Factor IX Concentrates

A to Z Drug Facts

Alphanine SD, Konyne 80, Profilnine SD, Proplex T, Benefix, Hemonyne, Mononine, Immunine VH

Class: Antihemophilic

 Action Restores hemostasis in patients with Factor IX deficiency.

 Indications Management of Factor IX deficiency (hemophilia B, Christmas disease), bleeding episodes in patients with inhibitors to Factor VIII; reversal of coumarin anticoagulant hemorrhage; prevention or control of bleeding in patients with Factor VII deficiency (Proplex T only).

 Contraindications Treatment of Factor VII deficiency (except for Proplex T); liver disease with signs of intravascular coagulation or fibrinolysis.

 Route/Dosage

ADULTS & CHILDREN: IV Dose based on patient condition, degree of deficiency and desired level of Factor IX to be achieved. Dosing guideline: 1 U/kg × body weight (kg) × desired increase (% of normal) Factor VII deficiency: 0.5 U/kg × body weight (kg) × desired increase (% of normal), repeated q 4 to 6 h prn.

Hemarthroses

In hemophiliacs with inhibitors to Factor VIII, IV 75 IU/kg. Maintenance: Usually, IV 10 to 20 IU/kg/day. Hemophilia A patients with inhibitors to Factor VIII: IV 75 IU/kg as single dose followed by second dose in 12 hr if necessary.

Prophylaxis

In patients with hemophilia B, IV 10 to 20 IU/kg 1 to 2 times/wk.

 Interactions

Aminocaproic acid: May increase risk of thrombosis.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Thrombosis or DIC; changes in BP; MI (with high doses). CNS: Headache. Nausea; vomiting. DERM: Flushing; urticaria. RESP: Pulmonary embolism. OTHER: Pyrogenic reactions (eg, fever and chills); tingling.

 Precautions

Pregnancy: Category C. Hepatitis and HIV infection: Some risk due to preparation from pooled units of plasma. Intravascular coagulation: If signs of DIC occur, stop infusion promptly.

 Administration/Storage

• Use powder and diluent at room temperature when reconstituting.
• Gently swirl solution during reconstitution to prevent foaming. Infuse within 3 hr of reconstitution.
• Administer by IV infusion only.
• Start infusion within 3 hr after reconstitution.
• Maintain prescribed rate of infusion, (eg, Konyne-80, 100 U/min; Profilnine SD, < 10 ml/min; Proplex T, < 3 ml/min.)
• Store powdered form of drug in refrigerator. Do not freeze.
• Do not refrigerate reconstituted solution.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hepatitis B vaccination.
• In patients with major bleeding or those being prepared for surgery, monitor Factor VII or IX assays daily prior to infusion.
• In patients receiving Factor IX for prolonged periods, monitor Factors II, IX and X daily.
• Assess BP and heart rate prior to and during infusion.
• Observe for signs of DIC, MI, pulmonary embolus and venous thrombosis.
• Monitor I&O and observe for hemolytic reaction.
• Stop infusion and notify physician if any of the following develops: tingling, urticaria, chills, fever, headache, flushing, nausea or vomiting, change in heart rate or BP. Infusion may be restarted at a slower rate when symptoms subside.
• Discontinue infusion if signs of DIC (eg, petechiae, oozing from puncture sites), tachycardia, tachypnea, or joint pain develop, and notify physician.

 Patient/Family Education

• Instruct patient to report any chills, headache, urticaria, tingling, flushing, or nausea and vomiting to nurse or physician.
• Tell patient to immediately report any chest pain/pressure or difficulty breathing.
• Caution patient to avoid activities that could lead to injury or bleeding.
• Instruct patient to report any signs of bleeding (eg, petechiae, purpura, bleeding gums or rectum, blood in urine).
• Discuss questions concerning HIV and hepatitis risk.
• Instruct patient to report any signs or symptoms of AIDS or hepatitis.
• Review methods of preventing and stopping bleeding.
• Advise patient to carry identification/information regarding bleeding tendency.

Books@Ovid
Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts