Details for: XYNTHA

You should always follow the specific instructions given by your hemophilia doctor.

The steps listed below are general guidelines for using Xyntha. If you are unsure of the procedures, please call your hemophilia doctor or nurse before using.

Your hemophilia doctor will decide the dose of Xyntha you will receive. The dose and duration of Xyntha treatment will depend on your individual need for replacement factor VIII therapy.

Your hemophilia doctor may decide to change your dose of Xyntha. In the presence of an inhibitor, you may need higher doses or specific treatment. Contact your hemophilia doctor or nurse immediately if bleeding is not controlled after using Xyntha.

Do not stop taking Xyntha or lower your dose, without checking with your hemophilia doctor, unless you think you are having an allergic reaction.

Your doctor may occasionally need to take blood tests to make sure that the level of factor VIII in your blood is high enough to allow normal blood clotting.

• 1 prefilled dual-chamber syringe of Xyntha powder and 4 mL sodium chloride diluent
• 1 plunger rod for the assembly
• 1 sterile infusion set
• 1 vented cap
• 2 alcohol swabs
• 1 bandage
• 1 gauze
• 1 package insert

Xyntha is supplied in a sterile, freeze-dried powder form, and it is intended for injection directly into your vein, usually either by yourself, your doctor, your hemophilia nurse, or other trained person.

Before it can be injected, the powder must be dissolved with the liquid diluent supplied (0.9% sodium chloride) to make it an injectable liquid.

RECONSTITUTION

Xyntha vial
Xyntha Solofuse prefilled dual-chamber syringe

Xyntha vial

Always wash your hands before performing the following procedures. Use germ-free methods during the preparation procedures.

Use only the materials provided in the Xyntha kit for dissolving the Xyntha powder with the sodium chloride diluent.

All components used in the mixing and injection of Xyntha should be used as soon as possible after opening their sterile containers to minimize unnecessary exposure to room air. Xyntha is administered by intravenous injection after dissolving with the supplied diluent (0.9% sodium chloride) in the pre-filled syringe.

Additional instructions for using Xyntha are provided after INFUSION (Intravenous Injection) that detail the use of a Xyntha vial or the combined used of Xyntha vial and a Xyntha Solofuse.

Note: If you use more than one vial of Xyntha per injection, each vial should be dissolved according to the following instructions. The empty syringe should be removed leaving the vial adapter in place, and a separate large luer lock syringe may be used to draw back the dissolved contents of each vial. 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.

1. Allow the vial of freeze-dried Xyntha powder and the pre-filled diluent syringe to reach room temperature.

2. Remove the plastic flip-top cap from the Xyntha vial to expose the central portions 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 penetrating the vial stopper.

6. Grasp the plunger rod as shown in the diagram. Avoid contact with the shaft of the plunger rod. Attach the threaded end of the plunger rod to the diluent syringe 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. 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 diluent syringe may need to be recapped (if the dissolved Xyntha is not used immediately), so place the cap on its top on a clean surface in a spot where it would be least likely to become contaminated.

8. Lift the package 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 depress 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.

Note: The final solution should be inspected visually for particulate matter before administration. The solution should be clear to slightly pearly and colorless. If it is not, the solution should be discarded and a new kit should be used.

12. Ensuring that the syringe plunger rod is still fully depressed, invert the vial. Slowly draw the solution into the syringe.

Note: If you prepared more than one vial of Xyntha, remove the diluent syringe from the vial adapter, leaving the vial adapter attached to the vial. Quickly attach a separate large luer lock syringe and draw back the dissolved contents 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. Detach the syringe from the vial adapter by gently pulling and turning the syringe counterclockwise. Discard the vial with the adapter attached.

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.

Xyntha should be infused within 3 hours after dissolving. The dissolved solution may be stored at room temperature prior to infusion.

INFUSION (Intravenous Injection)

You should inject Xyntha as instructed by your hemophilia doctor or nurse. Once you learn how to self-infuse, you can follow the instructions in this insert.

Xyntha should be administered using the pre-filled diluent syringe provided or a single sterile disposable plastic luer-lock syringe. In addition, the solution should be withdrawn from the vial using the vial adapter.

Xyntha should be administered using the pre-filled diluent syringe provided or a single sterile disposable plastic luer-lock syringe. In addition, the solution should be withdrawn from the vial using the vial adapter.

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

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, and remove the tourniquet. Infuse the reconstituted Xyntha product over several minutes. Your comfort level should determine the rate of infusion.

