What is it and how is it used?

ReFacto AF contains the active substance moroctocog alfa, human coagulation factor VIII produced by recombinant DNA technology. Factor VIII is necessary for the blood to form clots and stop bleedings. In patients with haemophilia A (inborn factor VIII deficiency), it is missing or not working properly.

ReFacto AF is used for the treatment and prevention of bleeding (prophylaxis) in adults and children of all ages (including newborns) with haemophilia A.

ReFacto AF does not contain von Willebrand factor, and hence is not indicated in von Willebrand?s disease.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not use ReFacto AF

  • if you are allergic (hypersensitive) to moroctocog alfa or any of the other ingredients of ReFacto AF (listed in section 6).
  • if you are hypersensitive to hamster proteins.

If you are unsure about this, ask your doctor.

Take special care with ReFacto AF

  • if you experience allergic reactions. Some of the signs of allergic (hypersensitivity) reactions are difficulty in breathing, shortness of breath, swelling, hives, itching, tightness of the 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. If any of these signs occur, stop the infusion immediately and contact a doctor or seek immediate emergency care. In case of severe allergic reactions, alternative therapy must be considered.
  • if your bleeding does not stop as expected and contact your doctor or seek immediate emergency care.
  • if bleeding is not adequately controlled with the usual dose. Patients receiving factor VIII products may sometimes develop antibodies to factor VIII (also known as factor VIII inhibitors), which may prevent the factor VIII product from working properly. While being treated with ReFacto AF, you should be monitored for the development of factor VIII inhibitors.
  • if you are elderly. Your doctor may change the dose.
Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or breast-feeding.

Your doctor will decide if ReFacto AF may be used during pregnancy and breast-feeding.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Important information about some of the ingredients of ReFacto AF

This medicinal product contains 1.23 mmol (or 29 mg) sodium per vial of reconstituted powder.Inform your doctor if you are on a controlled sodium diet.

How is it used?

Always take ReFacto AF exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will decide the dose of ReFacto AF you will receive. This dose and duration will depend upon your individual needs for replacement factor VIII therapy.

During your treatment, your doctor may decide to change the dose of ReFacto AF you receive. Consult with your health care provider before you travel. You should bring enough of your factor VIII product for anticipated treatment when travelling.

It is recommended that every time you use ReFacto AF, you record the name on the carton 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.

Reconstitution and administration

The procedures below are provided as guidelines for the reconstitution and administration of ReFacto AF. Patients should follow the specific reconstitution and administration procedures provided by their doctors.

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

ReFacto AF is administered by intravenous (IV) injection after reconstitution of the lyophilised powder for injection with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution] syringe. ReFacto AF 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:

1. Allow the vial of lyophilised ReFacto AF and the pre-filled solvent syringe to reach room temperature.

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

3. 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.

4. Peel back the lid from the clear plastic vial adapter package. Do not remove the adapter from the package.

5. 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.

6. Lift the package away from the adapter and discard the package.

7. Attach the plunger rod to the solvent syringe by inserting the rod into the opening in the syringe stopper and pushing and turning the rod firmly until it is securely seated in the stopper.

8. Break off the tamper-resistant plastic tip cap from the solvent syringe by snapping the perforation of the cap. This is done by bending the cap up and down 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. Place the vial on a flat surface. Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured.

10. Slowly depress the plunger rod to inject all the solvent into the ReFacto AF vial.

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

12. The final solution must be inspected visually for particulate matter before administration. The solution will appear clear to slightly opalescent and colourless.

Note: If you use more than one vial of ReFacto AF per infusion, each vial should be reconstituted as per the previous instructions. The solvent syringe should be removed, leaving the vial adapter in place, and a single large luer lock syringe may be used to draw back the reconstituted contents of each of the individual vials.

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

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

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

ReFacto AF must be used within 3 hours of reconstitution. The reconstituted solution may be stored at room temperature prior to administration.

Administration (Intravenous Injection):

ReFacto AF should be administered using the infusion set provided in this kit and the pre-filled solvent syringe provided or a single sterile disposable plastic luer lock syringe.

1. Attach the syringe to the luer end of the infusion set tubing.

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

3. 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 reconstituted product is to be injected intravenously over several minutes. Your doctor may change your recommended infusion rate to make the infusion more comfortable.

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

If you take more ReFacto AF than you should

Check with your doctor or pharmacist.

If you stop taking ReFacto AF

Do not stop using ReFacto AF without consulting your doctor.

If you have any further questions regarding this product, ask your doctor or pharmacist.

What are possible side effects?

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

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 ReFacto AF typically required to treat a bleed and/or continued bleeding after a treatment. In such cases, it is recommended that a specialised haemophilia centre be contacted. Your doctor may want to monitor you for inhibitor development. Development of inhibitors occurred in approximately 2% of patients receiving ReFacto AF in a research study.

If you experience a significant increase in your usage of ReFacto AF in order to control a bleed, please contact your doctor immediately.

Side effects may occur with certain frequencies, which are defined as follows:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
- not known: frequency cannot be estimated from the available data.

