An information booklet for patients

Getting to knowPr

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CONTENTS

What is XYNTHA? ..............................................................................................................................4

What is XYNTHA used for? ............................................................................................................4

Before you use XYNTHA ................................................................................................................5

Taking other medicines ..................................................................................................................5

While you are using XYNTHA ......................................................................................................6

Things you MUST do ...................................................................................................................6

Things you must NOT do ...........................................................................................................6

Possible side effects of XYNTHA ................................................................................................7

Storing XYNTHA ................................................................................................................................9

Before reconstitution ...................................................................................................................9

After reconstitution ......................................................................................................................9

Product description ....................................................................................................................... 10

What dosages of XYNTHA are available? ....................................................................... 10

Kit contents ...................................................................................................................................... 12

Using the XYNTHA R2 Rapid Reconstitution Vial Kit ...................................................... 14

Using XYNTHA SOLOFUSE ........................................................................................................ 20

Using multiple XYNTHA SOLOFUSE syringes ..................................................................... 22

Using a XYNTHA R2 Rapid Reconstitution Vial with XYNTHA SOLOFUSE ............ 26

Resources .......................................................................................................................................... 28

Your doctor has prescribed XYNTHA for you. This booklet answers some of the common questions about XYNTHA and how to use it properly. It does not contain all of the available information and does not take the place of talking to your doctor or nurse. Keep this booklet with your XYNTHA so you can refer to it when needed.

If you have any concerns about using XYNTHA, speak to your doctor or nurse.

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WHAT IS XYNTHA?XYNTHA (moroctocog alfa) is a form of coagulation factor VIII, manufactured using recombinant DNA technology. Coagulation factor VIII is a protein that is needed for your blood to clot.

XYNTHA does not contain any human blood or plasma, albumin, preservatives, or added animal or human components in the fi nal product. Therefore, XYNTHA is naturally free from the risk of transmission of blood-borne pathogens such as human immunodefi ciency virus (HIV), hepatitis viruses, and parvovirus.

WHAT IS XYNTHA USED FOR?XYNTHA is used to control and treat bleeding and for the routine and surgical prevention of bleeding in people with hemophilia A.

People with hemophilia A, a hereditary bleeding disease resulting from factor VIII defi ciency, do not have enough Factor VIII. This causes their blood to take longer to form a clot. When you infuse XYNTHA, the levels of factor VIII in your blood increase. This helps prevent and control bleeding episodes. XYNTHA has the same clot-promoting effects as factor VIII protein made from human plasma.

BEFORE YOU USE XYNTHAXYNTHA may not be suitable for everyone. You should not take XYNTHA unless your doctor confi rms you have hemophilia A. XYNTHA is not used to treat other clotting factor defi ciencies such as von Willebrand’s disease or hemophilia B.

Because XYNTHA is produced in hamster ovary cells, it may contain trace amounts of hamster proteins. If you have a known history of allergic reactions to hamster proteins, you should not take XYNTHA. Your doctor will advise you if you have had allergic reactions to hamster proteins. Do not take XYNTHA if you are allergic to moroctocog alfa or any of the ingredients of XYNTHA.

BEFORE you use XYNTHA talk to your hemophilia doctor if:

• You are pregnant or planning to become pregnant – it is not known whether XYNTHA can affect your ability to have children or harm your developing baby

• You are breastfeeding or planning to breastfeed. It is not known whether XYNTHA passes into breast milk

• You are taking other medicines

TAKING OTHER MEDICINESTell your doctor if you are taking any other medicines or naturopathic products, including any that you buy without a prescription from your pharmacy, supermarket, or health food store.

Your doctor will advise you whether or not to take XYNTHA and if you need to adapt your treatment.

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WHILE YOU ARE USING XYNTHAThings you MUST do

✓ Notify your hemophilia doctor if you are unable to prevent or control episodes of bleeding with your normal dose of XYNTHA.

✓ Always follow your doctor’s instructions carefully.

