(antihemophilic factor [recombinant])

Prescribing Information
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HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use XYNTHA safely and effectively. See full prescribing information for XYNTHA.

XYNTHA® (antihemophilic factor [recombinant]) lyophilized powder for solution, for intravenous injection
Initial U.S. Approval: 2008

INDICATIONS AND USAGE

  • XYNTHA is a recombinant antihemophilic factor indicated in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, for perioperative management, and for routine prophylaxis to reduce the frequency of bleeding episodes. (1)
  • XYNTHA is not indicated in patients with von Willebrand's disease. (1)

DOSAGE AND ADMINISTRATION

For intravenous use after reconstitution only (2)

  • The required dose is determined using the following formula:
    Required units = body weight (kg) × desired factor VIII rise (IU/dL or % of normal) × 0.5 (IU/kg per IU/dL), where IU = International Unit. (2.1)

Routine prophylaxis (2.1)

  • Adults and adolescents (≥12 years): The recommended starting regimen is 30 IU/kg of XYNTHA administered 3 times weekly.
  • Children (<12 years): The recommended starting regimen is 25 IU/kg of XYNTHA administered every other day. More frequent or higher doses may be required in children <12 years of age to account for the higher clearance in this age group.
  • Adjust the dosing regimen (dose or frequency) based on the patient's clinical response.
  • Frequency of XYNTHA administration is determined by the type of bleeding episode and the recommendation of the treating physician. (2.1, 2.2)

DOSAGE FORMS AND STRENGTHS

XYNTHA is available as lyophilized powder in single-use vials containing nominally 250, 500, 1000, or 2000 IU. (3)

CONTRAINDICATIONS

Do not use in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster proteins. (4)

WARNINGS AND PRECAUTIONS

  • Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster protein, which is present in trace amounts in XYNTHA. Should such reactions occur, discontinue treatment with the product and administer appropriate treatment. (5.1)
  • Development of neutralizing antibodies has been reported in patients using XYNTHA. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor VIII inhibitor concentration. (5.2, 5.3, 6.2)

ADVERSE REACTIONS

  • The most common adverse reactions (≥10%) with XYNTHA in adult and pediatric previously treated patients (PTPs) were headache, arthralgia, pyrexia, and cough. (6)
  • Across all studies, 4 subjects developed factor VIII inhibitors (2.4%). (6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals LLC. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

USE IN SPECIFIC POPULATIONS

Pediatrics: Half-lives are shorter, volumes of distribution are larger, and recovery is lower after XYNTHA administration in children. Higher or more frequent dosing may be needed. (8.4)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 7/2022

Medication Guide

FDA-APPROVED PATIENT LABELING

FDA-Approved Patient Labeling

Patient Information

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

Please read this patient information carefully before using XYNTHA and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical problems or your treatment.

What is XYNTHA?

XYNTHA is an injectable medicine that is used to help control and reduce bleeding in people with hemophilia A. Hemophilia A is also called classic hemophilia. Your healthcare provider may give you XYNTHA when you have surgery.

XYNTHA is not used to treat von Willebrand's disease.

What should I tell my healthcare provider before using XYNTHA?

Tell your healthcare provider about all of your medical conditions, including if you:

  • have any allergies, including allergies to hamsters.
  • are pregnant or planning to become pregnant. It is not known if XYNTHA may harm your unborn baby.
  • are breastfeeding. It is not known if XYNTHA passes into your milk and if it can harm your baby.

Tell your healthcare provider about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies.

How should I infuse XYNTHA?

Step-by-step instructions for infusing with XYNTHA are provided at the end of this leaflet.

The steps listed below are general guidelines for using XYNTHA. Always follow any specific instructions from your healthcare provider. If you are unsure of the procedures, please call your healthcare provider before using.

Call your healthcare provider right away if bleeding is not controlled after using XYNTHA.

Call your healthcare provider right away if you take more than the dose you should take.

Talk to your healthcare provider before traveling. Plan to bring enough XYNTHA for your treatment during this time.

What are the possible side effects of XYNTHA?

Call your healthcare provider or go to the emergency department right away if you have any of the following symptoms because these may be signs of a serious allergic reaction:

  • wheezing
  • difficulty breathing
  • chest tightness
  • turning blue (look at lips and gums)
  • fast heartbeat
  • swelling of the face
  • faintness
  • rash
  • hives

Common side effects of XYNTHA are

  • headache
  • joint pain
  • fever
  • cough
  • vomiting
  • diarrhea
  • weakness

Your body can make antibodies against XYNTHA (called "inhibitors") that may stop XYNTHA from working properly. Your healthcare provider may need to take blood tests from time to time to monitor for inhibitors.

Talk to your healthcare provider about any side effect that bothers you or that does not go away. You may report side effects to FDA at 1-800-FDA-1088.

How should I store XYNTHA?

Store XYNTHA in the refrigerator at 36° to 46°F (2° to 8°C). Store the diluent syringe at 36° to 77°F (2° to 25°C).

Do not freeze.

Protect from light.

XYNTHA can last at room temperature (below 77°F) for up to 3 months. If you store XYNTHA at room temperature, carefully write down the date you put XYNTHA at room temperature, so you will know when to either put it back in the refrigerator, use it immediately, or throw it away. There is a space on the carton for you to write the date.

If stored at room temperature, XYNTHA can be returned one time to the refrigerator until the expiration date. Do not store at room temperature and return it to the refrigerator more than once. Throw away any unused XYNTHA after the expiration date.

Infuse XYNTHA within 3 hours of reconstitution. You can keep the reconstituted solution at room temperature before infusion for up to 3 hours. If you have not used it in 3 hours, throw it away.

Do not use reconstituted XYNTHA if it is not clear to slightly opalescent and colorless.

Dispose of all materials, whether reconstituted or not, in an appropriate medical waste container.

What else should I know about XYNTHA?

Medicines are sometimes prescribed for purposes other than those listed here. Talk to your healthcare provider if you have any concerns. You can ask your healthcare provider for information about XYNTHA that was written for healthcare professionals.

Do not share XYNTHA with other people, even if they have the same symptoms that you have.

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You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.