BeneFix

BeneFix is used for:

Preventing and controlling bleeding in patients with factor IX deficiency (hemophilia B or Christmas disease), including control and prevention of bleeding in surgical settings.

BeneFix is a synthetic protein, clotting factor IX. It works by helping the blood form clots, which stops bleeding.

Do NOT use BeneFix if:

• you are allergic to any ingredient in BeneFix or hamster protein

Contact your doctor or health care provider right away if any of these apply to you.

Before using BeneFix :

Some medical conditions may interact with BeneFix . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have liver disease
• if you are at risk for developing blood clots
• if you have recently had surgery

Some MEDICINES MAY INTERACT with BeneFix . However, no specific interactions with BeneFix are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if BeneFix may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use BeneFix :

Use BeneFix as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• BeneFix is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using BeneFix at home, carefully follow the injection procedures taught to you by your health care provider.
• If BeneFix contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of BeneFix , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use BeneFix .

Important safety information:

• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using BeneFix .
• LAB TESTS, including factor IX levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using BeneFix during pregnancy. It is unknown if BeneFix is excreted in breast milk. If you are or will be breast-feeding while you are using BeneFix , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of BeneFix :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Store the unmixed medicine in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Prior to the expiration date, it may also be stored at room temperature not to exceed 77 degrees F (25 degrees C) for up to 6 months. You should make note of the date the product was placed at room temperature in the space provided on the outer carton. The product does not contain a preservative. After mixing it may be stored between 36 and 46 degrees F (2 and 8 degrees C) and must be used within 3 hours. Do not freeze. Keep BeneFix out of the reach of children and away from pets.

General information:

• If you have any questions about BeneFix , please talk with your doctor, pharmacist, or other health care provider.
• BeneFix is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about BeneFix . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.