Generic Name: factor ix (Intravenous route, Injection route)
Commonly used brand name(s)
In the U.S.
- Alphanine SD
- Bebulin VH
- Profilnine SD
- Proplex T
Available Dosage Forms:
- Powder for Solution
Therapeutic Class: Antihemophilic Agent
Uses For Bebulin VH
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.
Before Using Bebulin VH
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:
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.
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.
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.
|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 FeedingCoagulation Factor IX RecombinantFactor IX Fc Fusion Protein RecombinantFactor IX Albumin Fusion Protein RecombinantCoagulation Factor IX Recombinant, GlycoPEGylated
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.Factor IX
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Interactions with 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.
Interactions with Food/Tobacco/Alcohol
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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Blood clots or a history of medical problems caused by blood clots or
- Liver disease—Risk of bleeding or developing blood clots may be increased
Proper Use of factor ix
This section provides information on the proper use of a number of products that contain factor ix. It may not be specific to Bebulin VH. Please read with care.
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:
- Take the dry medicine and the liquid (diluent) out of the refrigerator and bring them to room temperature, as directed by your doctor.
- 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.
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.
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.
- 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) against this medicine.
Call your doctor or pharmacist for instructions.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Some factor IX products must be stored in the refrigerator, and some may be kept at room temperature for short periods of time. Store this medicine as directed by your doctor or the manufacturer.
Precautions While Using Bebulin VH
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.
Bebulin VH Side Effects
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: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 immediately if any of the following side effects occur:More common
- Bluish coloring (especially of the hands and feet)
- 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
Check with your doctor immediately if any of the following side effects occur:Less common
- Burning or stinging at place of injection
- changes in blood pressure or pulse rate
- nausea or vomiting
- redness of face
- shortness of breath
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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