Pronunciation:

an-tee-hee-moe-FIL-ik FAK-tor

Brand Names:

• Advate
• Helixate FS
• Hemofil-M
• Hyate:C
• Koate DVI
• Kogenate FS
• Kogenate FS w/BIO-SET
• Monarc-M
• Monoclate-P
• Recombinate
• Refacto
• Xyntha

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antihemophilic Agent

Uses of This Medicine:

Antihemophilic factor (AHF) is a protein produced naturally in the body. It helps the blood form clots to stop bleeding.

Hemophilia A, also called classical hemophilia, is a condition in which the body does not make enough AHF. If you do not have enough AHF and you become injured, your blood will not form clots as it should, and you may bleed into and damage your muscles and joints. One type of AHF is used to treat another condition called von Willebrand disease, in which there is a risk of bleeding. AHF also may be used for other conditions as determined by your doctor.

The AHF that your doctor will give you is obtained naturally from human or pig blood or artificially by a man-made process.

AHF obtained from human blood has been treated. It is not likely to contain harmful viruses such as hepatitis B virus; hepatitis C virus (non-A, non-B hepatitis); or human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). The man-made and pork AHF products do not contain these viruses.

AHF is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

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.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of AHF. Make sure you tell your doctor if you have any other medical problems.

Proper Use of This Medicine:

Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your health care professional will teach you how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be certain that you understand exactly how the medicine is to be prepared and injected.

To prepare this medicine:

• Take the dry medicine and the liquid (diluent) out of the refrigerator or freezer and bring them to room temperature, as directed by your doctor.
• Wipe rubber surface of bottles with alcohol swab and allow to dry.
• When injecting the liquid (diluent) into the dry medicine, aim the stream of liquid (diluent) against the wall of the container of dry medicine to prevent foaming.
• Swirl the container gently to dissolve the medicine. Do not shake the container.
• Check the solution to make sure it is clear. Do not use medicine if you can see anything solid in the solution or if the solution is cloudy

Use this medicine right away. It should not be kept longer than 3 hours after it has been prepared, as directed on the package or by your doctor.

A plastic disposable syringe and filter needle must be used with this medicine. The medicine may stick to the inside of a glass syringe, and you may not receive a full dose.

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 health care professional.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• Your body weight.
• The amount of AHF your body is able to make.
• How much, how often, and where in your body you are bleeding.
• Whether or not your body has built up a defense (antibody) against this medicine.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Some AHF products must be stored in the refrigerator and some in the freezer. However, some of them may be kept at room temperature for short periods of time. Store this medicine as directed by your doctor or by the manufacturer.

Precautions While Using This Medicine:

If you were recently diagnosed with hemophilia A, you should receive hepatitis A and hepatitis B vaccines to reduce even further your risk of getting hepatitis A or B from antihemophilic factor.

It is recommended that you carry identification stating that you have hemophilia A, and what medicine you are using. If you have any questions about what kind of identification to carry, check with your health care professional.

After a while, your body may build up a defense (antibody) against this medicine. Tell your doctor if this medicine seems to be less effective than usual.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

Changes in facial skin color

fast or irregular breathing

puffiness or swelling of the eyelids or around the eyes

shortness of breath, troubled breathing, tightness in chest, and/or wheezing

skin rash, hives, and/or itching

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Chills

fever

nausea

tenderness, pain, swelling, warmth, skin discoloration, and noticeable veins over affected area

sensation of burning, warmth, heat, numbness, tightness, or tingling

unusual bleeding or bruising

unusual tiredness or weakness

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:

Less common

Burning, stinging, or swelling at place of injection

dizziness or lightheadedness

dry mouth or bad taste in mouth

headache

nosebleed

redness of face

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.