✓ Tell your doctor, dentist, and pharmacist that you are taking XYNTHA. If you are about to start taking any new medication, tell your doctor and pharmacist that you are taking XYNTHA.

✓ Tell your hemophilia treatment centre and your doctor if you become pregnant while taking XYNTHA.

Things you must NOT do

✗ Do not give XYNTHA to anyone else, even if they have the same condition as you have.

✗ Do not stop taking XYNTHA or lower the dosage, without checking with your doctor, unless you think you are having an allergic reaction.

POSSIBLE SIDE EFFECTS OF XYNTHANotify your hemophilia doctor if you are unable to prevent or control episodes of bleeding with your normal dose of XYNTHA. Your body may produce inhibitors against XYNTHA. Inhibitors are antibodies produced by your immune system that can prevent XYNTHA from working properly. Check with your hemophilia doctor to make sure you are closely monitored with blood tests for the presence of inhibitors. XYNTHA may cause allergic reactions. Signs of allergy include hives (rash with itching), swelling, chest tightness, diffi culty breathing, wheezing, faintness and rapid heart rate. If any of these symptoms occur, stop using XYNTHA immediately and contact your hemophilia doctor or seek emergency medical care. The initial infusions of XYNTHA should be administered under proper medical supervision, where proper medical care for allergic reactions can be provided. Other possible side effects of XYNTHA include cold sensation, chest pain, rapid heartbeat, sweating, drowsiness, muscle weakness, loss of appetite, muscle pain, pain, coughing, shortness of breath, diarrhea, stomach cramps, altered taste, injection site pain or infl ammation and weakness. These are not all the possible side effects of XYNTHA.

Call your hemophilia doctor or nurse right away if any side effect becomes serious, if you notice any side effects not listed in this booklet, or if any other side effects concern you.

✓

✗

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Do not use XYNTHA after the expiry date (“Exp”) printed on the packaging or if the packaging is torn or shows signs of tampering.

STORING XYNTHABefore reconstitution• Freeze-dried XYNTHA SOLOFUSE® syringes, XYNTHA (R2) vials and

diluent syringes should be stored in the refrigerator at a temperature between 2° and 8°C (36° to 46°F).

• DO NOT freeze XYNTHA and avoid exposing XYNTHA to light.

• Keep XYNTHA and all XYNTHA kit contents out of the reach of children.

Storing XYNTHA at room temperature• XYNTHA SOLOFUSE and (R2) vial kits may be stored at room temperature below

25°C (77°F) for up to 3 months and not to exceed the expiration date. Write the date in the space provided on the outer packaging when you fi rst store the product at room temperature.

• At the end of 3 months:

- XYNTHA (R2) vials & diluent syringes can be returned to refrigerated storage until the expiration date.

- XYNTHA SOLOFUSE can be returned to refrigerated storage until the expiration date. Do not store XYNTHA at room temperature and return it to refrigerated storage more than once.

After reconstitutionXYNTHA does not contain a preservative. Use the solution as soon as possible after dissolving the powder. If you don’t use the solution right away, it can be stored at room temperature but must be used within 3 hours after mixing.

Possible serious side effects and what to do about them

Symptom/Effect Talk with your doctor

Stop infusing and call your doctor

UncommonHeadache ✓

RareFever ✓

Nausea ✓

Vomiting ✓

Very Rare

Bleeding does not stop as expected after infusing XYNTHA ✓

Using an increasing amount of XYNTHA to control your bleed ✓

Chills ✓

Flushing ✓

Allergic reactions ✓

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PRODUCT DESCRIPTIONXYNTHA is provided as a freeze-dried white powder in the XYNTHA R2 Rapid Reconstitution Vial Kit and the XYNTHA SOLOFUSE syringe kit. Both kits contain the same XYNTHA powder but use different reconstitution methods, which are discussed below.

What dosages of XYNTHA are available?

