For the millions of people living with a chronic medical condition, the challenge of managing the disease can seem overwhelming. For those with hemophilia, the diagnosis isn’t always the most difficult part of the disease—it is managing treatment. Hemophilia is a type of bleeding disorder that causes the blood to take a long time to clot, and occurs almost exclusively in males. This can cause abnormal bleeding, or bleeding that won't stop.
i Hemophilia A is the most common form of hemophilia, occurring in approximately 21 in every 100,000 males in the U.S.
ii It is estimated that there are about 14,000 people in the U.S. with hemophilia A.
iii People with hemophilia A have a deficiency in clotting factor VIII, meaning that clotting factor VIII is either missing or is very low.
i One of the most dangerous complications of hemophilia is the risk of prolonged bleeding. An important step to managing hemophilia A is taking steps to stop bleeds right when they start. Factor replacement therapy replaces the clotting factor that is missing in order to prevent or stop a bleed.
iv Most bleeds stop after one dose of clotting factor, while others may need several infusions to stop the bleeding. The amount of factor needed is based on the severity of the bleed. One of the challenges for patients requiring higher doses is the need for multiple vials or syringes, regardless of reconstitution device. “My son just left for college and naturally I worried about how he would manage his hemophilia away from home,” said Claudette L., mother and caregiver for a hemophilia A patient. “I did what I could for 17 years to make sure he was healthy and now it is his responsibility to infuse as his doctor prescribed.” Patients like Claudette’s son, Dominique, can use XYNTHA® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Solofuse to help control their bleeds. XYNTHA Solofuse® comes preloaded with factor and diluent to eliminate the transfer step. “With the travel-ready kit, it is easy for him to store his factor in his dorm room,” said Claudette. “Portability is really important to both of us.” XYNTHA is indicated for the control and prevention of bleeding episodes in patients with hemophilia A. Over the years, there have been many changes in the treatment of hemophilia, helping to make the condition less complicated to manage. For more information on XYNTHA Solofuse, please visit:
www.xynthasolofuse.com What Is XYNTHA? Xyntha® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A. XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand's disease.
Important Safety Information for 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, trouble breathing, chest tightness, turning blue (look at lips and gums), fast heartbeat, swelling of the face, faintness, rash or hives. XYNTHA contains trace amounts of hamster protein. You may develop an allergic reaction to these proteins. Tell your healthcare provider if you have had an allergic reaction to hamster protein.
- Call your healthcare 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 healthcare provider may need to take blood tests to monitor for inhibitors.
- The most common adverse reaction in the safety and efficacy study is headache (24% of subjects), and in the surgery study it is fever (43% of subjects). Other common side effects of XYNTHA include nausea, vomiting, diarrhea or weakness.
- XYNTHA is an injectable medicine administered by intravenous (IV) infusion. You may experience local irritation when infusing XYNTHA after reconstitution in XYNTHA Solofuse.
Please see full Prescribing Information for XYNTHA and XYNTHA SOLOFUSE at
www.xyntha.com.