Factor IX (Rx)

Brand and Other Names:AlphaNine SD, Mononine
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Dosing & Uses

AdultPediatric

Dosage Forms & 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

Dosage Forms & 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

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Interactions

Interaction Checker

and Factor IX

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (1)

            • prothrombin complex concentrate, human

              Factor IX increases effects of prothrombin complex concentrate, human by pharmacodynamic synergism. Contraindicated. Coadministration increases risk of thrombosis.

            Serious - Use Alternative (2)

            • tranexamic acid injection

              tranexamic acid injection increases effects of Factor IX by pharmacodynamic synergism. Contraindicated. Risk of thrombosis.

            • tranexamic acid oral

              tranexamic acid oral, Factor IX. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration may increase risk for thrombosis.

            Monitor Closely (0)

              Minor (0)

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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.

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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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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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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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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.