What Xyntha Solofuse is used for and how to use it
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Xyntha Solofuse - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Hemophilia A
Class: Miscellaneous coagulation modifiers
Form: Liquid solution, Intravenous (IV)
Ingredients: recombinant technology, polysorbate 80, sucrose, l-histidine, calcium chloride dihydrate, sodium chloride

Antihemophilic Factor (Recombinant) [BDDrFVIII]

About This Medication

What the Medication is Used For

Coagulation Factor VIII is a protein that is necessary for blood to clot. People who have the hereditary bleeding disease factor VIII deficiency (hemophilia A) lack this clotting factor, causing their blood to take longer to form a clot. Xyntha is a form of coagulation factor VIII.

Xyntha is used for the control and treatment of bleeding and the routine and surgical prevention of bleeding in people with hemophilia A.

What It Does

Administering Xyntha increases blood levels of factor VIII and helps prevent and control bleeding episodes in patients with hemophilia A. Xyntha has the same clot-promoting effects as factor VIII protein made from human plasma.

When It Should not be Used

You should not take Xyntha unless your doctor confirms you have hemophilia A. Xyntha should not be used for the treatment of other clotting factor deficiencies such as von Willebrand’s disease or hemophilia B.

Xyntha is produced in hamster cells and may contain trace amounts of hamster proteins. Patients who have a known history of allergic reactions to hamster proteins should not take Xyntha. Your doctor will advise you if you have had allergic reactions to hamster proteins.

Do not use Xyntha after the expiry date printed on the pack.

Do not use Xyntha if the packaging is torn or shows signs of tampering.

What the Medicinal Ingredient Is

Xyntha is a coagulation factor VIII product that is produced by recombinant technology.

Xyntha does not contain any human blood or plasma, albumin, preservatives, or added animal or human components in the final product, making it naturally free from the risk of transmission of blood-borne pathogens such as human immunodeficiency virus (HIV), hepatitis viruses, and parvovirus.

What the Important Nonmedicinal Ingredients Are

Polysorbate 80 (0.4 mg/prefilled dual-chamber syringe), Sucrose (12 mg/prefilled dual -chamber syringe), L-Histidine (6 mg/prefilled dual-chamber syringe), Calcium Chloride Dihydrate (1 mg/prefilled dual-chamber syringe), Sodium Chloride (72 mg/prefilled dual-chamber syringe) [after reconstitution with diluent].

What Dosage Form It Comes In

Xyntha vial kit:

Xyntha is supplied in kits that include single-use vials that contain nominally 250, 500, 1000, or 2000 IU per vial with pre-filled diluent syringe containing 4 mL 0.9% Sodium Chloride for reconstitution.

Xyntha Solofuse kit:

Xyntha Solofuse is supplied in a kit that includes the Xyntha freeze -dried powder that contain nominally 250, 500, 1000, 2000, or 3000 IU and 4 mL 0.9 % Sodium Chloride solution for reconstitution in a prefilled dual-chamber syringe.

Warnings and Precautions

Serious Warnings and Precautions

Xyntha may cause allergic reactions. Signs of allergy include hives (rash with itching), swelling, chest tightness, difficulty 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 could be provided.

Notify 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.

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 breast feed. It is not known whether Xyntha passes into breast milk.
  • You are taking other medicines. Tell your hemophilia 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 shop.

Your hemophilia doctor will advise you whether or not to take Xyntha or if you need to adjust the dose, or adapt your treatment.

Interactions With This Medication

No interactions of Xyntha with other medicinal products are known.

Proper Use of This Medication

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.

Each Xyntha Solofuse kit contains:

  • 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

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 Solofuse 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 Solofuse are provided after INFUSION (Intravenous Injection) that detail the combined use of a Xyntha Solofuse and a Xyntha vial or multiple Xyntha Solofuse.

Xyntha Solofuse:

  1. Allow the prefilled dual-chamber syringe of freeze-dried 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 an appropriate container for throwing away medical waste that might hurt others if not handled properly.


In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Side Effects and What to Do About Them

Xyntha may cause allergic reactions.

Some side effects of Xyntha include cold sensation, chest pain, rapid heart beat, sweating, drowsiness, muscle weakness, loss of appetite, muscle pain, pain, coughing, shortness of breath, diarrhea, stomach cramps, altered taste, injection site pain or inflammation and weakness.

Contact your hemophilia doctor immediately if your bleeding does not stop as expected.

Your body can also produce inhibitors, or antibodies, against Xyntha, which may prevent Xyntha from working properly. If your bleeding is not controlled with the usual dose of Xyntha, call your hemophilia doctor or nurse. You should be monitored in order to find out whether a factor VIII inhibitor is present.

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 leaflet, or if there is any other side effect that concerns you.

Tell all your doctors, dentists, and pharmacists who are treating you 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.

If you become pregnant while taking Xyntha, tell your hemophilia doctor and your doctor who will look after you during your pregnancy.

Serious Side Effects, how Оften They Happen and What to Do About Them

Symptom / effectTalk with
your doctor
Stop the
infusion and
call your doctor
Only if
severe
In all
cases
Uncommon
Headache
Rare
Fever
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 (such as skin rash, itching, chest tightness, wheezing, dizziness, hives, faintness, rapid heartbeat, shortness of breath, and/or a swollen face)

This is not a complete list of side effects. For any unexpected effects while taking Xyntha, contact your doctor or hemophilia treatment center.

How to Store It

Keep the freeze-dried Xyntha in the refrigerator at a temperature of 2° to 8°C.

Xyntha may be stored at room temperature not above 25°C for up to 3 months and not to exceed the expiration date. You should write the date in the space provided on the outer carton when you first store Xyntha at room temperature. After room temperature storage, the product 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.

DO NOT freeze.

DO NOT use after the expiration date (month and year) on the label, even if it has been stored properly.

Avoid exposure of Xyntha to light.

Xyntha does not contain a preservative. Use the dissolved solution as soon as possible after mixing. If the solution is not used right away, it can be stored at room temperature and must be used within 3 hours.

DO NOT use Xyntha if the dissolved solution is not clear to slightly pearly and colorless.

Keep Xyntha (and needles) where young children cannot reach it.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, Ontario
      K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be found at: www.pfizer.ca or can be obtained by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001 (Medical Information)