Recombinate

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|Recombinate

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ANTIHEMOPHILIC FACTOR (Systemic)

Some commonly used brand names are:

In the U.S.—

  • Alphanate
  • Advate
  • Bioclate
  • Helixate
  • Hemofil M
  • Humate-P
  • Hyate:C
  • Koate-HP
  • Kogenate
  • Kogenate FS
  • Helixate FS
  • Monarc-M
  • Monoclate-P
  • Recombinate

In Canada—

  • Hemofil M
  • Hyate:C
  • Koate-HP
  • Kogenate
  • Recombinate

Generic name product may be available in the U.S. and Canada.

Other commonly used names are AHF , factor VIII , and rAHF-PFM .

Category

  • Antihemorrhagic

Description

Antihemophilic (an-tee-hee-moe-FIL-ik) 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, in the following dosage form:

  • Parenteral
  • Injection (U.S. and Canada)

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 antihemophilic factor (AHF), the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to AHF. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether AHF passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

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.

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 health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 antihemophilic factor (AHF) will be different for different patients. The dose you receive will be based on:

  • 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.

Your dose of this medicine may even be different at different times. It is important that you follow your doctor"s orders .

Missed dose—If you miss a dose of this medicine, check with your doctor as soon as possible for instructions. If you cannot reach your doctor, use your usual dose as soon as you remember.

Storage—To store this medicine:

  • Keep out of the reach of children.
  • 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.
  • Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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, because they may mean that you are having a serious allergic reaction to the medicine:

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

Also, check with your doctor as soon as possible if any of the following 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

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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 above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 03/30/2004

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