Bebulin

Bebulin is a prescription medicine used to prevent and control bleeding in people with hemophilia B, an inherited bleeding disorder. Bebulin belongs to a group of drugs called antihemophilic agents. These work by replacing clotting factors required to stop bleeding that are missing in people with hemophilia B.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Bebulin include decreased blood pressure, itching and redness, fever, and chills.

Bebulin may cause dizziness. Do not drive or operate heavy machinery until you know how Bebulin affects you.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Bebulin, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Bebulin falls into category C. No studies have been done in animals, and there are no well-done studies in pregnant women. Bebulin should be given to a pregnant woman only if clearly needed.

Take Bebulin exactly as prescribed.

Bebulin is given directly into the bloodstream. Bebulin should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center. Many people with hemophilia B learn to infuse their Bebulin by themselves or with the help of a family member.

You may have to have blood tests done after getting Bebulin to be sure that your blood level of factor IX is high enough to clot your blood. Call your healthcare provider right away if your bleeding does not stop after taking Bebulin.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take 2doses of Bebulin at the same time.

• Store Bebulin at a refrigerated temperature of 2° to 8°C (35° to 46°F). Do not freeze.
• Do not use after the expiration date printed on the carton or vial.
• Do not share Bebulin with other people, even if they have the same symptoms as you do.
• Keep this and all medications out of reach of children.

Your doctor will perform blood tests to make sure factor IX deficiency is your specific clotting disorder. Factor IX complex would not be effective in treating deficiencies of other blood-clotting factors.

Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex.

To make sure factor IX complex is safe for you, tell your doctor if:

• you have liver disease;

• you are allergic to latex;

• you have recently had surgery; or

• you are scheduled to have surgery.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether factor IX complex passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Factor IX complex is not approved for use by anyone younger than 18 years old.

Factor IX complex is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

In the U.S.

• Alphanine SD
• Alprolix
• Bebulin
• Bebulin VH
• Benefix
• Idelvion
• Ixinity
• Mononine
• Profilnine SD
• Proplex T
• Rebinyn
• Rixubis

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antihemophilic Agent

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.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Anaphylactoid or anaphylactic reactions may occur following infusion of Bebulin. The occurrence of these reactions (e.g. fever, urticarial rashes, nausea, retching, dyspnea, anaphylactic shock) necessitates the interruption of replacement therapy. Mild reactions (transient discomfort that resolves spontaneously or with minimal intervention), such as rash, can be managed with antihistamines.

Bebulin unit carton for 200-1200 potency ranges

20 mL size, dried

NDC 64193-244-02

Factor IX Complex

Bebulin

Nanofiltered and Vapor Heated

BAXTER

For Intravenous Use Only

WARNING: Human plasma product. Human blood and its components may transmit infectious agents. The physician and patient should discuss the risks and benefits of this product.

Some components of the packaging material contain Dry Natural Rubber Latex.

Rx Only

Bebulin is a trademark of Baxter AG, Vienna, Austria: Baxter is a trademark of Baxter International Inc., registered in the U.S. Patent and Trademark Office.

Bebulin vial label for 200-1200 potency ranges

20 mL size, dried

NDC 64193-244-03

Factor IX Complex

Bebulin

Nanofiltered and Vapor Heated

BAXTER

For Intravenous Use Only

Rx Only

Directions for use: see package insert

Store between 2º and 8ºC (35º and 46ºF).

Reconstitute with 20 mL of Sterile Water for Injection

Bebulin is a trademark of Baxter AG, Vienna, Austria: Baxter is a trademark of Baxter International Inc., registered in the U.S. Patent and Trademark Office.

Baxter Healthcare Corporation

Westlake Village, CA 91362 USA

U.S. License No. 140

20 mL Sterile Water for Injection

NDC 0338-0764-62

20 mL

Single-Dose Container

Nonpyrogenic

Sterile Water for Injection, USP for reconstitution of accompanying product

Do not use unless clear. No antimicrobial agent or other substances has been added. Do not use for intravascular injection without making approximately isotonic by addition of suitable solute. Discard unused portion. Rx Only. This Product Contains Dry Natural Rubber.

BAXTER

Manufactured by

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Applies to factor ix complex: intravenous solution reconstituted

Units required to raise blood level percentages: 1.0 unit/kg x body weight (in kg) x desired increase (% of normal).
In preparation for and following surgery, levels above 25%, maintained for at least a week after surgery, are suggested. Laboratory control to assure such levels is recommended. To maintain levels above 25% for a reasonable time, each dose should be calculated to raise the level to 40% to 60% of normal.