Alphanate
Factor VIII / VWF complex is infused through the veins to treat or prevent bleeds in people with certain blood conditions called hemophilia A and von Willebrand disease (VWD). It's typically given in the hospital or clinic, and the length of your treatment depends on your health condition and how serious the bleed is. Some common side effects with Factor VIII / VWF complex include rash, itching, and chills.
What is Factor VIII / VWF complex?
What is Factor VIII / VWF complex used for?
- To treat or prevent bleeds in people with certain types of von Willebrand disease (VWD) and hemophilia A
How Factor VIII / VWF complex works
Factor VIII / VWF complex is a clotting factor replacement for people who are missing special proteins called clotting factors FVIII (in hemophilia A) or VWF (in von Willebrand disease). Factor VIII / VWF complex works by replacing these missing clotting factors in your body. By doing so, this medication works to treat or prevent bleeds in people who naturally don't have these clotting factors.
This medication contains FVIII and VWF as a complex, meaning these two clotting factors are linked together. In your body, FVIII and VWF travel together to the location where there's an injury in order to start the clotting process. One of the roles of VWF is to protect FVIII from being destroyed by certain proteins in your blood. Giving these two together means that FVIII won't get broken down as quickly and stays around in your body longer.
Drug facts
Side effects of Factor VIII / VWF complex
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Alphanate: Infusion-related side effects were reported (>1%) by people treated for VWD:
- Itching
- Headache
- Back pain
- Prickly or tingling sensation
- Trouble breathing
- Swelling in the face
- Pain
- Rash
- Chills
Humate-P
- Rash, redness, swelling, and other infusion-related side effects
- Bleeding at the injection site - more common in people having surgery
- Nosebleeds - more common in people having surgery
Wilate
- Hives and dizziness (VWD)
- Fever (hemophilia A)
Less Common Side Effects
- Nausea
- Shortness of breath
- Cough
- Chest discomfort
- Stomach pain
Factor VIII / VWF complex serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious allergic reaction (anaphylaxis): Difficulty breathing, hives, itching, fast heartbeat, tightness in the throat, nausea, stomach pain, dizziness, lightheadedness, swelling in the face or tongue
- Blood clot in the lungs: cough, difficulty breathing, chest pain
- Other types of blood clots: legs (redness, pain, tenderness, swelling of the skin), heart attack (chest pain, pain in the arms or shoulders, pain in the neck or jaw), stroke (difficulty speaking, numbness on one side of the body, confusion)
The following Factor VIII / VWF complex side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Difficulty with breathing or swallowing
dizziness
fast heartbeat
reddening of the skin, especially around the ears
swelling of the face, throat, or tongue
unusual tiredness or weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Factor VIII / VWF complex
Pros
- Works well to prevent or treat bleeds for hemophilia A and VWD
- Contains both FVIII and VWF, meaning FVIII sticks around longer since it's protected by VWF
- Dosing can be adjusted based on how your body responds
- Might be possible to set up home infusions for certain conditions
Cons
- Given intravenously (IV)
- Might need to get infusions up to 3 times a day, depending on your condition
- Not recommended in pregnancy because of possible harm to the unborn baby
- Raises your risk of clots
- Might not work well after a while because can develop inhibitors to the medication
Pharmacist tips for Factor VIII / VWF complex
- Some of the most common side effects with factor VIII / VWF complex are infusion-related side effects, such as flushing, rash, itching, and chills. If you've experienced these side effects, ask your provider if there is anything that can be done before your next infusion to ease these side effects. Your provider might also be able to slow down how fast you receive the infusion to lessen some of these reactions.
- Go to the emergency room right away if you experience symptoms of blood clots, including cough, difficulty breathing, chest pain, headache, trouble speaking, or weakness on one side of your body. Factor VIII / VWF complex can raise your risk of blood clots.
- Let your provider know if you think you might be sick with an infection and have symptoms such as fever, rash, joint pain, or sore throat. Factor VIII / VWF complex is made with human blood products and there's an extremely small risk that the medication might contain viruses or other bugs that can make you sick.
- Typically, you'll start receiving factor VIII / VWF complex in the hospital or clinic. But depending on your medical condition and level of comfort with self-infusions, they might train you to give these infusions to yourself at home or help arrange for home infusions.
Common questions about Factor VIII / VWF complex
Both hemophilia A and von Willebrand disease (VWD) are conditions that make it difficult for your blood to clot because of a missing clotting factor. People with hemophilia A are missing factor VIII (FVIII) and people with VWD are missing the von Willebrand factor (VWF). Both hemophilia A and VWD are typically genetic, meaning they're passed down from parent to child. Symptoms of both conditions can include bruising easily and bleeds that are difficult to stop.
