Factor IX (Rx)

>10%

Headache (10.8%)

1-10%

Dizziness (7.7%)

Rash (1.6-7.7%)

Injection site pain (6.2%)

Nausea (6.2%)

Urticaria (3.1-4.8%)

Rhinitis (4.6%)

Altered taste sense (4.6%)

Dyspnea (3.2%)

Fever (3.1%)

Flushing (3.1%)

Allergic reaction (1.5%)

Frequency Not Defined

Lethargy

Altered blood pressure (too rapid infusion)

Thrombosis (large dose)

Myocardial infarction (large dose)

DIC (large dose)

Chills

Tingling

Vomiting

Human-derived products: viral infection

Stinging at infusion site (large dose)

Hives

Anaphylaxis

Contraindications

Hypersensitivity to mouse proteins

Cautions

Theoretical risk of pathogen transmission with human-derived products

For minor spontaneous hemorrhage, goal should be 10-15% increase

For major trauma or surgery, goal should be 25% increase for 1 wk before & after

Factor IX (Human) may stick to glass, use plastic syringes only

Development of factor IX antibodies reported

Observe closely for signs or symptoms of thromboembolic disorders

Use caution in hepatic impairment

Pregnancy Category: C

Lactation: Not known if excreted in breast milk; use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Factor IX is a vitamin K-dependent coagulation factor sythesized in the liver; purified FActor IX from human plasma temporarily replace missing clotting factor IX to correct and/or prevent bleeding

Pharmacokinetics

Half-life: 11-28 hr

IV Incompatibilities

Incompatible with protein precipitants

IV Preparation

Prior to reconstitution, warm supplied diluent (SWI) to room temp; temperature of diluent should not exceed 37°C

Reconstitute aseptically according to the mfr's directions

Gently agitate vial until the powder is completely dissolved

Completely dissolve before administration to prevent active components from being removed during passage through the filter needle

IV Administration

Slow IV injection using a syringe or by IV infusion

Rate of administration should be individualized according to the specific product used and patient's response

Administer within 3 hr of reconstitution

If headache, flushing, or changes in pulse rate or blood pressure occur during administration of factor IX complex (human), decrease administration rate

Administer 100 IU/mL soln at ~2 mL/min; has been administered up to 225 IU/min without unusual AEs

Filter before administration

Storage

Store at 2-8°C

Protect from freezing