1 What is Advate?

Brand: Advate, Adynovate, Eloctate, Helixate FS, Hemofil-M, HyateC, Koate DVI, Kogenate FS, Monarc-M, Monoclate-P, Obizur, Xyntha

Generic: Antihemophilic Factor (AHF)

Advate is available only with your doctor’s prescription. This product is only available in the following forms: powder for solution.

The Antihemophilic Factor (AHF) injection treats and prevents serious bleeding in patients with a bleeding problem known as hemophilia A. Bleeding episodes may be related to an injury or a surgical procedure.

AHF is a protein that is naturally produced in the body. It helps create blood clots to prevent bleeding.

Hemophilia A, or “classical hemophilia”, is a condition in which the body does not make enough AHF. If you are injured and do not have enough AHF, your blood is unable to properly form clots. This may cause you to bleed into and damage your muscles and joints.

The AHF injection is given to increase the levels of AHF in the blood.

There are many different types of AHF. They may be made naturally from the human blood,or man-made (recombinant).

AHF made from human blood and artificially treated is unlikely to contain harmful viruses such as hepatitis B, hepatitis C, or the human immunodeficiency virus (HIV), which is the virus that causes acquired immunodeficiency virus (AIDS).

2 What To Know Before Using

As with all medicines before using Advate, the risks must be compared to how much it will help you. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

  • Allergies: Inform your doctor if you have ever had an allergic reaction to Doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.
  • Pediatric Usage: Up-to-date Pediatric appropriate studies have not indicated that the use of this medication causes any problems that would limit the use of Hemofil M in children. No information is available in regards to the relationship of age to the effects of this medication in children. Safety and efficacy have not been established.
  • Geriatric Usage: Although no appropriate studies in regards to the relationship of age to the effects of Advate, Eloctate, Kogenate FS, Novoeight, and Xyntha has been performed in the geriatric population, no specific problems have been documented in regards to the elderly population.However, the elderly are more likely to have age-related medical problems which may require caution and adjustment in the dose for patients receiving Advate, Eloctate, Kogenate FS, Novoeight, and Xyntha.
  • Pregnancy: This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.
  • Breastfeeding: Antihemophilic Factor Studies in breastfeeding women suggest that this medication poses little to no risk to the infant when used while breastfeeding. 
    • Antihemophilic Factor VIII (Recombinant)
    • Antihemophilic Factor VIII (Recombinant) Pegylated
    • Antihemophilic Factor (Recombinant) Porcine SequenceThere have been no adequate studies performed in breastfeeding women determining infant risk. Talk with your doctor about the potential risks and benefits before taking this medication while breastfeeding.
  • Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. Tell your doctor if you are taking any other prescription or over the counter medications.
  • Other Interactions: Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.
  • Other Medical Problems: Pre-existing medical problems may affect the use of this medication.

Be sure to tell your doctor if you have any other medical problems, especially:

  • Allergies to hamster or mouse proteins.
  • Von Willebrand disease (blood clotting disorder) - Should not be used in patients with these conditions.
  • Heart of blood vessel disease - Use with caution. May make these conditions worse.

3 Proper Usage

A doctor or other trained medical professional will give you Advate in a hospital, clinical setting or at home. This medication is given to you through an injection into a vein (intravenously).

If you or a family member is using this medication at home, your doctor will teach you how to prepare and inject the medication. Make sure you understand all the instructions before giving yourself or another the injection. If you have any questions, be sure to ask your doctor.

Your dose may change according to where you are bleeding. Do not use this medication more or less often than your doctor tells you to.

Use only the brand of this medication that your doctor prescribed. Not all brands are prepared in the same way and different brands may require different doses.

Every package of this medication comes with an information leaflet for patients. Read and follow the instructions carefully.

If you have any questions, ask your doctor.

To prepare the medicine using two vials or containers:

  • Take the bottles of powder medications and liquid (diluent) out of the refrigerator and warm them to room temperature.
  • Wipe the rubber surface of the bottles with an alcohol swab, then allow them to dry.
  • Follow the specific instructions of your brand of medication when you prepare the injection.
  • Add the liquid to the powder using the transfer needle or device that comes with the package.
  • When injecting the liquid into the dry powder, aim the liquid against the container wall to prevent foaming.
  • Swirl the bottle gently to dissolve the medication. Do not shake the bottle. Shaking will create foam in the mixture.
  • Check the mixture to see if it is clear. Do not use the medication if you see anything solid in the mixture, or the mixture is cloudy.
  • Use the plastic disposable syringe to remove the mixture from the container. Use a filter needle if your brand of medication provides one.
  • Give the injection as directed by your doctor.
  • If you are using more than one bottle of medication for your dose, prepare the second the same way. Add the second mixture to the same syringe.

