ReFacto AF 1000 IU powder and solvent for solution forinject

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Refacto AF Laboratory Standard
For doctors
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.
What do you have to consider before using it?
Do not use ReFacto AF
If you are unsure about this, ask your doctor.
Take special care with ReFacto AF
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.
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For doctors
What is it?
ReFacto AF is a powder and solvent that are mixed together to make up a solution for injection. ReFacto AF contains the active substance moroctocog alfa.
What is it used for?
ReFacto AF is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder). ReFacto AF can be used in patients of all ages, including newborns. The medicine can only be obtained with a prescription.
How is it used?
ReFacto AF should be started by a doctor who has experience in the treatment of haemophilia A. ReFacto AF is given by injection into a vein lasting several minutes. The dose and the frequency of injection depend on whether ReFacto AF is used to treat or prevent bleeding, or to reduce bleeding during surgery. The dose is adjusted depending on the severity and location of the bleeding, or the type of surgery. Full details on how to calculate the dose are included in the Package Leaflet. Patients or their carers can give injections of ReFacto AF, provided that they have been trained appropriately.
How does it work?
The active substance in ReFacto AF, moroctocog alfa, is a blood coagulation factor protein (a substance that helps the blood to clot). Patients with haemophilia A lack a protein called factor VIII, which is involved in blood clotting. The lack of factor VIII causes blood clotting problems, such as bleeding in the joints, muscles and internal organs. ReFacto AF is used to replace the missing factor VIII. It corrects the factor VIII deficiency and gives temporary control of the bleeding disorder. Moroctocog alfa is not extracted from human blood but is produced by a method known as ‘recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor VIII.
1 Previously known as ReFacto.
How has it been studied?
ReFacto AF was first authorised as ReFacto in April 1999, for use in previously treated and untreated patients with haemophilia A, based on the results of three main studies.
In February 2009, a number of changes to the way ReFacto is made were introduced. These included removal of the use of a protein called albumin, which is produced from human blood, from the manufacturing process. The name of the medicine was also changed from ReFacto to ReFacto AF. Following these changes, the company carried out a study to show that ReFacto and ReFacto AF were treated by the body in the same way. It also carried out two main studies looking at the effectiveness of ReFacto AF: the first looked at the prevention and treatment of bleeding episodes in 94 previously treated patients and the second looked at the prevention of bleeding in 22 patients having surgery.
What benefits has it shown during the studies?
The studies showed that ReFacto AF was as safe and effective as ReFacto in preventing and treating bleeding episodes in patients with haemophilia A.
What is the risk associated?
Haemophilia A patients may develop antibodies (inhibitors) to factor VIII. If this happens, ReFacto AF will not work effectively, which may result in a loss of bleeding control. The most common side effect with ReFacto AF (seen in more than 1 patient in 10) is vomiting. For the full list of all side effects reported with ReFacto AF, see the Package Leaflet.
ReFacto AF should not be used in people who may be hypersensitive (allergic) to human coagulation factor VIII, to any of the other ingredients or to hamster proteins.
Why has it been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that ReFacto AF was comparable to ReFacto, the original form of the medicine. Therefore, the Committee decided that ReFacto AF’s benefits are greater than its risks for the treatment and prevention of bleeding in patients with haemophilia A (congenital factor VIII deficiency). The Committee recommended that ReFacto AF be given marketing authorisation.
How has it been studied?
To prepare for the gradual replacement of ReFacto with ReFacto AF on the market, the company that makes the medicine will provide educational packs for healthcare workers who will prescribe or use ReFacto AF, for all associations of haemophilia patients in the European Union (EU), for patients receiving ReFacto AF and for laboratories that will monitor patients receiving ReFacto AF. These packs will include information on the differences between ReFacto and ReFacto AF, how to use ReFacto AF safely, how to report side effects, information on similar medicines available outside the EU, and a reminder that patients should carry enough ReFacto AF with them if they are travelling.
Further information
The European Commission granted a marketing authorisation valid throughout the EU for ReFacto on 13 April 1999. The marketing authorisation holder is Wyeth Europa Ltd. The marketing authorisation was renewed on 13 April 2004 and on 13 April 2009. The name of the medicine was changed to ReFacto AF on 18 December 2008.
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Name
ReFacto AF 500 IU powder and solvent for solution for
injection
Composition
Each vial contains nominally 500 IU* moroctocog alfa**.
After reconstitution, each ml of solution contains approximately 125 IU moroctocog alfa.
* The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ReFacto AF is 7,600-13,800 IU/mg protein.
** Human coagulation factor VIII produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Moroctocog alfa is a glycoprotein with 1438 amino acids with a sequence that is comparable to the 90 + 80 kDa form of factor VIII (i.e. B-domain deleted) and similar post-translational modifications to those of the plasma-derived molecule.
The manufacturing process for ReFacto has been modified to eliminate exogenous human- or animal-derived protein in the cell culture process, purification, or final formulation; and at the same time the invented name has been changed to ReFacto AF.
Excipients:
After reconstitution, 1.23 mmol (29 mg) sodium per vial.
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Powder and solvent for solution for injection.
White to off-white cake/powder.
Clear, colourless solvent.
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