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Factor IX (Rx)Brand and Other Names:AlphaNine SD, Mononine

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution reconstituted

  • 250 IU (Mononine)
  • 500 IU (AlphaNine SD, Mononine)
  • 1000 IU (AlphaNine SD, Mononine)
  • 1500 IU (Alphanine)
more...

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

Dosage Forms & Strengths

solution reconstituted

  • 250 IU (Mononine)
  • 500 IU (AlphaNine SD, Mononine)
  • 1000 IU (AlphaNine SD, Mononine)
  • 1500 IU (Alphanine)
more...

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

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Interactions

Interaction Checker

Factor IX and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse 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

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            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

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            Pregnancy & 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.

            more...
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            Pharmacology

            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

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            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

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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