Dosing and uses of AlphaNine SD, Mononine (Factor IX)
Adult dosage forms and strengths
solution reconstituted
- 250 IU (Mononine)
- 500 IU (AlphaNine SD, Mononine)
- 1000 IU (AlphaNine SD, Mononine)
- 1500 IU (Alphanine)
Hemophilia B
Indicated for control or prevention of bleeding in Factor IX deficient patients
Individualize dosing based on severity of factor IX deficiency, extent and location of bleeding, and clinical status of patient
AlphaNine SD, Mononine: 1 unit/kg x body wt (kg) x desired increase (% of normal) = Number of factor IX units required
Pediatric dosage forms and strengths
solution reconstituted
- 250 IU (Mononine)
- 500 IU (AlphaNine SD, Mononine)
- 1000 IU (AlphaNine SD, Mononine)
- 1500 IU (Alphanine)
Hemophilia B
Indicated for control or prevention of bleeding in Factor IX deficient patients
Individualize dosing based on severity of factorIX deficiency, extent and location of bleeding, and clinical status of patient
AlphaNine SD, Mononine: 1 unit/kg x body wt (kg) x desired increase (% of normal) = Number of factor IX units required
AlphaNine SD, Mononine (Factor IX) adverse (side) effects
>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
Warnings
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 and lactation
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.
Pharmacology of AlphaNine SD, Mononine (Factor IX)
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
Administration
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
