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factor ix (human),
AlphaNine SD(trade name),
Profilnine SD(trade name),
Proplex T(trade name),
Bebulin VH(trade name)
Pregnancy Category: C
Pharmacologic: blood products
ClassificationTherapeutic: hemostatic agents
Pharmacologic: blood products
Treatment of active or impending bleeding due to factor IX deficiency (hemophilia B, Christmas disease).Treatment of bleeding in patients with factor VIII inhibitors (Proplex T only).Prevention and treatment of bleeding in patients with factor VII deficiency (Proplex T only).
Factor IX complex preparations (Bebulin VH, Profilnine SD, Proplex T) contain blood coagulation factors II, VII, IX, and X. Purified protein preparations (AlphaNine SD, Benefix, Mononine) contain factor IX activity only. Benefix is made via recombinant DNA technology.
Replacement of deficient factor IX in hemophilia B.
Restoration of hemostasis.
Absorption: Administered IV only, resulting in complete bioavailability.
Metabolism and Excretion: Rapidly cleared from plasma by utilization in clotting process.
Half-life: Factor IX—24–32 hr; factor VII—3–6 hr.
Time/action profile (hemostasis)
|IV||immediate||10–30 min||1–2 days|
Contraindicated in: Factor VII deficiency (except Proplex T); Intravascular coagulation or fibrinolysis associated with liver disease; Allergy to mouse protein (Mononine).
Use Cautiously in: Postoperative period (increased risk of thrombosis).
Adverse Reactions/Side Effects
Central nervous system
- changes in BP
- changes in heart rate
- disseminated intravascular coagulation
- risk of transmission of viral hepatitis
- risk of transmission of HIV virus
- hypersensitivity reactions
Drug-Drug interactionUse with aminocaproic acid may ↑ risk of thrombosis.
Route/DosageThe following general formula may be used: Human-derived products—Dose (units) = body weight (kg) × 1 unit/kg × desired factor IX increase (% of normal). Recombinant DNA product—Dose (units) = body weight (kg) × 1.2 units/kg × desired factor IX increase (% of normal)
Intravenous (Adults and Children) Major bleeding—50–100% activity q 12–24 hr for 7–10 days; moderate bleeding—25–50% activity q 12–24 hr until bleeding stops and healing begins (2–7 days);minor bleeding—20–30% activity q 12–24 hr for 1–2 days.
Factor VII Deficiency(Proplex Tonly)
Intravenous (Adults and Children) 75 units/kg.
Injection: Vials containing 250 units, 500 units, 1000 units, 1200 units, 1500 units
- Monitor BP, pulse, and respirations frequently.
- Obtain history of current trauma; estimate amount of blood loss.
- Monitor for renewed or increased bleeding every 15–30 min. Immobilize and apply ice to affected joints.
- If hypersensitivity reaction (fever, chills, tingling, headache, urticaria, changes in BP or pulse, nausea and vomiting, lethargy) occurs, slow infusion and notify physician. Pyrogenic reactions (fever, chills) may also occur and are more common with high doses.
- Lab Test Considerations: Monitor coagulation studies (activated partial thromboplastin time [aPTT], plasma fibrinogen, platelet count, PT, factor IX plasma concentrations) before, during, and after therapy to assess effectiveness of therapy.
Potential Nursing DiagnosesIneffective tissue perfusion (Indications)
Risk for injury (Indications)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)
- Dose varies with degree of clotting factor deficit, desired level of clotting factors, and weight.
- Obtain type and crossmatch of blood in case a transfusion is necessary.
- Hepatitis B vaccine may be given prior to therapy to prevent hepatitis.
- Inform all personnel of patient’s bleeding tendency, to prevent further trauma. Apply pressure to all venipuncture sites for at least 5 min; avoid all IM injections.
- Diluent: Refrigerate concentrate until just prior to reconstitution. Warm diluent (sterile water for injection) to room temperature before reconstituting. Use plastic syringe for preparation and administration. Use the filter needle provided by the manufacturer as an air vent to the vial when reconstituting. After adding diluent, rotate vial gently until contents are completely dissolved. Reconstitution generally requires 5–10 min for factor IX complex and 1–5 min for coagulation factor IX. Do not administer solutions that are discolored or contain particulate matter. Do not refrigerate after reconstitution. Begin administration within 3 hr.
- Dry concentrates should be refrigerated; however, do not refrigerate after reconstitution.
- Discard partially used vials.
- Rate: Rate of administration should be individualized according to specific product and response of the patient. Rates of 100–200 units/min or 2–3 mL/min are suggested. Temporarily stop infusion and resume at slower rate if headache, flushing, or changes in pulse or BP occur.
- Additive Incompatibility: Reconstitute only with diluent provided. Administer through a separate line. Do not mix with other solutions or medications.
- Instruct patient to notify health care professional immediately if bleeding recurs.
- Advise patient to carry identification describing disease process at all times.
- Caution patient to avoid products containing aspirin or NSAIDs, because they may further impair clotting.
- Review with patient methods of preventing bleeding (use soft toothbrush, avoid IM and subcutaneous injections, avoid potentially traumatic activities).
- Advise patient that the risk of hepatitis or AIDS transmission may be decreased by use of heat-treated preparations. Current screening programs and vaccination with hepatitis B vaccine should help decrease the risk.
- Reinforce need for patients with hemophilia to receive close medical supervision.
- Prevention of spontaneous bleeding or cessation of bleeding in patients with factor IX deficiency (hemophilia B, Christmas disease), factor VIII inhibitors, factor VII deficiency, or anticoagulant overdose.