XYNTHA is available in fi ve doses: 250, 500, 1000, 2000, and 3000 IU

250 IU 500 IU 1000 IU 2000 IU 3000 IU

• The 250 IU and 500 IU doses are supplied in the R2 Rapid Reconstitution Vial Kit

• The 1000, 2000, and 3000 IU doses come in a kit that contains a SOLOFUSE dual-chamber syringe that comes pre-loaded with both XYNTHA powder and 0.9% sodium chloride diluent

• Other doses are possible by combining multiple XYNTHA R2 Rapid Reconstitution vials, a XYNTHA R2 Rapid Reconstitution Vial Kit with a SOLOFUSE syringe or by combining multiple SOLOFUSE syringes

R2 RAPID RECONSTITUTION VIAL KIT

SOLOFUSE SYRINGE KIT

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KIT CONTENTSEach XYNTHA kit contains everything you will need to reconstitute and infuse XYNTHA. Use only the materials provided in your XYNTHA R2 Rapid Reconstitution Vial Kit or XYNTHA SOLOFUSE kit for preparing and infusing XYNTHA.

XYNTHA SOLOFUSE Kit

1 package insert

1 gauze pad

1 bandage2 alcohol swabs

1 sterile infusion set

1 plunger rod for syringe

1 vial adapter

1 syringe pre-fi lled with 4 mL of 0.9% sodium chloride for reconstitution

1 vial ofXYNTHA powder (250 or 500 IU)

XYNTHA R2 Rapid Reconstitution Vial Kit1 pre-loaded

dual-chamber syringe of

XYNTHA powder (1000, 2000, or

3000 IU) and 4 mL 0.9% sodium

chloride for reconstitution

1 plunger rod for assembly

1 vented cap

1 sterile infusion set2 alcohol swabs

1 bandage

1 gauze pad

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• Attach plunger rod to diluent syringe by inserting the rod into the syringe and turning

• Remove plastic cap from diluent syringe by bending up and down to break the seal

• Remove plastic cover on vial adapter

Continues on next page.

USING THE XYNTHA R2 RAPID RECONSTITUTION VIAL KIT

The following steps are provided as general guidelines for preparing and administering XYNTHA using the R2 Rapid Reconstitution Vial Kit. Always follow the specifi c preparation and administration procedures provided by your hemophilia treatment centre.

• Remove XYNTHA from the refrigerator and allow it to come to room temperature

• Wash your hands with good soapy lather for at least 30 seconds

• Remove plastic fl ip-top cap

• Wipe top of vial with alcohol swab

• Remove cover from plastic vial adapter package

• Place adapter over XYNTHA vial, press down fi rmly until it snaps into place

• Leave plastic cover on adapter until you are ready to connect the syringe

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• Connect the syringe to adapter on XYNTHA vial

• Insert tip of syringe into adapter opening

• Push fi rmly and turn in a clockwise direction

• Slowly push down plunger of syringe to inject all diluent into XYNTHA vial

• Don’t remove syringe

• Gently swirl vial until all the XYNTHA powder is dissolved

• Solution should be clear and colourless

• Invert vial, slowly draw reconstituted XYNTHA into syringe

• Remove syringe from vial by pulling and turning counter clockwise

If using more than one vial• Prepare all the vials of XYNTHA you need, leaving

the diluent syringes attached until you are ready to draw back the solution

• Remove all the diluent syringes from the vial adapters, leaving the vial adapters in place

• Remove a 10 cc (or larger) Luer Lock syringe from its packaging, attach it to the vial adapter, and draw back the XYNTHA solution as in step 11

• Transfer the large syringe to the next vial adapter to draw back this XYNTHA solution

• Repeat these steps with as many vials as required

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Continued from previous page.

