breath, excessive sweating, weakness, injection site reactions including pain, slight increase in heart enzymes, increased liver enzymes, increased bilirubin.Additional information on the possible side effects can be found in the Patient Information Leaflet which is included in the pack.If you are concerned about any side effects (including any not listed above) please speak to the doctor or nurse at your haemophilia centre.

REPORTING OF SIDE EFFECTS

If you get any side effects, talk to a doctor, pharmacist or nurse. This includes any possible side effects not listed on the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.By reporting side effects you can help provide more information on the safety of this medicine.

INHIBITOR DEVELOPMENT

Patients with haemophilia A may develop neutralising antibodies (inhibitors) to factor VIII. If such inhibitors occur, a sign may be an increase in the amount of product typically required to treat a bleed and/or continued bleeding after a treatment. If you notice these symptoms you should contact the doctor or nurse at your haemophilia centre immediately.

Marketing Authorisation Holder: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

ReFacto AF should be kept refrigerated (at 2°C-8°C).

For your convenience, the product can be removed from the refrigerator and kept at room temperature (up to 25°C) for a single period of a maximum of 3 months. At the end of this period, the product must not be put back in the refrigerator but must be used or discarded. It is suggested that you record the date on which the carton was removed from the refrigerator. Keep the vial in the outer carton in order to protect from light.

Do not freeze, to prevent damage to the pre-filled solvent syringe.

Use the reconstituted solution immediately, or within 3 hours.

Do not use after the expiry date stated on the outer box and vial label.

The solution will be clear to slightly opalescent and colourless. Do not use ReFacto AF if you notice that it is cloudy or contains visible particles.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Local Haemophilia Centre contact details

STORING REFACTO AF

Haemophilia

Marketing Authorisation Holder: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Date of preparation: October 2018 PP-GIP-GBR-3963