Generic name: ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT RESIDUES 743-1636 DELETED 250[iU] in 4mL; ; ISOPROPYL ALCOHOL 0.42mL
Dosage form: injection
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Doses administered should be titrated to the patient's clinical response. In the presence of an inhibitor, higher doses may be required.1
One International Unit (IU) of factor VIII activity corresponds approximately to the quantity of factor VIII in one milliliter of normal human plasma. The calculation of the required dosage of factor VIII is based upon the empirical finding that, on average, 1 IU of factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2 IU/dL.2 The required dosage is determined using the following formula:
The labeled potency of XYNTHA is based on the European Pharmacopoeia chromogenic substrate assay, in which the Wyeth manufacturing standard has been calibrated using a one-stage clotting assay. This method of potency assignment is intended to harmonize XYNTHA with clinical monitoring using a one-stage clotting assay [see Clinical Pharmacology (12.3)].
Control and Prevention of Bleeding Episodes
In the case of the following bleeding events, consideration should be given to maintaining the factor VIII activity at or above the plasma levels (in % of normal or in IU/dL) outlined below for the indicated period.
The following chart can be used to guide dosing in bleeding episodes:
|Type of Bleeding Episode||Factor VIII Level Required (IU/dL or % of normal)||Frequency of Doses / Duration of Therapy|
|Early hemarthrosis, minor
muscle or oral bleeds.
|20–40||Repeat every 12-24 hours
as necessary until resolved.
At least 1 day, depending
upon the severity of the bleeding episode.
|Bleeding into muscles.
Mild head trauma.
Bleeding into the oral cavity.
|30–60||Repeat infusion every
12-24 hours for 3-4 days or
until adequate local
hemostasis is achieved.
or intrathoracic bleeding.
|60–100||Repeat infusion every 8-24
hours until bleeding is
Surgical Prophylaxis in Patients with Hemophilia A
In the case of the following bleeding events, consideration should be given to maintaining the factor VIII activity at or above the plasma levels (in % of normal or in IU/dL) outlined below for the indicated period. Monitoring of replacement therapy by means of plasma factor VIII activity is recommended, particularly for surgical intervention.
The following chart can be used to guide dosing in surgery:
|Type of Surgery||Factor VIII Level Required (IU/dL or % of normal)||Frequency of Doses / Duration of Therapy|
|Minor operations, including tooth extraction.||30–60||Repeat infusion every
12-24 hours for 3-4 days or
until adequate local
hemostasis is achieved.
For tooth extraction, a
single infusion plus oral
antifibrinolytic therapy within 1 hour may be sufficient.
|Major operations.||60–100||Repeat infusion every 8-24
hours until threat is
resolved, or in the case of
surgery, until adequate
local hemostasis and wound healing are achieved.
Instructions for Use
Patients should follow the specific reconstitution and administration procedures provided by their physicians. For instructions, patients should follow the recommendations in the FDA-Approved Patient Labeling (17). The procedures below are provided as general guidelines for the reconstitution and administration of XYNTHA.
Additional instructions are provided after Administration 2.5 that detail the use of a XYNTHA vial and Prefilled Dual-Chamber Syringe [see Use of a XYNTHA Vial Kit and a XYNTHA Prefilled Dual-Chamber Syringe Kit (2.6)].
Note: If the patient uses more than one vial and/or prefilled dual-chamber syringe of XYNTHA per infusion, each vial and/or syringe should be reconstituted according to the instructions for that respective product kit. A separate 10 cc or larger luer lock syringe (not included in this kit) may be used to draw back the reconstituted contents of each vial or syringe.
Preparation and Reconstitution
- Always wash your hands before performing the following procedures.
- Aseptic technique (meaning clean and germ-free) should be used during the reconstitution procedure.
- All components used in the reconstitution and administration of this product should be used as soon as possible after opening their sterile containers to minimize unnecessary exposure to the atmosphere.
Note: If you use more than one vial of XYNTHA per infusion, each vial should be reconstituted according to the following instructions. The diluent syringe should be removed, leaving the vial adapter in place, and a separate large luer lock syringe may be used to draw back the reconstituted 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.