Very common side effects

- Vomiting
- Inhibitor development for patients who have never been previously treated with factor VIII products

Common side effects

- Bleeding
- Inhibitor development for patients who have been previously treated with factor VIII products - headache, nausea
- joint pain, muscular pain
- fatigue, fever
- venous access catheter complications

Uncommon side effects

- Severe allergic reaction, dizziness, light-headedness, hives, itching, rash
- chest pain, shortness of breath, rapid heart beat
- diarrhoea, loss of appetite, stomach pain
- altered taste
- chills, sweating, muscle weakness
- sleepiness
- coughing
- injection site reactions (including burning and stinging at the infusion site), discomfort and swelling at the intravenous site
- slight increase in heart enzymes
- increased liver enzymes, increased bilirubin

The following adverse reactions have also been reported: numbness, blurred vision, acne, gastroenteritis, and pain.

Hypersensitivity/allergic reactions

If severe, sudden allergic reactions (anaphylactic) occur, the injection must be stopped immediately. You must contact your doctor immediately if you have any of the following early symptoms of allergic (hypersensitivity) 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

Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.

If you are concerned about any side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 ReFacto AF typically required to treat a bleed and/or continued bleeding after a treatment. In such cases, it is recommended that a specialised haemophilia centre be contacted. Your doctor may want to monitor you for inhibitor development.

How should it be stored?

Keep out of the reach and sight of children.

Do not use after the expiry date stated on the outer carton and vial label after EXP. The expiry date refers to the last day of that month.

Store and transport refrigerated (2-C ? 8-C). Do not freeze, in order to prevent damage to the pre-filled solvent syringe.

For your convenience, the product can be removed from such storage for one single period of maximum 3 months at room temperature (up to 25°C). At the end of this room temperature storage period, the product must not be put back in the refrigerator, but must be used or discarded. Record on the outer carton the date ReFacto AF is removed from the refrigerator and set at room temperature (up to 25 oC). Keep the vial in the outer carton in order to protect from light.

Use the reconstituted solution within 3 hours of reconstitution.

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.

Further information

What ReFacto AF contains

  • The active substance is moroctocog alfa (recombinant coagulation factor VIII). Each vial of ReFacto AF contains nominally 250, 500, 1000, or 2000 IU of moroctocog alfa.
  • The other ingredients are sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80 and sodium chloride. A solvent [sodium chloride 9 mg/ml (0.9%) solution for injection] is also supplied for reconstitution.
  • After reconstitution with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution], each vial contains 62.5, 125, 250, or 500 IU, respectively (based on the strength of moroctocog alfa, i.e., 250, 500, 1000, or 2000 IU), of moroctocog alfa per 1 ml of the prepared solution for injection.
What ReFacto AF looks like and contents of the pack

ReFacto AF is provided as a powder for injection in a glass vial and a solvent is provided in a pre-filled syringe.

The contents of the pack are:

  • one vial of moroctocog alfa 250, 500, 1000, or 2000 IU powder
  • one pre-filled syringe of solvent, 4 ml sterile sodium chloride 9 mg/ml (0.9 %) solution for injection for reconstitution, with one plunger rod
  • one sterile vial adapter reconstitution device
  • one sterile infusion set
  • two alcohol swabs
  • one plaster
  • one gauze pad

Marketing Authorisation Holder

Wyeth Europa Ltd.
Huntercombe Lane South
Taplow, Maidenhead
Berkshire, SL6 0PH
United Kingdom

Manufacturers

Wyeth Farma S.A.
Autovia del Norte A-1 Km 23
Desvio Algete Km 1
28700 San Sebastian de los Reyes
Madrid
Spain

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Magyarország Pfizer Kft Tel 36 1 488 3700 BelgiëBelgiqueBelgien LuxembourgLuxemburg Pfizer S.A. N.V. TélTel 32 02 554 62 11

Malta Vivian Corporation Ltd. Tel 356 21 344616 EestiLatvijaLietuva Slovenija Wyeth Whitehall Export GmbH Te.TelTãlr 43 1 89 1140

-eská republika

Pfizer s.r.o.
Tel: +420-283-004-111

Nederland

Wyeth Pharmaceuticals B.V. Tel: +31 23 567 2567

Danmark

Pfizer ApS
Tlf: +45 44 201 100

Norge
Pfizer AS
Tlf: +47 67 526 100

Deutschland Pfizer Pharma GmbH Tel 49 030 550055-51000 Österreich Pfizer Corporation Austria Ges.m.b.H. Tel 43 01 521 15-0

Pfizer Hellas A.E. . 30 210 6785 800 Polska Pfizer Sp. z o.o. Tel 48 22 335 61 00

España Pfizer, S.A. Télf 34914909900 Portugal Laboratórios Pfizer, Lda. Tel 351 21 423 55 00

France Pfizer Tél33 1 58 07 30 00 România Pfizer Romania S.R.L Tel 40 0 21 207 28 00

Ireland Wyeth Pharmaceuticals Tel353 1 449 3500 Slovenská republika Pfizer Luxembourg SARL, organizaná zloka Tel 421 2 3355 5500

Ísland Icepharma hf. Tel354 540 8000 SuomiFinland Pfizer Oy PuhTel 358 09 430 040

Italia Wyeth Lederle S.p.A. Tel39 06 927151 Sverige Pfizer AB Tel46 08 550 520 00

K Wyeth Hellas Cyprus Branch AEBE T357 22 817690 United Kingdom Wyeth Pharmaceuticals Tel44 845 367 0098

This leaflet was last approved in

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