Adult Dosing

Prevention and control of bleeding

Joint hemorrhage

• 50-100 units/kg IV q12hr until pain and acute disabilities are improved
• Max: 200 units/kg/day

Mucous membrane bleed

• 50-100 units/kg IV q6hr, At least 1 day or until bleeding is resolved.
• Max: 200 units/kg/day

Soft tissue hemorrhage

• 100 units/kg IV q12hrs until resolution of bleed
• Max: 200 units/kg/day

Severe hemorrhage

• 100 units/kg IV q6-12hr until resolution of bleed
• Max: 200 units/kg/day unless severity of hemorrhage justifies higher doses

Perioperative management

• Preoperative:50-100 units/kg IV once immediately prior to surgery
• Postoperative: 50-100 units/kg IV q6-12hr until resolution of bleeding and healing is achieved

Routine prophylaxis

• 85 units/kg IV every other day

Note:

• Refer package insert for preparation and reconstitution procedure

Pediatric Dosing

• Safety and efficacy has not been established in pediatric patients

[Outline]

• Adult Dosing
• Pediatric Dosing

• Use in hemophilia A and B patients with inhibitors for control and prevention of bleeding episodes, perioperative management and routine prophylaxis to prevent or reduce the frequency of bleeding episodes

• Hypersensitivity to any of the ingredients of the product
• Disseminated intravascular coagulation (DIC)
• Acute thrombosis or embolism (including myocardial infarction)
• Patients with normal coagulation
• Active fibrinolysis
• In the treatment of bleeding resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VII or IX

• Thromboembolic events have been reported during post-marketing surveillance following infusion of therapy, especially at high dose in patients with thrombotic risk factors. Closely monitor patients receiving therapy for signs and symptoms of thromboembolic events

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Thromboembolic events have been reported during post-marketing surveillance following infusion of therapy, especially at high dose in patients with thrombotic risk factors. Closely monitor patients receiving therapy for signs and symptoms of thromboembolic events
• Anaphylaxis and severe hypersensitivity reactions including urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotensionmay may occur. Should symptoms occur, discontinue treatment and administer provide appropriate supportive care
• As therapy contains human plasma it may carry a risk of transmitting infectious agents such as viruses, the variant Creutzfeldt-Jacob disease (vCJD) and theoretically, Creutzfeldt-Jacob disease (CJD) agent

Pregnancy Category:C

Breastfeeding: Safety unknown. Manufacturer advises caution

• CV: Stroke, pulmonary embolism, deep vein thrombosis, chest pain, MI
• CNS: Dizziness
• NEURO: Hypoesthesia
• GI: Diarrhea, nausea, vomiting, dysgeusia
• HEMA: Anemia, hemarthrosis
• RESP: Dyspnea
• MISC: Anaphylactic reactions, chills, lethargy
• HEPA: Hepatitis B surface antibody positive

• Coagulation factor/thrombotic agent; provides activated blood coagulation factors II, VII, IX and X from pooled human plasma and shortens the activated partial thromboplastin time of plasma containing factor VIII inhibitors
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Feiba NF

US Availability

Feiba NF

• INJ: 500 units
• INJ: 1000 units
• INJ: 2500 units

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Coagulation Factor/thrombotic Agent