There are currently 3 different brands of factor VIII / VWF complex: Wilate, Humate-P, and Alphanate. Your provider will help you decide which one is best for you. Some factors they'll consider include your age, how serious your hemophilia A or VWD is, and whether or not you'll need long-term treatment to prevent bleeds.
The length of time that you'll need to stay on factor VIII / VWF complex depends on your medical condition, how serious your bleed is, and whether or not the medication is working well for you. It typically ranges from 1 to 2 days, to about a week. But in some cases, you might need to take the medication for even longer, especially if you're using it routinely to prevent bleeds. Talk with your provider if you're not sure when you should stop the medications.
Yes, it's possible that factor VIII / VWF complex might stop working for you, even though it worked for you in the beginning. This is because people who receive medications with FVIII (one of the factors in these medications) can sometimes develop antibodies, also known as inhibitors, against FVIII. Inhibitors block the FVIII in the medication, causing it to not work well. Researchers don't know the exact reason why some people develop inhibitors, but it's possibly related to genetics and how often you've been treated with FVIII medications. Your provider might test you for inhibitors if your bleeding is difficult to treat or if you've been receiving factor VIII / VWF complex for a long time.
Ask your provider if it's appropriate for you to receive factor VIII / VWF complex treatment at home. These medications are usually started in the hospital or clinic. But depending on your medical condition and level of comfort with self-infusions, your provider might train you to give the infusions to yourself at home. They might also help set you up for home infusions if they think it's safe to do so. Look at the manufacturers' websites for guidance on how to prepare for home self-infusions of Alphanate, Humate-P, or Wilate.
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Risks and warnings for Factor VIII / VWF complex
Factor VIII / VWF complex can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Blood clot problems (for people with VWD only)
- Risk factors: Older adults | History of blood clot problems | High blood pressure | High cholesterol | High blood sugar | Larger waist size | Cancer | Surgery | Taking hormonal birth control | Smoking tobacco | Pregnancy
Taking factor VIII / VWF complex can raise your risk of getting blood clots. Your risk is higher if you're an older adult or have health conditions such as high blood pressure, blood sugar, or cholesterol. Because of this risk, your provider will check your labs regularly to make sure you don't have too much VWF and factor VIII. Symptoms of a blood clot might be different depending on the location of the clot, but they can include chest pain, difficulty breathing, swelling or warmth in the legs, and weakness of the face, legs, or arms. Call 911 if you have any of the symptoms above.
Damaged red blood cells (intravascular hemolysis) - Alphanate and Humate-P only
- Risk factors: Taking high or repeated doses of factor VIII / VWF complex | Having A, B, or AB blood type
Factor VIII / VWF complex can damage your red blood cells (RBCs) if you have blood type A, B, or AB, especially if you receive larger or repeated doses of the medication. This is because this medication contains antibodies that can attack the RBCs of people with these blood types, causing your RBCs to fall apart. Your body typically recovers from this side effect once you stop the medication. But if it doesn't, you might need to use a different medication. Let your provider know if you experience symptoms of damaged RBCs including dizziness, weakness, and feeling more tired.
Infection
- Risk factors: Medical conditions that lower your immune system | Taking medications that can lower your immune system
Because factor VIII / VWF complex is made from human blood products, there's a risk that it might contain viruses that can make you sick. But your risk of infection is pretty low because donors of these blood products are screened. Also, there are high manufacturing standards put into place to make sure the viruses are killed or removed. To prevent serious infections in the rare case that your medication is affected, let your provider know right away if you start to feel sick or have symptoms such as feeling confused and anxious, or having trouble maintaining your balance.
Development of antibodies against FVIII
There's a chance that factor VIII / VWF complex will stop working well for you even though it worked well in the beginning. This is because people who receive medications with FVIII (one of the factors in these medications) can sometimes develop antibodies, also known as inhibitors, against FVIII. The inhibitors block FVIII in the medication, causing it to not work well. Let your provider know if bleeding becomes difficult to control even after receiving factor VIII / VWF complex, they might need to check whether or not you have antibodies and make changes to your treatment.
Factor VIII / VWF complex dosage
Typical dosage for Factor VIII / VWF complex
Routine treatment to prevent bleeds in hemophilia A (Wilate only)
- The typical dose is Wilate 20 to 40 IU/kg infused into the veins every 2 to 3 days.
To prevent and control bleeds during and after surgery and/or trauma (Alphanate, Humate-P, and Wilate)
Your provider will calculate your starting dose based on things like body weight, how serious your bleed is, where the bleed is, and the desired level of FVIII or VWF in your body. The dose is given to you through the veins (IV) 1 to 3 times a day, depending on your condition. Your provider might adjust your dose throughout treatment based on how your body responds to this medication.
Interactions between Factor VIII / VWF complex and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
