antihemophilic factor (recombinant), porcine sequence

General

General

General

Pronunciation:
an-tee-hee-moh-fill-ik fak-to ree-kom-bi-nant por-seen see-qwence


Trade Name(s)

  • Obizur

Ther. Class.

hemostatic agents

Pharm. Class.

clotting factor replacements

Indications

Indications

Indications

Treatment of bleeding episodes associated with acquired hemophilia A.

Action

Action

Action

Temporarily replaces deficient levels of factor VIII.

Therapeutic Effect(s):

Decreased incidence and severity of bleeding.

Pharmacokinetics

Pharmacokinetics

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism and Excretion: Used up in the hemostatic process.

Half-life: Unknown.

TIME/ACTION PROFILE (effect on factor VIII levels)

ROUTEONSETPEAKDURATION
IVrapid30 min4–12 hr

Contraindication/Precautions

Contraindication/Precautions

Contraindication/Precautions

Contraindicated in:

  • Life-threatening hypersensitivity reactions to this product or any of its components (including hamster protein).

Use Cautiously in:

  • OB:  Safety not established in pregnancy;
  • Lactation: Safety not established in breastfeeding;
  • Pedi:  Safety and effectiveness not established in children.

Adverse Reactions/Side Effects

Adverse Reactions/Side Effects

Adverse Reactions/Side Effects

Misc: development of inhibitory antibodies to porcine factor VIII, HYPERSENSITIVITY REACTIONS (including anaphylaxis)

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Interactions

Interactions

Drug-Drug

Bleeding may be ↑ by  aspirin,  NSAIDs,  clopidogrel,  prasugrel,  ticagrelor,  dabigatran,  apixaban,  rivaroxaban,  edoxaban,  warfarin, or  SSRIs.

Route/Dosage

Route/Dosage

Route/Dosage

IV (Adults): 200 units/kg initially; further doses every 4–12 hr are titrated and based on clinical response and factor VIII recovery levels.

Availability

Availability

Availability

Lyophilized powder for injection: 500 units/vial

Assessment

Assessment

Assessment

  • Monitor for signs/symptoms of hypersensitivity reactions (angioedema, chest tightness, dyspnea, hypotension, wheezing, urticaria, pruritus).  If symptoms occurs,  discontinue infusion and provide symptomatic treatment.
  • Monitor for signs/symptoms of bleeding or hemorrhage (weakness, tachycardia, dyspnea, dizziness, pallor, petechiae, fatigue, tarry stools, coffee ground emesis, obvious severe bleeding). If bleeding does not stop, inhibitor/neutralizing antibodies may have formed.

Lab Test Considerations:

Perform one-stage clotting assay to confirm that adequate factor VIII levels have been achieved and maintained. Monitor factor VIII activity 30 min and 3 hr after initial dose. Monitor factor VIII activity 30 min after subsequent doses.  For superficial muscle bleeding with no neurovascular compromise, and joint bleeding,  factor VIII of 50–100 units/dL or % of normal are required.  For moderate to severe intramuscular bleeding, retroperitoneal, gastrointestinal, or intracranial bleeding,  use 100–200 units/dL or % normal to treat an acute bleed. Administer 50–100 units/dL or % of normal after acute bleed if more is required.

  • Monitor for development of factor VIII inhibitors (neutralizing antibodies) if expected plasma factor VIII activity levels are not attained or if bleeding is not controlled with the expected dose. Patients with ↑ factor VIII inhibitor levels may not respond or may require ↑ doses. Measure inhibitor levels in Bethesda units (the amount of factor VIII activity neutralized by 1 mL of patient plasma). If such inhibitory antibodies to antiporcine factor VIII are suspected and there is a lack of clinical response, consider other therapeutic options.

Implementation

Implementation

Implementation

IV Administration

IV Administration

IV Administration

  • IV Push:  Reconstitute by bringing solution to room temperature. Follow manufacturer's instructions for reconstitution. Inject all diluent from syringe into vial; gently swirl without removing syringe until completely dissolved. Use within 3 hr of reconstitution if stored at room temperature. Solution is clear and colorless; do not administer solutions that are discolored or contain particulate matter. Once all vials are reconstituted, connect large syringe to vial adapter and withdraw all solution. Repeat until total volume to be administered is reached. Discard unused reconstituted solution.
  • Rate: Inject at 1–2 mL/min.
  • Y-Site Incompatibility:
    • Do not administer other drugs through same IV line.

Patient/Family Teaching

Patient/Family Teaching

Patient/Family Teaching

  • Explain the purpose and side effects of antihemophilic factor porcine. Do not stop receiving drug without consulting health care provider. If an appointment is missed, reschedule as soon as possible. Advise patient to read  Medication Guide  before starting and periodically during therapy in case of changes.
  • Instruct patient to notify health care provider immediately if bleeding recurs. Advise patient to observe for bleeding in gums, skin, urine, stool, or emesis.
  • Inform patient that inhibitor formation may occur with treatment of hemophilia A. Advise patient to contact their health care provider if they experience lack of clinical response to factor VIII replacement therapy; may be due to an inhibitor.
  • Caution patient to avoid products containing aspirin or NSAIDs; they may further impair clotting.
  • Review prevention of bleeding with patient (use soft toothbrush, avoid IM and SUBQ injections, avoid potentially traumatic activities).
  • Advise patients and family to call 911 and seek urgent treatment for signs/symptoms of hypersensitivity reactions.
  • Advise patients to consult health care provider prior to travel. Advise patients who are traveling to bring an adequate supply of antihemophilic factor based on their current treatment regimen.
  • Advise patient to carry identification describing disease process at all times.
  • Rep:  Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

Evaluation/Desired Outcomes

Evaluation/Desired Outcomes

Decreased incidence and severity of bleeding.

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