17 PATIENT COUNSELING INFORMATION
Advise patients to:
- read the FDA-approved patient labeling (Patient Information and Instructions for Use).
- report any adverse reactions or problems that concern them when taking XYNTHA to their healthcare provider.
- discontinue use of the product, call their healthcare provider, and go to the emergency department if any allergic-type hypersensitivity reactions occur. Inform patients of the early signs of hypersensitivity reactions (including hives [rash with itching], generalized urticaria, tightness of the chest, wheezing, hypotension) and anaphylaxis.
- contact their healthcare provider if they experience a lack of a clinical response to factor VIII replacement therapy, as this may be a manifestation of an inhibitor.
- notify their healthcare provider if they become pregnant or intend to become pregnant during therapy, or if they are breastfeeding.
- Local irritation may occur when infusing XYNTHA SOLOFUSE.
FDA-Approved Patient Labeling
XYNTHA® SOLOFUSE® /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.
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.
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.
Step-by-step instructions for infusing with XYNTHA SOLOFUSE are provided at the end of this leaflet.
The steps listed below are general guidelines for using XYNTHA SOLOFUSE. 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 SOLOFUSE for your treatment during this time.
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:
- difficulty breathing
- chest tightness
- turning blue (look at lips and gums)
- fast heartbeat
- swelling of the face
Common side effects of XYNTHA are
- joint pain
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.
Store in the refrigerator at 36° to 46°F (2° to 8°C).
Do not freeze.
Protect from light.
XYNTHA SOLOFUSE can last at room temperature (below 77°F) for up to 3 months. If you store XYNTHA SOLOFUSE at room temperature, carefully write down the date you put XYNTHA SOLOFUSE at room temperature, so you will know when to throw it away. There is a space on the carton for you to write the date.
Throw away any unused XYNTHA SOLOFUSE after the expiration date.
Infuse within 3 hours after reconstitution or after removal of the grey rubber tip cap from the prefilled dual-chamber syringe. You can keep the reconstituted solution at room temperature before infusion for up to 3 hours. If it is not used 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.
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 SOLOFUSE that was written for healthcare professionals.
Do not share XYNTHA SOLOFUSE with other people, even if they have the same symptoms that you have.