Generic Name: coagulation factor ix injection (recombinant) (ko-ag-yoo-LAY-shun FAK-tor)
Brand Name: Examples include BeneFix and Rixubis
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 increasing the amount of clotting factor IX in the blood, helping the blood form clots and stop bleeding.
Do NOT use BeneFix if:
- you are allergic to any ingredient in BeneFix or to hamsters
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, planning 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 a certain blood problem called disseminated intravascular coagulation (DIC) or if you are at risk for DIC or bleeding or clotting problems
- if you have ever had a blood clot
- if you have kidney problems
- if you have recently had surgery
Some MEDICINES MAY INTERACT with BeneFix. However, no specific interactions with BeneFix are known at this time.
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.
- An extra patient leaflet is available with BeneFix. Talk to your pharmacist if you have questions about this information.
- BeneFix may be given as an injection at your doctor's office, hospital, or clinic. If you will be using BeneFix at home, a health care provider will teach you how to use it. Be sure you understand how to use BeneFix. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Wash your hands before and after use.
- If BeneFix was stored in the refrigerator, let it reach room temperature before mixing it. Do not heat it.
- Mix by gently swirling. Do not shake.
- After mixing, BeneFix must be used within 3 hours. Throw away any unused portion.
- Do not use BeneFix if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of BeneFix, contact your doctor right away.
Ask your health care provider any questions you may have about how to use BeneFix.
Important safety information:
- Patients receiving clotting factors sometimes develop antibodies or inhibitors to the medicine. This makes BeneFix less effective. If BeneFix stops working or does not work as well as it has before, contact your doctor immediately for instructions.
- Tell your doctor or dentist that you take BeneFix before you receive any medical or dental care, emergency care, or surgery.
- Blood clots have happened in certain people using products that contain factor IX. Discuss any questions or concerns with your doctor.
- LAB TESTS may be performed while you use BeneFix. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- PREGNANCY and BREAST-FEEDING: It is not known if BeneFix can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using BeneFix while you are pregnant. It is not known if BeneFix is found in breast milk. If you are or will be breast-feeding while you use BeneFix, check with your doctor. Discuss any possible 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Headache; irritation or pain where the injection was given.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blue lips or gums; burning, numbness, or tingling; calf or leg pain, swelling, or tenderness; change in how much urine is passed; chest pain; confusion; cough; coughing up blood; dizziness or light-headedness; fainting; fast heartbeat; flushing; nausea; one-sided weakness; restlessness; shortness of breath; sluggishness; sudden, severe headache or vomiting; unusual tiredness; vision or speech changes; wheezing.
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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of BeneFix:
Store BeneFix in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), or at room temperature up to 86 degrees F (30 degrees C). Be sure you know how long you can store BeneFix if stored in a refrigerator or at room temperature. Do not freeze. If stored at room temperature, make note of the date the product was placed at room temperature. Do not use past the expiration date. Do not place back in the refrigerator after storage at room temperature or after mixing it. Store away from heat, moisture, and light. Do not store in the bathroom. Keep BeneFix out of the reach of children and away from pets.
- 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take BeneFix or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about BeneFix. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to BeneFix. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using BeneFix.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.