To prepare the medication using a prefilled dual-chamber syringe (Xyntha):

  • Take the prefilled dual-chamber syringe out of the refrigerator and warm it to room temperature.
  • The syringe has the powder medication in one part and the liquid (diluent) in the second part.
  • Attach the plunger rod to the syringe according to the directions. Keep the syringe pointed up to prevent leaking.
  • Remove the white seal and grey rubber cap. Put the blue cap on the syringe. Do not touch the open ends of the syringe and blue cap.
  • Slowly push the plunger until the two stoppers inside the syringe are together. This will push all of the liquid into the chamber with the powder.
  • Keep the syringe pointed up and gently swirl the syringe to mix the liquid and powder.
  • Check the mixture to make sure it is clear. Do not use if you can see anything solid or the mixture is cloudy.
  • Keep the syringe pointed up and push the plunger until most of the air is gone.
  • A special infusion set comes with the package. Remove the blue cap and attach the infusion set to the syringe.
  • Give the injection as directed by your doctor.
  • If you are using more than one syringe of medication for your dose, prepare the second dual-chamber syringe the same way. The mixture from each syringe will be combined together in a separate syringe before your injection. Your doctor will show you how to do this.

Use the mixture within 3-4 hours after it is prepared. It cannot be stored and used at a later time. Do not put the mixture in the refrigerator.

Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container or dispose of them as directed by your doctor.

Talk to your doctor before traveling. You should plan to bring enough medication for your travels.


The dose of this medication will be different for different patients. The following information includes only the average dose of this medication.

If your dose is different, do not change it before speaking to your doctor.

The dose you are given, as well as the number of doses you take each day, the time between doses and the length of time you take this medication depends on the strength of the medication. Dose is based on body weight and type of bleeding episode. This dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions if you miss a dose of this medication.


Keep out of reach of children. Do not keep expired medication or medication you no longer need.

Ask your doctor how you should dispose of any medication you are not using.

The AHF products need to be stored in the original container in a refrigerator. They can also be stored at room temperature for short periods of time.

Do not let the packages freeze. Store the medication as directed by your doctor, or by the manufacturer of the brand you are prescribed. Protect the container from heat and light.

If you move the medication from the refrigerator to room temperature, write the date and time you move it.

The length of time the medication can remain at room temperature depends on the brand you use. If you have already stored the medication at room temperature, do not return it to the refrigerator.

If you do not use the medication within the recommended time frame, you must destroy the medication.

4 Precautions To Take

It is very important that the doctor checks in with the person receiving Advate often to make sure that it is working properly.

Blood tests may be needed. This medication may cause serious allergic reactions in some patients, including anaphylaxis. Anaphylaxis is a life-threatening condition and requires immediate medical attention.

Check with your doctor immediately if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, lightheadedness or dizziness, or any swelling of the hands, face or mouth after receiving this medication.

It is recommended that you carry an ID card or letter stating that you have hemophilia A and the type and brand of medication you are using. If you have any questions about the kind of ID to carry, ask your doctor.

Check with your doctor immediately if you have any symptoms of the parvovirus infection: Fever, chills, drowsiness, runny nose followed by a rash or joint pain.

Check with your doctor immediately if you have pain or tenderness in the upper stomach, pale stool, dark urine, loss of appetite, nausea, unusual tiredness or weakness, yellow eyes or skin. These could be symptoms of a serious liver problem.

This medication is made from donated human blood. Some human blood products can transmit certain viruses to the people who receive them.

However, this risk is low. Human donors and donated blood are tested for viruses to keep the risk of transmission low. Talk with your doctor about any concerns you may have.

The stopper of the vial contains dry, natural rubber, which may cause allergic reactions in people who are sensitive or allergic to latex. Tell your doctor if you have a latex allergy before beginning this medication.

5 Potential Side Effects

Advate may produce unwanted effects along with the intended 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 you experience any of the following side-effects:

More Common

Less common / Rare

  • Changes in facial color
  • Chills
  • Fast or irregular breathing
  • Nausea
  • Puffiness or swelling around the eyes
  • Sensation of burning, warmth, heat, numbness, tightness or tingling
  • Skin rash, hives or itching
  • Chest tightness or discomfort
  • Difficulty breathing
  • Unusual fatigue or weakness

You may experience some side effects that do not need medical attention. These side effects may leave as your body adjusts to treatment.

Your doctor may be able to tell you how to prevent or reduce some of these side effects.

Ask your doctor if any of the following side effects continue or are bothering you, or if you have any questions:

More Common

  • Headache

Less Common


  • Change in taste
  • Loss of taste

Other patients may report side-effects that may not be listed. If this occurs, notify your doctor.

Call your doctor for advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

6 Related Clinical Trials