FACTORIX (Systemic)
Some commonly used brand names are:
In the U.S.?
- AlphaNine SD
- Bebulin VH
- BeneFix
- Konyne 80
- Mononine
- Profilnine SD
- Proplex T
In Canada?
- AlphaNine SD
- Bebulin VH
- BeneFix
- Immunine VH
Other commonly used names are Christmasfactor, plasma thromboplastin component (PTC), and prothrombin complex concentrate (PCC).
Category
Description
Factor IX is a protein producednaturally in the body. It helps the blood form clots to stop bleeding. Injectionsof factor IX are used to treat hemophilia B, which is sometimes called Christmasdisease. This is a condition in which the body does not make enough factorIX. If you do not have enough factor IX and you become injured, your bloodwill not form clots as it should, and you may bleed into and damage your musclesand joints.
Injections of one form of factor IX, called factor IX complex, also areused to treat certain people with hemophilia A. In hemophilia A, sometimescalled classical hemophilia, the body does not make enough factor VIII, and,just as in hemophilia B, the blood cannot form clots as it should. Injectionsof factor IX complex may be used in patients in whom the medicine used totreat hemophilia A is no longer effective. Injections of factor IX complexalso may be used for other conditions as determined by your doctor.
The factor IX product that your doctor will give you is obtained naturallyfrom human blood or artificially by a man-made process. Factor IX obtainedfrom human blood has been treated and is not likely to contain harmful virusessuch as hepatitis B virus, hepatitis C (non-A, non-B) virus, or human immunodeficiencyvirus (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 followingdosage form:
Parenteral- Injection (U.S. and Canada)
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 followingshould be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic 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 donein either humans or animals.
Breast-feeding?It is not known whether the ingredients in factorIX products pass into breast milk. Although most medicines pass into breastmilk 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 discussthis with their doctor.
Children?Blood clots may be especially likely to occur inpremature and newborn babies, who are usually more sensitive than adults tothe effects of injections of factor IX.
Older adults?This medicine has been tested and has not been shownto cause different side effects or problems in older people than it does inyounger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are using any other prescription or nonprescription (over-the-counter[OTC]) medicine.
Other medical problems?The presence of other medicalproblems may affect the use of factor IX products. Make sure you tell yourdoctor if you have any other medical problems, especially:
- Blood clots or a history of medical problems caused by blood clotsor
- Liver disease?Risk of bleeding or developing blood clots maybe increased
Proper Use of This Medicine
Some medicinesgiven by injection may sometimes be given at home to patients who do not needto be in the hospital. If you are using this medicine at home, your healthcare professional will teach you how to prepare and inject the medicine. Youwill have a chance to practice preparing and injecting it. Be sure that you understand exactly how the medicine is to be prepared andinjected.
To prepare this medicine:
- Take the dry medicine and the liquid (diluent) out of the refrigeratorand bring them to room temperature, as directedby your doctor.
- When injecting the liquid (diluent) into the dry medicine, aim the stream of liquid (diluent) against the wall of the containerof dry medicine to prevent foaming.
- Swirl the container gently to dissolve the medicine.Do not shake the container.
Use this medicine right away. It should notbe kept longer than 3 hours after it has been prepared.
A plastic disposable syringe and filter needle mustbe used with this medicine. The medicine may stick to the inside ofa glass syringe, and you may not receive a full dose.
Do not reuse syringes and needles. Put used syringesand needles in a puncture-resistant disposable container, or disposeof them as directed by your health care professional.
Dosing?The dose of factor IX will be different fordifferent patients. The dose you receive will be based on:
- The condition for which you are using this medicine.
- Your body weight.
- The amount of factor IX 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) againstthis medicine.
Your dose of this medicine may even be different at different times. Itis important that you follow your doctor's orders.
Missed dose?If you miss a dose of this medicine, check withyour doctor as soon as possible for instructions.
Storage?To store this medicine:
- Keep out of the reach of children.
- Some factor IX products must be stored in the refrigerator, and somemay be kept at room temperature for short periods of time. Store this medicineas directed by your doctor or the manufacturer.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
If youwere recently diagnosed with hemophilia B, you should receive hepatitis Aand hepatitis B vaccines to reduce even further your risk of getting hepatitisA or hepatitis B from factor IX products.
After a while, your body may build up a defense (antibody) against thismedicine. Tell your doctor if this medicine seems tobe less effective than usual.
It is recommended that you carry identification statingthat you have hemophilia A or hemophilia B. If you have any questionsabout 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 sideeffects may occur, if they do occur they may need medical attention.
Check with your doctorimmediately if any of the following side effects occur, because theymay mean that you are having a serious allergic reaction to the medicine:
Less common or rare
Changes in facial skin color; fast orirregular breathing; puffiness or swelling of theeyelids 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 doctorimmediately if any of the following side effects occur, because theymay mean that you are developing a problem with blood clotting:
More common
Bluish coloring (especially of the hands and feet); convulsions; dizziness or lightheadednesswhen getting up from a lying or sitting position; increased heart rate; large blue or purplish patchesin 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 theneck, back, or left arm; severe, sudden headache; shortness of breath or fast breathing; sudden loss of coordination; suddenand unexplained slurred speech, vision changes, and/or weakness or numbnessin arm or leg
Also, check with your doctor immediately if any of the following side effects occur, because they may meanthat your medicine is being given too fast:
Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.
Revised: 10/17/2001
