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Antihemophilic Factor (Recombinant) (an tee hee moe FIL ik FAK tor ree KOM be nant)

Pediatric Medication

Brand Names: U.S.

Advate; Eloctate; Helixate FS; Kogenate FS; Kogenate FS Bio-Set; Recombinate; Xyntha; Xyntha Solofuse

Brand Names: Canada

Advate; Helixate FS; Kogenate FS; Xyntha; Xyntha Solofuse

What is this drug used for?

  • It is used to treat hemophilia.
  • It is used to treat or prevent bleeding.

What do I need to tell the doctor BEFORE my child takes this drug?

All products:

  • If your child has an allergy to any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.


  • If your child is allergic to cows, hamsters, or mice.

Advate®, Helixate FS®, and Kogenate FS®:

  • If your child is allergic to hamsters.
  • If your child is allergic to mice.

Xyntha® and Xyntha Solofuse®:

  • If your child is allergic to hamsters.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of their drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

  • Tell dentists, surgeons, and other doctors that your child is using this drug.
  • Allergic side effects may rarely happen.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • Call the doctor right away if the normal dose does not work as well.
  • Talk with the doctor before you travel. You will need to bring enough of this drug for use during travel.

If your child is pregnant or breast-feeding a baby:

  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks of using this drug.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

All products:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Dizziness or passing out.
  • Upset stomach.
  • Shortness of breath.

Helixate FS® and Kogenate FS®:

  • Redness or warmth where the shot was given.
  • Restlessness.
  • A fast heartbeat.
  • Tingling.

Helixate FS®, Kogenate FS®, and Recombinate®:

  • Cough.
  • Throwing up.
  • Flushing.
  • Feeling very tired or weak.
  • Fever or chills.
  • Chest pain or pressure.


  • A burning, numbness, or tingling feeling that is not normal.
  • Pale skin.


  • A burning, numbness, or tingling feeling that is not normal.
  • Flushing.

Xyntha® and Xyntha Solofuse®:

  • Change in color of mouth to blue.
  • A fast heartbeat.
  • Fever.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:


  • Joint pain.

Helixate FS®, Kogenate FS®, and Recombinate®:

  • Pain where the shot was given.
  • Irritation or swelling where the shot was given.


  • Cough.
  • Headache.
  • Nose and throat irritation.
  • Joint pain.
  • Throwing up.
  • Loose stools (diarrhea).

Xyntha® and Xyntha Solofuse®:

  • Loose stools (diarrhea).
  • Headache.
  • Feeling tired or weak.
  • Cough.
  • Joint pain.
  • Upset stomach or throwing up.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read and follow the dosing on the label closely.
  • It is given as a shot into a vein.
  • This drug may be given at home.
  • Your child’s doctor will teach you how to give the shot.
  • Follow how to use carefully.
  • Wash your hands before and after use.
  • If stored in a refrigerator, let this drug come to room temperature before mixing. Do not heat this drug.
  • Do not shake.
  • Use within 3 hours of making.
  • Most products will be clear and colorless after mixing. Some products may be clear to slightly cloudy and colorless after mixing. Some products may be colorless to a faint yellow after mixing. Be sure you know what the product will look like after mixing.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away any part of opened vial not used after use.
  • Throw away needles in a needle/sharp disposal box. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if my child misses a dose?

  • Call the doctor to find out what to do.

How do I store and/or throw out this drug?

All products:

  • Most of the time, this drug will be given in a hospital or doctor’s office. If stored at home, follow how to store as you were told by the doctor.
  • If this drug is given at home, store unopened vials at room temperature or in the refrigerator. Do not freeze.
  • If stored at room temperature, make a note of the date it was placed at room temperature.
  • Protect from light.
  • Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.


  • If stored at room temperature, after 3 months return Xyntha® vials to the refrigerator or throw away any part unused. You may return vials to the refrigerator only 1 time.

All other products:

  • Do not put this drug back in the refrigerator after it has been stored at room temperature.


  • If stored at room temperature, throw away any unused vials after 6 months.

Helixate FS® and Kogenate FS®:

  • If stored at room temperature, throw away any unused vials after 12 months.


  • If stored at room temperature, throw away any unused vials after 6 months.

Xyntha Solofuse®:

  • If stored at room temperature, throw away any unused vials after 3 months.

General drug facts

  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Last Reviewed Date



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