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factor IX (human)
factor IX (recombinant)
factor IX complex
Pharmacologic class: Blood modifier
Therapeutic class: Antihemophilic
Pregnancy risk category C
Converts fibrinogen to fibrin, increasing levels of clotting factors
Powder for injection: Various strengths; units specified on label
Indications and dosages
➣ Factor IX deficiency (hemophilia B or Christmas disease); anticoagulant overdose
Adults and children: Dosage individualized; drug administered I.V. Use following equations to calculate approximate units needed:
Human product-1 unit/kg times body weight (in kg) times desired increase in factor IX level, expressed as percentage of normal
Recombinant product-1.2 units/kg times body weight (in kg) times desired increase in factor IX level, expressed as percentage of normal
Proplex T-0.5 unit/kg times body weight (in kg) times desired increase in factor IX level, expressed as percentage of normal
• Hepatic dysfunction
• Unspecified GI hemorrhage (human product)
• Hypersensitivity to mouse or hamster protein (with BeneFix)
Use cautiously in:
• recent surgery
• pregnant patients
• children younger than age 6 (safety and efficacy not established).
☞ Give by slow I.V. infusion. Average infusion rate is 100 units (2 to 3 ml)/minute; don't exceed 10 ml/minute.
• If prescribed, administer hepatitis B vaccine before giving factor IX.
• Know that dosage is highly individualized according to degree of factor IX deficiency, patient's weight, and bleeding severity.
• Don't use glass syringe. Don't shake reconstituted solution or mix with other I.V. solutions.
CNS: light-headedness, paresthesia, headache
CV: blood pressure changes, thromboembolic reactions, myocardial infarction (MI)
EENT: allergic rhinitis
GI: nausea, vomiting
Hematologic: disseminated intravascular coagulation (DIC)
Respiratory: pulmonary embolism
Skin: rash, flushing, diaphoresis, pruritus, urticaria
Other: altered taste, fever, chills, burning sensation in jaw and skull, pain at I.V. injection site, hypersensitivity reactions including anaphylaxis
Drug-drug. Aminocaproic acid: increased risk of thrombosis
• Be aware that factor IX complex may transmit hepatitis.
• Closely monitor vital signs during infusion.
☞ Observe for hemolytic reaction. If it occurs, stop infusion, flush line with saline solution, and notify prescriber immediately.
• Monitor I.V. injection site closely.
☞ Monitor coagulation studies closely. Know that drug may cause thromboembolic disorders, including MI and DIC.
• Inform patient that drug may transmit diseases.
☞ Tell patient to immediately report signs and symptoms of hypersensitivity reaction, including rash, hives, tightness in chest, wheezing, shortness of breath, and swelling of throat or lips.
☞ Advise patient to immediately report unusual bleeding or bruising.
• Caution patient to avoid activities that can cause injury.
• Tell patient to wear medical identification stating that he has a blood-clotting disorder.
• Instruct patient to notify surgeon or dentist of his blood-clotting disorder before surgery or invasive dental procedures.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.
factor ix (human),
AlphaNine SD(trade name),
Profilnine SD(trade name),
Proplex T(trade name),
Bebulin VH(trade name)
ClassificationTherapeutic: hemostatic agents
Pharmacologic: blood products
Time/action profile (hemostasis)
|IV||immediate||10–30 min||1–2 days|
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)
Factor VII Deficiency(Proplex Tonly)
- 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.