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FACTOR IX (Systemic)
Some commonly used brand names are:
In the U.S.—
Other commonly used names are Christmas factor , plasma thromboplastin component (PTC) , and prothrombin complex concentrate (PCC) .
Factor IX is a protein produced naturally in the body. It helps the blood form clots to stop bleeding. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. This is a condition in which the body does not make enough factor IX. If you do not have enough factor IX and you become injured, your blood will not form clots as it should, and you may bleed into and damage your muscles and joints.
Injections of one form of factor IX, called factor IX complex, also are used to treat certain people with hemophilia A. In hemophilia A, sometimes called classical hemophilia, the body does not make enough factor VIII, and, just as in hemophilia B, the blood cannot form clots as it should. Injections of factor IX complex may be used in patients in whom the medicine used to treat hemophilia A is no longer effective. Injections of factor IX complex also may be used for other conditions as determined by your doctor.
The factor IX product that your doctor will give you is obtained naturally from human blood or artificially by a man-made process. Factor IX obtained from human blood has been treated and is not likely to contain harmful viruses such as hepatitis B virus, hepatitis C (non-A, non-B) virus, or human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). The man-made factor IX product does not contain these viruses.
Factor IX is available only with your doctor"s prescription, in the following dosage form:
Before Using This Medicine
In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For factor IX, the following should be considered:
Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to injections of factor IX, hamster protein, or mouse protein. 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.
Breast-feeding—It is not known whether the ingredients in factor IX products pass 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—Blood clots may be especially likely to occur in premature and newborn babies, who are usually more sensitive than adults to the effects of injections of factor IX.
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 factor IX products. Make sure you tell your doctor if you have any other medical problems, especially:
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 sure that you understand exactly how the medicine is to be prepared and injected .
To prepare this medicine:
Use this medicine right away . It should not be kept longer than 3 hours after it has been prepared.
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 factor IX will be different for different patients. The dose you receive will be based on:
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.
Storage—To store this medicine:
Precautions While Using This Medicine
If you were recently diagnosed with hemophilia B, you should receive hepatitis A and hepatitis B vaccines to reduce even further your risk of getting hepatitis A or hepatitis B from factor IX products.
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 .
It is recommended that you carry identification stating that you have hemophilia A or hemophilia B . If you have any questions about what kind of identification to carry, check with your health care professional.
Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted 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 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 immediately if any of the following side effects occur, because they may mean that you are developing a problem with blood clotting:
Bluish coloring (especially of the hands and feet); convulsions; dizziness or lightheadedness when getting up from a lying or sitting position; increased heart rate; large blue or purplish patches in the skin (at places of injection); nausea or vomiting; pains in chest, groin, or legs (especially calves); persistent bleeding from puncture sites, gums, or inner linings of the nose and/or mouth, or blood in the stool or urine; severe pain or pressure in the chest and/or the neck, back, or left arm; severe, sudden headache; shortness of breath or fast breathing; sudden loss of coordination; sudden and unexplained slurred speech, vision changes, and/or weakness or numbness in arm or leg
Also, check with your doctor immediately if any of the following side effects occur, because they may mean that your medicine is being given too fast:
Burning or stinging at place of injection; changes in blood pressure or pulse rate; chills; drowsiness; fever; headache; nausea or vomiting; redness of face; shortness of breath
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
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