Also found in: Dictionary, Thesaurus, Encyclopedia.
factor IX (human)
factor IX (recombinant)
factor IX complex
Pharmacologic class: Blood modifier
Therapeutic class: Antihemophilic
Pregnancy risk category C
Converts fibrinogen to fibrin, increasing levels of clotting factors
Powder for injection: Various strengths; units specified on label
Indications and dosages
➣ Factor IX deficiency (hemophilia B or Christmas disease); anticoagulant overdose
Adults and children: Dosage individualized; drug administered I.V. Use following equations to calculate approximate units needed:
Human product-1 unit/kg times body weight (in kg) times desired increase in factor IX level, expressed as percentage of normal
Recombinant product-1.2 units/kg times body weight (in kg) times desired increase in factor IX level, expressed as percentage of normal
Proplex T-0.5 unit/kg times body weight (in kg) times desired increase in factor IX level, expressed as percentage of normal
• Hepatic dysfunction
• Unspecified GI hemorrhage (human product)
• Hypersensitivity to mouse or hamster protein (with BeneFix)
Use cautiously in:
• recent surgery
• pregnant patients
• children younger than age 6 (safety and efficacy not established).
☞ Give by slow I.V. infusion. Average infusion rate is 100 units (2 to 3 ml)/minute; don't exceed 10 ml/minute.
• If prescribed, administer hepatitis B vaccine before giving factor IX.
• Know that dosage is highly individualized according to degree of factor IX deficiency, patient's weight, and bleeding severity.
• Don't use glass syringe. Don't shake reconstituted solution or mix with other I.V. solutions.
CNS: light-headedness, paresthesia, headache
CV: blood pressure changes, thromboembolic reactions, myocardial infarction (MI)
EENT: allergic rhinitis
GI: nausea, vomiting
Hematologic: disseminated intravascular coagulation (DIC)
Respiratory: pulmonary embolism
Skin: rash, flushing, diaphoresis, pruritus, urticaria
Other: altered taste, fever, chills, burning sensation in jaw and skull, pain at I.V. injection site, hypersensitivity reactions including anaphylaxis
Drug-drug. Aminocaproic acid: increased risk of thrombosis
• Be aware that factor IX complex may transmit hepatitis.
• Closely monitor vital signs during infusion.
☞ Observe for hemolytic reaction. If it occurs, stop infusion, flush line with saline solution, and notify prescriber immediately.
• Monitor I.V. injection site closely.
☞ Monitor coagulation studies closely. Know that drug may cause thromboembolic disorders, including MI and DIC.
• Inform patient that drug may transmit diseases.
☞ Tell patient to immediately report signs and symptoms of hypersensitivity reaction, including rash, hives, tightness in chest, wheezing, shortness of breath, and swelling of throat or lips.
☞ Advise patient to immediately report unusual bleeding or bruising.
• Caution patient to avoid activities that can cause injury.
• Tell patient to wear medical identification stating that he has a blood-clotting disorder.
• Instruct patient to notify surgeon or dentist of his blood-clotting disorder before surgery or invasive dental procedures.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.
BeneFixA recombinant factor IX for treating spontaneous bleeds (prophylaxis) and preventing bleeds during surgery and postoperatively in patients with haemophilia.
Dizziness, headache, altered taste, lightheadedness, nausea, cellulitis, phlebitis, injection-site reaction, neutralising antibodies resulting in factor IX inhibition.