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Confidence in Dosing
- Dosing should be individually determined for each patient based on variations in age, weight, severity of the factor IX deficiency, location and extent of bleed, and recovery of factor IX1
- BeneFIX dose should be titrated until desired clinical response is achieved1
| The BeneFIX Dosing Guide |
| Type of hemorrhage |
Circulating factor IX
activity required (%) |
Dosing
interval (h) |
Duration of
therapy (d) |
Minor
Uncomplicated hemarthroses, superficial muscle, or soft tissue |
20-30 |
12-24 |
1-2 |
Moderate
Intramuscle or soft tissue with dissection, mucous membranes, dental extractions, or hematuria |
25-50 |
12-24 |
Treat until bleeding stops and healing begins, about 2-7 days |
Major
Pharynx, retropharynx, retroperitoneum, CNS, surgery |
50-100 |
12-24 |
7-10 |
- Available in 250, 500, and 1000 IU vials
- Convenient peel-off labels
- The only factor IX that can be stored at room temperature (77ºF or 25ºC) for up to 6 months1,49-53
BeneFIX and Recovery
- Recovery is an important pharmacokinetic parameter used to determine the proper dose9
- Recovery can vary from patient to patient in both recombinant and plasma-derived products, and it can be influenced by age and weight9
- Diligent dose monitoring is necessary for all factor IX products
- Recovery variations among individuals are seen especially when comparing the recoveries of younger and older patients9
- BeneFIX has a 28% lower recovery when directly compared to plasma-derived product
- However, 20% more BeneFIX may be required to achieve a 1% per IU/kg per IU/dL rise in factor IX activity10
"In our study, the average
incremental recovery was also lower in younger participants (<15 years
of age), although this did not reach statistical significance. Therefore,
all individuals, and particularly young children, should have their recoveries
evaluated to ensure proper dosing."—Roth et al6
Indication
BeneFIX is indicated for the control and prevention of hemorrhagic episodes
in patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention
of bleeding in surgical settings. BeneFIX is not indicated for the treatment of other factor deficiencies (eg, factors II, VII, VIII and X)
nor the treatment of hemophilia A patients with inhibitors to factor VIII, nor the reversal of coumarin-induced anticoagulation, nor the
treatment of bleeding due to low levels of liver-dependent coagulation factors.
Important Safety Information
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As with the intravenous administration of any protein product, common adverse reactions may include headache, fever, chills, flushing, nausea, vomiting, or tiredness. |
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BeneFIX may be contraindicated in patients with a known history of hypersensitivity to hamster protein. |
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Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported for all factor IX products. Patients should be informed of the early symptoms and signs of hypersensitivity reactions. Patients should discontinue use of the product and contact their health care provider immediately and/or seek emergency care if any hypersensitivity reactions occur. |
Please see BeneFIX Prescribing Information
The health information contained herein is provided for educational purposes only and is not meant to replace personal discussions between health care providers and patients. All decisions about patient care must be made with a health care provider who can assess the special needs of each individual patient.
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