4. After injecting 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 sharps container used for throwing away waste that might hurt others if not handled properly.

You should record the lot number of the product every time you use Xyntha. The lot number can be found on the vial label. The peel-off label on the vial may be used to record the lot number.

Combined Use of a Xyntha Vial Kit and a Xyntha Solofuse Kit

These instructions are for the combined use of only one Xyntha vial kit and one Xyntha Solofuse Kit. For further information, please contact your healthcare provider.

1. Reconstitute the Xyntha vial using the instructions included with the kit. Detach the empty diluent syringe from the vial adapter by gently turning and pulling the syringe counterclockwise, leaving the contents in the vial and the vial adapter in place.

2. Reconstitute the Xyntha Solofuse using the instructions included with the kit, remembering to remove most, but not all, of the air from the drug product chamber.

3. After removing the protective blue vented cap, connect the Xyntha Solofuse to the vial adapter by inserting the tip into the adapter opening while firmly pushing and turning the syringe clockwise until secured.

4. Slowly depress the plunger rod of the Xyntha Solofuse until the contents empty into the Xyntha vial. The plunger rod may move back slightly after release.

5. Detach and discard the empty Xyntha Solofuse from the vial adapter.

Note: If the syringe turns without detaching from the vial adapter, grasp the white collar and turn.

6. Connect a sterile 10 cc or larger luer lock syringe to the vial adapter. You may want to inject some air into the vial to make withdrawing the vial contents easier.

7. Invert the vial and slowly draw the solution into the 10 cc or larger luer lock syringe.

8. Detach the syringe from the vial adapter by gently turning and pulling the syringe counterclockwise. Discard the vial with the adapter attached.

9. Attach the infusion set to the 10 cc or larger luer lock syringe as directed.

Note: Dispose of all unused solution, the empty Xyntha Solofuse, and other used medical supplies in an appropriate container for throwing away medical waste that might hurt others if not handled properly.

Xyntha Solofuse prefilled dual-chamber syringe

Always wash your hands before performing the following procedures. Use germ-free methods during the preparation procedures.

Use only the materials provided in the Xyntha kit for dissolving the Xyntha powder with the sodium chloride diluent.

All components used in the mixing and injection of Xyntha should be used as soon as possible after opening their sterile containers to minimize unnecessary exposure to room air. Xyntha is administered by intravenous injection after dissolving with the supplied diluent (0.9% sodium chloride) in the pre-filled syringe.

Additional instructions for using Xyntha are provided after INFUSION (Intravenous Injection) that detail the use of a Xyntha vial or the combined used of Xyntha vial and a Xyntha Solofuse.

Xyntha Solofuse:

1. Allow the prefilled dual-chamber syringe of freezedried Xyntha to reach room temperature.

2. Remove the contents of the Xyntha Solofuse Kit and place on a clean surface, making sure you have all the supplies you will need.

3. Grasp the plunger rod as shown in the following diagram. Avoid contact with the shaft of the plunger rod. Screw the plunger rod firmly into the opening in the finger rest of the Xyntha Solofuse by pushing and turning firmly until resistance is felt (approximately 2 turns).

Note: Once the white tamper-evident seal is removed, it is important to keep the Xyntha Solofuse in the upright position throughout the reconstitution process to prevent possible leakage.

4. Holding the Xyntha Solofuse upright, remove the white tamper evident seal by bending the seal right to left (or a gentle rocking motion) to break the perforation of the cap and expose the grey rubber tip cap of the Xyntha Solofuse.

5. Remove the protective blue vented sterile cap from its package.

While holding the Xyntha Solofuse upright, remove the grey rubber tip cap and replace it with the protective blue vented cap (prevents pressure build-up). Avoid touching the open end of both the syringe and the protective blue vented cap.

6. Gently and slowly advance the plunger rod by pushing until the two stoppers inside the Xyntha Solofuse meet, and all of the diluent is transferred to the chamber containing the Xyntha powder.

Note: To prevent the escape of fluid from the tip of the syringe, the plunger rod should not be pushed with excessive force.

7. With the Xyntha Solofuse remaining upright, swirl gently several times until the powder is dissolved.

Note: Look carefully at the solution in the Xyntha Solofuse. The solution should be clear to slightly pearly and colorless. If it is not, the solution should be discarded and a new kit should be used.

8. Again, holding the Xyntha Solofuse in an upright position, slowly advance the plunger rod until most, but not all, of the air is removed from the drug product chamber.

