Hemophilia A is a rare, inherited condition that prevents your blood from clotting the way it should. People with hemophilia A do not make enough of a protein called factor VIII, which normally works to stop bleeding when you get a cut or injury. With hemophilia A, even getting a minor injury can cause your body to bleed longer than normal.
Esperoct (antihemophilic factor, recombinant) is a medicine for hemophilia A that reduces the number of times you get bleeding episodes. It is given by injection into a vein to temporarily replace the missing factor VIII in your blood so it can clot properly.
Some other factor VIII medicines require infusions every other day. Esperoct is designed to last longer in your body, so you can use it less often. Most adults and teens use it about every four days, and children usually receive it twice a week. Your health care provider will tailor the schedule based on your individual needs.
How Does Esperoct Work for Hemophilia A?
People with hemophilia A do not make enough of a protein that is normally found in blood, called factor VIII, which helps your blood form clots. Without enough of this protein, bleeding can last longer than normal after an injury. Bleeding can even happen inside your body.
Esperoct is a human-made version of factor VIII that works by temporarily replacing the missing clotting protein in your blood. It raises your factor VIII levels so your body can form a normal blood clot and stop bleeding.
Esperoct is different from some older treatments for hemophilia A because it’s designed to last longer in your bloodstream. Because of this, many people don’t need to infuse Esperoct as often as some other medicines for hemophilia A.
Your health care provider may prescribe Esperoct for different reasons, such as:
- Treating a bleeding episode when it happens (called “on-demand treatment”)
- Preventing bleeds with regular infusions (called “routine prophylaxis”)
- Controlling bleeding during or after surgery
Even though Esperoct does not cure hemophilia A, using it regularly can help lower your risk for bleeding episodes, protect your joints from long-term damage, and make it easier to stay active in your daily life.
How Do I Use Esperoct?
Esperoct is given as an injection into a vein, which is also called an infusion. You can receive your infusion of Esperoct at a hemophilia treatment center, at your health care provider’s office, or at home after your health care provider gives you the proper training. The infusion takes one to three minutes to infuse into your vein, plus the time it takes to prepare for your infusion and clean up afterward.
Many people with hemophilia A learn to infuse Esperoct at home after receiving hands-on training from a health care provider. For some people, infusing their dose at home is a more convenient option than going to a treatment center or clinic. If you’re interested in learning how to infuse Esperoct at home, your health care provider can help you.
How Often Do I Use Esperoct?
Esperoct is a longer-acting form of factor VIII than some other medicines for hemophilia. Because Esperoct stays in your body longer, you may not need to get infusions as often as with some older treatments. For some people with hemophilia, this means more freedom and flexibility with your schedule.
The number of infusions you need depends on whether you’re using Esperoct to prevent bleeding episodes, treat a bleeding episode when it happens, or control bleeding during or after surgery.
For prevention of bleeding, which is also called prophylaxis, most adults and adolescents infuse Esperoct every four days. Children may need higher doses of Esperoct and they may need to receive their doses more often. This is because children may clear Esperoct from their bodies faster. Your child’s health care provider will determine the correct dose and frequency of Esperoct for your child.
To treat a bleed or to prevent bleeding before or after surgery, your health care provider will determine your dose of Esperoct and how often you need to receive it.
How Long Does It Take for Esperoct to Work?
Esperoct starts working right after it’s infused into your vein. Because it replaces the missing factor VIII clotting protein in your body, you may notice bleeding slow or stop soon after treatment begins. In clinical studies, most bleeds were controlled with one or two doses of Esperoct.
When used regularly to help prevent bleeding, Esperoct stays active in your body for several days. That’s why most adults and adolescents only need an infusion every four days to stay protected.
Children under 12 years old clear the medicine faster, so they may need higher or more frequent doses to maintain the same level of protection. Your health care provider will decide the right dose and schedule for you or your child.
How Will I Know If Esperoct Is Working?
After infusion, the factor VIII level in your body rises quickly and then gradually falls before your next dose. The lowest level of factor VIII in your body is called your trough level, and it happens right before your next infusion. Many other factor VIII medicines are designed to keep the trough level at 1%. In studies of Esperoct on adolescents and adults, their trough levels were at or above 3%. This is because Esperoct lasts longer in the body than other medicines, which means it can work longer to prevent bleeds.
How Was Esperoct Studied for Hemophilia A?
Researchers studied Esperoct in 254 males with severe hemophilia A who had previously been treated with other factor VIII products. The reason only males were included in the studies is because most people with hemophilia A are male. Females also can have hemophilia A in rare cases.
The people in the studies belonged to several age groups, including children younger than 6 years, children aged 6 to 12 years, adolescents aged 12 to 17 years, and adults aged 18 to 70 years. The studies looked at how well Esperoct prevented and treated bleeding episodes and how safe it was when people used it long-term.
Most of the people in the study used Esperoct on a regular schedule to help prevent bleeds. Many people went a full year without needing treatment for a bleed. On average, people in the study had about one treated bleed per year. When bleeding did occur, it was usually controlled with one or two Esperoct infusions. Doctors described the response to treatment as “excellent” or “good” in most cases.
In the people who received Esperoct before or after surgery, bleeding control was also rated “excellent” or “good” in 43 out of 45 cases (95.6%).
Side effects of Esperoct were studied in 270 people, including 68 children and 202 adolescents and adults. The side effects were generally mild, such as rash, itching, or redness where the medicine was injected. Only one person in the studies developed an immune response called an inhibitor, which made Esperoct less effective for a short time before resolving on its own.
How Can I Prevent or Manage Side Effects of Esperoct?
Most people who use Esperoct tolerate it well. The most common side effects are mild skin reactions, such as redness, itching, or discomfort where the medicine is injected.
Some people can have an allergic reaction to Esperoct. If you are having trouble breathing or your throat starts to swell, stop using the medicine and call for emergency medical help right away.
Because Esperoct is made using hamster cells, tell your health care provider if you’ve ever had a reaction to hamsters or hamster proteins.
Some people have an immune system reaction that causes Esperoct to stop working as well. This reaction is called inhibitors or neutralizing antibodies. If your usual dose doesn’t seem to work as well, your health care provider can check your blood for inhibitors and adjust your treatment plan if needed.
How Do I Get Esperoct, and Is Financial Help Available?
Esperoct is a prescription medicine that can be given by your health care provider at a hemophilia treatment center, a clinic, or at home once you have been trained. Because it’s a specialty medicine, it’s usually filled through a specialty pharmacy that works with your health care team to arrange delivery and insurance approval.
If you need help paying for treatment, the maker of Esperoct, offers different support options, including:
- A copay assistance program to help with out-of-pocket costs
- A patient assistance program (PAP) for people who qualify based on income or insurance
- A free medication trial program for eligible new users
Each program has its own eligibility requirements. To learn more, call NovoCare at 888-NOVO-444 (888-668-6444) or visit www.esperoct.com.