Devices and Kits

All-in-one reconstitution

Prefilled with XYNTHA and diluent, XYNTHA SOLOFUSE eliminates the transfer step and vials for all-in-one reconstitution.

Preparation

Available in a range of dosing options:

250 IU
500 IU
1000 IU
2000 IU
3000 IU

Dosing for XYNTHA prophylaxis

The recommended starting regimen for adults and adolescents (≥12 years) is 30 IU/kg administered 3 times weekly
The recommended starting regimen for children (<12 years) is 25 IU/kg 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
Your doctor may adjust the amount or frequency of your dose based on your individual response

Connect with your Patient Affairs Liaison to request a 4-in-1 portable travel case

Connect with your Patient Affairs Liaison to request a 4-in-1 portable travel case

The travel-ready kit

Everything you need to infuse on the go, XYNTHA SOLOFUSE comes in a portable and travel-ready kit.

Prefilled syringe
Plunger
Blue vented cap
Infusion set
Bandage
Alcohol swabs
Travel kit
Gauze pad

Pack 'em, flatten 'em, recycle 'em—

What to know about the cardboard packaging:

It's the same XYNTHA inside; environmentally friendly packaging outside
It's portable for an on-the-go lifestyle
It's compact and takes up less storage space
It can be flattened for disposal/recycling

250 IU
500 IU
1000 IU
2000 IU
3000 IU

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Rapid Reconstitution (R2) Kit

The one-of-a-kind R2 Kit comes with a low, 4-mL diluent volume, prefilled syringe; needleless transfer
system; and distinct vial adapter.

Available in a range of vial sizes:

250 IU
500 IU
1000 IU
2000 IU

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Important Safety Information

Call your health care 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, low blood pressure, or hives. XYNTHA contains trace amounts of hamster protein. You may develop an allergic reaction to these proteins. Tell your health care provider if you have had an allergic reaction to hamster protein.
Call your health care provider right away if bleeding is not controlled after using XYNTHA; this may be a sign of an inhibitor, an antibody that may stop XYNTHA from working properly. Your health care provider may need to take blood tests to monitor for inhibitors.
Across all clinical studies, the most common side effects (10% or more) with XYNTHA in adult and pediatric previously treated patients were headache (24% of subjects), joint pain (23%), fever (23%), and cough (12%). Other side effects reported in 5% or more of patients were diarrhea, vomiting, and weakness.
XYNTHA is an injectable medicine administered by intravenous (IV) infusion. You may experience local irritation when infusing XYNTHA after reconstitution in XYNTHA^® SOLOFUSE^®.

XYNTHA^® Antihemophilic Factor (Recombinant) is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia A. Hemophilia A is also called classic hemophilia. Your doctor might also give you XYNTHA before surgical procedures.

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

Please see full Prescribing Information for XYNTHA and XYNTHA SOLOFUSE.

Patients should always ask their doctors for medical advice about adverse events.
You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

© 2023 Pfizer Inc. All rights reserved.

This site is intended only for U.S. residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a health care provider.

PP-XYN-USA-0507

July 2023