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INFUSING USING THE XYNTHA R2 RAPID RECONSTITUTION VIAL KIT

You should inject XYNTHA as instructed by your hemophilia doctor or nurse. Once you learn how to self-infuse, you can follow the following instructions:

✓ Wash your hands with a good soapy lather for at least 30 seconds before infusing XYNTHA

✓ Infuse reconstituted XYNTHA within 3 hours of mixing

✓ Remember to use germ-free methods during infusion

✓ Inspect the XYNTHA solution – the solution should be colourless, clear to slightly pearly, and contain no particulate matter (If it is not, the solution should be discarded and a new kit should be used)

✓ Reconstituted XYNTHA should not be administered in the same tubing or container with other medicinal products

✓ Record the lot number (found on the vial label) of the product every time you use XYNTHA – you can use the peel-off label on the vial to record the lot number

Infuse XYNTHA using the pre-fi lled diluent syringe provided or a single sterile disposable plastic Luer-Lock syringe and the infusion set included in the kit. Use the vial adapter to withdraw the solution from the vial. Infuse according to the following steps:

Attach the syringe to the Luer end of the provided infusion set tubing and perform venipuncture as instructed by your hemophilia doctor or nurse.

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 and remove the tourniquet. Infuse the XYNTHA solution over several minutes. The infusion rate will depend on your comfort level.

After infusing XYNTHA, remove and discard the infusion set. The amount of XYNTHA left in the infusion set will not affect your treatment.

Dispose of all unused solution, the empty vial(s), and the used needles and syringes in an appropriate sharps container used for throwing away waste that might hurt others if not handled properly.

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USING XYNTHA SOLOFUSE

The following steps are provided as general guidelines for preparing and administering XYNTHA using the SOLOFUSE prefi lled dual-chamber syringe. Always follow the specifi c preparation and administration procedures provided by your hemophilia treatment centre.

• Remove XYNTHA SOLOFUSE from the refrigerator and allow it to come to room temperature

• Wash your hands with good soapy lather for at least 30 seconds

• Grasp plunger rod as shown in diagram, while avoiding contact with the shaft of the plunger rod

• Screw plunger rod fi rmly into opening in fi nger rest of SOLOFUSE

• Turn plunger fi rmly until you feel resistance (about 2 turns)

• Hold SOLOFUSE upright and remove white tamper-evident seal by bending it right to left to break cap perforation and expose grey rubber tip cap

• Keep syringe upright throughout reconstitution process

• Remove blue vented cap from package

• Remove grey rubber tip cap from SOLOFUSE and replace with blue cap

• Avoid touching open end of SOLOFUSE and blue cap

• Advance plunger gently and slowly until both stoppers inside SOLOFUSE meet and all diluent has transferred to the XYNTHA powder chamber

• With the XYNTHA SOLOFUSE remaining upright, swirl gently several times until the powder is dissolved

• Advance plunger rod slowly until until most, but not all, air is removed from XYNTHA chamber

• Remove blue vented cap and attach infusion set

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USING MULTIPLE XYNTHA SOLOFUSE SYRINGES

You may need to combine multiple XYNTHA SOLOFUSE syringes to achieve your required dose.

• Reconstitute all required XYNTHA SOLOFUSE syringes following steps 1-8 on page 20 of this brochure

• Remove Luer-to-Luer syringe connector from package

• Remove blue vented cap from XYNTHA SOLOFUSE

• Connect sterile 10 cc (or larger) Luer Lock syringe to one opening (port) in syringe connector

• Connect SOLOFUSE to other port

• With XYNTHA SOLOFUSE on top, depress plunger slowly until contents empty into the 10 cc (or larger) Luer Lock syringe

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• Remove empty XYNTHA SOLOFUSE and repeat steps 3 and 4 with remaining reconstituted XYNTHA SOLOFUSE syringes

• Remove Luer-to-Luer syringe connector from 10 cc (or larger) Luer Lock syringe

• Attach infusion set

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INFUSING USING XYNTHA SOLOFUSE

✓ Wash your hands with a good soapy lather for at least 30 seconds before infusing XYNTHA

✓ Infuse reconstituted XYNTHA within 3 hours of mixing – if not infused immediately, the syringe should be stored upright and the protective blue vent cap should remain on until ready to infuse

✓ Remember to use germ-free methods during infusion

✓ Inspect the XYNTHA solution – the solution should be colourless, clear to slightly pearly, and contain no particulate matter (if it is not, the solution should be discarded and a new kit should be used)

✓ Reconstituted XYNTHA should not be administered in the same tubing or container with other medicinal products

✓ Record the lot number of the product every time you use XYNTHA

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XYNTHA, as provided in the prefi lled dual-chamber syringe, should routinely be administered using the infusion set included in the kit and according to the following instructions:

After removing the protective blue vented cap, fi rmly attach the intravenous infusion set provided onto the XYNTHA SOLOFUSE.

