Factor IX complex (Rx)

Brand and Other Names:Bebulin, Profilnine SD, more...Bebulin VH
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Lyophilized powder for reconstitution

Derived from human plasma

Standardized in terms of Factor IX content and each vial is labeled for the Factor IX content indicated in International Units (IU)

Bebulin, Bebulin VH

  • Purified, sterile, stable, freeze-dried concentrate of the coagulation Factors IX (Christmas Factor) as well as II (Prothrombin) and X (Stuart Prower Factor) and low amounts of Factor VII
  • Contains small amounts of heparin (0.15 IU heparin or less per IU Factor IX)

Profilnine SD

  • Solvent Detergent Treated, is a sterile, lyophilized concentrate of Factor IX (antihemophilic factor B), Factor II (prothrombin), Factor X (Stuart-Prower Factor), and low levels of Factor VII (proconvertin) derived from human plasma
  • Factor II (<150 Units per 100 Factor IX Units), Factor X (<100 Units per 100 Factor IX Units), and Factor VII (<35 Units per 100 Factor IX Units)
  • Does not contain heparin

Hemophilia B

Indicated for prevention and control of hemorrhagic episodes

Bebulin, Bebulin VH: Number of Factor IX IU required = body weight (kg) x desired increase in plasma Factor IX (%) x 1.2 IU/kg

Profilnine SD: Number of Factor IX IU required = body weight (kg) x desired increase in plasma Factor IX (%) x 1 IU/kg

Management of bleeding

  • Typical initial doses suggested below; usually two-thirds of initial dose given for maintenance Minor: Single dose of 25-35 IU/kg IV x 1 dose; may repeat dose after 24 hr
  • Moderate: 40-55 IU/kg/day IV x 2 days or until adequate wound healing
  • Major: 60-70 IU/kg/day IV x 2-3 days or until adequate wound healing

Management of surgical procedures

  • Minor: 50-60 IU/kg IV on day of surgery, decrease to 25-55 IU/kg/day during initial postop period (ie, 1st to 2nd week)
  • Major: 70-95 IU/kg IV on day of surgery, decrease to 35-70 IU/kg/day during initial postop period (ie, 1st to 2nd week), THEN 25-35 IU/kg/day late postop period (ie, 3rd week onwards)

Dosing Considerations

A 1% increase in Factor IX (0.01 IU)/IU administered/kg can be expected

The dose required to establish hemostasis will vary with each patient and depend on the circumstances

Not indicated for treatment of Factor VII deficiency

Clinical studies have not been conducted showing benefit for treating coagulation factor deficiencies other than Factor IX deficiency

Safety and efficacy not established

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Interactions

Interaction Checker

and Factor IX complex

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            Adverse Effects

            Frequency Not Defined

            Formation of circulating antibodies inhibiting Factor IX

            Postmarketing Reports

            Blood and lymphatic system disorders: Disseminated intravascular coagulation

            Immune system disorder: Anaphylactic/anaphylactoid reactions, hypersensitivity

            Nervous system disorders: Headache

            Cardiac disorders: Tachycardia

            Vascular disorders: Thromboembolic events (including DVT, PE, thrombotic stroke), flushing

            Respiratory, thoracic, and mediastinal disorders: Dyspnea, bronchospasm, wheezing, cough

            Gastrointestinal disorders: Abdominal pain, nausea

            Skin and subcutaneous tissue disorders: Angioedema, facial edema, rash, pruritus

            Renal and urinary disorders: Nephrotic syndrome

            General disorders and administration site conditions: Infusion site reactions, including pain at infusion site

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            Warnings

            Contraindications

            Hypersensitivity

            Bebulin, Bebulin VH: Known allergy to heparin or history of heparin-induced thrombocytopenia

            Cautions

            Made from pooled human plasma, it may carry a risk of transmitting infectious agents (eg, viruses), and theoretically, the Creutzfeldt-Jakob disease (CJD) agent

            Thromboembolic events (DVT, PE, thrombotic stroke) as well as DIC reported

            Factor IX complex products may partically counteract the effect of warfarin treatment; does NOT include adequate FVII levels to be used to reverse warfarin-induced bleeding

            Formation of circulating antibodies inhibiting Factor IX reported

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Unknown if distributed in human breast milk

            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

            Mixture of vitamin K-dependent clotting factors; temporarily increases the plasma levels of Factor IX, thus minimizing the hazards of hemorrhage in patients with hemophilia B

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            Administration

            IV Preparation

            Remove lyophilized powder and diluent from refrigerator and bring to room temperature

            Reconstitute lyophilized product with provided diluent

            Do not refrigerate after reconstitution

            The solution does not contain a preservative and must be used within 3 hr of reconstitution

            IV Administration

            Infuse at IV rate comfortable to the patient, not to exceed 2 mL/min

            Discard partially used vials

            Storage

            Unopened vials (Bebulin)

            • Stable until date indicated on package
            • Store between 2-8°C [34-46°F]) in original carton and protect from light
            • Do not freeze

            Unopened vials (Profilnine SD)

            • Stable for 3 years, up to the expiration date printed on its label, provided storage temperature does not exceed 25°C [77°F])
            • Do not freeze
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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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