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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              Serious - Use Alternative (1)

              • tranexamic acid oral

                tranexamic acid oral, Factor IX complex. 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

                  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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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  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
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                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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                  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.