BeneFIX: Uses, Dosage, Side Effects, and Safety

BeneFIX injection is used to control active bleeding episodes, manage bleeding around surgery, and reduce the frequency of bleeding episodes in people with hemophilia B. 

BeneFIX Introduction and Uses

BeneFIX is a brand-name prescription product. It contains the active ingredient recombinant coagulation factor IX. 

This medication belongs to the drug class known as coagulation factors or hemostatics.

A healthcare provider may prescribe this medication for children and adults with hemophilia B to:

• Treat and control bleeding episodes 
• Manage bleeding around surgery 
• Reduce the frequency of bleeding episodes

In people with hemophilia B, blood doesn’t clot properly, as they have a coagulation factor IX deficiency. Factor IX deficiency causes abnormal bleeding after injuries or surgery. Severe hemophilia B may cause spontaneous joint or muscle bleeds. 

BeneFIX is not indicated for immune tolerance induction in people with hemophilia B. 

BeneFIX comes as a white powder in single-use vials. The powder must be mixed with the provided liquid (diluent) before infusion into a vein. 

Each BeneFIX kit contains:

• Single-use vial
• Sterile pre-filled diluent syringe
• Vial adapter reconstitution device
• Sterile infusion set
• Two alcohol swabs
• Bandage
• Gauze pad

The following strengths are available in the U.S.:

• 250 IU
• 500 IU
• 1,000 IU
• 2,000 IU
• 3,000 IU

BeneFIX Mechanism of Action

BeneFIX temporarily replaces the missing clotting factor IX. This helps restore the clotting process and control bleeding. 

Before Taking BeneFIX

Before you receive your first dose of BeneFIX for hemophilia B, inform your healthcare provider if you:

• Are allergic to any factor IX product or hamster proteins
• Have or have had any medical conditions
• Have or have previously developed factor IX inhibitors
• Are breastfeeding
• Are pregnant or planning to get pregnant

Don’t use BeneFIX if you are allergic to factor IX, any ingredients of this product, or hamster proteins. 

BeneFIX Dosing

Before administering BeneFIX, your healthcare provider will use a specific formula to determine the initial dose. The dose and duration of the treatment depend on:

• Age
• Body weight
• Severity of factor IX deficiency
• Desired factor IX level
• Patient’s condition
• Location and extent of bleeding

Dosing of BeneFIX to Control Bleeding Episodes and Manage Bleeding Around Surgery

Minor bleeding: The dose is calculated to achieve a factor IX activity of 20% to 30% of normal. May be repeated every 12 to 24 hours. Treatment lasts 1 to 2 days. 

Moderate bleeding: The dose is calculated to achieve a factor IX activity of 25% to 50% of normal. May be repeated every 12 to 24 hours. Treatment lasts until bleeding stops or healing occurs. This is typically 2 to 7 days. 

Major bleeding: The dose is calculated to achieve a factor IX activity of 50% to 100% of normal. May be repeated every 12 to 24 hours. Treatment lasts 7 to 10 days. 

Dosing for Routine Prevention of Bleeding Episodes

For long-term protection against bleeding, the recommended dose is 100 IU/kg once weekly. Your healthcare provider may adjust the dose or frequency based on your clinical response. 

Proper Use

• Use this or any medication exactly as directed. 
• Your healthcare provider may administer BeneFIX or teach you how to prepare and self-administer the medication. 
• Ask your doctor or pharmacist if you have problems understanding any part of the Instructions for Use. 
• The reconstituted solution should be clear and colorless. If it is not, don’t use it. 
• Use the reconstituted solution immediately or within 3 hours of mixing. 
• If you miss a scheduled dose, contact your healthcare provider for instructions. 
• Call your healthcare provider immediately if you take more than the prescribed dose. 
• Call your healthcare provider immediately if your bleeding does not stop after taking this medication. This may be a sign that the medication is not working as intended.

BeneFIX Storage and Handling

• Store BeneFIX at room temperature or in a refrigerator, between 2 and 30°C (36 and 86°F).
• Don’t freeze.
• Don’t use BeneFIX after the expiration date stated on the label.

BeneFIX Side Effects

Common Side Effects

• Fever
• Cough
• Nausea
• Pain, swelling, or redness at the injection site
• Headache
• Dizziness 
• Rash

Allergic Reactions

Seek emergency medical care if you have:

• Wheezing
• Difficulty breathing
• Chest tightness
• Bluish lips and gums
• Fast heartbeat
• Swelling of the face
• Rash
• Hives

Inhibitor (Antibody) Production

Your healthcare provider will likely order tests to measure factor IX inhibitors in your blood if:

• Factor IX level does not increase as expected after starting treatment
• Bleeding does not stop with an appropriate dose

Complications Due to Blocked Blood Vessels

Factor IX products may increase the risk of a blood vessel being blocked by a circulating blood clot. The risk may be higher if you receive continuous infusions through a large vein. 

Contact your healthcare provider immediately if you have:

• Chest pain
• Difficulty breathing
• Leg tenderness
• Swelling

BeneFIX Cost and Financial Assistance 

The amount you pay for BeneFIX can vary depending on your prescribed dose, treatment frequency, insurance coverage, pharmacy, and location. Because BeneFIX dosing is individualized, treatment costs can vary between patients.

Contact your insurance provider to find out if your plan covers BeneFIX or requires prior authorization. Insurance coverage and patient assistance programs may help reduce your out-of-pocket costs. Contact us if you are interested in exploring financial assistance or copay assistance for BeneFIX.