Adult Dosing
Hemophilia B
- Estimated dose (units) = [body wt (kg) x desired factor IX level (% or IU/dL) x 1.0 IU/kg (per IU/dL)]
Prophylaxis of minor spontaneous hemorrhage
- Initial loading dose: up to 20-30 IU/kg
- Individualize dose IV x 1, may repeat in 24 hrs if necessary
- Desired factor IX levels = 15-25%
Major Trauma or Surgery
- Initial loading dose: up to 75 IU/kg
- Individualize dose IV q18-30 hrs, depending on T1/2 and measured factor IX levels x 10 days
- Desired factor IX levels = 25-50%
Notes:- Indicated for IV administration only
- 1 U/kg will increase the circulating level of factor IX by approx 1% [IU/dL] of normal
- Dosage and duration of treatment for all factor IX products depend on severity of the factor IX deficiency, location and extent of bleeding, and the patient’s clinical condition, age and recovery of factor IX
- Rate of administration should be determined by the response and comfort of the patient
Pediatric Dosing
Hemophilia B
- Estimated dose (units) = [body wt (kg) x desired factor IX level (% or IU/dL) x 1.0 IU/kg (per IU/dL)]
Prophylaxis of minor spontaneous hemorrhage
- Initial loading dose: up to 20-30 IU/kg
- Individualize dose IV x 1, may repeat in 24 hrs if necessary
- Desired factor IX levels = 15-25%
Major Trauma or Surgery
- Initial loading dose: up to 75 IU/kg
- Individualize dose IV q18-30 hrs, depending on T1/2 and measured factor IX levels x 10 days
- Desired factor IX levels = 25-50%
Notes:- Indicated for IV administration only
- 1 U/kg will increase the circulating level off factor IX by approx 1% [IU/dL] of normal
- Dosage and duration of treatment for all factor IX products depend on severity of the factor IX deficiency, location and extent of bleeding, and the patient’s clinical condition, age and recovery of factor IX
- Rate of administration should be determined by the response and comfort of the patient
[Outline]
- This product is prepared from human plasma; products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Also, it may carry a risk of transmitting infectious agents such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk of transmission may be reduced by screening plasma donors for prior exposure to certain viruses and by inactivating and/or removing certain viruses during manufacture. Despite these measures, these products may still contain human pathogenic agents, including those not yet known or identified. Discuss the risks and benefits of this product with the patient
- Thromboembolic complications have been associated with the use of Factor IX Complex concentrates. Use of factor IX-containing products in patients with signs of fibrinolysis or disseminated intravascular coagulation (DIC) may be potentially hazardous
- Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported following administration of coagulation factor IX products. Inform patients of the early signs and symptoms of hypersensitivity reactions such as hives, generalized urticaria, angioedema, chest tightness, dyspnea, wheezing, faintness, hypotension, tachycardia, and anaphylaxis. Advise patients to discontinue the drug and immediately contact their clinician for appropriate emergency care depending on the severity of reaction, if such symptoms occur
- Relationship may exist between the presence of major deletion mutations in the factor IX gene and an increased risk of inhibitor formation and of acute hypersensitivity reactions. Closely monitor patients known to have major deletion mutations of the factor IX gene for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure
- Immune tolerance induction with factor IX products in hemophilia B patients with factor IX inhibitors and a history of allergic reactions to factor IX may cause nephrotic syndrome
- There have been reports of hepatitis A infections associated with the use of certain plasma-derived products. Physicians should be alert to the potential symptoms of hepatitis A infections and inform patients receiving therapy to promptly report potential symptoms
- Therapy should be administered intravenously at a rate that allows patient observation for any immediate reaction; rates of infusion up to 225 IU/min have been well tolerated with no adverse reactions. Decrease or stop the infusion if any hypersensitivity reaction is observed and administer appropriate countermeasures and supportive therapy
- Monitor daily factor IX levels during the course of treatment to guide the dose to be administered and the frequency of repeated infusions
- Cases of myocardial infarction, disseminated intravascular coagulation, venous thrombosis, and pulmonary embolism have been reported with high doses of Factor IX Complex concentrates. Factor IX level of 25-50% [IU/dL] is usually adequate for hemostasis, including major hemorrhages and surgery
Cautions: Use cautiously in
- Liver disease
- Post-operative patients
- Neonates
- Risk of thromboembolic phenomena
- DIC
- Fibrinolysis
Pregnancy Category:C
Breastfeeding: Safety unknown.
