What is Advate?

 

Advate, manufactured by Takeda Pharmaceuticals, is a recombinant antihemophilic factor medication that prevents bleeding episodes in patients with hemophilia A. It is plasma and albumin-free. Through a routine prophylaxis regimen, Advate (active substance octocog alfa) replaces the body’s antihemophilic factor, or clotting factor VIII. Along with controlling bleeding episodes, Advate is used for perioperative management (during surgery).

This replacement therapy is important if the patient has life-threatening bleeding episodes or major surgery. The use of Advate helps with the prevention of bleeding but does not contain the von willebrand factor, so it does not treat von Willebrand disease.

Advate can be used to treat children 0 to 18 years of age. A higher clearance has been noticed in pharmacokinetic studies in children, with a shorter half-life and a lower recovery of factor VIII (FVIII) compared to adults. Because of this, more frequent dose adjustments may be needed in this age group.

How does Advate work?

Advate comes in a powder that is then mixed with water, and used by intravenous injection. The injection comes in a vial, with recombinant factor VIII (FVIII) potency that changes in accordance to the patient’s body weight and severity of bleeding episodes. See the section on doses for more information. If a patient has hemophilia A, or it is being used for perioperative management, Advate provides the body with what it is missing in order to reach effective hemostasis: coagulation factor VIII. If reacting properly, the body can now clot blood.

What doses of Advate are available?

The duration and dosage of treatment will depend on the severity of the patient’s factor VIII deficiency, the location and extent of the bleeding episodes, body weight, and their clinical condition. The routine prophylactic treatment includes 20-40 IU/kg every other day, three to four times weekly, or for the on-demand treatment of bleeding episodes. If your doctor believes factor VIII levels will be a problem, Advate use every third day as a prophylactic regimen will help maintain levels ≥1%. Your healthcare provider will determine the correct dosage for you.

In single-use vials, Advate comes in its powder form of 250, 500, 1000, 1500, 2000, 3000 or 4000 IU (international units). Doses range from 10 to 50 (IU/kg). Dosages for perioperative management range from 30 (minor) to 60 (major) IU/kg.

How do you use Advate?

Advate is taken intravenously, but only after reconstitution. Check the prescribing information and speak to your healthcare provider for a full and patient-specific outline of how to take Advate. Advate can be infused at a hemophilia treatment center, your home, or at your healthcare provider’s office. Once comfortable, most patients infuse Advate at home by themselves, but your healthcare provider will still instruct you on dosage. See the dosage section for more information.

Clean your hands, the injection site, and work on a clean surface.

Blood tests should be done after receiving Advate to ensure factor viii levels in your bloodstream are high enough. Blood tests can also help monitor the development of whether people have factor viii inhibitors. All people treated with coagulation factor VIII products should be monitored carefully. Call your doctor immediately if your bleeding does not stop after injecting Advate.

Note: Contents can be drawn into the same syringe if the patient receives a mix of an Advate-Baxject II and an Adavate-Baxject III system or more than one Advate-Baxject III system.

What are the side effects of Advate?

The most common contraindications, or side effects, of Advate in clinical trials are as follows:

• Hypersensitivity reactions, including anaphylaxis

• Pyrexia

• Cough

• Headache.

• Diarrhea.

• Nasopharyngitis (common cold symptoms)

• Vomiting

• Upper respiratory tract infection

• Arthralgia

• Limb injury

Serious side effects include:

• Creation of factor viii inhibitors (antibodies)

Contact your healthcare professional for medical advice about any possible adverse effects you experience while taking Advate. You can report your adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

Note: They found no impairment of fertility at doses up to 10 times the maximum clinical dosage, validated through laboratory tests.

Advate drug interactions

When Advate is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Some drug interactions with Advate include:

• Pegvaliase

• Emicizumab

• Carfilzomib

• Efgartigimod alfa

• Pegloticase

Advate precautions

You should be sure that your healthcare provider is aware of all your medical conditions, including if you:

• Have allergies, including, and especially to any ingredient in Advate, with a specific allergic reaction to mouse or hamster proteins and glutathione. Symptoms include rash, hives, tightness of the throat, chest pain, lightheadedness or dizziness, and difficulty breathing.

• Are or become pregnant as it is unknown whether Advate can cause harm to the unborn baby.

• Are breastfeeding as it is unknown whether Advate can be passed through breast milk and cause harm to the baby.

• Have ever developed inhibitors (antibodies) to factor VIII in your body. This inhibitor development could be considered a normal bodily reaction to the drug. However, this may, in turn, stop Advate from working to its full extent.

Is there a generic available for Advate?

Currently, there is no generic available for Advate in the United States.

How do you store Advate?

Advate in powder form needs to be refrigerated at 36° - 46°F (2° - 8°C). After, the product must be stored at room temperature up to 86°F (30°C). After 6 months, or past the expiration date, Advate should no longer be used.

Related medications

• Recombinate (prescribed primarily for Hemophilia A) - prescription only

• Antihemophilic factor (prescribed primarily for Hemophilia A)

 

Sources

Advate Website: https://www.advate.com/

Advate Prescribing information: https://www.shirecontent.com/PI/PDFs/ADVATE_USA_ENG.pdf

Drugs.com: https://www.drugs.com/compare/advate

https://www.drugs.com/drug-interactions/antihemophilic-factor,advate.html