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

Remove the protective needle cover and insert the butterfl y needle of the infusion set tubing into your vein as instructed by your doctor or healthcare professional.

Remove the tourniquet. Infuse the XYNTHA solution over several minutes. The infusion rate will depend on your comfort level.

As with any intravenous administration, always verify proper needle placement. Discuss this procedure with your healthcare provider.

After infusing XYNTHA, remove and discard the infusion set. The amount of XYNTHA left in the infusion set will not affect your treatment.

Dispose of all unused solution, the empty SOLOFUSE syringe(s), and the used needles and syringes in an appropriate sharps container used for throwing away waste that might hurt others if not handled properly.

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• Detach the empty SOLOFUSE from the vial and discard it

• If the syringe turns but does not detach, grasp white collar and turn

• Connect the sterile 10 cc (or larger) Luer Lock syringe to the vial adapter

• Inject some air into the vial to facilitate withdrawal of contents

• Invert the vial and slowly draw the solution into the 10 cc (or larger) Luer Lock syringe

• Gently turn and pull the syringe counter-clockwise to detach syringe from vial adapter

• Discard vial with adapter attached

• Attach infusion set to 10 cc (or larger) Luer Lock syringe for infusion

• Infuse reconstituted XYNTHA within 3 hours of mixing

• Follow infusion instructions outlined on page 18 of this booklet

USING A XYNTHA R2 RAPID RECONSTITUTION VIAL WITH A XYNTHA SOLOFUSE SYRINGE

You may need to combine a XYNTHA vial and a XYNTHA SOLOFUSE syringe to achieve your required dose.

The following steps are provided as general guidelines for combining XYNTHA using an R2 Rapid Reconstitution vial and a SOLOFUSE prefi lled dual-chamber syringe. Always follow the specifi c preparation and administration procedures provided by your hemophilia treatment centre.

• Reconstitute a XYNTHA vial following instructions outlined on page 14

• Detach the empty syringe from the vial adapter (gently turn and pull syringe counter-clockwise)

• Leave vial contents and vial adapter in place

• Reconstitute XYNTHA SOLOFUSE using the steps outlined on page 20 of this booklet

• Remove the blue vented cap once you are ready

• Connect SOLOFUSE to the R2 vial adapter by inserting the tip into the adapter opening while turning the syringe clockwise until secured

• Depress the SOLOFUSE plunger slowly until contents empty into vial

• The plunger rod may move back slightly after release

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RESOURCES

Canadian Hemophilia Society301-666 Sherbrooke, WestMontréal, Québec H3A 1E7Tel: (514) 848-0503 Toll-free: (800) 668-2686Fax: (514) 848-9661Email: chs@hemophilia.caWebsite: http://www.hemophilia.ca

World Federation of Hemophilia1425 René Lévesque Boulevard, WestSuite 1010Montréal, Québec H3G 1T7Tel: (514) 875-7944 Fax: (514) 875-8916Email: wfh@wfh.orgWebsite: www.wfh.org

National Hemophilia Foundation116 West 32nd Street, 11th FloorNew York, NY 10001Tel: (212) 328-3700 Toll-free: (800) 424-2634Fax: (212) 328-3777Email: handi@hemophilia.orgWebsite: www.hemophilia.org

More Than MedicationWebsite: morethanmedication.ca

NOTES:

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NOTES:

© 2016P� zer Canada Inc.Kirkland, QuebecH9J 2M5www.p� zer.ca

XYNTHA and SOLOFUSE ® Wyeth LLC, owner/P� zer Canada Inc., Licensee

® P� zer Inc., used under license

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