Newer factor VIII recombinant products, such as Advate, are infused through the veins to treat or prevent bleeds in people with a certain blood condition called hemophilia A. These products are different from the older first-generation factor VIII products, such as Hemofil M, because the newer products are made with technology that don't use human plasma. In addition, the newer factor VIII recombinant products can be used on a regular basis to prevent bleeds, whereas older factor VIII products are typically only used during surgery or procedures.
Advate (factor VIII) is a clotting factor replacement for people who are missing special blood-clotting proteins called factor VIII (FVIII) due to hemophilia A. By replacing the missing clotting factor (FVIII, or antihemophilic factor) in people who naturally don't have it, bleeding episodes can be reduced or treated.
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.
The side effects below were reported by people who used Advate during clinical trials. If you're using a product besides Advate, the side effects you experience and your risk of side effects might be different.
Contact your healthcare provider immediately if you experience any of the following.
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 immediately if any of the following side effects occur:
More common
Less common or rare
Changes in facial skin color
chills
fast or irregular breathing
puffiness or swelling of the eyelids or around the eyes
sensation of burning, warmth, heat, numbness, tightness, or tingling
tightness in the chest
trouble breathing
unusual tiredness or weakness
Incidence not known
Bluish color of the fingernails, lips, skin, palms, or nail beds
blurred vision
chest pain or discomfort
confusion
deep or fast breathing with dizziness
difficult or labored breathing
difficulty with swallowing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fast, pounding, or irregular heartbeat or pulse
noisy breathing
numbness of the feet, hands, and around the mouth
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
slow or irregular heartbeat
sweating
swelling of the face, throat, or tongue
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Headache
Less common
Burning, stinging, or swelling at the injection site
dizziness or lightheadedness
dry mouth or bad taste in the mouth
lack or loss of strength
nosebleed
redness of the face
vomiting
Rare
Change in taste
loss of taste
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.
Some differences between the factor VIII products include how the products are made and how often they're dosed. 1) The older factor VIII products, such as Hemofil M, are made using human plasma. The products carry a risk for causing infection, but this risk is extremely small because manufacturers have high standards in making sure the products are free from any viruses. The newer factor VIII products, such as Advate and Novoeight, are made using no human products, so don't carry the same risk of infection. 2) In addition, the newer factor VIII products are designed to last longer in the body so that you won't need infusions as often. Depending on which brand you use, you might require different numbers of infusions. Speak to your provider about which factor VIII product is best for you.
Typically, your Advate (factor VIII) infusion will take 5 minutes or less. If you're using any other factor VIII product, the length of time for your infusion might be different, so please refer to the package insert or ask your provider if you've any questions. In general, the factor VIII infusions are completed in under 15 minutes. Let your provider know if you experience a rise in your pulse or any other reaction while receiving this medication. Depending on the product you're using, provider might be able to ease some side effects by slowing down your infusion.
Advate (factor VIII) works well to prevent bleeds. In a study that looked at people who used Advate (factor VIII) regularly for a year to prevent bleeds, 42% of those people didn't experience any bleeds during that year. Your response might be different depending on which brand you receive. But in general, people experience less bleeds when they use factor VIII products regularly to prevent bleeds.
If you're using Advate (factor VIII) or other factor VIII products to prevent bleeding episodes, you might be able to use it at home if your provider thinks it's safe for you to do so. Before giving Advate (factor VIII) to yourself at home, make sure you've completed training with your provider and understand how to use it safely. You'll need to infuse it into your veins yourself, or have a caregiver help you. In some cases, your provider might decide it's best for you to receive treatment at a hemophilia treatment center.
Some factor VIII products are made from donated human plasma (the liquid portion of blood) like Hemofil M and Alphanate, while others are made in a lab using recombinant technology (e.g., Advate, Xyntha, Novoeight). Recombinant products are generally considered safer because they're made in the lab and don't carry the same risk of potential infections from receiving human-derived products. Currently, providers typically prefer recombinant factor VIII products over ones made from human plasma.
Advate (factor VIII) 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.
Though rare, serious allergic reactions, including anaphylaxis, can happen with Advate (factor VIII) and other factor VIII products. Make sure to tell your provider all of your allergies before receiving treatment. If you experience rash, chest tightness, trouble breathing, or swelling in your lips, tongue, or throat after receiving Advate (factor VIII), get medical help right away.
There's a chance that Advate (factor VIII) or other factor VIII products will stop working well for you even though it worked well in the beginning. This is because people who receive medications with FVIII can sometimes develop antibodies, also known as inhibitors, against FVIII. The inhibitors block FVIII, causing it to not work well. Let your provider know if bleeding becomes difficult to control even after receiving Advate (factor VIII). They might need to check whether or not you have antibodies and make changes to your treatment.
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| single dose of 250iu | 1 kit | $486.25 | $486.25 |
| single dose of 500iu | 2 kits | $1,896.91 | $948.46 |
| single dose of 1000iu | 4 kits | $7,656.60 | $1,914.15 |
| single dose of 1500iu | 6 kits | $17,286.25 | $2,881.04 |
| single dose of 2000iu | 2 kits | $7,686.25 | $3,843.13 |
| single dose of 3000iu | 2 kits | $8,932.94 | $4,466.47 |
Routine treatment to prevent bleeds in hemophilia A
Your provider will calculate your dose based on things like age, body weight, and response to the medication. The dose is typically given through your veins (IV), and how often you receive it will depend on the brand.
To prevent and control bleeds during and after surgery and/or trauma
Your provider will calculate your dose based on things like body weight, how serious your bleed is, where the bleed is, and the desired level of FVIII in your body. The dose is typically given through your veins (IV), and how often you receive it will depend on the brand.
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.
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Advate (factor VIII) will not be safe for you to take.