Factor IX Complex Intravenous Administration
Name: Factor IX Complex Intravenous Administration
BEBULIN is indicated for the prevention and control of bleeding episodes in adult patients with hemophilia B (congenital Factor IX deficiency or Christmas disease).
BEBULIN is not indicated for use in the treatment of Factor VII deficiency. No clinical studies have been conducted to show benefit from this product for treating deficiencies other than Factor IX deficiency.
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The following adverse reactions were reported in clinical studies with a previous formulation of BEBULIN:
Hypotension, Dizziness, Urticaria, Erythema, Pyrexia, and Chills.
The formation of inhibitor antibodies to Factor IX has been observed with the administration of BEBULIN.
Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.
Table 2 lists the adverse reactions reported during postmarketing use of BEBULIN.
Table 2: Postmarketing Adverse Reactions
|Blood and Lymphatic System Disorders||Disseminated intravascular coagulation|
|Immune System Disorders||Anaphylactic/Anaphylactoid reactions, Hypersensitivity|
|Nervous System Disorders||Headache|
|Vascular Disorders||Thromboembolic events (including Deep vein thrombosis, Pulmonary embolism, Thrombotic stroke), Flushing|
|Respiratory, Thoracic, and Mediastinal Disorders||Dyspnea, Bronchospasm, Wheezing, Cough|
|Gastrointestinal Disorders||Abdominal pain, Nausea|
|Skin and Subcutaneous Tissue Disorders||Angioedema, Facial edema, Rash, Pruritus|
|Renal and Urinary Disorders||Nephrotic syndrome (following attempted immune tolerance induction)|
|General Disorders and Administration Site Conditions||Infusion site reactions, including Infusion site pain|
In addition to reactions listed above, myocardial infarction has been identified in the published literature with other Factor IX products.
BEBULIN is a combination of vitamin K-dependent clotting factors (Factor IX, II, X) and found in normal plasma. The administration of BEBULIN provides an increase in plasma levels of Factor IX and can temporarily correct the coagulation defect of patients with Factor IX deficiency. Plasma levels of Factors II and X will also be increased. However, no clinical studies have been conducted to show benefit from this product for treating deficiencies other than Factor IX deficiency.
In vivo recovery of BEBULIN was determined using the former International Standard, WHO 72/32 and was found to be 53.3% ±9.6%, 57.5% ±21.8%, and 53.24% ±16.95%, respectively. In the same studies, using different methodologies, half-lives were determined to be 19.4 hrs ±3.8 hrs, 24.6 hrs ±3.2 hrs, and 19.97 hrs ±8.24 hrs, respectively.1
1. T. Abe et al.: Clinical Study with BENOBIL TIM 4, Steam-Treated Factor IX Complex, Single Administration. Jap. Pharm. & Ther., 14, 1986, 1, pp. 19-31.
Inform patients of all signs and symptoms of immediate hypersensitivity reactions such as fever, urticaria/hives, rashes, nausea, retching, angioedema/swelling of face or other body areas, laryngeal edema, stridor, dysphonia, bronchospasm/wheezing, hypotension, dizziness, lightheadedness, or loss of consciousness. Advise patients to discontinue use of the product and contact their physician if these symptoms occur and seek emergency care immediately for serious symptoms.
Inform patients of all signs and symptoms of parvovirus B19 infection, which is especially serious in pregnant women or immune-compromised individuals. Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about two weeks later by a rash and joint pain.
No information provided.
- Feiba Vh
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