Generic name: factor IX complex
Brand names: Bebulin, Bebulin VH, Profilnine SD
Medically reviewed by A Ras MD.
What is Bebulin?
Bebulin is a prescription medicine that is used to treat hemophilia. It is used to treat or prevent bleeding.
BEBULIN (Factor IX Complex), Nanofiltered and Vapor Heated is a purified, sterile, freeze-dried concentrate of the Coagulation Factor IX (Christmas Factor) as well as Factor II (Prothrombin) and Factor X (Stuart-Prower Factor) and low amounts of Factor VII. In addition, the product contains small amounts of heparin ( ≤ 0.15 IU heparin per IU Factor IX).
BEBULIN is standardized in terms of Factor IX content and each vial is labeled for the Factor IX content indicated in International Units (IU). One International Unit of Factor IX (according to the current International Standard for Human Blood Coagulation Factors II, IX, and X in concentrates) corresponds to the activity of Factor IX in 1 mL of fresh normal human plasma.
BEBULIN is manufactured from large plasma pools of human plasma. Screening against potentially infectious agents begins with the donor selection process and continues throughout plasma collection and plasma preparation. Each individual plasma donation used in the manufacture of BEBULIN is collected only at FDA approved blood establishments and is tested by FDA licensed serological tests for Hepatitis B Surface Antigen (HBsAg), for antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2) and Hepatitis C Virus (HCV) in accordance with U.S. regulatory requirements. As an additional safety measure, mini-pools of the plasma are tested for the presence of HIV-1 and HCV by FDA licensed Nucleic Acid Testing (NAT) and found negative. Validated virus removal/inactivation steps have been integrated into the manufacturing process, namely 35 nm nanofiltration and a vapor heat treatment process [10 hours at 60°C and subsequent 1 hour at 80°C under the condition of 7-8% (w/v) residual moisture]. In addition, DEAE-Sephadex adsorption contributes to the virus safety profile of BEBULIN.
Before taking Bebulin, tell your doctor:
- If you are allergic to Bebulin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have had a low platelet count caused by heparin.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Bebulin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Bebulin?
- Tell all of your health care providers that you take Bebulin. This includes your doctors, nurses, pharmacists, and dentists.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
- There is a chance of very bad and sometimes deadly blood clots with Bebulin. There is also a chance of bleeding that is worse. Talk with the doctor.
- Call the doctor right away if the normal dose does not work as well.
- This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Bebulin.
- If you are 65 or older, use Bebulin with care. You could have more side effects.
- Use with care in newborns. Talk with the doctor.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Bebulin while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How is Bebulin best taken?
Use Bebulin as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given as a shot into a vein.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
What are the side effects of Bebulin that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of certain infections (parvovirus B19, hepatitis A) like fever or chills, feeling very sleepy, runny nose, rash, joint pain, tiredness, poor appetite, upset stomach or throwing up, belly pain, or yellow skin or eyes.
- Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Shortness of breath.
- A heartbeat that does not feel normal.
- Chest pain or pressure or a fast heartbeat.
- Coughing up blood.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Swelling, warmth, numbness, change of color, or pain in a leg or arm.
- Bleeding that is new or worse.
- A burning, numbness, or tingling feeling that is not normal.
- Upset stomach or throwing up.
What are some other side effects of Bebulin?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Bebulin?
- If you need to store Bebulin at home, talk with your doctor, nurse, or pharmacist about how to store it.
SRC: NLM .