XYNTHA® Solofuse Lyophilized Powder for Solution in Prefilled Dual-chamber Syringe Instructions For Use

Instructions for Use

XYNTHA SOLOFUSE /ZIN-tha/
[Antihemophilic Factor (Recombinant)]

XYNTHA SOLOFUSE is supplied as a pre-filled dual-chamber syringe with lyophilized XYNTHA powder in one chamber and 0.9% sodium chloride solution in the other chamber. Before you can infuse it (intravenous injection), you must reconstitute the powder by mixing it with the sodium chloride solution.

Reconstitute and infuse XYNTHA SOLOFUSE using the infusion set provided in this kit. Please follow the directions below for the proper use of this product.

PREPARATION AND RECONSTITUTION OF XYNTHA SOLOFUSE

Preparation

1. Always wash your hands before doing the following steps.
2. Keep everything clean and germ-free while you are reconstituting XYNTHA SOLOFUSE.
3. Once the syringes are open, finish reconstituting XYNTHA SOLOFUSE as soon as possible. This will help to keep them germ-free.
4. For additional instructions on the use of a XYNTHA SOLOFUSE and a XYNTHA vial or multiple XYNTHA SOLOFUSE, see the detailed information provided after INFUSION OF XYNTHA section.

Reconstitution

1. Allow the XYNTHA SOLOFUSE 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. Do not touch 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).
   Throughout the reconstitution process, it is important to keep the XYNTHA SOLOFUSE upright 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 push the plunger rod 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, do not push the plunger rod with excessive force.
   
7. With the XYNTHA SOLOFUSE remaining upright, swirl gently several times until the powder is dissolved.
   
   
   Look carefully at the solution in the XYNTHA SOLOFUSE. The solution should be clear to slightly opalescent and colorless. If it is not, throw away the solution and use a new kit.
8. 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.
   

Note:

• If you are not using the solution immediately, store the syringe upright and keep the protective blue vent cap on the XYNTHA SOLOFUSE until ready to infuse.
• Infuse XYNTHA solution within 3 hours after reconstitution or removal of the grey tip cap from the XYNTHA SOLOFUSE. The reconstituted solution may be kept at room temperature for up to 3 hours prior to infusion. If you have not used it in 3 hours, throw it away.
• If more than one XYNTHA SOLOFUSE is needed for each infusion, a luer-to-luer syringe connector can be used (not included in this kit). Please contact your doctor or healthcare provider, or call the Wyeth Medical Information Department at 1-800-438-1985, for additional information.

INFUSION OF XYNTHA

Your healthcare provider will teach you how to infuse XYNTHA yourself. Once you learn how to do this, you can follow the instructions in this insert.

Before XYNTHA can be infused, you must reconstitute it as instructed above in the PREPARATION AND RECONSTITUTION OF XYNTHA SOLOFUSE section.

After reconstitution, be sure to look carefully at the XYNTHA solution. The solution should be clear to slightly opalescent and colorless. If it is not, throw away the solution and use a new kit.

Use the infusion set included in the kit to infuse XYNTHA. Do not infuse XYNTHA in the same tubing or container with other medicines.

1. After removing the protective blue vented cap, firmly attach the intravenous infusion set provided in the kit 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 healthcare provider. Remove the tourniquet. Verify proper needle placement.
4. Infuse the reconstituted XYNTHA product over several minutes. Your comfort level should determine the rate of infusion.
   
5. After infusing XYNTHA, remove the infusion set and throw it away. The amount of liquid 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.
  
• 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.

ADDITIONAL INSTRUCTIONS

XYNTHA is also supplied in kits that include single-use vials with lyophilized powder and prefilled diluent syringes.

If you use one XYNTHA vial and one XYNTHA SOLOFUSE for the infusion, reconstitute the XYNTHA vial and the XYNTHA SOLOFUSE according to the specific directions for that respective product kit. Use a separate, 10 milliliter or larger luer lock syringe (not included in this kit) to draw back the reconstituted contents of the XYNTHA vial and the XYNTHA SOLOFUSE.

If you use multiple XYNTHA SOLOFUSE kits for the infusion, reconstitute each XYNTHA SOLOFUSE according to the directions above. Use a separate, 10 milliliter or larger luer lock syringe (not included in this kit) to draw back the reconstituted contents of any additional XYNTHA SOLOFUSE.

Use of a XYNTHA Vial Kit with a XYNTHA SOLOFUSE Kit

These instructions are for the use of only one XYNTHA vial kit with one XYNTHA SOLOFUSE Kit. For further information, please contact your healthcare provider or call the Medical Information Department at Wyeth Pharmaceuticals, 1-800-438-1985.

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 XYNTHA vial with the vial adapter in place.
   
2. Reconstitute the XYNTHA SOLOFUSE using the instructions included with the product kit, remembering to remove most, but not all, of the air from the syringe.
   
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 push the plunger rod of the XYNTHA SOLOFUSE to empty the contents into the XYNTHA vial. The plunger rod may move back slightly after release.
   
5. Detach the empty XYNTHA SOLOFUSE from the vial adapter and throw it away.
   If the syringe turns without detaching from the vial adapter, grasp the white collar and turn.
   
6. Connect a sterile 10 milliliter 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 XYNTHA vial and slowly draw the solution into the large luer lock syringe.
   
8. Detach the large luer lock syringe from the vial adapter by gently turning and pulling the syringe counterclockwise. Throw away the empty XYNTHA vial with the adapter attached.
9. Attach the infusion set to the large luer lock syringe as directed in the INFUSION OF XYNTHA section.

Note: Dispose of all unused solution, the empty XYNTHA SOLOFUSE, and other used medical supplies in an appropriate container.

Use of Multiple XYNTHA SOLOFUSE Kits

The instructions below are for the use of multiple XYNTHA SOLOFUSE kits with a 10 milliliter or larger luer lock syringe. For further information, please contact your healthcare provider or call the Medical Information Department at Wyeth Pharmaceuticals, 1-800-438-1985.

Note: Luer-to-luer syringe connectors are not provided in the kits. Contact your XYNTHA supplier to order.

1. Reconstitute all XYNTHA SOLOFUSE according to instructions described in PREPARATION AND RECONSTITUTION OF XYNTHA SOLOFUSE section. Holding the XYNTHA SOLOFUSE in an upright position, slowly push the plunger rod until most, but not all, of the air is removed from the syringe.
   
2. Remove the luer-to-luer syringe connector from its package.
3. After removing the protective blue vented cap, connect a sterile 10 milliliter 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 push the plunger rod to empty all the XYNTHA SOLOFUSE content into the large luer lock syringe.
   
5. Remove the empty XYNTHA SOLOFUSE and repeat procedures 3 and 4 above for any additional XYNTHA SOLOFUSE.
6. Remove the luer-to-luer syringe connector from the large luer lock syringe and attach the infusion set as directed in the INFUSION OF XYNTHA section.

Note: Dispose of all unused solution, the empty XYNTHA SOLOFUSE, and other used medical supplies in an appropriate container.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

License no: 3
LAB-0500-13.0