- Allow the vials of freeze-dried XYNTHA and the pre-filled diluent syringe to reach room temperature.
- Remove the plastic flip-top cap from the XYNTHA vial to expose the central portions of the rubber stopper.
- 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.
- Peel back the cover from the clear plastic vial adapter package. Do not remove the adapter from the package.
- Place the vial on a flat surface. While holding the adapter package, place the vial adapter over the vial and press down firmly on the package until the adapter spike penetrates the vial stopper.
- 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 plunger by pushing and turning firmly.
- 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 not administering reconstituted XYNTHA immediately), so place the cap on its top on a clean surface in a spot where it would be least likely to become environmentally contaminated.
- Lift the package away from the adapter and discard the package.
- Place the vial on a flat surface. Connect the diluent syringe to the vial adapter by inserting the tip into the adapter opening while firmly pushing and turning the syringe clockwise until secured.
- Slowly depress the plunger rod to inject all the diluent into the XYNTHA vial.
- Without removing the syringe, 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 opalescent and colorless. If it is not, the solution should be discarded and a new kit should be used.
- Invert the vial and slowly draw the solution into the syringe.
- Detach the syringe from the vial adapter by gently pulling and turning the syringe counter‑clockwise. 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, when reconstituted, contains polysorbate 80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC). This should be considered during the preparation and administration of XYNTHA, including storage time elapsed in a PVC container following reconstitution. It is important that the recommendations in Dosage and Administration (2) be followed closely.
XYNTHA is administered by intravenous (IV) infusion after reconstitution of the freeze-dried powder with the diluent (0.9% Sodium Chloride) syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
XYNTHA should be administered using the tubing provided in this kit and the pre‑filled diluent syringe provided, or a single sterile disposable plastic syringe. In addition, the solution should be withdrawn from the vial using the vial adapter.
- Attach the syringe to the luer end of the infusion set tubing provided.
- Apply a tourniquet and prepare the injections site by wiping the skin well with an alcohol swab provided in the kit.
- Remove the protective needle cover and perform venipuncture. Insert the needle on the infusion set tubing into the vein, and remove the tourniquet. The reconstituted XYNTHA product should be injected intravenously over several minutes. The rate of administration should be determined by the patient's comfort level. As with any intravenous administration, always verify proper needle placement.
Use of a XYNTHA Vial Kit and a XYNTHA Prefilled Dual-Chamber Syringe Kit
These instructions are for the use of only one XYNTHA vial kit and one XYNTHA Pre-filled Dual-Chamber Syringe Kit. For further information, please contact the Medical Information Department at Wyeth Pharmaceuticals, 1-800-934-5556.
- Reconstitute the XYNTHA vial using the instructions included with this 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.
- Reconstitute the XYNTHA Prefilled Dual-Chamber Syringe using the instructions included with the kit, remembering to remove most, but not all, of the air from the drug product chamber.
- After removing the protective blue vented cap, connect the XYNTHA Prefilled Dual‑Chamber Syringe to the vial adapter by inserting the tip into the adapter opening while firmly pushing and turning the syringe clockwise until secured.
- Slowly depress the plunger rod of the XYNTHA Prefilled Dual-Chamber Syringe until the contents empty into the XYNTHA vial. The plunger rod may move back slightly after release.
- Detach and discard the empty XYNTHA Prefilled Dual-Chamber Syringe from the vial adapter.
Note: If the syringe turns without detaching from the vial adapter, grasp the white collar and turn.
- 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.
- Invert the vial and slowly draw the solution into the 10 cc or larger luer lock syringe.
- Detach the syringe from the vial adapter by gently turning and pulling the syringe counterclockwise. Discard the vial with the adapter attached.
- Attach the infusion set to the 10 cc or larger luer lock syringe as directed [see Dosage and Administration (2.5)].
Note: Dispose of all unused solution, the empty XYNTHA Prefilled Dual-Chamber Syringe, and other used medical supplies in an appropriate container for throwing away medical waste that might hurt others if not handled properly.