Xyntha should be infused within 3 hours after reconstitution or removal of the grey tip cap from the prefilled dual-chamber syringe. The reconstituted solution may be stored at room temperature prior to infusion. If you have not used it in 3 hours, throw it away.

If the solution is not used immediately, the syringe should be stored upright and the protective blue vent cap should remain on the Xyntha Solofuse until ready to infuse.

If more than one prefilled dual-chamber syringe of Xyntha is needed for each infusion, a luer-to-luer syringe connector can be used (not included in this kit).

INFUSION (Intravenous Injection)

You should inject Xyntha as instructed by your hemophilia doctor or nurse. Once you learn how to self-infuse, you can follow the instructions in this insert.

Always wash your hands before doing the following procedures. Germ-free methods should be used during injection.

Xyntha Solofuse:

1. After removing the protective blue vented cap, firmly attach the intravenous infusion set provided onto the Xyntha Solofuse.

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

3. Remove the protective needle cover and 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.

As with any intravenous administration, always verify proper needle placement.

Discuss this procedure with your health care provider.

Reconstituted Xyntha should not be administered in the same tubing or container with other medicinal products.

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.

Note: Dispose of all unused solution, the empty Xyntha Solofuse, and other used medical supplies 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 Solofuse label every time you use Xyntha. You can use the peel-off label found on the Xyntha Solofuse to record the lot number.

Combined Use of a Xyntha Vial Kit and a Xyntha Solofuse Kit

These instructions are for the combined use of only one Xyntha vial kit and one Xyntha Solofuse Kit. For further information, please contact your healthcare provider.

1. Reconstitute the Xyntha vial using the instructions included with the kit. Detach the empty diluent syringe from the vial adapter by gently turning and pulling the syringe counterclockwise, leaving the contents in the vial and the vial adapter in place.

2. Reconstitute the Xyntha Solofuse using the instructions included with the kit, remembering to remove most, but not all, of the air from the drug product chamber.

3. After removing the protective blue vented cap, connect the Xyntha Solofuse to the vial adapter by inserting the tip into the adapter opening while firmly pushing and turning the syringe clockwise until secured.

4. Slowly depress the plunger rod of the Xyntha Solofuse until the contents empty into the Xyntha vial. The plunger rod may move back slightly after release.

5. Detach and discard the empty Xyntha Solofuse from the vial adapter.

Note: If the syringe turns without detaching from the vial adapter, grasp the white collar and turn.

6. Connect a sterile 10 cc or larger luer lock syringe to the vial adapter. You may want to inject some air into the vial to make withdrawing the vial contents easier.

7. Invert the vial and slowly draw the solution into the 10 cc or larger luer lock syringe.

8. Detach the syringe from the vial adapter by gently turning and pulling the syringe counterclockwise. Discard the vial with the adapter attached.

9. Attach the infusion set to the 10 cc or larger luer lock syringe as directed.

Note: Dispose of all unused solution, the empty Xyntha Solofuse, and other used medical supplies in an appropriate container for throwing away medical waste that might hurt others if not handled properly.

Multiple Xyntha Solofuse Reconstitution to a 10 cc or Larger Luer Lock Syringe

The instructions below are for the use of multiple Xyntha Solofuse kits with a 10 cc or larger luer lock syringe. For further information, please contact your healthcare provider. Note: Luer-to-luer syringe connectors are not provided in the kits. For information on how to obtain the Luer-to-luer syringe connectors please contact 1-855-212-3788.

1. Reconstitute all Xyntha Solofuse according to instructions shown above in the reconstitution directions.
Holding the Xyntha Solofuse in an upright position, slowly advance the plunger rod until most, but not all, of the air is removed from the drug product chamber.

2. Remove the luer-to-luer syringe connector from its package.

3. After removing the protective blue vented cap, connect a sterile 10 cc or larger luer lock syringe to one opening (port) in the syringe connector and the Xyntha Solofuse to the remaining open port on the opposite end.

4. With the Xyntha Solofuse on top, slowly depress the plunger rod until the contents empty into the 10 cc or larger luer lock syringe.

5. Remove the empty Xyntha Solofuse and repeat procedures 3 and 4 above for any additional reconstituted syringes.

6. Remove the luer-to-luer syringe connector from the 10 cc or larger luer lock syringe and attach the infusion set as directed.

Note: Dispose of all unused solution, the empty Xyntha Solofuse, and other used medical supplies in Note: Dispose of all unused solution, the empty Xyntha Solofuse, and other used medical supplies in