Antihemophilic factor (recombinant)
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Instructions for Use XYNTHA is administered by intravenous (IV) infusion after reconstitution of the freeze-dried powder with the supplied pre-filled diluent (0.9% Sodium Chloride solution) syringe. 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 .
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 ].
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 Preparation 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.
Reconstitution 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. The reconstituted solution may be stored at room temperature prior to administration, but should be administered within 3 hours.
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 be followed closely. Remove plastic flip-top cap Place vial on flat surface Grasp plunger rod Break off tamper-resistant plastic tip cap Life package away Place vial on flat surface Slowly depress plunger Invert vial
Administration 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.
Reconstituted XYNTHA should not be administered in the same tubing or container with other medicinal products. 3 After infusing XYNTHA, remove the infusion set and discard. The amount of drug product left in the infusion set will not affect treatment. Note: Dispose of all unused solution, the empty vial(s) and other used medical supplies in an appropriate container for throwing away medical waste that might hurt others if not handled properly.
Apply tourniquet Remove protective needle cover
| Type of Bleeding Episode | Factor VIII Level Required (IU/dL or % of normal) | Frequency of Doses / Duration of Therapy |
|---|---|---|
| Minor | ||
| 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. |
| Moderate | ||
| 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. |
| Major | ||
| Gastrointestinal bleeding. Intracranial, intra-abdominal or intrathoracic bleeding. Fractures. | 60–100 | Repeat infusion every 8-24 hours until bleeding is resolved. |
| Type of Surgery | Factor VIII Level Required (IU/dL or % of normal) | Frequency of Doses / Duration of Therapy |
|---|---|---|
| Minor | ||
| 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 | ||
| 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. |
Drug interactions
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- Antihemophilic factor (recombinant)
Label text (1 paragraph)
None known. None.
Contraindications
None. None.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for antihemophilic factor (recombinant). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free. It is also not known whether XYNTHA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. XYNTHA should be given to a pregnant woman only if clinically indicated.
Lactation
8.3 Nursing Mothers It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, caution should be exercised if XYNTHA is administered to nursing mothers. XYNTHA should be given to nursing mothers only if clinically indicated.
Breastfeeding (LactMed)
No information is available on the clinical use of antihemophilic factor (coagulation factor VIII) during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Until more data become available, antihemophilic factor should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.