XYNTHA™
(ZIN-tha)

[ANTIHEMOPHILIC FACTOR (RECOMBINANT), PLASMA/ALBUMIN-FREE]

Please read this Patient Information carefully before using XYNTHA and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical problems or your treatment.

What is XYNTHA?

XYNTHA is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia A. Hemophilia A is also called classic hemophilia.

XYNTHA is not used to treat von Willebrand's Disease.

What should I tell my doctor before using XYNTHA?

Tell your doctor about all of your medical conditions, including if you

• are pregnant or planning to become pregnant. It is not known if XYNTHA may harm your unborn baby.
• are breastfeeding. It is not known if XYNTHA passes into your milk and if it can harm your baby.

Tell you doctor and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.

How should I infuse XYNTHA?

See the step-by-step instructions for infusing XYNTHA at the end of this leaflet. You should always follow the specific instructions given by your doctor. The steps listed below are general guidelines for using XYNTHA. If you are unsure of the procedures, please call your doctor or pharmacist before using.

Call your doctor right away if bleeding is not controlled after using XYNTHA.

Your doctor will prescribe the dose that you should take.

Your doctor may need to take blood tests from time to time.

Talk to your doctor before traveling. You should plan to bring enough XYNTHA for your treatment during this time.

What if I take too much XYNTHA?

Call your doctor if you take too much XYNTHA.

What are the possible side effects of XYNTHA?

Allergic reactions may occur with XYNTHA. Call your doctor or get emergency treatment right away if you have any of the following symptoms:

wheezing
difficulty breathing
chest tightness
turning blue (look at lips and gums)
fast heartbeat
swelling of the face
faintness
rash
hives

Your body can also make antibodies, called “inhibitors,” against XYNTHA, which may stop XYNTHA from working properly.

Some common side effects of XYNTHA are headache, fever, nausea, vomiting, diarrhea, or weakness.

These are not all the possible side effects of XYNTHA.

Tell your doctor about any side effect that bothers you or that does not go away.

How should I store XYNTHA?

Do not freeze XYNTHA.

Store XYNTHA in the refrigerator at 36° to 46°F (2° to 8°C). XYNTHA can last at room temperature (below 77°F) for up to 3 months. If you store XYNTHA at room temperature, be careful to write down the date you put XYNTHA at room temperature, so you will know when to throw it out. There is a space on the carton for you to write the date.

Throw away any unused XYNTHA after the expiration date.

After reconstituting XYNTHA, you can store it at room temperature for up to 3 hours. If you have not used it in 3 hours, throw it away.

Store the diluent syringe at 36° to 77°F (2° to 25°C).

Do not use reconstituted XYNTHA if it is not clear to slightly opalescent and colorless.

What else should I know about XYNTHA?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use XYNTHA for a condition for which it is not prescribed. Do not share XYNTHA with other people, even if they have the same symptoms that you have.

This leaflet summarizes the most important information about XYNTHA. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about XYNTHA that was written for healthcare professionals.

Instructions for Using XYNTHA

XYNTHA is supplied as a powder. Before it can be infused in your vein (intravenous injection), you must reconstitute the powder by mixing it with the liquid diluent supplied. The liquid diluent is 0.9% sodium chloride. XYNTHA should be reconstituted and infused using the infusion set, diluent, syringe, and adapter provided in this kit, and by following the directions below.

RECONSTITUTION

Always wash your hands before doing the following steps. Try to keep everything clean and germ-free while you are reconstituting XYNTHA. Once you open the vials, you should finish reconstituting XYNTHA as soon as possible. This will help to keep them germ-free.

Note: If you use more than one vial of XYNTHA for each infusion, reconstitute each vial according to steps 1 through 11.

1. Let the vial of XYNTHA and the pre-filled diluent syringe reach room temperature.
2. Remove the plastic flip-top cap from the XYNTHA vial to show the center part 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 cover 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 in the 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 going into the vial stopper.
6. Grasp the plunger rod as shown in the picture below. Do not touch the shaft of the plunger rod. Attach the threaded end of the plunger rod to the diluent syringe plunger by pushing and turning firmly.
7. Break off the tamper-resistant, plastic-tip cap from the diluent syringe by snapping the perforation of the cap. Do not touch the inside of the cap or the syringe tip. The diluent syringe may need to be recapped (if reconstituted XYNTHA is not used immediately), so place the cap on its top on a clean surface in a spot where it will stay clean.
8. Lift the package cover away from the adapter and discard the package.
9. Place the vial on a flat surface. Connect the diluent 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 push the plunger rod to inject all the diluent into the XYNTHA vial.
11. With the syringe still connected to the adapter, gently swirl the contents of the vial until the powder is dissolved.
    
    Look at the final solution before infusing it. The solution should be clear to slightly opalescent and colorless. If it is not, throw away the solution and use a new kit.
12. Make sure the syringe plunger rod is still fully pressed down, then turn over the vial. Slowly pull the solution into the syringe. Turn the syringe upward again and remove any air bubbles by gently tapping the syringe with your finger and slowly pushing air out of the syringe.
    
    If you reconstituted more than one vial of XYNTHA, remove the diluent syringe from the vial adapter and leave the vial adapter attached to the vial. Quickly attach a separate large luer lock syringe and pull the reconstituted solution as instructed above. Repeat this procedure with each vial in turn. Do not detach the diluent syringes or the large luer lock syringe until you are ready to attach the large luer lock syringe to the next vial adapter.
13. Remove the syringe from the vial adapter by gently pulling and turning the syringe counterclockwise. Throw away the vial with the adapter attached.

If you are not using the solution right away, you should carefully replace the syringe cap. Do not touch the syringe tip or the inside of the cap.

XYNTHA should be infused within 3 hours after reconstitution. The reconstituted solution may be stored at room temperature prior to infusion.

INFUSION (Intravenous Injection)

Your doctor or healthcare professional should teach you how to infuse XYNTHA. Once you learn how to self-infuse, you can follow the instructions in this insert.

1. Attach the syringe to the luer end of the provided 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 butterfly needle of the infusion set tubing into your vein as instructed by your doctor or healthcare professional. Remove the tourniquet. Infuse the reconstituted XYNTHA product over several minutes. Your comfort level should determine the rate of infusion.
4. After infusing XYNTHA, remove the infusion set and discard. The amount of drug product 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 container used for throwing away waste that might hurt others if not handled properly.

It is a good idea to record the lot number from the XYNTHA vial label every time you use XYNTHA. You can use the peel-off label found on the vial to record the lot number.

This Patient Package Insert has been approved by the U.S. Food and Drug Administration.

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