antihemophilic factor (recombinant) Fc fusion protein

General

Pronunciation:
an-tee-hee-moe-feel-ik fak-tor ree-kom-bi-nant eff-cee fyoo-zhun proh-teen


Trade Name(s)

  • Eloctate

Ther. Class.

hemostatic agents

Pharm. Class.

clotting factor replacements

Indications

Control/prevent bleeding episodes, perioperative management, and routine prophylaxis of bleeding episodes in patients with hemophilia A.

Action

Replaces deficient antihemophilic factor (factor VIII). Produced via recombinant DNA technology; presence of fusion protein delays degradation.

Therapeutic Effect(s):

Decreased incidence and severity of bleeding.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism and Excretion: Unknown.

Half-life: Unknown; clearance is more rapid in children.

TIME/ACTION PROFILE (effects on hemostasis)

ROUTEONSETPEAKDURATION
IVrapidend of infusion6 hr–5 days†
†Depends on patient age and clinical situation.

Contraindication/Precautions

Contraindicated in:

  • Previous life-threatening hypersensitivity.

Use Cautiously in:

  • OB:  Safety not established in pregnancy;
  • Lactation:  Safety not established in breastfeeding;
  • Pedi:  ↑ doses/↓ interval may be required in children 2–5 yr due to ↑ clearance.

Adverse Reactions/Side Effects

MS: arthralgia

Neuro: malaise

Misc: HYPERSENSITIVITY REACTIONS (including anaphylaxis), neutralizing antibodies

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

Interactions

Drug-Drug

 Anticoagulants,  thrombolytics,  antiplatelet agents,  NSAIDs,  SSRIs, and  SNRIs  may ↑ risk of bleeding.

Route/Dosage

One unit/kg body weight will ↑ factor VIII level by 2%.

Control/Prevention of Bleeding Episodes

IV (Adults and Children  ≥6 yr): Minor or moderate bleeding (requires factor VIII level of 40–60% of normal): 20–30 units/kg every 24–48 hr until bleeding episode is resolved;  Major bleeding (requires factor VIII level of 80–100% of normal): 40–50 units/kg every 12–24 hr until bleeding episode is resolved (7–10 days).

IV (Children  <6 yr): Minor or moderate bleeding (requires factor VIII level of 40–60% of normal): 20–30 units/kg every 12–24 until bleeding episode is resolved;  Major bleeding (requires factor VIII level of 80–100% of normal): 40–50 units/kg every 8–24 hr until bleeding episode is resolved (7–10 days).

Perioperative Management

IV (Adults and Children  ≥6 yr): Minor procedures (requires factor VIII level 50–80% of normal): 25–40 units/kg every 24 hr for 24 hr until healing is achieved;  Major procedures (requires factor VIII level 80–120% of normal): 40–60 units/kg preoperatively, followed by 40–50 units/kg after 8–24 hr and then every 24 hr to maintain factor VIII level in desired range; continue until wound healing and then for ≥7 days to maintain factor VIII level in desired range.

IV (Children  <6 yr): Minor procedures (requires factor VIII level 50–80% of normal): 25–40 units/kg every 12–24 hr for 24 hr until healing is achieved;  Major procedures (requires factor VIII level 80–120% of normal): 40–60 units/kg preoperatively, followed by 40–50 units/kg after 6–24 hr and then every 24 hr to maintain factor VIII level in desired range; continue until wound healing and then for ≥7 days to maintain factor VIII level in desired range.

Routine Prophylaxis

IV (Adults and Children): 50 units/kg every 4 days (range 25–65 units/kg every 3–5 days), doses up to 80 units/kg or more frequent doses may be required in children <6 yr.

Availability

Lyophilized powder for injection: 250 units factor VIII potency/vial, 500 units factor VIII potency/vial, 750 units factor VIII potency/vial, 1000 units factor VIII potency/vial, 1500 units factor VIII potency/vial, 2000 units factor VIII potency/vial, 3000 units factor VIII potency/vial, 4000 units factor VIII potency/vial, 5000 units factor VIII potency/vial, 6000 units factor VIII potency/vial

Assessment

  • Assess for signs/symptoms of hypersensitivity reaction (angioedema, dyspnea, wheezing, tachycardia, urticaria, hives, chest tightness, pruritus).  If reaction occurs, discontinue infusion immediately and treat symptomatically.
  • 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:

Monitor plasma factor VIII activity to confirm adequate factor VIII levels are achieved and maintained.

  • Monitor for the 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).

Implementation

IV Administration

  • IV Push:  Allow medication and diluent to reach room temperature. Follow manufacturer's recommendations for preparation. Do not shake. Reconstituted solution is clear to slightly opalescent and colorless; do not administer solutions that are discolored or contain precipitate matter. Infuse as soon as possible, ≤3 hr after reconstitution. Protect from light; do not refrigerate reconstituted solution.
  • Rate: Infuse at ≤10 mL/min; determine rate by patient's comfort level.
  • Y-Site Incompatibility:
    • Do not administer other drugs through same IV line.

Patient/Family Teaching

  • Explain the purpose and side effects of antihemophilic factor Fc fusion protein. 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.
  • Medical ID describing disease process and medication regimen should be worn at all times in case of emergencies.
  • Rep:  Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Prevention of spontaneous bleeding.
  • Cessation of bleeding.
  • Decreased incidence and severity of bleeding in patients with hemophilia A.